GenSight Biologics Postpones Release of 2025 Half-Year Financial Results




GenSight Biologics Postpones Release of 2025 Half-Year Financial Results

PARIS–(BUSINESS WIRE)–Regulatory News:

GenSight Biologics (“GenSight Biologics” or the “Company“) (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced that the release of its half-year financial results, originally scheduled for September 19, 2025, has been postponed to September 29, 2025, after the market closes.

The postponement allows the Company’s external auditors to complete all necessary audit procedures to the highest professional standards. The Company confirms that the postponement relates only to the time required for the audit rather than to any material issues with the financial statements. The extension permits full compliance with regulatory requirements and maintains the Company’s commitment to accurate and transparent financial reporting.

The Company’s Audit Committee and Board of Directors meetings have been rescheduled accordingly:

• Audit Committee: postponed to September 24, 2025
• Board Meeting: postponed to September 26, 2025

The half-year results will be made available in the investor relations section of the Company’s website immediately following the September 29 announcement.

About GenSight Biologics S.A.

GenSight Biologics S.A. is a clinical-stage biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. GenSight Biologics’ pipeline leverages two core technology platforms, the Mitochondrial Targeting Sequence (MTS) and optogenetics, to help preserve or restore vision in patients suffering from blinding retinal diseases. GenSight Biologics’ lead product candidate, GS010 (lenadogene nolparvovec)/GS010 is in Phase III in Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease that leads to irreversible blindness in teens and young adults. Using its gene therapy-based approach, GenSight Biologics’ product candidates are designed to be administered in a single treatment to each eye by intravitreal injection to offer patients a sustainable functional visual recovery. The product candidate GS010 is currently in clinical development, has not to date been granted marketing authorization in France or any other jurisdiction, and is therefore not available commercially.

Contacts

GenSight Biologics
Chief Financial Officer

Jan Eryk Umiastowski

jeumiastowski@gensight-biologics.com

Binge Eating Disorders Global Market Research Report 2025-2035 | Growth Influenced by Rising Prevalence, Improved Diagnosis, Mental Health Awareness, and Advances in Patient-Centric Treatments – ResearchAndMarkets.com




Binge Eating Disorders Global Market Research Report 2025-2035 | Growth Influenced by Rising Prevalence, Improved Diagnosis, Mental Health Awareness, and Advances in Patient-Centric Treatments – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Binge Eating Disorders Market – A Global and Regional Analysis: Focus on Drug Class and Region – Analysis and Forecast, 2025-2035” report has been added to ResearchAndMarkets.com’s offering.

BED is characterized by recurrent episodes of excessive food consumption accompanied by feelings of loss of control and distress, impacting both psychological and physical health. Notably, advances in screening tools, behavioural therapies, and pharmacological treatments are enabling earlier and more accurate diagnosis, boosting demand for personalized intervention strategies.

However, challenges such as social stigma, limited access to specialized care in low-resource settings, and reimbursement barriers continue to restrict market penetration. Additionally, the heterogeneous nature of BED symptoms and the requirement for integrated, long-term care complicate treatment standardization and scalability. Nevertheless, increasing government initiatives, growing investment in mental health research, and expanded patient support programs are fostering new growth opportunities. Collaborative efforts among healthcare providers, researchers, and advocacy organizations are advancing clinical outcomes and improving quality of life for individuals affected by BED.

Impact

Technological advancements in digital health, teletherapy, and data analytics are significantly improving the diagnosis and management of binge eating disorders (BED). Innovations such as AI-powered screening tools and mobile health applications enable more accurate identification of symptoms and personalized treatment plans. The rise of digital therapeutics and remote counselling platforms is expanding access to behavioural interventions, especially in underserved or remote regions.

Anticonvulsant medications hold the largest market share. This dominance is attributed to robust clinical evidence supporting their efficacy in reducing binge episode frequency and severity. Topiramate has demonstrated significant effectiveness in clinical trials, leading to its widespread adoption in treating moderate to severe BED.

