Stallergenes Greer Expands Venom Immunotherapy Production Capacity With Acquisition of Entomon s.r.l.

Stallergenes Greer Expands Venom Immunotherapy Production Capacity With Acquisition of Entomon s.r.l.




Stallergenes Greer Expands Venom Immunotherapy Production Capacity With Acquisition of Entomon s.r.l.

BAAR, Switzerland–(BUSINESS WIRE)–Stallergenes Greer, a global leader in allergy therapeutics, today announced that it has entered into an agreement to acquire Entomon s.r.l., an Italian company specialising in the production of certified stinging-insect venom extracts, notably of the Hymenoptera order, used for the manufacture of diagnostic preparations and Venom Immunotherapy (VIT). The transaction is expected to close by the end of January.


Entomon, currently recognised as the only company in Europe capable of extracting pure venom from Hymenoptera insects, produces pharmaceutical-grade insect venom using proprietary techniques (Entomon Capillary Extracted Venom®) for medical use.

Through this acquisition, Stallergenes Greer bolsters its venom manufacturing capabilities and supply of raw materials for life-saving VIT treatments, whilst safeguarding patient care continuity.

Hymenoptera venom allergy is the most common trigger of severe anaphylaxis in adults1. According to the EAACI guidelines on venom immunotherapy, VIT is the only treatment that can prevent systemic inflammatory reactions to bee or wasp stings and significantly improve quality of life, even for people with less severe allergic reactions.2

Entomon’s activities complement Stallergenes Greer’s portfolio and strengthen our control of critical allergen extracts, notably Hymenoptera venoms used in allergen immunotherapy” stated Dr. Andreas Amrein, Chairman and CEO of Stallergenes Greer. “This acquisition secures long-term access to high-quality venom extracts in a market constrained by limited global capacity. It also builds on our existing partnerships and supports a diversified model for venom immunotherapy components. By reinforcing supply chain diversification and building on our well-established position in venom immunotherapy with Albey®, we strengthen our ability to support patients and healthcare professionals worldwide and deliver on our long-term commitment to high-standard, reliable allergy care. We are delighted to welcome Entomon to the Stallergenes Greer Group.”

Becoming part of Stallergenes Greer marks a transformative moment for Entomon. It is a testament to our expertise in the extraction of pure Hymenoptera venom and our ability to deliver high-quality raw materials which are essential for life-saving allergen immunotherapies. We are excited to embark on this new chapter,” declared Dr. Elisabetta Francescato, CEO and founder of Entomon s.r.l.

About hymenoptera venom allergies

Stinging-insect venom sensitisation is common in the general population (between 9.3% and 28.7%), and more than half of the population will be stung by an insect at least once in their lifetime depending on the living environment and type of activity.3 4

Venom allergy is an IgE-mediated hypersensitivity reaction triggered by stings from insects such as bees, wasps, hornets, or other Hymenoptera species. While local reactions are common and usually mild, venom-allergic individuals can experience systemic responses ranging from widespread hives to severe anaphylaxis. Hymenoptera venom allergy is the primary cause of anaphylaxis in adults in Europe, being responsible for 48.2% of cases and 20.2% in children worldwide5. Based on national mortality surveillance, fatal anaphylaxis due to Hymenoptera stings accounts for approximately 72 deaths per year in the United States6, while European data indicate a comparable burden of about 73 deaths annually across 32 countries7.

Diagnosis relies on a combination of clinical history, skin testing, and specific IgE measurement to identify the responsible insect. Venom immunotherapy is the only treatment proven to modify the natural course of venom allergy. It provides long-term protection by inducing immune tolerance8, markedly reducing the risk of systemic reactions to future stings and improving patients’ quality of life.

Because Hymenoptera venoms differ by species, the availability and quality of venom extracts are essential to enable accurate diagnosis and effective immunotherapy, ensuring patients receive targeted and reliable treatment.

About Albey® Venoms

Albey® Venoms are standardised purified extracts derived from hymenoptera species, including honeybee (Apis mellifera), yellow jacket (Vespula spp.), and paper wasp (Polistes spp.). These extracts are specifically designed for Venom Immunotherapy (VIT), the only proven treatment to prevent severe systemic allergic reactions.

Albey® holds marketing authorisations in France, Italy, Australia and New Zealand. It is also available in Italy under ope legis status.

About Entomon

Based in Florence (Italy), Entomon s.r.l. is a privately held company established by leading biologists and naturalists with deep expertise in the study of insects and their impact on human health and activity. The company specialises in the extraction of pure insect venom extracts for diagnostic reagents and venom immunotherapy for individuals with insect sting allergies. Entomon is the sole producer in Europe of insect of pure, certified Hymenoptera venom extracts. For more information, please visit: www.entomon.it

About Stallergenes Greer

Headquartered in Baar (Switzerland), Stallergenes Greer is a global healthcare company specialising in the diagnosis and treatment of allergies through the development and commercialisation of allergen immunotherapy products and services. Supported by more than 100 years of expertise and innovation, our products are available for patients in over 40 countries. For more information, please visit www.stallergenesgreer.com.

1 Hymenoptera (bee and wasp) Stevens et al. Recent insights into the mechanisms of anaphylaxis. Curr Opin Immunol. 2023 Apr;81

2 EAACI guidelines on allergen immunotherapy: Hymenoptera venom allergy (Allergy. 2018 Apr;73(4):744-764)

3 Bilò, M. B., Pravettoni, V., Bignardi, D., Bonadonna, P., Mauro, M., Novembre, E., … & Pastorello, E. A. (2019). Hymenoptera venom allergy: management of children and adults in clinical practice. Journal of investigational allergology & clinical immunology, 29(3), 180-205.

4 Golden, D. B., Demain, J., Freeman, T., Graft, D., Tankersley, M., Tracy, J., … & Wallace, D. (2017). Stinging insect hypersensitivity: a practice parameter update 2016. Annals of Allergy, Asthma & Immunology, 118(1), 28-5

5 Rueff et al., (2023) Diagnosis and treatment of Hymenoptera venom allergy

6 QuickStats: Number of Deaths from Hornet, Wasp, and Bee Stings Among Males and Females — National Vital Statistics System, United States, 2011–2021. MMWR Morb Mortal Wkly Rep 2023;72:756.

