MUNICH - Friday, 07. August 2026
(BUSINESS WIRE)--2Q 2026
Total business volume at 45.6 billion euros, an internal growth of 5.7 percent1, with contributions from all segments. Asset Management delivers excellent growth.
Operating profit rises 10.6 percent to a record level of 4.9 billion euros.
Shareholders’ core net income at 2.6 billion euros; 12.7 percent below last year. Adjusted for a divestment gain last year and offsetting measures following the sale of the stake in our Indian JVs, underlying growth is strong at 10 percent.
6M 2026
Total business volume at 98.6 billion euros, an internal growth of 4.3 percent1, driven by Property-Casualty and especially Asset Management.
Operating profit rises 8.6 percent and reaches a record level of 9.4 billion euros.
Shareholders’ core net income advances 15.5 percent to 6.4 billion euros. Adjusted for divestment effects and offsetting measures, underlying growth is strong at 9 percent2.
Core earnings per share increase 17.5 percent and reach 16.44 euros. Adjusted for the above-mentioned effects, underlying growth is excellent at 10 percent 2 .
Annualized core RoE at 20.7 percent; underlying level very strong at 19 percent 2 .
Solvency II ratio3 increases by 7 percentage points to 225 percent4. Capital generation remains very good.
Outlook & other
Allianz is fully on track to achieve its full-year operating profit outlook of 17.4 billion euros, plus or minus 1 billion euros5.
Share buy-back program of up to 2.5 billion euros announced on February 25, 2026 underway; 1.4 billion euros completed in the first half of 2026.
CEO comment
"Allianz has once more delivered strong results for the second quarter and first half of 2026, confirming the power of our customer-centered strategy. Our excellent performance gives us the ability – as well as the obligation – to bring superior advice, protection, and retirement solutions within reach for more customers around the world.
Insurance costs are rising faster than disposable income, and we take that challenge seriously. Through our investments in AI, risk prevention, and smarter services, we are determined to help more customers protect what matters to them at a price they can afford. This value creation is how Allianz earns the trust that sets us apart and drives our growth."
- Oliver Bäte, Chief Executive Officer of Allianz SE
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Contacts
Media contacts
Frank Stoffel Tel. +49 160 9011 5157 e-mail: frank.stoffel@allianz.com
Ann-Kristin Manno Tel. +49 151 2990 1517 e-mail: ann-kristin.manno@allianz.com
Johanna Oltmann Tel. +49 151 1164 6551 e-mail: johanna.oltmann@allianz.com
Fabrizio Tolotti Tel. +49 151 5995 6396 e-mail: fabrizio.tolotti@allianz.com
Investor Relations contacts
Andrew Ritchie Tel. +49 89 3800 3963 e-mail: andrew.ritchie@allianz.com
Reinhard Lahusen Tel. +49 89 3800 17224 e-mail: reinhard.lahusen@allianz.com
Christian Lamprecht Tel. +49 89 3800 3892 e-mail: christian.lamprecht@allianz.com
Tobias Rupp Tel. +49 89 3800 7151 e-mail: tobias.rupp@allianz.com
Monday, August 10, 2026
Sunday, August 9, 2026
ICC Arbitral Tribunal Issues Quantum Award for AOP Health in BESREMi® Proceedings
VIENNA - Saturday, 08. August 2026 AETOSWire Print
(BUSINESS WIRE)--An ICC Arbitral Tribunal has awarded AOP Orphan Pharmaceuticals GmbH (“AOP Health”) a total of about EUR 112 Mio in a quantum award issued in the ongoing arbitration proceedings with PharmaEssentia Corp. (“PharmaEssentia”) concerning BESREMi® (ropeginterferon alfa-2b). The award quantifies AOP Health’s damage claims for PharmaEssentia’s intentional breaches at ca. EUR 82 Mio. It also awards AOP Health ca. EUR 31 Mio plus interest as reimbursement for AOP Health overpayments made to PharmaEssentia as a result of excessive pricing in the years 2019-2022. The Tribunal thereby confirmed that PharmaEssentia has been overcharging AOP Health by up to 900% over these years. The Tribunal affirmed AOP Health's valid set-off of the profit-sharing payments amount owed to PharmaEssentia of approximately EUR 17 Mio against AOP Health's substantially exceeding damages claims. This means that AOP Health shall not make any payment to PharmaEssentia. Interest on AOP Health’s claims will continue to accrue until PharmaEssentia has made payment. All of PharmaEssentia’s remaining claims of the quantum stage of the proceedings were dismissed.
The decision follows the partial final award received in February 2025, in which the ICC Arbitral Tribunal found, among other things, that PharmaEssentia had intentionally breached its contractual obligations and was liable for several claims arising out of the parties’ licensing agreement. The quantum award now determines the amounts due in relation to these claims.
Tribunal confirms PharmaEssentia’s excessive pricing of up to 900%
Applying the Tribunal’s reasoning in the quantum award to the product deliveries for the years 2023-2025, PharmaEssentia has overcharged AOP Health by another ca. EUR 65 Mio. After set-off with profit sharing amounts for these years, PharmaEssentia will still owe a substantial amount to AOP Health. In short, AOP Health owes no payment to PharmaEssentia. Meanwhile, PharmaEssentia’s liability towards AOP Health is currently in the three-digit EUR million range.
Safeguarding Patient Access
AOP Health welcomes the decision, which the company sees as a further confirmation of its position and its conduct in the proceedings. The company remains focused on ensuring stable and sustainable access to BESREMi® for patients in need. In its seventh year after its approval by European Medicines Agency (“EMA”), AOP Health has successfully made BESREMi® available to an estimated 12,600 patients in AOP Health’s licensed territory.
Dr. Rudolf Widmann, one of the two founders of AOP Health, says: “After eight years of legal dispute, we welcome the tribunal’s decision because it reduces uncertainty. This award gives us a stronger basis to continue our mission: developing and making available medicines that address high unmet medical needs.”
As with the previous award, PharmaEssentia may seek a limited review of the quantum award before the competent German courts. Proceedings concerning the review of the February 2025 merit award which was confirmed by the Higher Regional Court of Frankfurt in April 2026 are still pending before the German Federal Court of Justice.
Background to the dispute
The conflict concerns BESREMi®, a treatment for rare blood cancers, particularly polycythemia vera. AOP Health acquired the rights for the development and commercialization of BESREMi® in the European, Commonwealth of Independent States (CIS), and Middle Eastern markets from PharmaEssentia in 2009.