North America holds the highest market share in the binge eating disorders (BED) market, primarily driven by increased awareness, better diagnostic facilities, and higher healthcare expenditure in the region. The U.S. has a well-established healthcare infrastructure and strong government initiatives focused on mental health, facilitating early diagnosis and treatment of BED. Additionally, the presence of major pharmaceutical companies actively investing in research and development for novel BED therapies further consolidates North America’s leading position.

How can this report add value to an organization?

Product/Innovation: This report provides comprehensive insights into the current trends in binge eating disorders, helping companies identify opportunities for drug and technology development. Organizations can leverage these insights to design therapies, medications, and platforms tailored to the needs of patients suffering from binge eating disorders, improving outcomes and enhancing market penetration.

Competitive: A detailed competitive landscape analysis helps organizations benchmark their market standing against key players. By understanding the strengths and weaknesses of competitors, companies can position themselves more effectively in the global binge eating disorders market.

Demand Drivers and Limitations

Demand Drivers for the Global Binge Eating Disorders Market:

• The growing prevalence and diagnosis of binge eating disorder globally and expanding the patient pool. This increased detection fuels demand for effective treatments.
• Enhanced mental health awareness and reduced stigma encourage more individuals to seek professional help. Greater acceptance supports higher treatment adoption rates.
• Advancements in treatment options and patient centric care models improve outcomes. Personalized approaches are attracting more patients to engage in care.

Limitations for the Global Binge Eating Disorders Market:

• Underdiagnosis remains a significant issue due to social stigma and limited public awareness. This results in many patients not receiving timely or appropriate treatment.
• The high cost of innovative therapies restricts access for a large portion of the patient population. Affordability remains a barrier, especially in lower-income regions.
• Regulatory hurdles contribute to prolonged approval timelines for new drugs. These delays slow down the availability of advanced treatment options in the market.

Key Market Players and Competition Synopsis

The companies profiled in this report have been selected based on their market presence, product portfolio, and competitive positioning in the global binge eating disorders market

• Eli Lilly and Company
• Amneal Pharmaceuticals, Inc.
• Takeda Pharmaceutical, Ltd.
• Tryp Therapeutics Inc.
• Tonix Pharmaceuticals Corp.
• Sumitomo Pharma Ltd.
• VIVUS Inc
• Novartis AG
• Pfizer Inc.

Key Topics Covered:

1. Global Binge Eating Disorders Market: Industry Analysis

1.1 Market Overview and Ecosystem

1.2 Epidemiological Analysis

1.3 Key Market Trends

1.3.1 Impact Analysis

1.4 Regulatory Landscape

1.5 Pipeline Analysis

1.6 Market Dynamics

1.6.1 Overview

1.6.2 Market Drivers

1.6.3 Market Restraints

1.6.4 Market Opportunities

2. Global Binge Eating Disorders Market (by Drug Class), Value ($million), 2023-2035

2.1 Antidepressant

2.2 Anticonvulsant

2.3 Anti-obesity

2.4 Others

3. Global Binge Eating Disorders Market (by Region), Value ($Million), 2023-2035

3.1 North America

3.1.1 Market Dynamics

3.1.2 Market Sizing and Forecast

3.1.3 North America Binge Eating Disorders Market, by Country ($Million), 2023-2035

3.1.3.1 U.S.

3.1.3.2 Canada

3.2 Europe

3.2.1 Market Dynamics

3.2.2 Market Sizing and Forecast

3.2.3 Europe Binge Eating Disorders Market, by Country ($Million), 2023-2035

3.2.3.1 U.K.

3.2.3.2 France

3.2.3.3 Germany

3.2.3.4 Italy

3.2.3.5 Spain

3.2.3.6 Rest-of-Europe

3.3 Asia-Pacific

3.3.1 Market Dynamics

3.3.2 Market Sizing and Forecast

3.3.3 Asia-Pacific Binge Eating Disorders Market, by Country ($Million), 2023-2035

3.3.3.1 Japan

3.3.3.2 China

3.3.3.3 India

3.3.3.4 Australia

3.3.3.5 South Korea

3.3.3.6 Rest-of-Asia-Pacific

3.4 Rest-of-the-World

3.4.1 Market Dynamics

3.4.2 Market Sizing and Forecast Rest-of-the-World Binge Eating Disorders Market, by Type ($Million), 2023-2035

3.4.3 Rest-of-the-World Binge Eating Disorders Market, by Country ($Million), 2023-2035

3.4.3.1 Latin America

3.4.3.2 Middle East and Africa

4. Competitive Landscape and Company Profiles

4.1 Competitive Landscape

4.1.1 Mergers and Acquisitions

4.1.2 Partnership, Alliances and Business Expansion

4.1.3 New Offerings

4.1.4 Regulatory Activities

4.1.5 Funding Activities

4.2 Company Profiles

4.2.1 Eli Lilly and Company

4.2.1.1 Overview

4.2.1.2 Top Products / Product Portfolio

4.2.1.3 Top Competitors

4.2.1.4 Target Customers/End-Users

4.2.1.5 Key Personnel

4.2.1.6 Analyst View

4.2.2 Amneal Pharmaceuticals, Inc.

4.2.3 Takeda Pharmaceutical, Ltd.

4.2.4 Tryp Therapeutics Inc

4.2.5 Tonix Pharmaceuticals Corp.

4.2.6 Sumitomo Pharma Ltd.

4.2.7 VIVUS Inc

4.2.8 Novartis AG

4.2.9 Pfizer Inc.

5. Research Methodology

For more information about this report visit https://www.researchandmarkets.com/r/rrk8fm

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

For E.S.T Office Hours Call 1-917-300-0470

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Alpha Cognition Inc. (Nasdaq: ACOG) Announces Participation in Key September Investor Conferences




Alpha Cognition Inc. (Nasdaq: ACOG) Announces Participation in Key September Investor Conferences

VANCOUVER, British Columbia & DALLAS–(BUSINESS WIRE)–Alpha Cognition Inc. (Nasdaq: ACOG), a commercial-stage biopharmaceutical company dedicated to developing innovative treatments for neurodegenerative diseases, today announced that Chief Executive Officer Michael McFadden will present at two prominent healthcare investor conferences this September.

• Cantor Global Healthcare Conference 2025
  Date/Time: Friday, September 5, 7:00 a.m. ET
• H.C. Wainwright & Co. Healthcare Conference 2025
  Date/Time: Tuesday, September 9, 2:00 p.m. ET

Presentation transcripts will be made available on Alpha Cognition’s website following the events and will remain accessible for 30 days.

About Alpha Cognition Inc.

Alpha Cognition Inc. is a commercial stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer’s disease and Cognitive Impairment with mild Traumatic Brain Injury (“mTBI”), for which there are currently no approved treatment options.

ZUNVEYL is a patented drug approved as a new generation acetylcholinesterase inhibitor for the treatment of Alzheimer’s disease, with expected minimal gastrointestinal side effects. ZUNVEYL’s active metabolite is differentiated from donepezil and rivastigmine in that it binds neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cognition. ALPHA-1062 is also being developed in combination with memantine to treat moderate to severe Alzheimer’s dementia, and as an intranasal formulation for Cognitive Impairment with mTBI.