7 Feás, X.; Vidal, C.; Remesar, S. What We Know about Sting-Related Deaths? Human Fatalities Caused by Hornet, Wasp and Bee Stings in Europe (1994–2016). Biology 2022, 11, 282. https://doi.org/10.3390/biology11020282
8 Golden et al. J Allergy Clin Immunol. 2011 Apr ;127(4):852-4.e1-23

Contacts

Stallergenes Greer
Communications

Catherine Kress

Tel: +33 (0)1 55 50 26 05

Email: catherine.kress@stallergenesgreer.com

World-renowned Immunologist and Distinguished Scientist Joins CancerVax as Senior Scientific Advisor

World-renowned Immunologist and Distinguished Scientist Joins CancerVax as Senior Scientific Advisor




World-renowned Immunologist and Distinguished Scientist Joins CancerVax as Senior Scientific Advisor

Dr. Mark Davis, discoverer of the first T-cell receptor genes and Stanford Professor, to advise the Company on immunological strategies for its novel cancer treatment platform

Lehi Utah, Jan. 07, 2026 (GLOBE NEWSWIRE) — Lehi, Utah, January 7, 2026 – CancerVax, Inc., the developer of a breakthrough universal cancer treatment platform that uses the body’s immune system to treat cancer, today announced that Mark M. Davis, PhD will serve as the Company’s Senior Scientific Advisor.

Dr. Davis was the founding Director of the Stanford Institute for Immunity, Transplantation and Infection (ITI), and turned it into an international leader in the development of transformative technologies and approaches to better understand the human immune system and its responses to infectious diseases and autoimmunity. He is currently a Professor of Microbiology and Immunology and the Director of the Center for Human Systems Immunology and co-Director of the Parker Center for the Immunotherapy of Cancer at Stanford.

Dr. Davis is well known for identifying the first T-cell receptor genes, which are responsible for T lymphocytes’ ability to “see” foreign pathogens such as viruses, solving a major mystery in immunology at that time. He and his research group have made many subsequent discoveries about this type of molecule, demonstrating that T-cells are able to detect and respond to even a single molecule of their ligand-fragments of antigens bound to Major Histocompatibility Complex cell surface molecules. He also developed a novel way of labeling specific T lymphocytes according to the molecules that they recognize, and this procedure is now an important method in many clinical and basic studies of T-cell activity, as are other technologies developed by his group.

CancerVax was founded on the idea that disguising cancer cells to resemble foreign pathogens, such as the measles virus, can effectively “trick” the immune system into recognizing and aggressively attacking them. The disguise is done by precisely detecting cancer cells at the genetic level, then forcing them to express harmless protein fragments associated with viruses. This then activates T-cell killing of cancer cells through the mechanisms that Dr. Davis discovered and continues to research. Recent in-vitro lab experiments have proven that this is possible with the CancerVax technology – a major milestone for the Company.

Dr. Davis, commented, “I’ve observed many novel cancer immunotherapies over the years. I find the CancerVax approach quite clever and interesting. Instead of teaching immune cells to recognize cancer through a new learned immunity, disguising cancer cells with viral antigens to activate strong existing immunity is a very exciting idea. I look forward to helping anyway I can.”

“Mark’s groundbreaking work and foundational discoveries revealed how T cells ‘see’ foreign antigens and transformed the world’s understanding of adaptive immunity. It is one of the most important advances in modern immunology,” said Dr. George Katibah, Chief Scientific Officer of CancerVax. “Dr. Davis has pioneered transformative technologies such as peptide-MHC tetramers and advanced systems-level approaches to human immunology, and his research continues to fuel translational innovations from vaccines to cancer therapies. His extraordinary scientific leadership and deep expertise align powerfully with CancerVax’s novel approach to treating cancer. It is a privilege for all of us at CancerVax to work with Dr. Davis.”

According to research.com, Dr. Davis has authored over 500 publications with over 125,000 citations. He has received numerous awards and honors for his work, including memberships in the National Academy of Sciences, The National Academy of Medicine and the Royal Society.

To learn more about the CancerVax platform, please watch the Short Explainer Video at https://cancervax.com/explainer

About CancerVax

CancerVax is a pre-clinical biotech company developing a novel Universal Cancer Treatment platform that will be customizable, as an injection, to treat many types of cancer. Our innovative approach DETECTS, MARKS, and KILLS only cancer cells. By making cancer cells look like well-immunized common diseases, such as measles or chickenpox, we intend to use the body’s natural immune system to easily kill the cancer cells. We look forward to the day when treating cancer will be as simple as getting a shot — a better way to fight cancer. To learn more, please visit www.CancerVax.com

Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations, and assumptions regarding the future of our business, plans and strategies, projections, anticipated events and trends, the economy, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict, many of which are outside our control. Our actual results and financial condition may differ materially from those in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Any forward-looking statement made by us in this release is based only on information currently available to us and speaks only as of the date it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments, or otherwise.

Press Contact:
CancerVax, Inc.
Tel: (805) 356-1810
communications@CancerVax.com

Relation Announces Strategic Collaboration with Deerfield Management to Advance Novel Therapeutics

Relation Announces Strategic Collaboration with Deerfield Management to Advance Novel Therapeutics




Relation Announces Strategic Collaboration with Deerfield Management to Advance Novel Therapeutics

LONDON, Jan. 07, 2026 (GLOBE NEWSWIRE) — Relation and healthcare investment firm Deerfield Management, a current investor, today announced the establishment of a new research collaboration to advance therapeutic discovery projects for diseases of high unmet need.

“The opportunity to combine Relation’s and Deerfield’s capabilities across AI, biology, discovery and development is a compelling proposition,” said David Roblin, MD, CEO of Relation. “We believe that this partnership will enable us to expand our R&D efforts and portfolio and ultimately help patients in need.”

Relation is founded on the premise that better success in drug development requires confidence in the biology driving disease. To deliver this confidence in biology, Relation’s “Lab-in-the-Loop” platform aims to integrate state-of-the-art AI with patient-derived multi-omic data and proprietary experimental systems to uncover causal genes and refine target hypotheses. Relation develops medicines to clinical value inflection points across a range of therapy areas, all under the central theme of capitalising on better biological understanding. The company’s portfolio spans immunology, metabolic disease, and bone disease.

Under the terms of the agreement, Relation may nominate targets discovered using its platform for downstream development via a NewCo, jointly owned by the Parties. The parties will work collaboratively to develop target product profiles, and Deerfield will provide due diligence support and drug development plans for projects that the parties mutually decide to advance. Both Relation and Deerfield are entitled to royalties of the net sales of any future products.

“We are inspired by what the Relation team is working to achieve and look forward to collaborating as we strive to better understand target biology,” said Matt Nelson, PhD, VP, Genetics and Genomics at Deerfield Discovery and Development (3DC), Deerfield’s internal drug discovery and development engine. “In combining forces, we hope to expand the boundaries of what we know and leverage therapeutically relevant insights to make a difference for patients.”

About Relation

Relation is a technology-enabled biopharmaceutical company developing medicines across immunology, metabolic and bone diseases. The company builds AI and experimental systems, across the drug development cycle, all under the central theme of capitalising on better biological understanding.