Since 2017, PharmaEssentia has repeatedly attempted to terminate its agreement with AOP Health regarding BESREMi®. In October 2020, an ICC Arbitral Tribunal rejected these attempts and awarded AOP Health damages, while dismissing PharmaEssentia’s counterclaims. Subsequent set-aside proceedings confirmed the award in its essentials, while identifying procedural issues relating to the quantification of damages.
In November 2020, PharmaEssentia initiated a further legal action against AOP Health, alleging damage claims. AOP Health in turn claimed damages for delays in BESREMi®’s European approval caused by PharmaEssentia and for the use of AOP Health’s clinical trial data in connection with PharmaEssentia’s U.S. marketing authorization. In February 2025, the ICC Arbitral Tribunal issued a partial final award in AOP Health’s favor on liability and dismissed PharmaEssentia’s liability claims in its entirety. The newly received quantum award now specifies the amounts due for the claims upheld in the partial final award.
About BESREMi®
BESREMi® is the first interferon that was approved for polycythemia vera, a myeloproliferative neoplasm (MPN), indicated in the European Union as monotherapy in adults for treatment of polycythemia vera without symptomatic enlarged spleen. Its overall safety and efficacy were demonstrated in multiple clinical studies.
BESREMi® (ropeginterferon alfa-2b) is a long-acting, mono-pegylated proline interferon (ATC L03AB15). It is administered once every 2 weeks initially, or up to every 4 weeks after stabilization of blood values. BESREMi® is designed to be self-administered subcutaneously with a pre-filled pen.
Please visit: European Medicines Agency Summary of Product Characteristics for: BESREMi®
About AOP Health
AOP Health Group is a global pharmaceutical enterprise with headquarters in Vienna. Its mission is to address high unmet medical needs through impactful, science-driven therapies and care models. Since 1996, AOP Health has pioneered research where limited therapies exist, to develop solutions for patients with rare diseases and severe conditions in niche therapeutic areas. Guided by the principle "Needs. Science. Trust.” the AOP Health Group demonstrates its strong commitment to patients and healthcare professionals through innovation and long-term partnerships, to improve patient outcomes worldwide.
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Contacts
Isolde Fally
Corporate Communications Manager
Isolde.Fally@aop-health.com
+43 676 500 4048
Energy Vault Announces Strategic Agreement to Deploy 1.25 GW of Integrated Power Infrastructure for Hyperscaler AI Data Center with Leading Power Generation EPC Deploying Caterpillar Gensets
WESTLAKE VILLAGE, Calif. -
Partnership combines Energy Vault's FEOC-compliant BESS, grid-forming PCS, and AI infrastructure control software with partner’s turnkey power generation, Caterpillar gensets and EPC capabilities
Reference architecture delivers firm grid-independent power, essential grid stabilization and load balancing to deliver modular, scalable, gigawatt-scale AI campuses with "always-on" availability
Second strategic framework agreement together advances Energy Vault's AI infrastructure strategy and establishes a repeatable “speed-to-power” deployment platform
Initial 1.25 GW is backed by a hyperscaler customer contract for deployment in Texas
Energy Vault expects a revenue impact of ~$500 - $600 million in 2H 2026 and 2027, which will be discussed during the upcoming earnings call on August 11, 2026
(BUSINESS WIRE)--Energy Vault Holdings, Inc. (NYSE: NRGV) ("Energy Vault"), a global leader in sustainable energy infrastructure, today announced the execution of a strategic commercial agreement under which Energy Vault will supply battery energy storage systems ("BESS"), grid-forming power conversion systems and AI infrastructure control software to support an initial deployment totaling 1.25 gigawatts ("GW") of integrated power infrastructure for hyperscaler AI data centers.
The agreement establishes a repeatable AI power infrastructure platform that combines dispatchable power generation, intelligent battery energy storage, grid-forming inverter systems, advanced AI infrastructure controls software and turnkey EPC and plant integration into a single integrated solution designed specifically for hyperscaler AI data centers and high-performance computing campuses.
The companies will jointly deploy fully integrated, off-grid power systems capable of bringing AI compute capacity online significantly faster than traditional utility interconnection schedules while providing the reliability, resiliency and operational flexibility required by next-generation AI workloads.
Initial deployments are expected over the next four to twelve months, supporting an accelerated speed-to-power schedule that is not dependent on traditional utility interconnection timelines.
As hyperscaler AI infrastructure continues to expand globally, developers increasingly require complete power infrastructure platforms rather than individual technologies. AI computing loads can change rapidly as GPU clusters ramp up and down, creating demanding transient, voltage, frequency and power-quality requirements that generation assets alone may not efficiently manage.
The integrated solution has been specifically designed to address these requirements through a fully integrated architecture that intelligently coordinates generation, energy storage and site-wide electrical infrastructure in real time. The solution is designed to support FEOC-compliant deployments while providing a repeatable reference architecture for integrated digital control, power distribution, grid stabilization and active load optimization.
Unlike traditional deployments where individual assets operate independently, the integrated platform continuously orchestrates and optimizes the generation, battery storage, power conversion, redundancy systems and electrical infrastructure as a single intelligent power plant.
Energy Vault's AI infrastructure controls software functions as a mission-critical operating system for the site's power infrastructure, dynamically balancing power flows, maintaining voltage and frequency stability, minimizing generator cycling, improving fuel efficiency and ensuring the rapid response required by highly dynamic AI compute environments.
The modular architecture also enables customers to deploy AI infrastructure ahead of permanent grid interconnection, while providing the flexibility to integrate utility power, renewable generation and additional distributed energy resources as campus requirements expand.
The national turnkey power generation engineering, procurement and construction ("EPC") contractor contributes decades of experience delivering complex generation projects across natural gas reciprocating engines, gas turbines, diesel generation, solar PV and emerging hydrogen technologies. Energy Vault complements these capabilities with one of the industry's broadest portfolios of utility-scale battery energy storage systems, intelligent energy management software and hybrid power plant integration expertise developed across projects worldwide.
"Artificial intelligence is fundamentally changing how critical power infrastructure is designed, deployed and operated," said Robert Piconi, Chairman and Chief Executive Officer of Energy Vault. "Customers are no longer procuring individual technologies—they require integrated power infrastructure capable of delivering reliable, always-on electricity at unprecedented speed and scale. With this agreement we have created a highly differentiated platform that combines industry-leading power generation, intelligent energy storage and advanced power plant software into a single integrated solution purpose-built for AI infrastructure.
"As our largest single contract executed to date, this milestone agreement represents another important step in Energy Vault's strategic evolution from an energy storage technology pioneer into an integrated energy infrastructure provider. More importantly, it establishes a repeatable commercial platform that we believe can support substantial future expansion as hyperscaler AI infrastructure investments continue to accelerate globally."