Forward-looking Statements

This news release includes forward-looking statements within the meaning of applicable securities laws. Except for statements of historical fact, any information contained in this news release may be a forward-looking statement that reflects the Company’s current views about future events and are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward‐looking statements by the words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “target,” “seek,” “contemplate,” “continue” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. Although the Company believes to have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. The Company cannot assure that the actual results will be consistent with these forward-looking statements. These forward-looking statements are subject to certain risks, including risks regarding our ability to raise sufficient capital to implement our plans to commercialize ZUNVEYL, risks regarding the efficacy and tolerability of ZUNVEYL, risks related to ongoing regulatory oversight on the safety of ZUNVEYL, risk related to market adoption of ZUNVEYL, risks related to the Company’s intellectual property in relation to ZUNVEYL, risks related to the commercial manufacturing, distribution, marketing and sale of ZUNVEYL, risks related to product liability and other risks as described in the Company’s filings with Canadian securities regulatory authorities and available at www.sedar.com and the Company’s filings with the United States Securities and Exchange Commission (the “SEC”), including those risk factors under the heading “Risk Factors” in the Company’s [Form S-1/A registration statement as filed with the SEC on November 6, 2024 and available at www.sec.gov.] These forward‐looking statements speak only as of the date of this news release and the Company undertakes no obligation to revise or update any forward‐looking statements for any reason, even if new information becomes available in the future, except as required by law.

Contacts

Investor Relations

IR@alphacognition.com
https://www.alphacognition.com/

ZHEN-AO GROUP Unveils TRIAL RESULTS: 5′-Nucleotide Reduces DNA Methylation Age by 3.08 Years




ZHEN-AO GROUP Unveils TRIAL RESULTS: 5′-Nucleotide Reduces DNA Methylation Age by 3.08 Years

PARIS–(BUSINESS WIRE)–On August 24, 2025, the 23rd International Congress of Nutrition (ICN) convened in Paris, France, under the theme “Sustainable Food for Global Health.” As the premier platform in nutritional science, the event brought together experts from 120 countries.

At the conference, researcher Mei-Hong Xu from Peking University presented groundbreaking findings from a randomized double-blind human trial (RCT) on nucleotide-based anti-aging. The study demonstrated that 5′-nucleotide supplementation over 19 weeks reduced DNA methylation age—the gold standard for epigenetic aging—by an average of 3.08 years in 60-70-year-old participants, alongside improvements in insulin resistance and visceral fat. The 5′-nucleotides, derived from yeast hydrolysis of eukaryotic cells, were validated in the study published in the prestigious journal Advanced Science.

The research was commissioned by ZhenAo and initiated in 2006. The team pioneered a “four-generation rat” safety trial, confirming 5′-nucleotide safety while observing lifespan extensions of up to 270 days (equivalent to up to 30 human years) in rats receiving lifelong supplementation.

Building on these breakthroughs, the team launched systematic research in 2020 to explore 5′-nucleotide mechanisms in lifespan extension. Multi-level experiments—spanning whole organisms, cells, genomics, and microbiota—revealed that lifelong 5′-nucleotide intervention extended median lifespan in SAMP8 mice by 9.21% to 12.6% (almost equal to 8.76-12.01 human years).

These findings underscore 5′-nucleotide’s potential in anti-aging, offering robust scientific support for prolonging healthspan and contributing a “Chinese solution” to global longevity research.

Contacts

ZHEN-AO GROUP CO., LTD.

Wenxuan Zhang, zjx@zhen-ao.com

Compass Pathways to Participate in Four Investor Conferences in September




Compass Pathways to Participate in Four Investor Conferences in September

LONDON & NEW YORK–(BUSINESS WIRE)–$CMPS #Biotech–Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that management will participate in the following September investor conferences:

• Cantor Global Healthcare Conference – New York, NY: Fireside chat at 1:35 PM EST on September 3, 2025
• Morgan Stanley 23rd Annual Global Healthcare Conference – New York, NY: Fireside chat at 10:45 AM EST on September 9, 2025
• H.C. Wainwright 27th Annual Global Investment Conference – New York, NY: Fireside chat at 9:00 AM EST on September 9, 2025
• TD Cowen’s 5th Annual Novel Mechanisms in Neuropsychiatry & Epilepsy Summit: Virtual fireside chat at 10:40 AM EST on September 17, 2025

A live audio webcast of these events will be accessible from the “Events” page of the Investors section of the Compass website. A replay of the webcast will be accessible for 30 days following each event.