About Deerfield Management

Deerfield is an investment management firm committed to advancing healthcare through investment, intelligence, and philanthropy. The Firm works across the healthcare ecosystem to connect people, capital, ideas, and technology in bold, collaborative, and inclusive ways. For more information, please visit www.deerfield.com.

Media contact:

press@relationrx.com

kimberly.ha@kkhadvisors.com

Bavarian Nordic Launches Planned Share Buy-Back Program

Bavarian Nordic Launches Planned Share Buy-Back Program




Bavarian Nordic Launches Planned Share Buy-Back Program

COPENHAGEN, Denmark, January 7, 2026 – Bavarian Nordic A/S (OMX: BAVA) today launches the first tranche of the share buy-back program announced on December 2, 2025, under which the Company intends to repurchase own shares for up to DKK 500 million during 2026.

The first tranche will comprise buy-back of shares for up to DKK 150 million, which will be held as treasury stock for the purpose of adjusting the capital structure.

The share buy-back program is initiated pursuant to the authorization granted at the annual general meeting on April 9, 2025, and in accordance with Regulation (EU) No. 596/2014 (as amended) of the European Parliament and of the Council on market abuse and Commission Delegated Regulation (EU) 2016/1052, which together constitute the Safe Harbour Regulation.

Bavarian Nordic has appointed Nordea as lead manager to execute the share buy-back in accordance with the terms of the program and with authorization to make trading decisions independently and without influence of Bavarian Nordic.

Terms of the program

  • The share buy-back program will commence on January 7, 2026, and will be completed by February 13, 2026, at the latest.
  • Shares of up to a maximum aggregate purchase price of DKK 150 million may be repurchased.
  • A maximum of 1,500,000 shares will be repurchased within the duration of the program.
  • The maximum number of shares, which can be purchased on any single trading day, may not exceed 25% of the average daily trading volume of Bavarian Nordic shares traded on Nasdaq Copenhagen during the preceding 20 trading days before the trading day.
  • The shares may not be purchased at a price exceeding the higher of the price of the last independent trade, or the highest independent purchase bid on Nasdaq Copenhagen.

Details of transactions under the program will be published weekly after commencement and at completion of the program.

Prior to the initiation of this program, Bavarian Nordic held 966,845 treasury shares, corresponding to 1.22 % of the Company’s share capital.

//

About Bavarian Nordic
Bavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. For more information, visit www.bavarian-nordic.com

Forward-looking statements
This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.

Contact investors:
Europe: Disa Tuominen, IR Manager, detu@bavarian-nordic.com
US: Graham Morrell, Gilmartin Group, graham@gilmartinir.com, Tel: +1 781 686 9600

Contact media:
Nicole Seroff, Vice President Corporate Communications, nise@bavarian-nordic.com, Tel: +45 53 88 06 03

Company Announcement no. 01 / 2026

Attachment

Pentixapharm Receives FDA Feedback for Phase 3 Diagnostic Study in Hypertension

Pentixapharm Holding AG

/ Key word(s): Study

Pentixapharm Receives FDA Feedback for Phase 3 Diagnostic Study in Hypertension (news with additional features)

07.01.2026 / 08:00 CET/CEST

The issuer is solely responsible for the content of this announcement.


Pentixapharm Receives FDA Feedback for Phase 3 Diagnostic Study in Hypertension

 

  • Formal written minutes from the U.S. FDA confirms no major concerns identified for the planned Phase 3 PANDA study of [⁶⁸Ga]Ga-PentixaFor in treatment-resistant hypertension and Primary Aldosteronism
  • Type B pre-IND meeting provided non-binding guidance on key statistical and methodological aspects, enabling refinement of the Phase 3 study design
  • Feedback clarifies evidence requirements relevant to a potential approval pathway, supporting the planned IND submission for the company’s leading CXCR4-directed flagship program

 

Berlin, Germany, January 07, 2026 – Pentixapharm Holding AG (Frankfurt Prime Standard: PTP), an advanced clinical-stage biotech developing novel radiopharmaceuticals, today announced that it has received the formal written minutes from its recent scientific advice meeting with the U.S. Food and Drug Administration (FDA) for the planned Phase 3 PANDA study of [⁶⁸Ga]Ga-PentixaFor, the company’s leading CXCR4-directed flagship program. The PANDA study will evaluate the radiodiagnostic as a potential new tool to improve the diagnostic pathway for patients with treatment-resistant hypertension and primary aldosteronism (PA). By enabling disease subtyping, PET/CT imaging with [⁶⁸Ga]Ga-PentixaFor has the potential to better guide the most appropriate therapy, supporting more precise and effective treatment decisions.

The FDA’s minutes provide further clarification on several important statistical,  methodological aspects, and criteria for assessing diagnostic performance of the planned Phase 3 study and expand on the preliminary feedback from the meeting,  previously communicated on December 3, 2025.

“The FDA’s formal written feedback provides important clarity on key design and analysis elements of our planned Phase 3 PANDA study with [⁶⁸Ga]Ga-PentixaFor and confirms that no major concerns have been identified,” said Dr. Dirk Pleimes, CEO and CMO of Pentixapharm. “Importantly, the feedback also provides guidance on the evidence requirements toward potential approval, including the role of confirmatory evidence in combination with this single Phase 3 study. This guidance strengthens our preparations for the planned IND submission and further supports the development of a potentially scalable, non-invasive diagnostic tool for patients with primary aldosteronism – the most common cause of secondary hypertension and a condition that remains significantly underdiagnosed.”
 

 About [⁶⁸Ga]Ga-PentixaForin treatment-resistant hypertension and primary aldosteronism

[⁶⁸Ga]Ga-PentixaFor is a novel, potentially first-in-class gallium-68-labeled radiodiagnostic designed to selectively target the chemokine receptor CXCR4 and to visualize its expression using high-resolution PET/CT imaging. Clinical experience with [⁶⁸Ga]Ga-PentixaFor PET/CT is documented in more than 100 scientific publications encompassing over 2,600 patients across multiple indications, including more than 1,600 patients with primary aldosteronism. In published and ongoing studies, the diagnostic has demonstrated reproducible in vivo imaging of CXCR4 expression with a favorable safety profile.

Recent research has shown strong CXCR4 overexpression in aldosterone-producing adrenal tumors, a hallmark of unilateral primary aldosteronism. Primary aldosteronism is a common but historically underdiagnosed cause of secondary hypertension, largely because reliably distinguishing unilateral from bilateral disease remains challenging with current diagnostic tools. Unilateral disease is typically treated by surgical removal of the affected adrenal gland whereas bilateral disease requires life-long medical therapy. By visualizing CXCR4 expression in aldosterone-producing tissue, [⁶⁸Ga]Ga-PentixaFor has the potential to support more reliable subtyping of primary aldosteronism and thereby better guide appropriate treatment decisions.
 