A senior executive at Energy Vault’s strategic power infrastructure partner commented, "Energy Vault's BESS, grid-forming technology and software platform are central to this solution. By integrating those systems into our modular plant design, we can bring large blocks of dependable power online quickly while maintaining the performance, scalability and flexibility that hyperscale campuses require."
The companies intend to jointly pursue additional hyperscaler, neocloud and AI infrastructure opportunities in markets where constrained grid capacity, extended utility interconnection timelines and increasing electricity demand are driving the need for rapidly deployable behind-the-meter and bridge-power solutions. The partnership is designed as a scalable commercial platform capable of supporting significant future expansion beyond the initial contracted deployment.
About Energy Vault
Energy Vault® develops, deploys and operates utility-scale energy storage solutions designed to transform the world’s approach to sustainable energy storage. The Company’s comprehensive offerings include proprietary battery, gravity and green hydrogen energy storage technologies supporting a variety of customer use cases delivering safe and reliable energy system dispatching and optimization. Each storage solution is supported by the Company’s technology-agnostic energy management system software and integration platform. Unique to the industry, Energy Vault’s innovative technology portfolio delivers customized short, long and multi-day/ultra-long duration energy storage solutions to help utilities, independent power producers, large industrial energy users, and AI/cloud infrastructure companies significantly reduce levelized energy costs while maintaining power reliability. Please visit www.energyvault.com for more information.
Forward-Looking Statements
This press release includes forward-looking statements that reflect the Company’s current views with respect to, among other things, the Company’s operations and financial performance. Forward-looking statements include information concerning possible or assumed future results of operations, including descriptions of our business plan and strategies. These statements often include words such as “anticipate,” “expect,” “contemplate,” “continue,” “suggest,” “plan,” “potential,” “predict,” “believe,” “intend,” “project,” “forecast,” “estimate,” “target,” “project,” “projections,” “should,” “target,” “could,” “would,” “may,” “might,” “will” and other similar expressions. We base these forward-looking statements or projections on our current expectations, plans and assumptions, which we have made in light of our experience in our industry, as well as our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate under the circumstances at the time. These forward-looking statements are based on our beliefs, assumptions and expectations of future performance, taking into account the information currently available to us. These forward-looking statements are only predictions based upon our current expectations and projections about future events. These forward-looking statements involve significant risks and uncertainties that could cause our actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements, including changes in our strategy, expansion plans, customer opportunities, future operations, future financial position, estimated revenues and losses, expected monetization of tax credits, expected financings, projected costs, prospects and plans; the uncertainty of our awards, bookings, backlog and developed pipeline equating to future revenue; our ability to successfully provide AI power infrastructure and secure additional AI power infrastructure work; the lack of assurance that non-binding letters of intent and other indications of interest can result in binding financings, orders or sales; the possibility of our products or services to be or alleged to be defective or experience other failures; the implementation, market acceptance and success of our business model and growth strategy; our ability to develop and maintain our brand and reputation; developments and projections relating to our business, our competitors, and industry; the impact of macroeconomic uncertainty, including with respect to uncertainty about the future relationship between the United States and other countries with respect to trade policies and tariffs; changes in tax laws and government regulations and the impact of those changes on us, including as a result of the One Big Beautiful Bill Act and its changes to the Internal Revenue Code of 1986, as amended and the clean-energy tax credits established under the Inflation Reduction Act of 2022; investment in development projects that may not achieve commercial operations in our predicted timeframe or at all; our efforts to diversify our supply chain to lessen the impact of tariffs; the ability of our suppliers to deliver necessary components or raw materials for construction of our energy storage systems in a timely manner; our expectations regarding our ability to obtain and maintain intellectual property protection and not infringe on the rights of others; our future capital requirements and sources and uses of cash; developments in U.S. and global trade policy; the international nature of our operations and the impact of war or other hostilities on our business and global markets; our ability to obtain funding for our operations and future growth; and our business, expansion plans and opportunities, including our expansion into owned and operated projects; and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on March 18, 2026, as such factors may be updated from time to time in its other filings with the SEC, accessible on the SEC’s website at www.sec.gov. New risks emerge from time to time and it is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Any forward-looking statement made by us in this press release speaks only as of the date of this press release and is expressly qualified in its entirety by the cautionary statements included in this press release. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable laws. You should not place undue reliance on our forward-looking statements.
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Energy Vault:
Investors energyvaultIR@icrinc.com
Media media@energyvault.com
Friday, August 7, 2026
U.S. FDA Approves Takeda’s ORZEYFUL™ (oveporexton), the First and Only Medicine to Treat the Underlying Cause of Narcolepsy Type 1
OSAKA, Japan & CAMBRIDGE, Mass. - Thursday, 06. August 2026
Adults Taking ORZEYFUL Experienced Significant and Meaningful Improvements Across the Full Range of Symptoms of Narcolepsy Type 1 (NT1) in Clinical Trials Compared to Those on Placebo
As a First-in-Class Orexin Treatment, ORZEYFUL has the Potential to Redefine NT1 Care Beyond Individual Symptoms
Takeda is Advancing U.S. Launch Preparations and Expects to Make ORZEYFUL Available Following Completion of the Drug Enforcement Administration (DEA) Scheduling Process
(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) announced that the U.S. Food and Drug Administration (FDA) approved ORZEYFUL™ (oveporexton), an oral orexin receptor 2 (OX2R) agonist, for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults.* The persistent 24-hour nature of NT1 is driven by orexin deficiency and can severely impact people’s lives. As a first-in-class orexin treatment, ORZEYFUL is the only medicine indicated in the U.S. to treat the disease holistically rather than individual symptoms.
“The FDA approval of ORZEYFUL marks a new chapter for the narcolepsy type 1 community, as we introduce an entirely new class of medicine that will potentially redefine how this disease is managed and how people feel on treatment,” said Julie Kim, president and chief executive officer of Takeda. “We are proud to have discovered and developed this orexin treatment innovation and will bring it to adults living with NT1 as quickly as possible.”
NT1 is a rare, chronic neurological disease driven by a loss of orexin and affects an estimated 120,000 people in the U.S. People with NT1 experience excessive daytime sleepiness, cataplexy (sudden loss of muscle tone), cognitive symptoms and disrupted nighttime sleep that can severely impact multiple aspects of daily life, including work, education and social interactions.