About Compass Pathways

Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are living with mental health challenges and who are not helped by existing standards of care. We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthesized psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD).

Compass is headquartered in London, UK, with offices in New York in the U.S. We envision a world where mental health means not just the absence of illness but the ability to thrive.

Contacts

Enquiries

Media: Dana Sultan-Rothman, media@compasspathways.com, +1 484 432 0041

Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324

European Commission Approves TEVIMBRA® as Neoadjuvant/Adjuvant NSCLC Treatment Ahead of Late-Breaking Data Presentation at WCLC 2025




European Commission Approves TEVIMBRA® as Neoadjuvant/Adjuvant NSCLC Treatment Ahead of Late-Breaking Data Presentation at WCLC 2025

Final analysis of RATIONALE-315 demonstrates clear overall survival benefit in perioperative setting in resectable non-small cell lung cancer

Broad EU label with nine approved indications in solid tumors, including five in lung cancer, highlights TEVIMBRA’s therapeutic range and strong clinical profile throughout the care continuum

SAN CARLOS, Calif.–(BUSINESS WIRE)–$ONC #BeOne—BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the European Commission (EC) has approved TEVIMBRA (tislelizumab), in combination with platinum-containing chemotherapy as neoadjuvant treatment followed by TEVIMBRA monotherapy as adjuvant treatment, for adult patients with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence. The EC approval is based on results from the Phase 3 RATIONALE-315 trial. The preplanned final analysis of RATIONALE-315 demonstrates that TEVIMBRA, combined with platinum-based chemotherapy before surgery and continued as monotherapy afterward, showed statistically significant and clinically meaningful benefit in overall survival (OS) compared with chemotherapy combined with placebo. Data from this trial will be presented as a Late-Breaking Abstract (#MA04.08)¹ at the IASLC 2025 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer in Barcelona, Spain, September 6-9, 2025.

“Delivering a statistically significant overall survival benefit – a critical endpoint in oncology studies – alongside the European Commission’s approval of TEVIMBRA in perioperative resectable NSCLC marks a pivotal moment for patients and physicians,” said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne. “As only the second PD-1 inhibitor to demonstrate an OS benefit in this setting, TEVIMBRA is poised to reshape lung cancer treatment in Europe.”

Building on the RATIONALE-315 results previously reported at the European Society for Medical Oncology (ESMO) Congress Virtual Plenary in February 2024² and published in The Lancet Respiratory Medicine³, which showed the dual primary endpoints of event-free survival (EFS) and major pathologic response (MPR) were met at the interim analyses, key findings from the final analysis (n=453 patients; randomized 1:1) include:

• With a median trial follow-up of 38.5 months, the TEVIMBRA-based regimen showed a statistically significant and clinically meaningful benefit in OS versus the chemotherapy + placebo arm (HR=0.65 [95% CI: 0.45, 0.93]; one-sided P=0.0093).
• The significant EFS benefit previously reported with TEVIMBRA versus chemotherapy + placebo was sustained in this analysis (HR=0.58 [95% CI: 0.43, 0.79]), and this improvement was consistent across both independent review committee (IRC) and investigator assessments, reinforcing the consistency and robustness of the findings.
• OS and EFS benefits were observed across major sub-groups, regardless of PD-L1 expression, disease stage, and histology.
• As reported at the interim analyses, the trial showed a clinically meaningful and statistically significant improvement in EFS, MPR and pathological complete response (pCR) vs. chemotherapy + placebo.
• The safety profile was consistent with the treatment components and the interim analyses. No new safety signals were identified, and the most common (≥ 10%) Grade 3 or 4 treatment-related adverse events (TRAEs) in both arms were decreased neutrophil count and decreased white blood cell count.