 About Pentixapharm

Pentixapharm is an advanced clinical-stage biotech expanding the boundaries of radiopharmaceuticals. Headquartered in Berlin, Germany, the company develops precision diagnostics and therapeutics in oncology and cardiology to transform patient care. Its clinical pipeline is anchored by CXCR4-targeted PET-CT programs, including a Phase 3-ready candidate for the improved diagnosis of hypertensive patients with primary aldosteronism, which is intended to enable targeted treatment of the underlying causes of hypertension. CXCR4-based developments also include pioneering therapeutic programs in hematological cancers. Furthermore, Pentixapharm is advancing a next-generation antibody platform targeting CD24, an emerging immune-checkpoint marker over-expressed in multiple hard-to-treat cancers. Complemented by CXCR4 and CD24 intellectual property protection and a reliable isotope supply chain, Pentixapharm is poised to deliver meaningful patient benefit and sustainable growth in one of the fastest-growing areas of precision medicine.

 

Pentixapharm Investor and Media Contact

ir@pentixapharm.com


Additional features:

File: 20260107 – Pentixapharm PR FDA Meeting Minutes EN_Final


07.01.2026 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.


Language: English
Company: Pentixapharm Holding AG
Robert-Rössle-Straße 10
13125 Berlin
Germany
E-mail: info@pentixapharm.com
Internet: https://www.pentixapharm.com/
ISIN: DE000A40AEG0
WKN: A40AEG
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2255670

 
End of News EQS News Service

2255670  07.01.2026 CET/CEST

Newron Pharmaceuticals S.p.A.: EA Pharma, a subsidiary of Eisai, Announces the Initiation of its Phase III Clinical Trial with Evenamide, a Novel Treatment for Schizophrenia, in Japan

Newron Pharmaceuticals S.p.A.

/ Key word(s): Study

Newron Pharmaceuticals S.p.A.: EA Pharma, a subsidiary of Eisai, Announces the Initiation of its Phase III Clinical Trial with Evenamide, a Novel Treatment for Schizophrenia, in Japan

07.01.2026 / 07:00 CET/CEST

The issuer is solely responsible for the content of this announcement.


Newron Pharmaceuticals S.p.A.: EA Pharma, a subsidiary of Eisai, Announces the Initiation of its Phase III Clinical Trial with Evenamide, a Novel Treatment for Schizophrenia, in Japan

Milan, Italy, and Morristown, NJ, USA, January 7, 2026 – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, is pleased to note that its partner EA Pharma Co., Ltd. (EAP), has  announced today the initiation of its Phase III clinical trial with evenamide, a novel excessive glutamate release modulator, in Japan.

Stefan Weber, CEO of Newron Pharmaceuticals, commented: “The initiation of EA Pharma’s Phase III study of evenamide in Japan represents an important step in the global development of the program. This milestone, together with Newron’s ongoing global (excluding EAP territories) ENIGMA-TRS Phase III studies reflects continued progress and momentum for evenamide and further supports its potential as a differentiated add-on therapy in schizophrenia.”

The full text of the announcement from EAP is as follows:

EA Pharma Announces Initiation of Phase III Clinical Trial of EA8001, a Novel Treatment for Schizophrenia, in Japan

EA Pharma Co., Ltd. (Head Office, Chuo-ku, Tokyo, Japan; President, Hidenori Yabune; “EA Pharma”) announced today that Phase III clinical trial of EA8001 (non -proprietary name: evenamide), a novel excessive glutamate release modulator, is now ready to begin in Japan (hereinafter the “Trial”).  

EA Pharma initiates the Trial after review by the institutional review board of the clinical site and other related procedures. This Trial is a multicenter randomized double-blind placebo-controlled clinical trial in patients with treatment-resistant schizophrenia who show poor or inadequate response to at least two different types of antipsychotics, evaluating the efficacy, safety and tolerability of EA8001 as an add-on treatment. EA Pharma is striving to quickly contribute to addressing the needs of, and increasing the benefits provided to, patients with schizophrenia, their families and healthcare providers.

Inquiries

EA Pharma Co., Ltd.
Corporate Communication Dept. Mail: contact_ea@ eapharma.co.jp

《More Information》

  1. About schizophrenia

Schizophrenia, which approximately 1% of the Japanese population is affected by, consists of positive symptoms (such as hallucinations and delusions), negative symptoms (such as reduced emotions and avolition), and cognitive impairment (such as memory and decision-making difficulties), and those symptoms may cause difficulty in everyday life and social activities [1]. Current antipsychotics mainly function through the dopamine and/or serotonin pathways, and those antipsychotics are known to show side effects (such as extrapyramidal symptoms, weight gain, and prolactin elevation). Among those patients treated with current antipsychotics, a considerable number of patients become treatment-resistant or poor responsive. Therefore, there is a demand for a drug which can address all those points.

  1. About evenamide

Evenamide is the first new chemical entity that has demonstrated significant benefits in this difficult-to-treat patient population, as seen in the potentially pivotal Phase III study 008A trial [2], as an add-on treatment to second generation anti-psychotics, in 291 poorly responding patients with chronic schizophrenia. The primary endpoint, the Positive and Negative Syndrome Scale (PANSS) [3], and the key secondary endpoint, the Clinical Global Impressions Scale – Severity (CGI-S), were met and showed statistical significance compared to placebo. Importantly, evenamide treatment was associated with statistically significant increase in proportion of patients who experienced “clinically meaningful benefit*” on the outcome variables[4]. 

*Against placebo in the two categories: at least 20% improvement in PANSS, and Score 2 or below in Clinical Global Impression Scale – Corrections (CGI-C)

3. About Alliance between EA Pharma and Newron Pharmaceuticals S.p.A.

EA Pharma obtained the right to develop, manufacture and commercialize evenamide in Japan and other key Asian territories [5] under the license agreement with Newron Pharmaceuticals S.p.A. as of December 2024. 

For more details, please see https://www.eapharma.co.jp/en/investors/news/2024/1213.

  1. About EA Pharma Co., Ltd.

EA Pharma Co., Ltd. is a subsidiary of Eisai Co., Ltd. It was established in April 2016 by integration of the gastrointestinal business unit with more than 60 year’s history of the Eisai Group and the gastrointestinal business unit of the Ajinomoto Group having amino acid as its business core. EA Pharma Co., Ltd., is a specialty pharmaceutical company with a full value chain covering R&D, production & logistics and sales & marketing. 

For further information on EA Pharma Co., Ltd., please visit   https://www.eapharma.co.jp/en/

[1] National Center of Neurology and Psychiatry (https://www.ncnp.go.jp/en/)

[2] A “pivotal phase III trial” is a key clinical trial to collect definitive evidence of efficacy and safety in primary endpoints that can support a regulatory approval. Usually, data collected from multiple confirmatory trials (pivotal trials) are required for a regulatory approval in many countries. 