"For those of us living with narcolepsy type 1, symptoms reshape everyday life and extend far beyond what most people understand about the condition," said Julie Flygare, President and CEO at Project Sleep and a person with NT1. "ORZEYFUL’s approval is a historic moment that expands our treatment choices and gives me great hope for the future and for our community."
“Until now, people have managed narcolepsy type 1 with treatments that target symptom relief,” said Dr. Emmanuel Mignot, M.D., Ph.D., principal U.S. investigator in the ORZEYFUL Phase 3 program. “As the first and only approved orexin therapy to treat the broad spectrum of the disease, ORZEYFUL can enable a different kind of conversation in the doctor’s office about treatment options.”
The approval is based on a comprehensive clinical program including the global Phase 3 FirstLight (TAK-861-3001) and RadiantLight (TAK-861-3002) studies that showed oveporexton offers statistically significant improvements across the full range of symptoms of the disease. These included improvements in excessive daytime sleepiness, cataplexy and health-related quality of life. Oveporexton was generally well-tolerated with a safety profile consistent across clinical studies to date. The most common side effects include trouble sleeping (insomnia), urinary urgency, urinary frequency and excessive saliva. Learn more about the Phase 3 data results here.
"With this approval, we are turning scientific discovery into reality for adults living with narcolepsy type 1," said Andy Plump, M.D., Ph.D., President, Research & Development, Takeda. "ORZEYFUL is just the beginning. With orexin emerging as a powerful therapeutic pathway, Takeda is unlocking the potential of this new class of medicine for patients across a range of disorders.”
Next Steps for ORZEYFUL Availability
The controlled substance classification for ORZEYFUL is currently under review by the Drug Enforcement Administration (DEA) and is expected within 90 days. After the controlled substance classification is determined, ORZEYFUL will be made available through a specialty pharmacy to U.S. healthcare providers and adults living with NT1. To sign up for updates visit ORZEYFUL.com.
The FDA approval is not expected to have a significant impact on the full year consolidated financial forecast for the fiscal year ending March 31, 2027.
*For information regarding the submission of the new drug application for oveporexton to the U.S. FDA, please refer to Takeda’s press release dated February 10, 2026, “U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Takeda’s Oveporexton (TAK-861) as a Potential First-in-Class Therapy for Narcolepsy Type 1”.
About ORZEYFUL (oveporexton)
ORZEYFUL (oveporexton) is an oral orexin receptor 2 (OX2R) agonist, which selectively stimulates the OX2R to restore signaling and address the underlying orexin deficiency associated with narcolepsy type 1 (NT1). By activating OX2Rs, ORZEYFUL promotes wakefulness and reduces abnormal rapid eye movement (REM)-sleep like phenomena, including cataplexy (sudden and temporary loss of muscle tone), to address a range of daytime and nighttime symptoms as evaluated in clinical studies and consistent with the approved label.
INDICATION
ORZEYFUL is indicated for the treatment of narcolepsy type 1 (narcolepsy with cataplexy) in adult patients.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
ORZEYFUL is contraindicated in patients taking strong CYP3A inhibitors.
WARNINGS AND PRECAUTIONS
Insomnia: In pooled phase 3 studies in patients with NT1, 60%, 55%, and 1% of patients in the ORZEYFUL 2 mg twice daily, ORZEYFUL 1 mg twice daily, and placebo groups, respectively, developed insomnia. Prior to ORZEYFUL treatment initiation, inform patients about the risk of insomnia at initiation of treatment. If insomnia persists beyond 7 days and significantly impacts daytime functioning or quality of life, consider ORZEYFUL dosage reduction or discontinuation.
Urinary Frequency and Urgency: ORZEYFUL may cause or worsen urinary frequency and urgency. In pooled phase 3 studies in patients with NT1:
58%, 53%, and 5% of patients in the ORZEYFUL 2 mg twice daily, ORZEYFUL 1 mg twice daily, and placebo groups, respectively, developed urinary frequency.
16%, 15%, and 1% of patients in the ORZEYFUL 2 mg twice daily, ORZEYFUL 1 mg twice daily, and placebo groups, respectively, developed urinary urgency.
These lower urinary tract symptoms are consistent with ORZEYFUL’s mechanism of action through agonism of the orexin receptor 2 (OX2R) on central micturition pathways. Prior to initiation of ORZEYFUL treatment, inform patients about the risk of urinary frequency and urgency and screen for lower urinary tract symptoms. Monitor ORZEYFUL-treated patients with a history of overactive bladder for worsening urinary tract symptoms.
Creatine Phosphokinase Elevations: In pooled phase 3 studies in patients with NT1, asymptomatic creatine phosphokinase elevations >5x ULN were observed in 11% (21/196) of ORZEYFUL-treated patients and 5% (4/76) of placebo treated patients. Two of these cases were characterized by markedly elevated CPK and transaminase levels; both patients discontinued treatment. None of the cases were associated with myoglobinuria or renal impairment. Advise patients to report unexplained muscle pain, weakness, or dark urine, particularly when engaging in vigorous physical activity or taking concomitant drugs associated with myotoxicity.
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥5% and greater than placebo) reported in phase 3 studies with ORZEYFUL were insomnia, pollakiuria, micturition urgency, and salivary hypersecretion.
DRUG INTERACTIONS
Concomitant use with strong or moderate CYP3A inhibitors increases oveporexton exposures, which may increase the risk of ORZEYFUL-associated adverse reactions
Concomitant use of strong and moderate CYP3A inducers can increase oveporexton metabolism and decrease plasma levels of oveporexton, which may decrease the effectiveness of ORZEYFUL
USE IN SPECIFIC POPULATIONS
Pregnancy: There is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to ORZEYFUL during pregnancy. Patients should be encouraged to enroll in the ORZEYFUL pregnancy registry if they become pregnant. To enroll or obtain information from the registry, patients can call 1-877-371-0309. Available data from clinical trials with ORZEYFUL use during pregnancy are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
Lactation: There are no data available on the presence of oveporexton in human milk, the effects on the breastfed infant, or the effects on milk production. Animal studies indicate that oveporexton was present in the milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk.
Hepatic Impairment: Avoid use of ORZEYFUL in patients with severe hepatic impairment (Child-Pugh C), as it has not been studied in this population.
Renal Impairment: Avoid use of ORZEYFUL in patients with severe renal impairment on dialysis (eGFR <15 mL/minute), as it has not been studied in this population.
DRUG ABUSE AND DEPENDENCE
ORZEYFUL contains oveporexton. Controlled substance schedule to be determined after review by the Drug Enforcement Administration.