“Patients with resectable non-small cell lung cancer still face alarmingly high recurrence rates,” said Dr. Mariano Provencio, Head of the Medical Oncology Department at Hospital Universitario Puerta de Hierro and Professor at Universidad Autónoma de Madrid. “The RATIONALE-315 results confirm that starting tislelizumab in the neoadjuvant phase, and continuing after surgery, has proven to be a powerful approach to improve outcomes for these patients. Now, with approval in the EU, we have a clinically validated new treatment option in the perioperative setting.”

In lung cancer, TEVIMBRA is already approved in the EU in four indications:

• first-line treatment of patients with squamous NSCLC;
• first-line treatment of patients with non-squamous NSCLC with PD-L1 high expression;
• treatment of patients with locally advanced or metastatic NSCLC after prior platinum-based therapy; and
• first-line treatment for extensive-stage small cell lung cancer (ES-SCLC).

It is also approved in the EU in the following indications:

• first-line treatment for patients with gastric or gastroesophageal junction (G/GEJ) adenocarcinoma;
• first-line treatment for unresectable esophageal squamous cell carcinoma (ESCC);
• second-line treatment in ESCC after prior platinum-based chemotherapy; and
• first-line treatment for patients with nasopharyngeal carcinoma (NPC).

About NSCLC

Lung cancer is the most commonly diagnosed type of cancer and the leading cause of cancer-related death worldwide.⁴ In Europe, lung cancer is the third most frequent cancer, with 484,306 new cases diagnosed in 2022.⁵ NSCLC accounts for 80–90% of all lung cancers⁶, of which resectable NSCLC patients at diagnosis represent around 25–30%⁷.

About RATIONALE-315

RATIONALE-315 (NCT04379635) is a randomized (1:1), double-blind, placebo-controlled, multicenter, Phase 3 trial, which evaluated TEVIMBRA neoadjuvant/adjuvant treatment in 453 adult patients with previously untreated, resectable, stage II or IIIA NSCLC. The dual primary endpoints are event-free survival (EFS) and major pathologic response (MPR). Key secondary endpoints include overall survival (OS), pathologic complete response (pCR), and disease-free survival (DFS).

About TEVIMBRA (tislelizumab)

TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.

TEVIMBRA is the foundational asset of BeOne’s solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes almost 14,000 patients enrolled to date in 35 countries and regions across 70 trials, including more than 20 registration-enabling studies. TEVIMBRA is approved in 47 markets, and more than 1.7 million patients have been treated globally.

Important Safety Information

The current European Summary of Product Characteristics (SmPC) for TEVIMBRA is available from the European Medicines Agency.

The information in this press release is intended for a global audience. Product indications vary by region.

About BeOne Medicines

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X, Facebook and Instagram.

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the ability of TEVIMBRA to improve patient outcome and potentially alter the course of the disease and to potentially help patients earlier in their treatment journey; the impact of TEVIMBRA on lung cancer treatment in Europe; the ability of BeOne to deliver more comprehensive and effective cancer treatment to more patients; and BeOne’s plans, commitments, aspirations, and goals under the heading “About BeOne Medicines.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeOne’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeOne’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne’s subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law.

To access BeOne media resources, please visit our Newsroom site.

Contacts

Investor Contact
Liza Heapes

+1 857-302-5663

ir@beonemed.com

Media Contact
Navneet Miller

+1 857-301-6440

media@beonemed.com

I2Pure and Caracal Announce Expanded Collaboration and Go-To-Market Effort for Novel Iodine Products




I2Pure and Caracal Announce Expanded Collaboration and Go-To-Market Effort for Novel Iodine Products

ASHBURN, Va.–(BUSINESS WIRE)–I2Pure and Caracal Products & Services, through its Caracal Healthcare Products division, today announce an expansion of their relationship. I2Pure’s proprietary iodine formulations and product concepts have received an overwhelmingly favorable response from Caracal’s healthcare customer base. Based on that positive feedback, I2Pure and Caracal have committed joint efforts to accelerate manufacturing and product delivery.