[3] Positive and Negative Syndrome Scale (PANSS) is widely used in clinical trials of schizophrenia and is considered the “gold standard” for assessment of antipsychotic treatment efficacy (Innvo Clin Neurosci, 2017: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5788255/)

[4] Efficacy and safety of evenamide, a glutamate modulator, added to a second-generation antipsychotic in inadequately/poorly responding patients with chronic schizophrenia: Results from a randomized, double-blind, placebo-controlled, phase 3, international clinical trial. (Neuropharmacology. 2025: https://pubmed.ncbi.nlm.nih.gov/39708914/)

[5] Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, Vietnam

About Newron Pharmaceuticals

Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the development of innovative therapies for patients with diseases of the central and peripheral nervous system. Headquartered in Bresso near Milan, Italy, the Company has a strong track record of advancing neuroscience-based treatments from discovery to market. Newron’s lead compound, evenamide, is a first-in-class glutamate modulator and has the potential to be the first add-on therapy for treatment-resistant schizophrenia (TRS) and for poorly responding patients with schizophrenia. Evenamide is currently developed in the global pivotal ENIGMA-TRS Phase III development program. Clinical trial results to date demonstrate the benefits of this drug candidate in the TRS as well as poorly responding patient population, with significant improvements across key efficacy measures increasing over time, as well as a favorable safety profile, which is uncommon for available antipsychotic medications. Newron has signed development and commercialization agreements for evenamide with EA Pharma (a subsidiary of Eisai) for Japan and other Asian territories, as well as Myung In Pharm for South Korea. Newron’s first marketed product, Xadago®/safinamide has received marketing authorization for the treatment of Parkinson’s disease in the European Union, Switzerland, the UK, the USA, Australia, Canada, Latin America, Israel, the United Arab Emirates, Japan and South Korea. The product is commercialized by Newron’s partner Zambon, with Supernus Pharmaceuticals holding marketing rights in the U.S., and Meiji Seika responsible for development and commercialization in Japan and other key Asian territories. For more information, please visit: www.newron.com

For more information, please contact:

Newron
Stefan Weber – CEO; +39 02 6103 46 26, pr@newron.com

UK/Europe
Simon Conway / Ciara Martin / Natalie Garland-Collins, FTI Consulting; +44 20 3727 1000, SCnewron@fticonsulting.com 

Switzerland
Valentin Handschin, IRF; +41 43 244 81 54, handschin@irf-reputation.ch

Germany/Europe
Anne Hennecke / Maximilian Schur, MC Services; +49 211 52925227, newron@mc-services.eu

USA
Paul Sagan, LaVoieHealthScience; +1 617 865 0041, psagan@lavoiehealthscience.com

Important Notices

This document contains forward-looking statements, including (without limitation) about (1) Newron’s ability to develop and expand its business, successfully complete development of its current product candidates, the timing of commencement of various clinical trials and receipt of data and current and future collaborations for the development and commercialization of its product candidates, (2) the market for drugs to treat CNS diseases and pain conditions, (3) Newron’s financial resources, and (4) assumptions underlying any such statements. In some cases, these statements and assumptions can be identified by the fact that they use words such as “will”, “anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “target”, and other words and terms of similar meaning. All statements, other than historical facts, contained herein regarding Newron’s strategy, goals, plans, future financial position, projected revenues and costs and prospects are forward-looking statements. By their very nature, such statements and assumptions involve inherent risks and uncertainties, both general and specific, and risks exist that predictions, forecasts, projections and other outcomes described, assumed or implied therein will not be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. These factors include (without limitation) (1) uncertainties in the discovery, development or marketing of products, including without limitation difficulties in enrolling clinical trials, negative results of clinical trials or research projects or unexpected side effects, (2) delay or inability in obtaining regulatory approvals or bringing products to market, (3) future market acceptance of products, (4) loss of or inability to obtain adequate protection for intellectual property rights, (5) inability to raise additional funds, (6) success of existing and entry into future collaborations and licensing agreements, (7) litigation, (8) loss of key executive or other employees, (9) adverse publicity and news coverage, and (10) competition, regulatory, legislative and judicial developments or changes in market and/or overall economic conditions. Newron may not actually achieve the plans, intentions or expectations disclosed in forward-looking statements and assumptions underlying any such statements may prove wrong. Investors should therefore not place undue reliance on them. There can be no assurance that actual results of Newron’s research programs, development activities, commercialization plans, collaborations and operations will not differ materially from the expectations set out in such forward-looking statements or underlying assumptions. Newron does not undertake any obligation to publicly update or revise forward-looking statements except as may be required by applicable regulations of the SIX Swiss Exchange or the Dusseldorf Stock Exchange where the shares of Newron are listed. This document does not contain or constitute an offer or invitation to purchase or subscribe for any securities of Newron and no part of it shall form the basis of or be relied upon in connection with any contract or commitment whatsoever.


07.01.2026 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.


Language: English
Company: Newron Pharmaceuticals S.p.A.
via Antonio Meucci 3
20091 Bresso
Italy
Phone: +39 02 610 3461
Fax: +39 02 610 34654
E-mail: pr@newron.com
Internet: www.newron.com
ISIN: IT0004147952
WKN: A0LF18
Listed: Regulated Unofficial Market in Dusseldorf (Primärmarkt); SIX
EQS News ID: 2255678

 
End of News EQS News Service

2255678  07.01.2026 CET/CEST

RoslinCT and BOOST Pharma Announce Strategic Manufacturing Agreement to Advance Cell Therapy for Infants with Osteogenesis Imperfecta

RoslinCT and BOOST Pharma Announce Strategic Manufacturing Agreement to Advance Cell Therapy for Infants with Osteogenesis Imperfecta




RoslinCT and BOOST Pharma Announce Strategic Manufacturing Agreement to Advance Cell Therapy for Infants with Osteogenesis Imperfecta

EDINBURGH, Scotland–(BUSINESS WIRE)–RoslinCT, a global contract development and manufacturing organization (CDMO) specializing in advanced cell therapies, and BOOST Pharma, a clinical-stage biotechnology company developing first-in-class cell therapies for rare paediatric skeletal diseases, today announced a strategic manufacturing partnership to support the development of BOOST Pharma’s cell therapy, BT-101, for the treatment of infants with Osteogenesis Imperfecta (OI), also known as brittle bone disease.


Under the service agreement, BOOST Pharma has transferred its manufacturing process to RoslinCT’s state-of-the-art facilities in Edinburgh, Scotland. The partnership will progress toward GMP manufacturing of starting materials and clinical drug product, supporting Phase III clinical development of BT-101. The therapy is an allogeneic mesenchymal stem cell (MSC) product designed to address the underlying cause of OI at the earliest stages of life.