ORZEYFUL has potential for abuse and misuse. Carefully evaluate patients for a recent history of drug abuse, especially those with a history of CNS stimulant, and follow such patients closely, observing them for signs of misuse or abuse of ORZEYFUL.
Important Note: Prescribing Information is subject to change pending DEA scheduling and final label publication.
Please click for Full Prescribing Information.
About Takeda’s Orexin Franchise
Takeda is the leader in orexin science with a tailored portfolio of investigational orexin agonists in pre-clinical and clinical stages for multiple-sleep wake disorders and other indications where orexin plays a role including respiration, mood and metabolism. ORZEYFUL (oveporexton) is the lead orexin receptor 2 (OX2R) agonist asset in Takeda’s orexin franchise and has been approved by regulatory bodies in China and the United States for the treatment of narcolepsy type 1 (NT1). The company is also investigating other oral orexin agonists, including TAK-360 being investigated for the treatment of NT1, narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH), as well as TAK-495.
About Takeda
Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.
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For the purposes of this notice, “press release” means this document, any oral presentation, any question-and-answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.
The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.
Forward-Looking Statements
This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects”, “forecasts”, “outlook” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States and with respect to international trade relations; competitive pressures and developments; changes to applicable laws and regulations, including tax, tariff and other trade-related rules; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic; the success of our environmental sustainability efforts, in enabling us to reduce our greenhouse gas emissions or meet our other environmental goals; the extent to which our efforts to increase efficiency, productivity or cost-savings, such as the integration of digital technologies, including artificial intelligence, in our business or other initiatives to restructure our operations will lead to the expected benefits; and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings-and-security-reports/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.
Medical Information
This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.
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Media Relations
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Tsuyoshi Tada (Tokyo)
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Adults Taking ORZEYFUL Experienced Significant and Meaningful Improvements Across the Full Range of Symptoms of Narcolepsy Type 1 (NT1) in Clinical Trials Compared to Those on Placebo
As a First-in-Class Orexin Treatment, ORZEYFUL has the Potential to Redefine NT1 Care Beyond Individual Symptoms
Takeda is Advancing U.S. Launch Preparations and Expects to Make ORZEYFUL Available Following Completion of the Drug Enforcement Administration (DEA) Scheduling Process
(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) announced that the U.S. Food and Drug Administration (FDA) approved ORZEYFUL™ (oveporexton), an oral orexin receptor 2 (OX2R) agonist, for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults.* The persistent 24-hour nature of NT1 is driven by orexin deficiency and can severely impact people’s lives. As a first-in-class orexin treatment, ORZEYFUL is the only medicine indicated in the U.S. to treat the disease holistically rather than individual symptoms.
“The FDA approval of ORZEYFUL marks a new chapter for the narcolepsy type 1 community, as we introduce an entirely new class of medicine that will potentially redefine how this disease is managed and how people feel on treatment,” said Julie Kim, president and chief executive officer of Takeda. “We are proud to have discovered and developed this orexin treatment innovation and will bring it to adults living with NT1 as quickly as possible.”
NT1 is a rare, chronic neurological disease driven by a loss of orexin and affects an estimated 120,000 people in the U.S. People with NT1 experience excessive daytime sleepiness, cataplexy (sudden loss of muscle tone), cognitive symptoms and disrupted nighttime sleep that can severely impact multiple aspects of daily life, including work, education and social interactions.
"For those of us living with narcolepsy type 1, symptoms reshape everyday life and extend far beyond what most people understand about the condition," said Julie Flygare, President and CEO at Project Sleep and a person with NT1. "ORZEYFUL’s approval is a historic moment that expands our treatment choices and gives me great hope for the future and for our community."
“Until now, people have managed narcolepsy type 1 with treatments that target symptom relief,” said Dr. Emmanuel Mignot, M.D., Ph.D., principal U.S. investigator in the ORZEYFUL Phase 3 program. “As the first and only approved orexin therapy to treat the broad spectrum of the disease, ORZEYFUL can enable a different kind of conversation in the doctor’s office about treatment options.”
The approval is based on a comprehensive clinical program including the global Phase 3 FirstLight (TAK-861-3001) and RadiantLight (TAK-861-3002) studies that showed oveporexton offers statistically significant improvements across the full range of symptoms of the disease. These included improvements in excessive daytime sleepiness, cataplexy and health-related quality of life. Oveporexton was generally well-tolerated with a safety profile consistent across clinical studies to date. The most common side effects include trouble sleeping (insomnia), urinary urgency, urinary frequency and excessive saliva. Learn more about the Phase 3 data results here.
"With this approval, we are turning scientific discovery into reality for adults living with narcolepsy type 1," said Andy Plump, M.D., Ph.D., President, Research & Development, Takeda. "ORZEYFUL is just the beginning. With orexin emerging as a powerful therapeutic pathway, Takeda is unlocking the potential of this new class of medicine for patients across a range of disorders.”
Next Steps for ORZEYFUL Availability
The controlled substance classification for ORZEYFUL is currently under review by the Drug Enforcement Administration (DEA) and is expected within 90 days. After the controlled substance classification is determined, ORZEYFUL will be made available through a specialty pharmacy to U.S. healthcare providers and adults living with NT1. To sign up for updates visit ORZEYFUL.com.
The FDA approval is not expected to have a significant impact on the full year consolidated financial forecast for the fiscal year ending March 31, 2027.
*For information regarding the submission of the new drug application for oveporexton to the U.S. FDA, please refer to Takeda’s press release dated February 10, 2026, “U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Takeda’s Oveporexton (TAK-861) as a Potential First-in-Class Therapy for Narcolepsy Type 1”.
About ORZEYFUL (oveporexton)
ORZEYFUL (oveporexton) is an oral orexin receptor 2 (OX2R) agonist, which selectively stimulates the OX2R to restore signaling and address the underlying orexin deficiency associated with narcolepsy type 1 (NT1). By activating OX2Rs, ORZEYFUL promotes wakefulness and reduces abnormal rapid eye movement (REM)-sleep like phenomena, including cataplexy (sudden and temporary loss of muscle tone), to address a range of daytime and nighttime symptoms as evaluated in clinical studies and consistent with the approved label.
INDICATION
ORZEYFUL is indicated for the treatment of narcolepsy type 1 (narcolepsy with cataplexy) in adult patients.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
ORZEYFUL is contraindicated in patients taking strong CYP3A inhibitors.