Three offerings make up the initial product entry: a topical iodine soak, a nasal decolonization product, and a topical iodine skin ointment. Additional products in development include surgical scrub, hand sanitizer, and several other topical iodine products.

“Since announcing our collaboration last year, Caracal has been amazed by the appetite of our healthcare customers for novel iodine products. The healthcare community clearly values the antimicrobial capability of iodine, as well as its long history of biosafety and biocompatibility,” said Don Roberts, CEO of Caracal Products & Services. “In a very short time, I2Pure’s technologies and products have become a primary interest within our healthcare customer base. We’re excited to begin marketing and delivering I2Pure products later this year.”

“A lot of hard work by our incredible team has put I2Pure in position to begin making our vision a reality. We’re thrilled to be in production now to start delivering products through Caracal later this year,” said Jeff Jochims, I2Pure CEO. “The world is ready for the next iteration of iodine chemistry. With ever-increasing antibiotic resistance and global pathogen risk, the time is right to harness the incredible antimicrobial broad-spectrum efficacy of molecular iodine, which has a time-proven safety profile and no known resistance development.”

I2Pure’s products will be available to most healthcare customers exclusively through Caracal Products & Services. Product samples will be available in September. Product delivery is expected to begin in the fourth quarter of 2025 and to expand throughout 2026.

Caracal and I2Pure expect to begin marketing products at healthcare conferences later this year, including the American Association of Hip and Knee Surgeons annual meeting in October and the National Minority Supplier Development Council’s Annual Conference & Exchange in early November in Miami.

About Caracal Products & Services: Founded in Detroit, Michigan, in 2004, Caracal is a U.S. based company with a focus on creating jobs and value in the healthcare industry through pioneering products and innovative services. As a sourcing solutions provider, Caracal offers a wide range of high-quality products and value-added services to businesses, government agencies, and educational institutions of all sizes. Caracal has cultivated strong, established partnerships in the healthcare, insurance, and financial services industries. Known for its proactive communication and stable, strategic vendor relationships, Caracal prides itself on living up to the Caracal motto each day: Supplying everything but surprises. For more information about Caracal Products & Services please visit https://www.caracalcorp.com or contact Sarah Herschelman at sherschelman@caracalcorp.com.

About I2Pure: I2Pure is an iodine technology company dedicated to advancing health and biosafety through its patented, non-toxic molecular iodine solutions. I2Pure’s mission is to prevent pathogenic threats to the world. Our technology can be utilized for countless applications across healthcare, industrial biosafety, consumer products, and food processing. The platform technology can be delivered directly or through carriers via solutions, nano particles, polymers and coatings. For more information about I2Pure, visit https://www.i2pure.com or contact the company at info@i2pure.com.

Contacts

info@i2pure.com

Acadia Pharmaceuticals to Participate at Upcoming Investor Conferences




Acadia Pharmaceuticals to Participate at Upcoming Investor Conferences

SAN DIEGO–(BUSINESS WIRE)–Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that it will participate at three upcoming investor conferences:

Morgan Stanley 23rd Annual Global Healthcare Conference

Fireside Chat: Monday, September 8, 2025 at 10:45 a.m. Eastern Time in New York, NY

H.C. Wainwright 27th Annual Global Investment Conference

Fireside Chat: Tuesday, September 9, 2025 at 8:00 a.m. Eastern Time in New York, NY

TD Cowen’s 5th Annual Novel Mechanisms in Neuropsychiatry & Epilepsy Summit

Fireside Chat: Thursday, September 18, 2025 at 1:40 p.m. Eastern Time (Virtual)

Live webcasts of each fireside chat will be accessible on the company’s website, acadia.com, under the investors section and an archived recording will be available on the website for approximately one month following each presentation.