BOOST Pharma was founded on pioneering science originating from Karolinska Institutet, a world leader in cell therapy research. Its lead program, BT-101, is a novel MSC-based therapy with high bone-forming capability. Preclinical and clinical studies have demonstrated promising results, including improved bone formation, reduced fracture rates, and sustained growth in children with severe forms of OI, with no observed immune response to donor cells.

OI is a rare, inherited genetic disorder characterized by extremely fragile bones, skeletal deformities, pain, and reduced quality of life. There are currently no EMA or FDA approved disease-modifying treatments for OI, and existing interventions are largely palliative. By enabling early intervention, including prenatal or early postnatal treatment, BT-101 has the potential to significantly alter disease progression and long-term outcomes for affected children.

“This partnership with RoslinCT represents a critical milestone as we prepare for late-stage clinical development,” said Lilian Walther Jallow, Co-founder and Chief Development Officer of BOOST Pharma. “We know all too well the challenges associated with the CMC part for cell therapies, so for BOOST, it was of great importance to early prioritize finding a partner that we could work with all the way through to a commercial product. RoslinCT brings deep technical expertise and GMP manufacturing capability that will be essential as we advance BT-101 toward Phase III and, ultimately, toward patients who urgently need new treatment options.”

From RoslinCT’s perspective, the agreement reflects a shared, long-term commitment to patient-focused innovation in rare paediatric diseases.

“At the heart of this partnership are infants and families facing a devastating diagnosis with no curative treatment options,” said Peter Coleman, Chief Executive Officer of RoslinCT. “Supporting the manufacture of a therapy that has the potential to reduce fractures, ease pain, and fundamentally change the life trajectory of children with Osteogenesis Imperfecta is deeply meaningful for our team. We see this as a long-term manufacturing relationship, supporting BOOST Pharma not only through Phase III, but also through commercial manufacturing as this therapy moves closer to becoming a reality for patients.”

RoslinCT will provide end-to-end CDMO support, leveraging its expertise in allogeneic cell therapies, process transfer, and GMP manufacturing to ensure robust, scalable production aligned with BOOST Pharma’s clinical and future commercial goals.

About BOOST Pharma ApS

BOOST Pharma is a clinical-stage biopharmaceutical company focused on the development of novel cell therapy treatments. The company is currently developing a first-in-class therapy to treat Osteogenesis Imperfecta, a severe, inherited rare genetic disease leading to significant physical disability. BOOST Pharma is supported by Industrifonden, Sound Bioventures and Karolinska Development, Sweden.

About Osteogenesis Imperfecta

Osteogenesis Imperfecta (OI), also known as Brittle Bone Disease, is a rare and devastating genetic disease, with currently no approved therapies. OI is characterized by fragile bones and reduced bone mass resulting in bones that break easily, loose joints, and weakened teeth. In severe cases, those with OI may experience hundreds of fractures in a lifetime. In addition, people with OI often suffer muscle weakness, early hearing loss, fatigue, curved bones, scoliosis, respiratory problems, and short stature, leading to significant effects on overall health and quality of life. Current treatment of OI is only supportive, focusing on minimizing fractures and maximizing mobility, but to date there are no FDA or EU approved treatments. OI is estimated to affect 1 in 15,000 people globally.

About RoslinCT

RoslinCT is a leading global CDMO focused on advanced cell therapies. With 22 purpose-built cGMP cell therapy suites across sites in Edinburgh, Scotland, and Hopkinton, Massachusetts, RoslinCT provides process and analytical development, clinical and commercial manufacturing for autologous and allogeneic cell therapies, as well as iPSC cell line development, gene editing, and differentiation services.

Founded in 2005 and built on the scientific heritage of the Roslin Institute – home of the groundbreaking cloning of Dolly the Sheep – RoslinCT has played a pivotal role in advancing innovative cell-based medicines from early development through commercialization, with manufacture of commercial products at both sites.

RoslinCT is a GHO Capital portfolio company.

Learn more at: www.roslinct.com

Contacts

Media

BOOST Pharma
Hans Schambye

Email: Hans.Schambye@boostpharma.com

RoslinCT
Katerina Tsita

Email: Katerina.Tsita@roslinct.com
Tel: +44 (0)7867 494071

Daiichi Sankyo and GENESIS Pharma Enter Exclusive Agreement for VANFLYTA® Commercialization in Central and Eastern Europe

Daiichi Sankyo and GENESIS Pharma Enter Exclusive Agreement for VANFLYTA® Commercialization in Central and Eastern Europe




Daiichi Sankyo and GENESIS Pharma Enter Exclusive Agreement for VANFLYTA® Commercialization in Central and Eastern Europe

  • Exclusive agreement covers 13 Central and Eastern European markets
  • Collaboration will help expand access to VANFLYTA for patients with newly diagnosed FLT3-ITD positive AML

MUNICH–(BUSINESS WIRE)–Daiichi Sankyo (TSE: 4568) and GENESIS Pharma have entered into an exclusive license and supply agreement for the distribution and commercialization of VANFLYTA® (quizartinib) in 13 markets across Central and Eastern Europe for the treatment of adult patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML).


Under the terms of the agreement, Daiichi Sankyo will be responsible for the manufacturing and supply of VANFLYTA while GENESIS Pharma will lead medical affairs, market access and commercialization efforts in Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Romania, Slovakia and Slovenia. Financial terms of the agreement are not being disclosed.

VANFLYTA was approved in the EU in November 2023 for the treatment of adult patients with newly diagnosed FLT3-ITD positive AML in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as maintenance monotherapy following consolidation, based on the results from the QuANTUM-First trial.

“This agreement with GENESIS Pharma represents an important step in our ambition to expand access to our innovative targeted medicine across Central and Eastern Europe,” said Markus Kosch, MD, Head, Oncology Business Division Europe and Canada, Daiichi Sankyo. “By combining our scientific expertise with the strong regional footprint of GENESIS Pharma, we aim to accelerate access to VANFLYTA for patients with newly-diagnosed FLT3-ITD positive AML and ultimately help improve outcomes in this high-risk population.”

“This new strategic collaboration marks another significant milestone for our company, reinforcing our long-standing expertise and focus on advancing medicines for difficult-to-treat cancers,” said Constantinos Evripides, Managing Director, GENESIS Pharma. “Daiichi Sankyo has entrusted us with a broad territory across Central and Eastern Europe and we look forward to working together to accelerate access to VANFLYTA across the region.”

