Takeda Announces Positive Results from Two Pivotal Phase 3 Studies of Oveporexton (TAK-861) in Narcolepsy Type 1




Takeda Announces Positive Results from Two Pivotal Phase 3 Studies of Oveporexton (TAK-861) in Narcolepsy Type 1

– Both Phase 3 Studies Met all Primary and Secondary Endpoints Demonstrating Statistically Significant Improvements Across Symptoms at All Doses, Building Upon Phase 2b Results

– Oveporexton was Generally Well-Tolerated in Phase 3 Safety Profile

– Takeda is Rapidly Advancing Regulatory Submissions and Launch Preparedness with the Aim to Bring Oveporexton to People Living with Narcolepsy Type 1 as Quickly as Possible

– These Results Mark a Major Advancement Toward Transforming the Standard of Care by Addressing the Underlying Cause of Narcolepsy Type 1

OSAKA, Japan & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Takeda (TSE:4502/NYSE:TAK) today announced that all primary and secondary endpoints were met in two Phase 3 randomized, double-blind, placebo-controlled studies of oveporexton (TAK-861), a potential first-in-class investigational oral orexin receptor 2 (OX2R)-selective agonist, in narcolepsy type 1 (NT1). NT1 is caused by the loss of orexin-producing neurons in the brain. Orexin agonists are designed to address this underlying orexin deficiency. For the first time, this mechanism of action has been validated in Phase 3 studies demonstrating significant improvement across a broad range of symptoms. These results reinforce the potential of oveporexton to transform the standard of care.

“We are thrilled to reach this pivotal milestone for the oveporexton program. Oveporexton is a testament to Takeda’s strength in discovering and developing a potential new class of medicines for difficult to treat diseases such as narcolepsy type 1,” said Christophe Weber, president and chief executive officer at Takeda. “Our leadership in orexin biology and building a multi-asset orexin franchise with transformative potential will position Takeda for long-term future growth.”

The FirstLight (TAK-861-3001) and RadiantLight (TAK-861-3002) studies were two large, global Phase 3 studies conducted in 19 countries. Both studies achieved statistically significant improvement compared to placebo with p-values of <0.001 for all primary and secondary endpoints across all doses at week 12. The primary and secondary endpoints measuring objective and patient reported improvements in wakefulness, excessive daytime sleepiness, cataplexy, ability to maintain attention, overall quality of life and daily life functions demonstrate statistically significant and clinically meaningful improvements achieving near normal ranges across the broad range of symptoms investigated.

Oveporexton was generally well-tolerated with a safety profile from the Phase 3 studies overall consistent with oveporexton studies to date including the Phase 2b study. No serious treatment-related adverse events were reported. The most common adverse events were insomnia, urinary urgency and frequency. More than 95 percent of the participants who completed the studies enrolled in the ongoing long-term extension (LTE) study.

“We are grateful to the patients who took part in these clinical studies and to their families, the investigators and clinical staff. The studies were accelerated at an unprecedented pace with the aim to bring this potential treatment to people living with narcolepsy type 1 as quickly as possible,” said Andy Plump, M.D., Ph.D., president of R&D at Takeda. “The comprehensive assessments from our Phase 3 studies build on the transformative results we saw with our Phase 2b study with most participants reaching normative ranges and reporting clinically meaningful improvement across a broad range of symptoms at the end of the 12-week treatment period. The positive results also reinforce the continued momentum for our late-stage pipeline, which we believe will deliver value to the patients we serve around the world.”

Takeda intends to present the results at upcoming medical congresses and plans to submit a New Drug Application with the United States Food and Drug Administration and additional global regulatory authorities in fiscal year 2025.

Results from the Phase 3 studies have no significant impact on the full year consolidated forecast for the fiscal year ending March 31, 2026.

About Narcolepsy Type 1 (NT1) and Orexin Science

NT1 is a chronic, rare neurological disease that results in a range of debilitating symptoms including excessive daytime sleepiness (EDS), cataplexy, disrupted nighttime sleep, sleep paralysis and hallucinations upon falling asleep or waking. Additionally, individuals living with NT1 often report cognitive symptoms, including difficulty thinking clearly, remembering, concentrating and paying attention. NT1 is caused by loss of the orexin-producing neurons in the brain, which regulate wakefulness and sleep, and is also believed to be essential to other functions such as attention through activation of orexin receptors. Currently, the standard of care is limited to symptomatic therapies that may only partially address some of the symptoms people face.

About Oveporexton (TAK-861)

Oveporexton (TAK-861) is an investigational orexin receptor 2 (OX2R)-selective agonist, which selectively stimulates the OX2R to restore signaling and address the underlying orexin deficiency that causes narcolepsy type 1 (NT1). By activating OX2Rs, oveporexton is designed to promote wakefulness and reduce abnormal rapid eye movement (REM)-sleep like phenomena, including cataplexy, to address the broad spectrum of daytime and nighttime symptoms.

About the FirstLight and RadiantLight Phase 3 Studies

FirstLight (TAK-861-3001; NCT06470828) and RadiantLight (TAK-861-3002; NCT06505031) are global, multicenter, placebo-controlled studies to evaluate the efficacy, safety and tolerability of oveporexton compared to placebo in patients with narcolepsy type 1 (NT1) over 12 weeks. The studies were conducted in 19 countries with enrollment completed within six months. The FirstLight study enrolled 168 participants randomized to one of three dosing arms (high dose, low dose and placebo). The RadiantLight study enrolled 105 participants randomized to two dosing arms (high dose and placebo). The primary endpoint in both studies was improvement in excessive daytime sleepiness (EDS) as measured by the Maintenance of Wakefulness Test (MWT), a standard measure of wakefulness. Key secondary endpoints included improvement in EDS as measured by the Epworth Sleepiness Scale (ESS) and in the Weekly Cataplexy Rate (WCR), a measure evaluating cataplexy. The studies also evaluated the effect of oveporexton on participants’ ability to maintain attention, participants’ overall quality of life, the spectrum of narcolepsy symptoms and daily life functions, as well as the safety and tolerability of oveporexton.

About Takeda’s Orexin Agonists for Sleep-Wake Disorders

Takeda is leading the field of orexin science with a multi-asset franchise. Orexin is a key regulator of sleep and wake patterns and contributes to other essential functions including attention, mood, metabolism and respiration. Oveporexton (TAK-861) is the lead investigational orexin receptor 2 (OX2R) agonist asset in Takeda’s orexin franchise and received Breakthrough Therapy designation for the treatment of excessive daytime sleepiness in narcolepsy type 1 (NT1) from the U.S. Food and Drug Administration and the Center for Drug Evaluation of China’s National Medical Products Administration. The company is also investigating other orexin agonists in populations with orexin levels in the normal range, including TAK-360, an oral OX2R agonist initially being investigated for the treatment of narcolepsy type 2 (NT2), idiopathic hypersomnia (IH), and other potential indications where orexin signaling is implicated. ​

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.

Contacts

Japanese Media

Yuko Yoneyama

yuko.yoneyama@takeda.com

U.S. and International Media

Rachel Wallace

rachel.wallace2@takeda.com

U.S. FDA Approves KERENDIA® (finerenone) to Treat Patients With Heart Failure With Left Ventricular Ejection Fraction ≥40% Following Priority Review




U.S. FDA Approves KERENDIA® (finerenone) to Treat Patients With Heart Failure With Left Ventricular Ejection Fraction ≥40% Following Priority Review

• KERENDIA^® (finerenone), a non-steroidal mineralocorticoid receptor antagonist (MRA), is the only MRA approved by the U.S. Food and Drug Administration (FDA) for adults with heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40% ¹
• By demonstrating a significant reduction in cardiovascular (CV) death, hospitalization for HF, and urgent HF visits, ¹ KERENDIA is now a core pillar of treatment for patients with HF with LVEF ≥40%
• This FDA approval marks a significant milestone in treatment for the approximately 3.7 million adults in the U.S. with HF with LVEF ≥40%, a population at high risk of hospitalization for heart failure and CV death, even with guideline-directed medical treatment ²

WHIPPANY, N.J.–(BUSINESS WIRE)–Bayer today announced that the U.S. Food and Drug Administration (FDA) approved KERENDIA^® (finerenone) to treat patients with heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40%, ¹ following the agency’s Priority Review of its supplemental New Drug Application (sNDA).