About Acadia Pharmaceuticals

Acadia is advancing breakthroughs in neurological and rare diseases to elevate life. Since our founding we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson’s disease psychosis and the first and only approved drug in the United States and Canada for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer’s disease psychosis and multiple other programs targeting neuroscience and neuro-rare diseases. For more information, visit us at acadia.com and follow us on LinkedIn and X.

Contacts

Investor Contact:
Acadia Pharmaceuticals Inc.

Al Kildani

(858) 261-2872

ir@acadia-pharm.com

Acadia Pharmaceuticals Inc.

Jessica Tieszen

(858) 261-2950

ir@acadia-pharm.com

Savara Announces Participation in Upcoming Investor Healthcare Conferences




Savara Announces Participation in Upcoming Investor Healthcare Conferences

LANGHORNE, Pa.–(BUSINESS WIRE)–Savara Inc. (Nasdaq: SVRA) (the “Company”), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced members of the management team will host 1×1 meetings and present at two upcoming healthcare conferences.

Wells Fargo Securities Healthcare Conference

September 3, 2025, 4:30pm ET/1:30pm PT

H.C. Wainwright Global Healthcare Conference

September 9, 2025, 1:00pm ET/10:00am PT

The live webcasts and subsequent replays will be available on the “Events & Presentations” section of the Company’s corporate website and will be archived for 90 days.

About Savara

Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, MOLBREEVI*, is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). MOLBREEVI is delivered via an investigational eFlow^® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of a large molecule. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com and LinkedIn.

*MOLBREEVI is the FDA and EMA conditionally accepted trade name for molgramostim inhalation solution. It is not approved in any indication. MOLBREEVI is a trademark of Savara Inc.

Contacts

Media and Investor Relations Contact
Savara Inc.

Temre Johnson, Executive Director, Corporate Affairs

ir@savarapharma.com

Arcturus Therapeutics to Attend Upcoming Investor Conferences




Arcturus Therapeutics to Attend Upcoming Investor Conferences

SAN DIEGO–(BUSINESS WIRE)–$ARCT #ClinicalTrial–Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a commercial messenger RNA medicines company focused on the development of liver and respiratory rare disease therapeutics and infectious disease vaccines, today announced that the Company will participate in the following investor conferences:

Citi’s 2025 Biopharma Back to School Conference (Fireside Chat)

• Tuesday, September 2, 2025 (11:15 a.m. ET)

2025 Wells Fargo Healthcare Conference (Fireside Chat)

• Wednesday, September 3, 2025 (8:00 a.m. ET)

Cantor Global Healthcare Conference (Fireside Chat)

• Friday, September 5, 2025 (8:00 a.m. ET)

H.C. Wainwright 27^th Annual Global Investment Conference (Presentation)

• Tuesday, September 9, 2025 (8:30 a.m. ET)

About Arcturus

Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a commercial mRNA medicines and vaccines company with enabling technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR® mRNA technology (sa-mRNA) and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus developed KOSTAIVE®, the first self-amplifying messenger RNA (sa-mRNA) COVID vaccine in the world to be approved. Arcturus has an ongoing global collaboration for innovative mRNA vaccines with CSL Seqirus, and a joint venture in Japan, ARCALIS, focused on the manufacture of mRNA vaccines and therapeutics. Arcturus’ pipeline includes RNA therapeutic candidates to potentially treat OTC deficiency and cystic fibrosis (CF), along with its partnered mRNA vaccine programs for SARS-CoV-2 (COVID-19) and influenza. Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, circular RNA, antisense RNA, self-amplifying RNA, DNA, and gene editing therapeutics. Arcturus’ technologies are covered by its extensive patent portfolio (over 500 patents and patent applications in the U.S., Europe, Japan, China, and other countries). For more information, visit www.ArcturusRx.com. In addition, please connect with us on X (formerly Twitter) and LinkedIn.

Contacts

Arcturus Therapeutics

Public Relations & Investor Relations

Neda Safarzadeh

VP, Head of IR/PR/Marketing

(858) 900-2682
IR@ArcturusRx.com