About FLT3-ITD Positive Acute Myeloid Leukemia

Almost 487,300 new cases of leukemia were reported globally in 2022, with more than 305,400 deaths.1 AML accounts for 23.1% of total leukemia cases worldwide and is most common in adults.2,3 In Europe, approximately 18,000 people are diagnosed with AML each year and the five-year survival rate is reported at 17% for adult patients.4,5 A number of gene mutations have been identified in AML and FLT3 (FMS-like tyrosine kinase 3) mutations are the most common.6 Approximately 80% of FLT3 mutations are FLT3-ITD mutations, which drive cancer growth and contribute to particularly unfavorable prognosis including increased risk of relapse and shorter overall survival.7,8 FLT3-ITD mutations occur in about 25-30% of all adult patients suffering from AML.7,8

About VANFLYTA

VANFLYTA is an oral, highly potent and selective type II FLT3 inhibitor approved in more than 30 countries/regions in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as maintenance monotherapy following consolidation, for the treatment of adult patients with newly diagnosed AML that is FLT3-ITD positive based on the results from the QuANTUM-First trial. In the U.S., VANFLYTA is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT); improvement in overall survival with VANFLYTA in this setting has not been demonstrated.

In Japan, VANFLYTA is also approved for the treatment of patients with relapsed/refractory AML that is FLT3-ITD mutation positive, as detected by an approved test, based on results from the QuANTUM-R trial.

About Daiichi Sankyo

Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit www.daiichi-sankyo.eu.

About GENESIS Pharma

GENESIS Pharma is a regional biopharma company focused on the commercialization of innovative biopharmaceutical products targeting severe and rare diseases in Central and Eastern Europe. Established in 1997, GENESIS Pharma was among the first pharmaceutical companies in Europe to specialize in the marketing, sales and distribution of biopharmaceutical products. GENESIS Pharma maintains a strong portfolio in therapeutic areas with high unmet medical need through long standing strategic alliances with some of the leading global biopharma companies. For more information, please visit www.genesispharma.com and follow us on LinkedIn.

 

References:

1 Global Cancer Observatory. Population Fact Sheet: World. Updated February 2024.

2 American Cancer Society: Key Statistics for Acute Myeloid Leukemia. Updated January 2023

3 Dong Y, et al. Exp Hematol Oncol. (2020);9:14.

4 Rodriguez-Abreu D, et al. Ann Oncol. (2007);18 Suppl 1:i3-i8

5 Heuser M, et al. Ann Oncol. (2020) 31(6):697-712.

6 Kennedy VE, et al. Front Onc. 23 December 2020;10. Volume 10 – 2020

7 Daver N, et al. Leukemia. (2019) 33:299-312.

8 Patel JP, et al N Engl J Med. (2012) Mar 22;366(12):1079-89.

 

Contacts

Media:
Simone Jendsch-Dowé

Daiichi Sankyo Europe GmbH

Simone.Jendsch-Dowe@daiichisankyo.com
+49 (89) 78080 (office)

Natalia Karahaliou

GENESIS Pharma

nkarahaliou@genesispharma.com
+30 210 87 71 605

Ionis partner GSK announces positive topline results from B-Well 1 and B-Well 2 Phase 3 studies for bepirovirsen, a potential first-in-class medicine for chronic hepatitis B

Ionis partner GSK announces positive topline results from B-Well 1 and B-Well 2 Phase 3 studies for bepirovirsen, a potential first-in-class medicine for chronic hepatitis B




Ionis partner GSK announces positive topline results from B-Well 1 and B-Well 2 Phase 3 studies for bepirovirsen, a potential first-in-class medicine for chronic hepatitis B

Primary endpoint met in both trials –

Bepirovirsen demonstrated a statistically significant and clinically meaningful functional cure rate –

Chronic hepatitis B (CHB) accounts for ~56% of liver cancer cases and affects more than 250 million people worldwide –

Global regulatory filings planned from Q1 2026 –

CARLSBAD, Calif.–(BUSINESS WIRE)–Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) partner GSK today announced positive results from two pivotal Phase 3 studies, B-Well 1 and B-Well 2, evaluating the safety and efficacy of bepirovirsen, an investigational antisense oligonucleotide (ASO) for the treatment of chronic hepatitis B (CHB). The studies included over 1,800 patients from 29 countries. GSK licensed bepirovirsen from Ionis and the two companies have collaborated on its development.


CHB is a major health challenge affecting over 250 million people worldwide and is the leading cause of liver cancer. The current standard of care, nucleos(t)ide analogues, often requires lifelong therapy and the functional cure rates remain low, typically only 1%. Functional cure for CHB is when the virus can no longer be detected in the blood as measured by the sustained loss of hepatitis B surface antigen (HBsAg), a viral protein that signals ongoing infection, and undetectable hepatitis B virus DNA for at least 24 weeks after a finite course of treatment. Functional cure is associated with significant reduction in the risk of long-term liver complications, including liver cancer, as well as all-cause mortality.

The B-Well studies met their primary endpoint, and bepirovirsen demonstrated a statistically significant and clinically meaningful functional cure rate. Functional cure rates were significantly higher with bepirovirsen plus standard of care compared with standard of care alone. Results were statistically significant across all ranked endpoints, including in patients with baseline surface antigen (HBsAg) ≤1000 IU/ml where an even greater effect was demonstrated. The studies demonstrated an acceptable safety and tolerability profile consistent with what was reported in other studies.

“CHB is one of the most common, persistent viral infections in the world, with currently no approved therapy that can achieve meaningful functional cure. Bepirovirsen is uniquely positioned to effectively treat CHB based on its potential to reduce the replication of hepatitis B virus, suppress hepatitis B surface antigen and stimulate the immune system,” said Brett P. Monia, Ph.D., chief executive officer, Ionis. “Today’s positive results are made possible by the strategic collaboration between Ionis and GSK, and demonstrate that bepirovirsen has the potential to bring hope to the millions of people living with CHB. This is the first of five anticipated Phase 3 readouts from Ionis’ partnered programs this year, underscoring the broad applicability of our technology.”

Full results will be submitted for presentation at an upcoming scientific congress, published in a peer-reviewed journal and used to support regulatory submissions to health authorities worldwide. If approved, bepirovirsen has the potential to become the first finite, six-month therapeutic option for CHB and to serve as a backbone for future sequential treatment strategies.

Bepirovirsen has been recognized by global regulatory authorities for its innovation and potential to address significant unmet need in hepatitis B with Fast Track designation from the US FDA, Breakthrough Therapy designation in China and SENKU designation in Japan.

GSK licensed bepirovirsen from Ionis in 2019 under a collaborative development and licensing agreement. Under the terms of the agreement, Ionis received an upfront payment, license fee and development milestone payments and is eligible to receive an additional $150 million in regulatory and sales milestone payments as well as tiered royalties of 10-12% on net sales of bepirovirsen.