Even with guideline-directed medical treatment, the approximately 3.7 million adults in the U.S. with HF with LVEF ≥40%, also known as mildly reduced ejection fraction (HFmrEF) and preserved ejection fraction (HFpEF), face high rates of hospitalization for HF, impacting survival and placing considerable strain on healthcare systems. ² Each hospitalization is associated with a more than two-fold increase in patients’ risk of cardiovascular (CV) death. ³

The approval was based on results from the Phase III FINEARTS-HF trial, which showed that, on top of standard of care, KERENDIA achieved a 16% relative risk reduction of the composite primary endpoint of CV death and total HF events, defined as hospitalization for HF or an urgent HF visit, compared to placebo on top of standard of care (RR=0.84, 95% CI: 0.74-0.95, p=0.007). 1 The treatment effect was consistent across all prespecified subgroups including with or without SGLT2i use. ¹

KERENDIA is a non-steroidal mineralocorticoid receptor antagonist (nsMRA) that selectively and potently blocks mineralocorticoid receptor overactivation in the heart and kidneys, ^1,4,5 taking aim at HF with LVEF ≥40% from a different angle. ¹

The overall safety profile of KERENDIA was consistent across all studied indications. ¹ From FINEARTS-HF, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (9.7% vs 4.2%), hypotension (7.6% vs 4.7%), hyponatremia (1.9% vs 0.9%), ⁶ and events related to worsening renal function (18% vs 12%). ¹

Detailed results from the Phase III FINEARTS-HF trial were published in the New England Journal of Medicine.⁷

“The FDA’s approval of finerenone expands treatment options for patients with heart failure with a left ventricular ejection fraction of ≥40% – a large and growing group of patients with a poor prognosis,” said Scott D. Solomon, MD, Professor of Medicine, Harvard Medical School, Director, Clinical Trials Outcomes Center, Mass General Brigham, and Chair of the Executive Committee for the FINEARTS-HF study. “Based on the clinical efficacy we saw in the FINEARTS-HF study, finerenone can become a new pillar of comprehensive care.”

“People with heart failure with left ventricular ejection fraction ≥40% face the very real possibilities of hospitalization for heart failure or CV death due to their disease,” ^2,3 said Alanna Morris-Simon, MD, MSc, Senior Medical Director of U.S. Medical Affairs at Bayer. “Even with current treatments, 21% of patients with symptomatic heart failure escalate to hospitalization for heart failure or CV death, ⁸ and 25% who experience hospitalization are readmitted due to heart failure within one year of discharge. ⁹ Now, as a core pillar of treatment, KERENDIA can help patients reduce these risks.”

Since July 2021, KERENDIA has been approved to reduce the risk of CV death, hospitalization for HF, non-fatal myocardial infarction (MI), sustained estimated glomerular filtration rate (eGFR) decline, and end-stage kidney disease in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D). ¹ This new indication expands KERENDIA’s established cardiovascular benefit to a new patient population not limited to CKD associated with T2D—adult patients with HF with LVEF ≥40%. ¹

About FINEARTS-HF ¹⁰

The FINEARTS-HF trial, a randomized, double-blind, placebo-controlled, multicenter, event-driven Phase III trial evaluated the efficacy and safety of KERENDIA for the reduction of risk of CV death and total HF events in patients with a diagnosis of symptomatic HF (New York Heart Association class II-IV) with an LVEF ≥40%, measured by local imaging within the last 12 months as well as receiving diuretic treatment for at least 30 days prior to randomization. The primary endpoint of FINEARTS-HF was the composite of CV death and total (first and recurrent) HF events, defined as hospitalizations for HF or urgent HF visits. Approximately 6,000 participants were randomized to receive either KERENDIA or placebo once daily for up to 42 months in addition to their background HF therapies.

The FINEARTS-HF trial is part of KERENDIA’s MOONRAKER program, which is expected to be one of the largest HF study programs to date. With more than 15,000 patients worldwide, MOONRAKER aims to establish a comprehensive body of evidence for KERENDIA across a broad spectrum of patients and clinical settings. ¹¹

About KERENDIA’s Clinical Trial Program

KERENDIA’s clinical trial program—called FINEOVATE—currently comprises 10 Phase III studies with dedicated programs in HF (MOONRAKER) and CKD (THUNDERBALL). The MOONRAKER program includes FINEARTS-HF as well as the ongoing, collaborative, investigator-sponsored studies REDEFINE-HF, ¹² CONFIRMATION-HF ¹³ and FINALITY-HF. ¹⁴ The THUNDERBALL CKD program consists of the completed studies FIDELIO-DKD and FIGARO-DKD as well as the ongoing investigational studies FIND-CKD, ¹⁵ FIONA, ¹⁶ FIONA-OLE, ¹⁷ and FINE-ONE. ¹⁸

About KERENDIA^® (finerenone) ¹

INDICATIONS:

KERENDIA (finerenone) is indicated to reduce the risk of:

• sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) (10mg, 20mg tablets)
• cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (HF LVEF) ≥40% (10mg, 20mg, 40mg tablets)

IMPORTANT SAFETY INFORMATION ¹

CONTRAINDICATIONS:

• Hypersensitivity to any component of this product ¹
• Concomitant use with strong CYP3A4 inhibitors ¹
• Patients with adrenal insufficiency ¹

WARNINGS AND PRECAUTIONS:

• Hyperkalemia: KERENDIA can cause hyperkalemia. The risk for developing hyperkalemia increases with decreasing kidney function and is greater in patients with higher baseline potassium levels or other risk factors for hyperkalemia. 1

  Measure serum potassium and eGFR in all patients before initiation of treatment with KERENDIA and dose accordingly. Do not initiate KERENDIA if serum potassium is >5 mEq/L. Measure serum potassium periodically during treatment with KERENDIA and adjust dose accordingly. More frequent monitoring may be necessary for patients at risk for hyperkalemia, including those on concomitant medications that impair potassium excretion or increase serum potassium. ¹
  
  

• Worsening of Renal Function in Patients with Heart Failure: KERENDIA can cause worsening of renal function in patients with heart failure. Rarely, severe events associated with worsening renal function, including events requiring hospitalization, have been observed. 1

  Measure eGFR in all patients before initiation of treatment or with dose titration of KERENDIA and dose accordingly. Initiation of KERENDIA in patients with heart failure and an eGFR <25 mL/min/1.73 m² is not recommended. Measure eGFR periodically during maintenance treatment with KERENDIA in patients with heart failure. Consider delaying up-titration or interrupting treatment with KERENDIA in patients who develop clinically significant worsening of renal function. ¹

MOST COMMON ADVERSE REACTIONS:

• CKD associated with T2D: From the pooled data of FIDELIO-DKD and FIGARO-DKD, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (14% vs 6.9%), hypotension (4.6% vs 3%), and hyponatremia (1.3% vs 0.7%). ¹
• HF LVEF ≥40%: From FINEARTS-HF, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (9.7% vs 4.2%), hypotension (7.6% vs 4.7%), and hyponatremia (1.9% vs 0.9%). ⁶ Events related to worsening renal function were reported more frequently in the KERENDIA group (18%) compared with placebo (12%). ¹

DRUG INTERACTIONS:

• Strong CYP3A4 Inhibitors: Concomitant use of KERENDIA with strong CYP3A4 inhibitors is contraindicated. Avoid concomitant intake of grapefruit or grapefruit juice. ¹
• Moderate and Weak CYP3A4 Inhibitors: Monitor serum potassium during drug initiation or dosage adjustment of either KERENDIA or the moderate or weak CYP3A4 inhibitor, and adjust KERENDIA dosage as appropriate. ¹
• Strong and Moderate CYP3A4 Inducers: Avoid concomitant use of KERENDIA with strong or moderate CYP3A4 inducers. ¹
• Sensitive CYP2C8 Substrates at KERENDIA 40mg: Monitor patients more frequently for adverse reactions caused by sensitive CYP2C8 substrates if KERENDIA 40mg is co-administered with such substrates, since minimal concentration changes may lead to serious adverse reactions. ¹