WARNINGS AND PRECAUTIONS
Insomnia: In pooled phase 3 studies in patients with NT1, 60%, 55%, and 1% of patients in the ORZEYFUL 2 mg twice daily, ORZEYFUL 1 mg twice daily, and placebo groups, respectively, developed insomnia. Prior to ORZEYFUL treatment initiation, inform patients about the risk of insomnia at initiation of treatment. If insomnia persists beyond 7 days and significantly impacts daytime functioning or quality of life, consider ORZEYFUL dosage reduction or discontinuation.
Urinary Frequency and Urgency: ORZEYFUL may cause or worsen urinary frequency and urgency. In pooled phase 3 studies in patients with NT1:
58%, 53%, and 5% of patients in the ORZEYFUL 2 mg twice daily, ORZEYFUL 1 mg twice daily, and placebo groups, respectively, developed urinary frequency.
16%, 15%, and 1% of patients in the ORZEYFUL 2 mg twice daily, ORZEYFUL 1 mg twice daily, and placebo groups, respectively, developed urinary urgency.
These lower urinary tract symptoms are consistent with ORZEYFUL’s mechanism of action through agonism of the orexin receptor 2 (OX2R) on central micturition pathways. Prior to initiation of ORZEYFUL treatment, inform patients about the risk of urinary frequency and urgency and screen for lower urinary tract symptoms. Monitor ORZEYFUL-treated patients with a history of overactive bladder for worsening urinary tract symptoms.
Creatine Phosphokinase Elevations: In pooled phase 3 studies in patients with NT1, asymptomatic creatine phosphokinase elevations >5x ULN were observed in 11% (21/196) of ORZEYFUL-treated patients and 5% (4/76) of placebo treated patients. Two of these cases were characterized by markedly elevated CPK and transaminase levels; both patients discontinued treatment. None of the cases were associated with myoglobinuria or renal impairment. Advise patients to report unexplained muscle pain, weakness, or dark urine, particularly when engaging in vigorous physical activity or taking concomitant drugs associated with myotoxicity.
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥5% and greater than placebo) reported in phase 3 studies with ORZEYFUL were insomnia, pollakiuria, micturition urgency, and salivary hypersecretion.
DRUG INTERACTIONS
Concomitant use with strong or moderate CYP3A inhibitors increases oveporexton exposures, which may increase the risk of ORZEYFUL-associated adverse reactions
Concomitant use of strong and moderate CYP3A inducers can increase oveporexton metabolism and decrease plasma levels of oveporexton, which may decrease the effectiveness of ORZEYFUL
USE IN SPECIFIC POPULATIONS
Pregnancy: There is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to ORZEYFUL during pregnancy. Patients should be encouraged to enroll in the ORZEYFUL pregnancy registry if they become pregnant. To enroll or obtain information from the registry, patients can call 1-877-371-0309. Available data from clinical trials with ORZEYFUL use during pregnancy are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
Lactation: There are no data available on the presence of oveporexton in human milk, the effects on the breastfed infant, or the effects on milk production. Animal studies indicate that oveporexton was present in the milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk.
Hepatic Impairment: Avoid use of ORZEYFUL in patients with severe hepatic impairment (Child-Pugh C), as it has not been studied in this population.
Renal Impairment: Avoid use of ORZEYFUL in patients with severe renal impairment on dialysis (eGFR <15 mL/minute), as it has not been studied in this population.
DRUG ABUSE AND DEPENDENCE
ORZEYFUL contains oveporexton. Controlled substance schedule to be determined after review by the Drug Enforcement Administration.
ORZEYFUL has potential for abuse and misuse. Carefully evaluate patients for a recent history of drug abuse, especially those with a history of CNS stimulant, and follow such patients closely, observing them for signs of misuse or abuse of ORZEYFUL.
Important Note: Prescribing Information is subject to change pending DEA scheduling and final label publication.
Please click for Full Prescribing Information.
About Takeda’s Orexin Franchise
Takeda is the leader in orexin science with a tailored portfolio of investigational orexin agonists in pre-clinical and clinical stages for multiple-sleep wake disorders and other indications where orexin plays a role including respiration, mood and metabolism. ORZEYFUL (oveporexton) is the lead orexin receptor 2 (OX2R) agonist asset in Takeda’s orexin franchise and has been approved by regulatory bodies in China and the United States for the treatment of narcolepsy type 1 (NT1). The company is also investigating other oral orexin agonists, including TAK-360 being investigated for the treatment of NT1, narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH), as well as TAK-495.
About Takeda
Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.
Important Notice
For the purposes of this notice, “press release” means this document, any oral presentation, any question-and-answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.
The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.
Forward-Looking Statements
This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects”, “forecasts”, “outlook” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States and with respect to international trade relations; competitive pressures and developments; changes to applicable laws and regulations, including tax, tariff and other trade-related rules; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic; the success of our environmental sustainability efforts, in enabling us to reduce our greenhouse gas emissions or meet our other environmental goals; the extent to which our efforts to increase efficiency, productivity or cost-savings, such as the integration of digital technologies, including artificial intelligence, in our business or other initiatives to restructure our operations will lead to the expected benefits; and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings-and-security-reports/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.
Medical Information
This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.
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Christopher O’Reilly
takeda.ir.contact@takeda.com
Media Relations
Cassie Ercanbrack (Boston)
Media_relations@takeda.com
Tsuyoshi Tada (Tokyo)
Toiawase_kouhou@takeda.co.jp
Mary Kay’s Pink Changing Lives® Program Turns Purpose Into Measurable Impact for Women Around the World
More than 4 million women have benefited through nonprofit organizations supported by the program since its launch.
(BUSINESS WIRE)--Mary Kay Inc., a global advocate for women’s empowerment, proudly reaffirms its commitment to enriching women’s lives worldwide through its signature Pink Changing Lives® Program – a multi-faceted global initiative that blends purpose-driven giving with cause-marketing to create meaningful, measurable impact across communities. Since 1996, the program has provided over $230 million in monetary and product donations to nonprofit organizations empowering women, transforming women’s health and safety, and protecting our natural resources.
Rooted in the Company’s mission of enriching women’s lives, the Pink Changing Lives® cause-marketing campaign transforms everyday beauty purchases into powerful acts of giving. With over $19 million funneled back into local communities, funded through a portion of sales from designated products across participating markets, the program enables Mary Kay to partner locally and act globally – supporting causes that matter most to women and their families. Each purchase of a Pink Changing Lives®-designated product directly contributes to charitable efforts, allowing consumers to participate in giving back through their everyday choices.
“At Mary Kay, we believe in the power of small acts to create extraordinary change,” said Allison Levy, Chief Legal Officer and Corporate Secretary at Mary Kay Inc. “Through Pink Changing Lives®, every market, consumer, Independent Beauty Consultant and designated purchase has the power to uplift a woman, support a family, and strengthen a community. This program reflects who we are at our core – a company committed to turning purpose into action and creating a world where every woman can thrive.”