About B-Well 1 and B-Well 2

B-Well 1 (NCT05630807) and B-Well 2 (NCT05630820) trials are global multi-center, randomized, double-blind, placebo-controlled trials conducted in 29 countries. They assessed the efficacy, safety, pharmacokinetic profile, and the durability of functional cure in nucleos(t)ide analogue (NA)-treated participants with chronic hepatitis B and baseline surface antigen (HBsAg) ≤3000 IU/ml. The primary endpoint assessed the proportion of participants achieving functional cure in patients with baseline surface antigen (HBsAg) ≤3000 IU/ml. A key secondary endpoint evaluated functional cure in participants with baseline HBsAg ≤1000 IU/ml. Functional cure is defined as hepatitis B surface antigen (HBsAg) loss and undetectable HBV DNA for at least 24 weeks after a finite course of treatment.

About Chronic Hepatitis B (CHB)

Hepatitis B is a viral infection that can cause both acute and chronic liver disease. Chronic hepatitis B occurs when the immune system is unable to clear the virus, resulting in long-lasting infection that affects more than 250 million people worldwide. The disease causes approximately 1.1 million deaths each year, and accounts for approximately 56% of liver cancer cases globally. Many patients often require lifelong antiviral therapy for viral suppression; making functional cure a critical goal in disease management.

About Bepirovirsen

Bepirovirsen is an investigational antisense oligonucleotide (ASO) designed to recognize and orchestrate the destruction of the genetic components (i.e. RNA) of the hepatitis B virus that can lead to chronic disease, potentially allowing a person’s immune system to regain control. Bepirovirsen inhibits the replication of viral DNA in the body, suppresses the level of hepatitis B surface antigen (HBsAg) in the blood, and stimulates the immune system to increase the chances of a durable and sustained response.

About Ionis Pharmaceuticals, Inc.

For three decades, Ionis has invented medicines that bring better futures to people with serious diseases. Ionis has marketed medicines and a leading pipeline in neurology, cardiometabolic and other areas of high patient need. As the pioneer in RNA-targeted medicines, Ionis continues to drive innovation in RNA therapies in addition to advancing new approaches in gene editing. A deep understanding of disease biology and industry-leading technology propels our work, coupled with a passion and urgency to deliver life-changing advances for patients. To learn more about Ionis, visit Ionis.com and follow us on X (Twitter), LinkedIn and Instagram.

Forward-looking Statements

This press release includes forward-looking statements regarding Ionis’ business and the therapeutic and commercial potential of bepirovirsen, our commercial medicines, additional medicines in development and technologies. Any statement describing Ionis’ goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties including those inherent in the process of discovering, developing and commercializing medicines that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such medicines. Ionis’ forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Ionis’ forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Ionis. Except as required by law, we undertake no obligation to update any forward-looking statements for any reason. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Ionis’ programs are described in additional detail in Ionis’ annual report on Form 10-K for the year ended December 31, 2024, and most recent Form 10-Q, which are on file with the Securities and Exchange Commission. Copies of these and other documents are available from the Company. In this press release, unless the context requires otherwise, “Ionis,” “Company,” “we,” “our” and “us” all refer to Ionis Pharmaceuticals and its subsidiaries.

Ionis Pharmaceuticals® is a trademark of Ionis Pharmaceuticals, Inc.

Contacts

Ionis Investor Contact:

D. Wade Walke, Ph.D.

IR@ionis.com
760-603-2331

Ionis Media Contact:
Hayley Soffer

media@ionis.com
760-603-4679

Number of Shares and Voting Rights of Innate Pharma as of December 31, 2025

Number of Shares and Voting Rights of Innate Pharma as of December 31, 2025




Number of Shares and Voting Rights of Innate Pharma as of December 31, 2025

MARSEILLE, France–(BUSINESS WIRE)–#immunotherapy–Regulatory News:


Pursuant to the article L. 233-8 II of the French “Code de Commerce” and the article 223-16 of the French stock-market authorities (Autorité des Marchés Financiers, or “AMF”) General Regulation, Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) releases its total number of shares outstanding as well as its voting rights as of December 31, 2025:

Total number of shares outstanding:

93,719,323 ordinary shares

 

6,324 Preferred Shares 2016

7,581 Preferred Shares 2017

Total number of theoretical voting rights (1):

Total number of exercisable voting rights (2):

94,484,443

94,465,868

(1) The total number of theoretical voting rights (or “gross” voting rights) is used as the basis for calculating the crossing of shareholding thresholds. In accordance with Article 223-11 of the AMF General Regulation, this number is calculated on the basis of all shares to which voting rights are attached, including shares whose voting rights have been suspended. The total number of theoretical voting rights includes voting rights attached to AGAP 2016, i.e. 130 voting rights for the AGAP 2016-1 and 111 voting rights for the AGAP 2016-2. No voting rights attached to AGAP 2017.

(2) The total number of exercisable voting rights (or “net” voting rights) is calculated without taking into account the shares held in treasury by the Company, with suspended voting rights. It is released so as to ensure that the market is adequately informed, in accordance with the recommendation made by the AMF on July 17, 2007.

About Innate Pharma

Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Leveraging its expertise on antibody-engineering and innovative target identification, Innate Pharma is developing innovative and differentiated next-generation antibody therapeutics.

Innate Pharma is advancing a portfolio of differentiated potential first and/or best-in-class assets, focused on areas of high unmet medical need, including IPH4502, a differentiated Nectin-4 ADC developed in solid tumors, lacutamab, an anti-KIR3DL2 antibody developed in cutaneous T cell lymphomas and peripheral T cell lymphomas, and monalizumab, an anti-NKG2A antibody developed in collaboration with AstraZeneca in non-small cell lung cancer.

Innate Pharma has established collaborations with leading biopharmaceutical companies, including Sanofi and AstraZeneca, as well as renowned academic and research institutions, to advance innovation in immuno-oncology.

Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US.

Learn more about Innate Pharma at www.innate-pharma.com and follow us on LinkedIn and X.

Information about Innate Pharma shares

ISIN code
Ticker code
LEI

FR0010331421

Euronext: IPH Nasdaq: IPHA

9695002Y8420ZB8HJE29

Disclaimer on forward-looking information and risk factors

This press release contains certain forward-looking statements, including those within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. The use of certain words, including “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “may,” “might,” “potential,” “intend,” “should,” “will,” or the negative of these and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s reliance on third parties to manufacture its product candidates, the Company’s commercialization efforts and the Company’s continued ability to raise capital to fund its development. For an additional discussion of risks and uncertainties, which could cause the Company’s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque”) section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website http://www.amf-france.org or on Innate Pharma’s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2024, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public by the Company. References to the Company’s website and the AMF website are included for information only and the content contained therein, or that can be accessed through them, are not incorporated by reference into, and do not constitute a part of, this press release.

In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by the Company or any other person that the Company will achieve its objectives and plans in any specified time frame or at all. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.

Contacts

For additional information, please contact:

Innate Pharma

Stéphanie Cornen

stephanie.cornen@innate-pharma.fr

Investor Relations
investors@innate-pharma.fr

Medias
communication@innate-pharma.com