USE IN SPECIFIC POPULATIONS:

• Lactation: Avoid breastfeeding during treatment with KERENDIA and for 1 day after treatment. ¹
• Hepatic Impairment: Avoid use of KERENDIA in patients with severe hepatic impairment (Child Pugh C) and consider additional serum potassium monitoring with moderate hepatic impairment (Child Pugh B). ¹

Please see the Prescribing Information for KERENDIA.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com/
Follow us on Facebook: http://www.facebook.com/bayer
Follow us on X: @BayerPharma

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports, which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Contacts

Media:
Elaine Colón

Bayer Media Relations

elaine.colon@bayer.com
+1-732-236-1587

Samsung Bioepis’ European Whitepaper Proposes Solutions to Bridge Policy Gaps that Hinder Healthy Market Competition and Timely Access to Biosimilar Medicines




Samsung Bioepis’ European Whitepaper Proposes Solutions to Bridge Policy Gaps that Hinder Healthy Market Competition and Timely Access to Biosimilar Medicines

• Despite contributing €56 billion in cost savings across Europe, biosimilars face inadequate and misaligned policies that discourage continued investment in biosimilar development, resulting in ‘biosimilar void’
• Whitepaper proposes multiple policy recommendations to ensure the value of biosimilars is fairly reflected in access and pricing decisions, enabling the biosimilar industry to remain sustainable and continue providing high-quality medicines at affordable prices

INCHEON, Korea–(BUSINESS WIRE)–#biosimilars–Samsung Bioepis Co., Ltd. today published a whitepaper titled ‘Solving the Biosimilar Void in Europe’ that proposes policy recommendations to fully recognize the value of biosimilars and ensure a more sustainable market in Europe.

Biosimilars have played a significant role in alleviating the financial burden on the European healthcare system, having delivered €56 billion in cumulative cost savings across Europe over the past 11 years (2013-2024).¹ However, the current policy environment in Europe, particularly the post-launch pathways, is misaligned to incentivize biosimilar competition. With post-marketing challenges, on top of high development costs, many biologics will not face biosimilar competition at the point of loss of exclusivity (LoE) within the next decade.

The whitepaper proposes several measures to improve current practices that hinder healthy market competition and timely access to biosimilar medicines:

• Health Technology Assessment (HTA) needs to be tailored for biosimilars: With its origin in innovative medicine, HTA is a multidisciplinary process that evaluates the medical, social, economic, and ethical implications of health technologies. Some countries often have oversimplified HTA requirements for biosimilars, where reimbursement decisions are solely based on price comparisons and do not take into account biosimilars’ additional benefits or where the reference biologic is not reimbursed. In many cases, HTA is relevant, but with limited guidance to properly assess the biosimilar’s value. HTA can be more streamlined and tailored to speed up the entry of biosimilars to the market.
• In some countries, pricing and reimbursement (P&R) policies focus on achieving the lowest possible prices through mechanisms such as price linkage and reference pricing, thereby accelerating price erosion: Out of 28 European countries, 12 countries use external reference pricing methods and 17 countries mandate arbitrary discounts on biosimilar prices at an average of 28% below reference product.² Already set at significantly lower levels, biosimilar prices are driven further downward as competition begins, often leading to price erosion that drives players out of the market. Instead of arbitrary price-controls, free pricing will allow price discounts to be achieved naturally through free competition.
• Tenders often favor a single-winner system and tend to overlook broader qualitative factors such as supply stability and quality assurance: National, regional, and local tenders should support supply diversification and fair competition through multi-winner systems, with greater transparency in communication and more periodic tender reopenings so that late entrants are also given opportunities to participate. Security and stability of supply should be given higher priority in tenders to enhance demand predictability and incentivize manufacturers to secure more robust supply chains.
• Biosimilar uptake cannot be achieved without the support of physicians and pharmacists who prescribe and dispense these medicines: Incentives extended to healthcare professionals to encourage the prescribing and dispensing of biosimilars vary significantly across European countries. In some countries, prescriber incentives are misaligned, discouraging the use of biosimilar medicines. Incentive programs should be based on shared decision-making between physicians and patients, rather than automatic switching. Gainsharing can be introduced to stimulate biosimilar uptake while preserving competition and autonomy. Education programs for physicians, pharmacists, and patients should be continued to support wider use of biosimilars.

“Biosimilars are not one-size-fits-all, and establishing a sustainable framework for biosimilars requires a nuanced understanding of their heterogeneous applications across clinical settings. It is vital to tailor key solutions that address the unique challenges faced by different product types, prescribing patterns, and patient and disease characteristics. It is also important to consider the future viability of the market when reshaping policies, as the market needs clear signals of long-term sustainability to encourage continued investments in the biosimilar pipeline,” said Adam Levysohn, Vice President and Head of Commercial Strategy Europe, at Samsung Bioepis. “It is important for healthcare systems to recognize that biosimilars are not merely a cost-saving tool for organizations. Policies should take a patient-centric approach, positioning biosimilars as part of the solution to expand access, improve patient outcomes, ensure supply continuity, and strengthen system resilience.”

Samsung Bioepis is a biopharmaceutical company that develops and manufactures high-quality biosimilars to accelerate patient access to biologic medicines. As a world leader in biosimilars, Samsung Bioepis has a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. Of the 11 biosimilars approved worldwide, eight products are available across Europe.

To access the report Solving the Biosimilar Void in Europe, please visit HERE.

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – LinkedIn, X.

Contacts

MEDIA CONTACT
Anna Nayun Kim, nayun86.kim@samsung.com
Yoon Kim, yoon1.kim@samsung.com

Golden Age Health and Innostellar Biotherapeutics Sign Exclusive 10-Year Collaboration to Accelerate LX-101 Gene Therapy for Inherited Retinal Dystrophies due to RPE 65 gene mutation in Mainland China




Golden Age Health and Innostellar Biotherapeutics Sign Exclusive 10-Year Collaboration to Accelerate LX-101 Gene Therapy for Inherited Retinal Dystrophies due to RPE 65 gene mutation in Mainland China

SHANGHAI–(BUSINESS WIRE)–Golden Age Health Pte. Ltd. (“GAH”) and Innostellar Biotherapeutics Co., Ltd. (“Innostellar”) today announced an exclusive ten-year Promotion Services Agreement that grants GAH sole rights to commercialise and promote Innostellar’s first-in-class gene-therapy candidate LX-101 across Mainland China. Leveraging its full-spectrum patient-focused launch platform covering disease and medical education, market access and patient support to address the unmet needs along the patient journey such as disease awareness, timely diagnosis and treatment, treatment accessibility and affordability. GAH, along with Innostellar will act with urgency to bring this life-changing therapy to patients affected by inherited retinal dystrophies due to RPE 65 gene mutation in Mainland China so they can “see the future, clearly”.

“Partnering with Innostellar positions GAH at the forefront of gene therapy in China’s rapidly expanding ophthalmology market,” said Francis Wan, Chief Executive Officer of Golden Age Health. “Our integrated approach aims to deliver sight-saving innovation to patients swiftly and comprehensively.”

Dr Wang Fenghua, Founder & CEO of Innostellar, added: “By joining forces with GAH, we can ensure LX-101 reaches patients across China rapidly and—crucially—at prices families can afford, thanks to efficiencies gained through local development and manufacturing. Improving patient access lies at the heart of our mission.

About Inherited Retinal Dystrophies

Inherited retinal dystrophies (IRDs)—including retinitis pigmentosa (RP)—are genetic disorders that progressively destroy photoreceptors, leading to severe vision impairment or blindness, often from childhood. RP affects approximately 1 in 3,000–4,000 people worldwide and is officially listed in China’s National Rare Disease Catalog (first list, 2018), underscoring the country’s commitment to improving outcomes for affected patients.