Since its inception, the program has evolved into a cornerstone of Mary Kay’s global social impact strategy, supporting initiatives that advance cancer research, aid survivors of domestic violence, expand access to education, protect the environment, and help communities thrive around the world.
A Global Movement, Powered Locally
Pink Changing Lives® drives impact through the passion of Mary Kay’s independent sales force and employees, who activate the program in markets around the world, bringing its mission to life through locally relevant partnerships and initiatives. Across regions, markets are turning shared purpose into tangible outcomes:
Mary Kay China: Through the Hope for Pearl Program, Beauty Consultants help fund educational opportunities for girls from disadvantaged backgrounds, linking beauty experiences to life-changing educational access.
Mary Kay Germany global outreach efforts: Partnerships with organizations like the Reiner Meutsch FLY & HELP Foundation have expanded access to education through the construction and renovation of 12 schools in underserved regions, including Africa and South Asia.
Mary Kay Colombia: In partnership with Fundación Colombianitos, funding supports the creation of safe spaces for children to learn, grow, and play. Projects have included the restoration of a neglected sports field and multipurpose room to allow for after-school activities and community building through sport, play, recreation, education, and health.
Other global markets: Thousands of nonprofit partnerships support critical causes from domestic violence prevention and cancer care to community beautification projects - all tailored to the needs of local communities.
By empowering each Mary Kay market to select causes and partners aligned with local priorities, Pink Changing Lives® ensures that impact is not only global in scale but deeply personal in execution.
Cause Marketing That Creates Lasting Impact
Pink Changing Lives® is a powerful cause-marketing model – where purpose and product intersect. This model not only raises critical funds but also builds awareness and engagement, creating a ripple effect of purpose that extends far beyond the point of sale. The result is a sustainable approach to philanthropy – one that empowers individuals, drives community involvement, and reinforces Mary Kay’s longstanding commitment to social good.
Did You Know:
Mary Kay ranked #8 out of 5,500 brands on Forbes’s 2026 Best Brands for Social Impact1 moving up from stellar #9 achieved in 2025. Mary Kay is the only beauty brand in the Top 15 and the only direct selling company on the list.
Mary Kay has a presence in 40 markets around the world.
About Mary Kay
One of the original glass ceiling breakers, Mary Kay Ash founded her dream beauty brand in Texas in 1963 with one goal: to enrich women’s lives. That dream has blossomed into a global company with millions of independent sales force members in 40 markets. For over 60 years, the Mary Kay opportunity has empowered women to define their own futures through education, mentorship, advocacy, and innovation. Mary Kay is dedicated to investing in the science behind beauty and manufacturing cutting-edge skincare, color cosmetics, nutritional supplements, and fragrances. Mary Kay believes in preserving our planet for future generations, protecting women impacted by cancer and domestic abuse, and encouraging youth to follow their dreams. Learn more at marykayglobal.com. Find us on Facebook, Instagram, and LinkedIn.
____________________________
1 Alan Schwarz (March 17, 2026). Forbes - Best Brands For Social Impact 2026. https://www.forbes.com/lists/best-brands-social-impact/
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Perpetuals Reports 380% Hypothetical Return in Backtest of AI Engine Powering Risk-Free Trading Platform ‘UpsideOnly’
- Results provide early evidence that BayesShield can identify potentially profitable trading signals by finding repeatable skill in trader activity
- 375-day backtest using Perpetuals’s production code generated a hypothetical 380% non-compounded return, a period in which Bitcoin fell 40.2%
- The strategy achieved a return-to-drawdown ratio of 4.4, a measure comparing its overall return with the largest decline it experienced during the test
(BUSINESS WIRE)--Perpetuals.com Ltd (Nasdaq: PDC) today announced backtest results for version two of BayesShield, its patent-pending AI engine developed for UpsideOnly.
UpsideOnly is a risk-free paper trading platform where users simulate trades using virtual money across global equity, commodity, foreign exchange and crypto markets. The platform is powered by BayesShield, an AI model that uses machine learning to identify consistently successful traders. It generates automated signals when enough qualified traders independently take the same position at approximately the same time. These signals inform UpsideOnly's trading strategies, with profits shared among eligible top-performing users.
Using the same production code that powers the live platform, Perpetuals replayed approximately 1.07 billion historical order fills. Over the 375-day test period, the strategy generated a hypothetical, non-compounded return of 380%, with a maximum drawdown, meaning its largest decline from a previous peak, of 27%. It achieved a return-to-drawdown ratio of 4.4, indicating that its overall gains were substantially greater than its largest setback during the test.
Starting with $400,000 in simulated deployed capital, the system generated $1.522 million in hypothetical profit, ending the test with $1.922 million. If replicated in live markets, the results point to a different role for AI in trading: identifying repeatable human skill across large volumes of market activity and turning it into automated trading signals, rather than trying to predict prices directly.
Encouragingly, the strategy remained resilient under market stress. It recorded a positive return in every calendar quarter and zero liquidations across the 375-days, a period when Bitcoin fell 40.2%. During the sharp market sell-off on October 10, 2025, the system was essentially flat, declining by just 0.7%, while Bitcoin fell 16% within hours.
"This massive backtesting effort has provided promising signals that our BayesShield AI algorithm is working as intended,” said Patrick Gruhn, CEO of Perpetuals. "Our early live, real-money results have been encouraging and generally consistent with this testing”
This testing protocol was designed to reduce bias and prevent the use of future information, drawing on data from more than 429,000 trading accounts, 70.8 million positions sourced from PM MTF Ltd and more than 22 billion historical retail trades.
UpsideOnly launched in May 2026 and now has more than 225,000 users and recorded $70 billion in simulated notional trading volume across 25 assets. The live trading period remains too limited to draw conclusions about future performance.
About Perpetuals.com Ltd
Perpetuals.com Ltd (Nasdaq: PDC) is a fintech company developing AI-powered trading products and prediction markets, with a global footprint across the United States, Europe, and Asia. Its mission is to reduce risk through empowering retail users with intuitive, secure, and efficient trading experiences that span the world’s capital markets. UpsideOnly, the company's flagship consumer product, is the first risk-free trading platform, pairing human market insight with proprietary BayesShield AI so users can share in trading profits without ever risking their own money.