About LX-101

LX-101 is an adeno-associated-virus (AAV) gene therapy delivering a functional RPE65 gene directly to retinal cells, aiming to restore the visual cycle in patients with biallelic RPE65-mutation IRDs. The programme is in Phase III clinical development in China, with top-line results expected in Q4 2025 and initiate NMPA New Drug Application soon after. If approved, LX-101 would provide eligible patients with a single-dose, durable treatment designed to halt—or potentially reverse—vision loss.

About Golden Age Health

Golden Age Health is a specialty pharmaceutical company dedicated to redefining patient access to medicine across China, Asia-Pacific and beyond. Headquartered in Singapore, GAH pairs data-driven market-access expertise with deep medical-affairs and RWE capabilities to bring high-impact therapies to underserved populations.

About Innostellar Biotherapeutics

Innostellar Biotherapeutics is a Shanghai-based biotechnology firm advancing innovative gene-therapy medicines for ocular and other genetic diseases and chronic diseases. Its pipeline is led by LX-101, the first gene therapy of its kind to enter late-stage development in China.

Forward-Looking Statements

This release contains forward-looking statements, including expectations regarding clinical development, regulatory approvals and commercial launches. These statements involve risks and uncertainties that may cause actual outcomes to differ materially.

Contacts

Media & Investor Contacts

Golden Age Health
https://www.gahbioventures.com/
Media/IR: info@gahbioventures.com

Innostellar Biotherapeutics
https://www.innostellarbio.cn/
Media/IR: ir@innostellar.cn

Amylyx Pharmaceuticals Presents New Exploratory Analyses from Phase 2 and Phase 2b Clinical Trials of Avexitide in Post-Bariatric Hypoglycemia at ENDO 2025




Amylyx Pharmaceuticals Presents New Exploratory Analyses from Phase 2 and Phase 2b Clinical Trials of Avexitide in Post-Bariatric Hypoglycemia at ENDO 2025

– Pivotal Phase 3 LUCIDITY trial of avexitide, a potential first-in-class GLP-1 receptor antagonist with FDA Breakthrough Therapy designation, underway in post-bariatric hypoglycemia; completion of recruitment expected in 2025, with topline data anticipated in first half of 2026

– In the Phase 2b trial, avexitide 90 mg once daily led to a 64% least-squares mean reduction in the composite rate of Level 2 and Level 3 hypoglycemic events in post-bariatric hypoglycemia, the FDA-agreed upon primary outcome that LUCIDITY is evaluating

– Population pharmacokinetic and pharmacodynamic data demonstrated avexitide 90 mg once daily has sustained therapeutic exposure for 24 hours

– Amylyx to host an in-person and virtual investor event today, July 13, 2025, at 6:00 p.m. PT / 9:00 p.m. ET

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced the presentation of new exploratory analyses from the Phase 2 PREVENT and Phase 2b clinical trials of avexitide, an investigational, first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist for the treatment of post-bariatric hypoglycemia (PBH) at the Endocrine Society’s annual meeting (ENDO 2025).

In the Phase 2b trial, avexitide 90 mg once daily, the dose being evaluated in the pivotal Phase 3 LUCIDITY trial, led to a 64% least-squares (LS) mean reduction (p=0.0031) vs. baseline in the composite rate of Level 2 and Level 3 hypoglycemic events in PBH, with more than half of the participants experiencing no events during the treatment period. LUCIDITY is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating the efficacy and safety of avexitide in approximately 75 participants with PBH following Roux-en-Y gastric bypass surgery. The FDA-agreed-upon primary endpoint of LUCIDITY is reduction in the composite of Level 2 and Level 3 hypoglycemic events. Consistent reductions in composite rate of Level 2 and Level 3 hypoglycemic events also were seen with avexitide 45 mg twice daily studied in the Phase 2b trial and avexitide 30 mg twice daily and 60 mg once daily studied in the Phase 2 PREVENT trial. New pharmacokinetic (PK) and pharmacodynamic (PD) data were also presented demonstrating continuous pharmacologic activity of the 90 mg once daily dose regimen for a 24-hour period.

“Post-bariatric hypoglycemia can profoundly disrupt daily life, requiring individuals to carefully manage meals, social interactions, and routines, often while living in fear of their next hypoglycemic event. The new analysis presented at ENDO 2025 continues to support that avexitide may significantly reduce the frequency of these events,” said Marilyn Tan, MD, FACE, Principal Investigator of the LUCIDITY trial and Clinical Associate Professor at Stanford University.

Camille L. Bedrosian, MD, Chief Medical Officer of Amylyx, added, “Post-bariatric hypoglycemia is a serious and underrecognized condition with no FDA-approved treatments. The data presented show that, in an exploratory analysis from the Phase 2 PREVENT and Phase 2b clinical trials, avexitide significantly reduced the composite rate of Level 2 and 3 hypoglycemic events, including at the 90 mg once daily dose that is being studied in our pivotal Phase 3 LUCIDITY trial. We are particularly encouraged that over half of participants did not experience Level 2 or Level 3 hypoglycemic events during the treatment period. In addition, the pharmacokinetic and pharmacodynamic data demonstrated continuous pharmacologic activity of avexitide 90 mg once daily dose over 24 hours. We continue to be encouraged by avexitide’s potential to deliver consistent, meaningful benefit to people living with PBH.”

The population PK and PD analyses presented at ENDO 2025 demonstrated that avexitide 90 mg once daily maintained consistent GLP-1 receptor inhibition from morning to midnight and between doses. In vitro potency studies showed an IC₅₀ of approximately 20-30 nM (70-100 ng/mL), indicating robust target inhibition even in the presence of significant levels of GLP-1. PK modeling demonstrated that avexitide plasma levels exceeded IC₅₀ for a full 24-hour period.

LUCIDITY was informed by data from five PBH clinical trials of avexitide showing consistent, dose-dependent effects, including statistically significant and clinically meaningful reductions in hypoglycemic events. Avexitide was generally well-tolerated, with a favorable safety profile replicated across clinical trials. Completion of recruitment for LUCIDITY is expected in 2025, with a data readout anticipated in the first half of 2026 and, if approved, commercial launch anticipated in 2027.

The presentation and posters are available on the “Presentations” tab of the Amylyx website.

Webcast Information

Amylyx will host an investor event today, July 13, 2025, at 6:00 p.m. PT / 9:00 p.m. ET in San Francisco to discuss post-bariatric hypoglycemia and avexitide. A live webcast of the presentation and Q&A portion of the event can be accessed under “Events and Presentations” in the Investor section of the Company’s website, https://investors.amylyx.com/events-presentations. The webcast will be archived and available for replay for 90 days following the event.

About Avexitide

Avexitide is an investigational, first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist that has been evaluated in five Phase 1 and Phase 2 clinical trials for post-bariatric hypoglycemia (PBH) and has also been studied in congenital hyperinsulinism (HI). The U.S. Food and Drug Administration (FDA) has granted avexitide Breakthrough Therapy Designation for both indications, Rare Pediatric Disease Designation in congenital HI, and Orphan Drug Designation for the treatment of hyperinsulinemic hypoglycemia (which includes PBH and congenital HI). Avexitide is designed to bind to the GLP-1 receptor on pancreatic islet beta cells and inhibit the effect of GLP-1 to mitigate hypoglycemia by decreasing insulin secretion and stabilizing blood glucose levels. In PBH, excessive GLP-1 can lead to the hypersecretion of insulin and subsequent debilitating hypoglycemic events. In two Phase 2 PBH clinical trials, avexitide demonstrated highly statistically significant reductions in hypoglycemic events. These events can lead to autonomic and neuroglycopenic symptoms that can have a devastating impact on daily living.

About Post-Bariatric Hypoglycemia (PBH)

Post-bariatric hypoglycemia (PBH) is a condition that is estimated to affect approximately 8% of people in the U.S. who have undergone the two most common types of bariatric surgery, sleeve gastrectomy and Roux-en-Y gastric bypass (approximately 160,000 people in the U.S.). PBH is thought to be caused by an excessive glucagon-like peptide-1 (GLP-1) response leading to hypoglycemia and impaired quality of life. PBH can cause debilitating hypoglycemic events associated with inadequate supply of glucose to the brain, known as neuroglycopenia. Clinical manifestations can include impaired cognition, loss of consciousness, and seizures. PBH is also associated with a high degree of disability that can result in major disruptions to independent living. There are no approved therapies for PBH.

About the LUCIDITY Trial

LUCIDITY (NCT06747468) is an approximately 75-participant, multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating the efficacy and safety of avexitide in participants with PBH following Roux-en-Y gastric bypass (RYGB) surgery. The Phase 3 trial will be conducted at approximately 20 sites in the U.S. Participants will be randomized 3:2 to receive either 90 mg of avexitide subcutaneously once daily or placebo. The trial includes an up to six-week screening period, including a three-week run-in period, and a 16-week double-blind treatment period. Participants who complete the double-blind period will be eligible to enter an open-label extension (OLE) period with a duration of 32 weeks. The primary efficacy objective of LUCIDITY will evaluate the FDA-agreed upon primary outcome of reduction in the composite of Level 2 and Level 3 hypoglycemic events through Week 16. Safety and tolerability will also be evaluated.

About Amylyx Pharmaceuticals

At Amylyx, our mission is to usher in a new era of treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are currently focused on three investigational therapies across several neurodegenerative and endocrine diseases in which we believe they can make the greatest impact. For more information, visit amylyx.com and follow us on LinkedIn and X. For investors, please visit investors.amylyx.com.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, Amylyx’ expectations regarding: the potential of avexitide as a treatment for PBH; expectations regarding the timing for recruitment completion and topline data readout of the Phase 3 LUCIDITY trial of avexitide in PBH; and expectations regarding timing for potential commercialization of avexitide. Any forward-looking statements in this press release and related comments in the Company’s earnings conference call are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of Amylyx’ program development activities; Amylyx’ ability to execute on its regulatory development plans and expectations regarding the timing of results from its planned data announcements and initiation of clinical studies; the risk that early-stage results may not reflect later-stage results; Amylyx’ ability to fund operations, and the impact that global macroeconomic uncertainty, geopolitical instability, and public health events will have on Amylyx’ operations, as well as the risks and uncertainties set forth in Amylyx’ United States Securities and Exchange Commission (SEC) filings, including Amylyx’ Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent filings with the SEC. All forward-looking statements contained in this press release and related comments in our earnings conference call speak only as of the date on which they were made. Amylyx undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Contacts

Media
Amylyx Media Team

(857) 320-6191

amylyxmediateam@amylyx.com

Investors
Lindsey Allen

(857) 320-6244

Investors@amylyx.com

Quanterix Corporation Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)




Quanterix Corporation Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

BILLERICA, Mass.–(BUSINESS WIRE)–Quanterix Corporation (“Quanterix” or the “Company”) (NASDAQ: QTRX), a company fueling scientific discovery through ultra-sensitive biomarker detection, today announced that on July 8, 2025, the Company approved inducement grants of restricted stock units (“RSUs”) representing 267,269 shares of Quanterix common stock to twenty employees newly-hired in connection with the acquisition of Akoya Biosciences, Inc. The equity awards were granted pursuant to the Nasdaq Rule 5635(c)(4) inducement grant exception as a component of each individual’s employment compensation and were granted as an inducement material to his or her acceptance of employment with the Company. The RSUs vest in full on the one year anniversary of the grant date, subject to the applicable individual’s continued employment with the Company or one of its subsidiaries through the vesting date.

About Quanterix

Quanterix is a global leader in ultra-sensitive biomarker detection, enabling breakthroughs in disease research, diagnostics, and drug development. Its proprietary Simoa^® technology delivers industry-leading sensitivity, allowing researchers to detect and quantify biomarkers in blood and other fluids at concentrations far below traditional limits. With more than 3,400 peer-reviewed publications, Quanterix has been a trusted partner to the scientific community for nearly two decades. In 2025, Quanterix acquired Akoya Biosciences, The Spatial Biology Company^®, adding multiplexed tissue imaging with single-cell resolution to its portfolio. Together, the combined company offers a uniquely integrated platform that connects biology across blood and tissue—advancing precision medicine from discovery to diagnostics.

Learn more at www.quanterix.com.

Contacts

Media
Marissa Klaassen

media@quanterix.com

Investor Relations
Joshua Young

ir@quanterix.com

SINOVAC Board Sets the Record Straight on July 8 Special Meeting of Shareholders




SINOVAC Board Sets the Record Straight on July 8 Special Meeting of Shareholders

Special Meeting validly adjourned until the appropriate court makes a final decision on validity of the PIPE shares and will be reconvened

SAIF and the Dissenting Investor Group’s deceptive claims of a “continuation of the Special Meeting” and a pretend “Board” are fake and without legal basis

Current Board remains the only valid board of directors of SINOVAC and will continue to govern the Company

BEIJING–(BUSINESS WIRE)–The Board of Directors of SINOVAC Biotech Ltd. (NASDAQ: SVA) (“SINOVAC” or the “Company”) today issued the following update to set the record straight regarding the Special Meeting of Shareholders (the “Special Meeting”):

• The Special Meeting was validly adjourned by SINOVAC Chairman Chiang Li on July 8, 2025, due to pending litigation in Antigua regarding the validity of the shares purportedly issued following an invalid private investment in public equity (“PIPE”) to Advantech/Prime and Vivo Capital (together known as the “Dissenting Investor Group”). The adjournment has been recognized by the independent Inspector of Elections who has the sole authority to announce and certify the results of the Special Meeting.

• SAIF’s false claim that a “continuation of the Special Meeting” occurred is intentionally deceptive and entirely illegal under the Company’s bylaws and Antiguan law. Immediately after the Special Meeting was validly adjourned and the virtual meeting was terminated, a group of lawyers representing SAIF and the Dissenting Investor Group purportedly self-organized an invalid, pretend special meeting at an unannounced location and time. This group did not give advance notice to valid shareholders or give them an option to attend, and they did not contact SINOVAC Chairman Chiang Li, the only authorized chair for the Special Meeting. No inspector of elections presided over the pretend special meeting. The current SINOVAC Board understands Mr. Yuk Lam Lo attended the invalid meeting with the understanding that he had no authority to chair any such shareholder meeting. At the pretend special meeting, this group announced pretend “voting results” from a “vote” that did not take place due to the valid adjournment. The following day, SAIF and the Dissenting Investor Group held a pretend meeting to elect a pretend Chairman. Valid SINOVAC shareholders are admonished to ignore these theatrics. The Board, consisting of Dr. Chiang Li (Chairman), Mr. Yuk Lam Lo, Mr. Sven Borho and Mr. Geoffrey Hsu, retains full authority to run SINOVAC. None of the pretend board’s rogue actions are valid or legal. SAIF and the Dissenting Investor Group will be held responsible.

• At the time of the Special Meeting, the injunction granted by the Eastern Caribbean Supreme Court of Antigua and Barbuda (the “Antigua High Court”) on July 7, 2025 – prohibiting the PIPE shares from voting at the meeting – had not been overturned. While the Eastern Caribbean Court of Appeal temporarily stayed the injunction order, the stay is in place until a hearing is held to determine whether such stay should have been granted. On July 11, 2025, Judge Bakre of the Antigua High Court issued a ruling, which stated that granting a stay would make a “mockery” of this case.

• There are ongoing legal proceedings in Antigua to determine the validity of the PIPE shares. The current Board will reconvene the Special Meeting once this issue is resolved by the proper court. During this period, voting is unavailable. All valid shareholders will have their vote counted at the validly reconvened Special Meeting.

• The current SINOVAC Board remains in place, is governing the Company, and is executing on its stated priorities. These include dividend distributions according to its previously announced policy, in addition to the ongoing payment of the US$55.00 per common share special cash dividend paid to valid shareholders or their brokers beginning on July 7, 2025, working with NASDAQ to resume trading, the appointment of a new auditor, and exploring a future listing on the Stock Exchange of Hong Kong to promote liquidity and maximize value creation.