Perpetuals’s proprietary AI system, BayesShield AI, combines advanced AI and data analysis. The technology is trained on billions of trades, monitors market activity in real time, identifies patterns for trading and risk decisions, and provides multi-asset coverage. The company’s technology is used by the EU-licensed Perpetual Markets Multilateral Trading Facility (MTF), PM MTF Ltd, which operates under full MiFID II, MiCA, DORA, and EMIR compliance.
Forward-Looking Statements: This press release contains forward-looking statements as defined within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the anticipated profitability to the company and users of UpsideOnly. Words such as “expect,” “will,” “positions,” “advancing,” “projected,” “anticipated,” and other similar expressions indicate forward-looking statements, though not all forward-looking statements contain such words. These statements reflect the company’s current view with respect to future events and are subject to risks and uncertainties that could cause actual results to differ materially. The performance results described in this release are derived from a back-test conducted using historical data under specified assumptions and methodologies. Back-tested results are achieved through the application of hindsight and do not represent the results of actual trading or live operation. Such results are subject to inherent limitations, including assumptions regarding historical data, model design, and analytical methodology, and may not reflect the impact of market conditions, execution factors, transaction costs, liquidity constraints, or other variables that could affect actual performance. Past or simulated performance is not indicative of future results, and there can be no assurance that similar results will be achieved in actual operation. Future results are subject to, among other things, the efficacy and accuracy of BayesShield AI, regulatory scrutiny, continued user participation in the UpsideOnly platform, market conditions, the issuance and enforceability of the patent covering BayesShield AI, the company’s ability to raise capital to support the operation of the UpsideOnly platform, and risks detailed in the company’s filings with the Securities and Exchange Commission. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the company, are inherently subject to significant business, economic, competitive, political, regulatory, and social uncertainties and contingencies. Should one or more of these risks or uncertainties materialize, or should the assumptions set out by the company underlying those forward-looking statements prove incorrect, actual results may vary materially from those described herein. Individuals are cautioned that forward-looking statements are not guarantees of future performance and accordingly investors are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty therein. These forward-looking statements are made as of the date of this press release and the company does not undertake any obligation to update these forward-looking statements, except as required by law. Perpetuals.com Ltd has an option agreement to acquire the affiliate company PM MTF Ltd, which will require a change of control approval by CySEC if exercised. Risk-free trading means that no losses from trading losses can occur to users, but does not include risks from other sources, including, but not limited to, the operational risks of the company.
We may use blog posts on our website as well as our social media accounts, including our accounts on X, LinkedIn, and Facebook, to disclose material information about the company from time to time.
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Laserfiche Launches Advanced Enterprise Security to Deliver Multi-Region Disaster Recovery and GovRAMP-Ready Compliance for Highly Regulated Industries
New security suite extends Laserfiche’s proven security controls and adds near real-time data replication for governments, law enforcement and security-conscious enterprises.
(BUSINESS WIRE) -- Laserfiche — the leading SaaS provider of intelligent content management — today announced the launch of Enterprise Security, an advanced suite of security enhancements designed for organizations navigating complex regulatory environments. Enterprise Security addresses GovRAMP and CJIS (Criminal Justice Information Services) security requirements based on the NIST SP 800-53 framework. For organizations handling privileged citizen, legal or corporate data, these built-in controls streamline audit preparation and fortify defenses.
With organizations placing a higher priority on data stewardship and corporate governance, enterprise IT leaders require a security architecture that protects data without slowing down operations. Laserfiche Enterprise Security extends Laserfiche Cloud’s highly resilient infrastructure with multi-region data replication, elevated security controls for privileged accounts, and built-in governance safeguards.
“Maintaining data integrity and compliance has always been at the heart of Laserfiche’s operations,” said Michael Allen, CTO at Laserfiche. “With Enterprise Security, Laserfiche provides enterprise IT users, especially those in government, law enforcement and highly regulated industries, with the complementary controls designed to meet stringent information security standards and protect their most sensitive assets.”
High-Security Controls and Regulatory Alignment
Laserfiche Enterprise Security introduces multi-region disaster recovery, enhanced oversight capabilities, and government-ready cloud security controls tailored for mission-critical data and sensitive operations.
Key capabilities included with Enterprise Security:
GovRAMP and CJIS Readiness: Deploys advanced operational controls designed to meet strict government and criminal justice compliance mandates for sensitive data handling.
Multi-region disaster recovery: Safeguards critical operations against large-scale infrastructure failures with near real-time, account-level repository data replication and multi-region failover.
Advanced audit tracking and analytics: Provides complete visibility into user login activity, system changes, and security events
Proactive threat augmentation: Bolsters existing security measures by adding specialized protections against unauthorized AI bot scraping and distributed denial of service (DDoS) attacks.
Laserfiche is listed on the GovRAMP Progressing Product List, with the Enterprise Security suite delivering the architectural controls required to support these standards.
Tailored for Mission-Critical Operations
Enterprise Security is built for organizations that safeguard heavily regulated and sensitive data, where seamless recovery and strict information control are vital to everyday operations:
Government agencies and law enforcement: Safely manage records and criminal justice information while strictly adhering to CJIS and GovRAMP standards.
Large enterprises and financial services: Protect proprietary corporate data and client financials with strong cryptographic modules and advanced visibility into user activity.
“Highly regulated sectors, from law enforcement to state and local governments, face a unique challenge: They must modernize content management while upholding non-negotiable security standards,” said Andrea Malick, principal advisory director at Info-Tech Research Group. “Solutions that offer built-in compliance frameworks like CJIS and GovRAMP give enterprise IT buyers the confidence to migrate sensitive workloads to the cloud without compromising control.”
Pricing and Availability
Enterprise Security is available starting today as a supplemental SKU for qualifying Laserfiche Cloud deployments.
Laserfiche is also introducing Business+, a new comprehensive subscription tier designed for organizations that want high-level security capabilities built directly into their standard platform deployment.
For More Information
For a deep-dive into Laserfiche security and governance, visit laserfiche.com/products/trust-security.
About Laserfiche
Laserfiche is the leading enterprise platform that helps organizations digitally transform operations and manage their content with AI-powered solutions. Through scalable workflows, customizable forms, no-code templates and AI-enabled capabilities, the Laserfiche® document management platform accelerates how business gets done. Trusted by organizations of all sizes — from startups to Fortune 500 enterprises — Laserfiche empowers teams to boost productivity, foster collaboration, and deliver a superior customer experience at scale. Headquartered in Long Beach, California, Laserfiche operates globally, with offices across North America, Europe and Asia.
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Contacts
Media Contact:
Linda Domingo
Communications Director, Laserfiche
Linda.domingo@laserfiche.com
562-988-1688 ext. 234
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