The SINOVAC Board urges all shareholders to rely only on official communications from the rightful Board for accurate information. The Board remains committed to transparency and the rule of law and will provide further updates as developments occur.

For ongoing updates and further information, please visit www.votesinovac.com.

About SINOVAC

Sinovac Biotech Ltd. (SINOVAC) is a China-based biopharmaceutical company that focuses on the R&D, manufacturing, and commercialization of vaccines that protect against human infectious diseases.

SINOVAC’s product portfolio includes vaccines against COVID-19, enterovirus 71 (EV71) infected Hand-Foot-Mouth disease (HFMD), hepatitis A, varicella, influenza, poliomyelitis, pneumococcal disease, etc.

The COVID-19 vaccine, CoronaVac®, has been approved for use in more than 60 countries and regions worldwide. The hepatitis A vaccine, Healive®, passed WHO prequalification requirements in 2017. The EV71 vaccine, Inlive®, is an innovative vaccine under “Category 1 Preventative Biological Products” and commercialized in China in 2016. In 2022, SINOVAC’s Sabin-strain inactivated polio vaccine (sIPV) and varicella vaccine were prequalified by the WHO.

SINOVAC was the first company to be granted approval for its H1N1 influenza vaccine Panflu.1®, which has supplied the Chinese government’s vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine, Panflu®, to the Chinese government stockpiling program.

SINOVAC continually dedicates itself to new vaccine R&D, with more combination vaccine products in its pipeline, and constantly explores global market opportunities. SINOVAC plans to conduct more extensive and in-depth trade and cooperation with additional countries, and business and industry organizations.

Important Additional Information and Where to Find It

In connection with SINOVAC’s Special Meeting, SINOVAC has filed with the U.S. Securities and Exchange Commission (“SEC”) and mailed to shareholders of record entitled to vote at the Special Meeting a definitive proxy statement and other documents, including a WHITE proxy card. SHAREHOLDERS ARE ENCOURAGED TO READ THE PROXY STATEMENT AND ALL OTHER RELEVANT DOCUMENTS WHEN FILED WITH THE SEC AND WHEN THEY BECOME AVAILABLE BECAUSE THOSE DOCUMENTS WILL CONTAIN IMPORTANT INFORMATION. Investors and other interested parties will be able to obtain the documents free of charge at the SEC’s website, www.sec.gov, or from SINOVAC at its website: https://www.sinovac.com/en-us/Investors/sec_filings. You may also obtain copies of SINOVAC’s definitive proxy statement and other documents, free of charge, by contacting SINOVAC’s Investor Relations Department at ir@sinovac.com.

Safe Harbor Statement

This announcement contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “may,” “will,” “expect,” “anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,” “potential,” “continue,” “is/are likely to” or other similar expressions. Such statements are based upon current expectations and current market and operating conditions and relate to events that involve known or unknown risks, uncertainties and other factors, all of which are difficult to predict and many of which are beyond the Company’s or Board’s control, which may cause actual results, performance or achievements to differ materially from those in the forward-looking statements. Further information regarding these and other risks, uncertainties or factors is included in the Company’s filings with the U.S. Securities and Exchange Commission. The Company and Board do not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under law.

Contacts

Investor and Media Contact


FGS Global

Sinovac@fgsglobal.com

Median Technologies Signs Financial Agreement for up to €37.5 Million New Financing Facility With the European Investment Bank (EIB)




Median Technologies Signs Financial Agreement for up to €37.5 Million New Financing Facility With the European Investment Bank (EIB)

SOPHIA ANTIPOLIS, France–(BUSINESS WIRE)–Regulatory News:

Median Technologies (FR0011049824, ALMDT, PEA-PME scheme eligible, “Median” or the “Company”), manufacturer of eyonis^®, a suite of artificial intelligence (AI) powered Software as a Medical Device (SaMD) for early cancer diagnosis, and a globally leading provider of AI-based image analyses and central imaging services for oncology drug developers, announced today that the Company signed a financial agreement with the European Investment Bank (EIB) for a new financing facility of up to €37.5 million, on July 11, 2025.

The signature of the financial agreement is in line with previous announcements on January 24, 2025, and April 24, 2025 stating that Median and the EIB were working to conclude an agreement for a new financing facility.

“We welcome the conclusion of our discussions with the European Investment Bank and the signature of the financial agreement”, said Fredrik Brag, CEO and Founder of Median Technologies. “We are very honored to belong to the European innovative ecosystem supported by the EIB, and to contribute to the European technological sovereignty. Proceeds from this new EIB financing facility will strengthen our financial independence to negotiate the best possible options for the commercialization of eyonis^® LCS in U.S. and in Europe.”

Financing Facility Structure

The EIB 2025 financing facility could be drawn in three (3) tranches, i.e., €19 million (Tranche A), €8.5 million (Tranche B) and €10 million (Tranche C).

Median Technologies will request the drawdown of the €19 million Tranche A, as soon as all contractual conditions with respect to such tranche, are satisfied, specifically:

• Full issuance of the EIB new Tranche A warrants to the EIB and registration, in accordance with the warrant issuance agreement,
• Completion of a share capital increase for an amount at least equal to €16 million (issuance premium included),
• Repayment of the first tranche of the previous EIB 2019 loan, for which the maturity has been extended from April to October 2025.

Furthermore, the Company has undertaken to have secured by June 30, 2026, incremental equity financing in a total amount of at least €10 million.

The characteristics of tranche A are:

• Maturity of 72 months, and monthly amortization over a period of 36 months after a 36-month grace period,
• Annual interest rate of 5%.

The release of the tranche A of €19 million will result in the issuance of warrants which quantity and exercise price will depend on the stock price on the date of issuance. At current trading stock price, and after fulfilment of all drawdown conditions, the total amount of shares resulting from the exercise of the warrants would represent 10% of the share capital.

As stated in the financial agreement, Tranche B and Tranche C disbursements remain at Median’s discretion, subject to certain conditions which are specified in the financial agreement.

Intended use of proceeds

The EIB funds will be to support eyonis^® Lung Cancer Screening (LCS) progress towards major milestones consisting of commercial launch and sales development in the U.S and in Europe, and to accelerate the expansion of Median’s proprietary suite of Software as a Medical Device, eyonis^®, for image-based early cancer diagnosis, notably the scientific and clinical development of eyonis^® IPN for incidental findings of pulmonary nodules, and eyonis^® HCC, for primary liver cancer early diagnosis.

eyonis^® LCS progress status and next steps

Regulatory filings for marketing in U.S. and Europe and marketing authorizations:

• On May 14, 2025, Median Technologies announced the filing of an application to the U.S. Food and Drug Administration (FDA) for 510(k) clearance of eyonis^® LCS.
• On July 1, 2025, the Company announced the filing of an application for Class IIb CE marking of eyonis^® LCS.
• Given the usual timelines for regulatory review, the U.S. FDA 510(k) clearance for eyonis^® LCS is expected around the end of Q3 2025, expected to be followed by commercial launch in the US. Median Technologies expects European marketing authorization for eyonis^® LCS as soon as Q1 2026.

Commercial launch

• Median Technologies is actively engaged in discussions with several leading players in AI- diagnostic and imaging equipment manufacturing, for the commercialization of eyonis^® LCS. Some of these strategic partnerships are expected to be finalized upon FDA marketing authorization of eyonis^® LCS.
• The Company has finalized its US market access strategy, based on a comprehensive mapping of medical institutions involved in screening procedures, particularly in the United States, eyonis^® LCS’ first and leading market. This mapping has enabled the identification of health institutions generating the highest volume of lung cancer screening procedures, positioning them as key drivers for the commercial launch of eyonis^® LCS.
• Discussions with U.S. payers will be initiated upon FDA marketing authorization. At this stage, preliminary studies have been conducted to estimate the projected economic benefits of using eyonis^® LCS in lung cancer screening programs. To date, the Company has developed a detailed mapping of payers in the United States. Furthermore, an initial analysis based on a health economics Markov model simulating lung cancer progression over five years and incorporating the performance of eyonis^® LCS, demonstrates that eyonis^® LCS enhances early detection and characterization, reduces unnecessary health procedures, and generates significant cost savings for U.S. payers. The results of this preliminary analysis were presented at ISPOR 2025, the leading global conference for health economics and market access, held this past May. Results from the study are available on Median’s website.
• Over the past year, the Median eyonis^® team has built a very substantial network of early adopters composed of key opinion leaders. The team has conducted numerous visits to leading healthcare institutions and actively participated in major medical conferences organized by medical societies in pulmonology, oncology, and radiology, both in the U.S. and Europe, including the Radiological Society of North America (RSNA), the European Radiology Society (ESR), the American Thoracic Society (ATS), the European Society of Thoracic Imaging (ESTI), the European Society of Medical Oncology (ESMO), and the American Society of Clinical Oncology (ASCO). The Company now enjoys strong recognition of its eyonis^® LCS technology within the medical community, along with a strong brand image associated with the product. Most of the leading healthcare institutions in contact with Median have expressed interest in participating in future health economics studies, which will be launched following regulatory market approvals.

About Median Technologies: Pioneering innovative software as a medical device and imaging services, Median Technologies harnesses cutting-edge AI to enhance the accuracy of early cancer diagnoses and treatments. Median’s offerings include iCRO, which provides medical image analysis and management in oncology trials, and eyonis™, an AI/ML tech-based suite of software as a medical device (SaMD). Median empowers biopharmaceutical entities and clinicians to advance patient care and expedite the development of novel therapies. The French-based company, with a presence in the U.S. and China, trades on the Euronext Growth market (ISIN: FR0011049824, ticker: ALMDT). Median is also eligible for the French SME equity savings plan scheme (PEA-PME). For more information, visit www.mediantechnologies.com.

Forward-Looking Statements

This press release contains forward-looking statements. These statements are not historical facts. They include projections and estimates, as well as the assumptions on which these are based, statements concerning projects, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, or future performance.

These forward-looking statements can often be identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates” or “plans” and any other similar expressions. Although Median’s management believes that these forward-looking statements are reasonable, investors are cautioned that forward-looking statements are subject to numerous risks and uncertainties, many of which are difficult to predict and generally beyond the control of Median Technologies, that could cause actual results and events to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements.

All forward-looking statements in this press release are based on information available to Median Technologies as of the date of the press release. Median Technologies does not undertake to update any forward-looking information or statements, subject to applicable regulations, in particular Articles 223-1 et seq. of the General Regulation of the French Autorité des Marchés Financiers.

Contacts

MEDIAN TECHNOLOGIES
Emmanuelle Leygues

VP, Corporate Marketing & Financial Communications

+33 6 10 93 58 88

emmanuelle.leygues@mediantechnologies.com

Investors – SEITOSEI ACTIFIN
Ghislaine Gasparetto

+33 6 21 10 49 24

ghislaine.gasparetto@seitosei-actifin.com

U.S. media & investors – COHESION BUREAU
Chris Maggos

+41 79 367 6254

chris.maggos@cohesionbureau.com

Press – ULYSSE COMMUNICATION
Bruno Arabian

+33 6 87 88 47 26

barabian@ulysse-communication.com
Nicolas Entz

+33 6 33 67 31 54

nentz@ulysse-communication.com

Walgreens Boots Alliance Shareholders Overwhelmingly Approve Transaction with Sycamore Partners




Walgreens Boots Alliance Shareholders Overwhelmingly Approve Transaction with Sycamore Partners

Transaction expected to close in the third or fourth quarter of calendar year 2025

DEERFIELD, Ill.–(BUSINESS WIRE)–Walgreens Boots Alliance, Inc. (Nasdaq: WBA) (the “Company” or “WBA”) today announced that at the Company’s Special Meeting of Shareholders (the “Special Meeting”), WBA shareholders approved the previously announced acquisition of the Company by entities affiliated with Sycamore Partners Management, L.P. (“Sycamore”).

According to the preliminary results, approximately 96% of votes cast at the Special Meeting by all shareholders were voted in favor of the merger agreement proposal. In addition, approximately 95% of the votes cast at the Special Meeting by unaffiliated shareholders were voted in favor of the merger agreement proposal.

“We appreciate the consideration and overwhelming support from our shareholders in our value-maximizing transaction with Sycamore,” said Tim Wentworth, Chief Executive Officer of Walgreens Boots Alliance. “With Sycamore’s partnership, we will be better positioned to accelerate our turnaround strategy, further enhance the customer, patient and team member experience and become the first choice for pharmacy, retail and health services. We look forward to closing the transaction and entering this next chapter.”

As previously announced on March 6, 2025, under the terms of the Merger Agreement, WBA shareholders will receive $11.45 per share in cash at closing, and one non-transferable Divested Asset Proceeds Right to receive up to an additional $3.00 in cash per share from the future monetization of WBA’s debt and equity interests in VillageMD, which includes the Village Medical, Summit Health and CityMD businesses.

WBA expects to close the transaction in the third or fourth quarter of calendar year 2025, subject to customary closing conditions, including the receipt of required regulatory approvals.

The final voting results of the Special Meeting will be reported in a Form 8-K filed by WBA with the U.S. Securities and Exchange Commission.

Advisors

Centerview Partners is acting as financial advisor, Kirkland & Ellis LLP is acting as legal advisor and Ropes & Gray LLP is acting as healthcare regulatory counsel to WBA. Morgan Stanley & Co. LLC was also a financial advisor, and provided a fairness opinion to the WBA Board of Directors.

About Walgreens Boots Alliance

Walgreens Boots Alliance (Nasdaq: WBA) is an integrated healthcare, pharmacy and retail leader serving millions of customers and patients every day, with a 175-year heritage of caring for communities.

A trusted, global innovator in retail pharmacy with approximately 12,500 locations across the U.S., Europe and Latin America, WBA plays a critical role in the healthcare ecosystem. Through dispensing medicines, improving access to pharmacy and health services, providing high quality health and beauty products and offering anytime, anywhere convenience across its digital platforms, WBA is shaping the future of healthcare in the thousands of communities it serves and beyond.

WBA employs approximately 312,000 people, with a presence in eight countries and consumer brands including: Walgreens, Boots, Duane Reade, No7 Beauty Company and Benavides. The Company is proud of its contributions to healthy communities, a healthy planet, an inclusive workplace and a sustainable marketplace. In fiscal 2024, WBA scored 100% on the Disability Equality Index for disability inclusion.

More Company information is available at www.walgreensbootsalliance.com.

(WBA-GEN)

Forward-Looking Statements

This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include all statements that do not relate solely to historical or current facts, such as statements regarding our expectations, intentions or strategies regarding the future. In some cases, you can identify forward-looking statements by the use of forward-looking terminology such as “accelerate,” “aim,” “ambition,” “anticipate,” “approximate,” “aspire,” “assume,” “believe,” “can,” “continue,” “could,” “create,” “enable,” “estimate,” “expect,” “extend,” “forecast,” “future,” “goal,” “guidance,” “intend,” “long-term,” “may,” “model,” “ongoing,” “opportunity,” “outlook,” “plan,” “position,” “possible,” “potential,” “predict,” “preliminary,” “project,” “seek,” “should,” “strive,” “target,” “transform,” “trend,” “vision,” “will,” “would,” and variations of these terms or other similar expressions, although not all forward-looking statements contain these words. Such statements include, but are not limited to, statements regarding the proposed transaction, our ability to consummate the proposed transaction on the expected timeline or at all, the anticipated benefits of the proposed transaction, and the terms, the impact of the proposed transaction on our future business, results of operations and financial condition and the scope of the expected financing in connection with the proposed transaction. Forward-looking statements are based on current estimates, assumptions and beliefs and are subject to known and unknown risks and uncertainties, many of which are beyond our control, that may cause actual results to vary materially from those indicated by such forward-looking statements. Such risks and uncertainties include, but are not limited to: (i) the risk that the proposed transaction may not be completed in a timely manner or at all; (ii) the ability of affiliates of Sycamore Partners to obtain the necessary financing arrangements set forth in the commitment letters received in connection with the proposed transaction; (iii) the failure to satisfy any of the conditions to the consummation of the proposed transaction, including the receipt of certain regulatory approvals; (iv) the occurrence of any event, change or other circumstance or condition that could give rise to the termination of the transaction agreements, including in circumstances requiring the Company to pay a termination fee; (v) the effect of the announcement or pendency of the proposed transaction on the Company’s business relationships, operating results and business generally; (vi) the risk that the proposed transaction disrupts the Company’s current plans and operations; (vii) the Company’s ability to retain and hire key personnel and maintain relationships with key business partners and customers, and others with whom it does business; (viii) risks related to diverting management’s attention from the Company’s ongoing business operations; (ix) significant or unexpected costs, charges or expenses resulting from the proposed transaction; (x) pending and potential litigation relating to the proposed transaction against the parties to the transaction agreements or their respective directors, managers or officers, including the effects of any outcomes related thereto; (xi) uncertainties related to the continued availability of capital and financing and rating agency actions; (xii) certain restrictions during the pendency of the proposed transaction that may impact the Company’s ability to pursue certain business opportunities or strategic transactions; (xiii) uncertainty as to timing of completion of the proposed transaction; (xiv) the risk that the holders of Divested Asset Proceed Rights will receive less-than-anticipated payments or no payments with respect to the Divested Asset Proceed Rights after the closing of the proposed transaction and that such rights will expire valueless; (xv) the impact of adverse general and industry-specific economic and market conditions; (xvi) the possibility that alternative transaction proposals will or will not be made; (xvii) though no such transactions existed, the possibility that, if the Company did not enter into the transaction agreements, it potentially could have, at a later date, attempted to engage in other, unspecified transactions, including restructuring efforts, special dividends or the sale of some or all of the Company’s assets that may have produced a higher aggregate value than that available to the Company’s stockholders in the merger; (xviii) the risk that the Company’s stock price may decline significantly if the merger is not completed and (xviv) other risks, assumptions and uncertainties described in Item 1A (Risk Factors) of our Form 10-K for the fiscal year ended August 31, 2024, as amended and supplemented by those described in Item 1A (Risk Factors) of our Form 10-Q for the fiscal quarter ended May 31, 2025, and in other documents that we file or furnish with the SEC.

These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions, known or unknown, that could cause actual results to vary materially from those indicated or anticipated. If one or more of these risks or uncertainties materializes, or if underlying assumptions prove incorrect, actual results may vary materially from those indicated or anticipated by such forward-looking statements. All forward-looking statements we make or that are made on our behalf are qualified by these cautionary statements. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made.

We do not undertake, and expressly disclaim, any duty or obligation to update publicly any forward-looking statement after the date of this release, whether as a result of new information, future events, changes in assumptions or otherwise.

Contacts

Media:
Jonathon Hosea

Media@wba.com

Investor Relations:
Brian Holzer

Investor.relations@wba.com

CEL-SCI to Sign Partnership Agreement With Leading Saudi Arabian Pharma Company for Multikine in the Treatment of Head & Neck Cancer




CEL-SCI to Sign Partnership Agreement With Leading Saudi Arabian Pharma Company for Multikine in the Treatment of Head & Neck Cancer

Strong interest from Saudi investment funds in CEL-SCI, Multikine, and potential joint venture to address the wider Middle East and North Africa market

Patient access and reimbursement/sale in Saudi Arabia within approximately 60 days following filing for Breakthrough Medicine Designation

VIENNA, Va.–(BUSINESS WIRE)–$CVM #Multikine—CEL-SCI Corporation (NYSE American: CVM) today announced it has reached an agreement with one of Saudi Arabia’s premier pharmaceutical and healthcare companies for a partnership that spans regulatory and commercial activities for Multikine* (Leukocyte Interleukin, Injection) in the Kingdom of Saudia Arabia. The formal agreement is expected to be signed with the Saudi pharmaceutical partner which will file a Breakthrough Medicine Designation application for Multikine with the Saudi Food and Drug Authority (SFDA) in the coming weeks. According to the SFDA, the response time to a Breakthrough Medicine Designation application is approximately 60 days. Following the granting of the Breakthrough Medicine Designation, Multikine would immediately become available for patient access and reimbursement/sale in Saudi Arabia. Several leading Saudi funds have expressed interest in investing in Multikine, CEL-SCI, and/or a potential joint venture to serve the wider Middle East and North Africa (MENA) market.

While CEL-SCI has the option of filing for Breakthrough Medicine Designation directly, the Company made a strategic decision to collaborate with its local partner for the regulatory filing and subsequent commercial distribution in Saudi Arabia. In a prior meeting with the SFDA, the Saudi regulatory agency provided guidance and encouragement to seek breakthrough approval for Multikine in head and neck cancer. CEL-SCI and its Saudi pharma partner believe that Multikine meets all requirements for Breakthrough Medicine Designation as published by the SFDA and are now developing a comprehensive commercialization plan. This plan leverages the partner’s deep expertise in the local healthcare market to rapidly take Multikine through regulatory approvals and into distribution.

“We have been directly, and through our representative, First Berlin of Germany and its local Saudi representatives, engaging with medical, regulatory and financial experts in Saudi Arabia in preparation for the regulatory filing to the SFDA. These meetings and the support of leaders in the pharmaceutical industry, healthcare and other sectors in Saudi Arabia, are critical ingredients to bringing our cancer drug to market in the Kingdom. Several meetings have also occurred with some of the most important Saudi Arabian funds that have expressed interest in investing in CEL-SCI directly or the venture between CEL-SCI and our Saudi pharma partner,” stated CEL-SCI CEO, Geert Kersten.

Martin Bailey, Managing Director and Founder of First Berlin, commented, “We are seeing a significant level of interest in Multikine and CEL-SCI amongst Saudi investment and healthcare leaders. What CEL-SCI offers is exactly in line with Saudi Arabia’s Vision 2030 initiative which seeks to make the Kingdom a global biotech hub. Given the SFDA’s short timeline, this is a near term opportunity for local in-country investors to help bring a much-needed cancer treatment to market while also supporting their nation’s health-tech goals.”

Multikine is an immunotherapy administered before surgery as a treatment for newly diagnosed previously untreated head and neck cancer. In the world’s largest head and neck cancer study spanning 20 countries, Multikine increased the 5-year survival rate of the target patient population to 73% vs 45% in patients treated with standard of care alone. The 5-year risk of death was halved from 55% to 27%.

About the SFDA’s Breakthrough Medicine Program

The SFDA Breakthrough Medicine Program aims to facilitate and accelerate development and review of new drugs that address unmet medical needs in the treatment of serious or life-threatening conditions in alignment with Saudi Arabia’s Vision 2030 initiative. The program is voluntary and based on early dialogue with drug developers to optimize development plans and speed up evaluation. The goal is to ensure that promising medicines are available as soon as it can be concluded that the medicines’ benefits justify their risks.

Eligibility include having to fulfill all of the following four criteria in order to gain a Breakthrough Medicine Designation:

• Target serious debilitating or life-threatening conditions with unmet medical need.
• The medicinal product is likely to offer major advantage over methods currently used.
• The potential adverse effects of the medicinal product are considered to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit/risk balance.
• The product is not registered at any regulatory authority at the time of submission of the designation request.

About CEL-SCI Corporation

CEL-SCI believes that boosting a patient’s immune system before surgery, radiotherapy and chemotherapy have damaged it, should provide the greatest possible impact on survival. Multikine is designed to help the immune system “target” the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor.

Multikine (Leukocyte Interleukin, Injection), given right after diagnosis and before surgery, has been dosed in over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.

The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words “intends,” “believes,” “anticipated,” “plans” and “expects,” and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, inability to receive necessary regulatory approvals, difficulties in manufacturing any of the Company’s potential products, inability to raise the necessary capital, inability to finalize a partnering agreement and the risk factors set forth from time to time in CEL-SCI’s filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2024. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company’s future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.

Contacts

COMPANY CONTACT:

Gavin de Windt

CEL-SCI Corporation

(703) 506-9460