Author Archives:

EnteroBiotix Announces Completion of Enrolment in Phase 2a Trial Evaluating EBX-102-02 Prior to Allogeneic Stem Cell Transplantation

Posted on by

EnteroBiotix Announces Completion of Enrolment in Phase 2a Trial Evaluating EBX-102-02 Prior to Allogeneic Stem Cell Transplantation




EnteroBiotix Announces Completion of Enrolment in Phase 2a Trial Evaluating EBX-102-02 Prior to Allogeneic Stem Cell Transplantation

GLASGOW, United Kingdom, March 10, 2026 (GLOBE NEWSWIRE) — EnteroBiotix, a clinical-stage biopharmaceutical company developing best-in-class microbiome therapies, today announced that the investigator-initiated Phase 2a MAST trial (Intestinal Microbiota Transplant prior to Allogeneic Stem Cell Transplantation) has completed its enrolment of 50 adult patients undergoing allogeneic haematopoietic stem cell transplantation (allo-HSCT) for defined haematological malignancies. Participants receive EBX-102-02 or matched placebo prior to conditioning chemotherapy and are followed for 12 months post-transplant.

The study is sponsored by Imperial College London and funded by the Medical Research Council (MRC). It is led by Co-Chief Investigators Professor Julian Marchesi and Dr Jiri Pavlu, together with haematologists across leading UK transplant centres. EnteroBiotix is supplying EBX-102-02 for use in the trial.

Profound disruption of the gut microbiome is common during allo-HSCT, and loss of microbial diversity has been associated with increased risk of infection, graft-versus-host disease (GVHD) and reduced overall survival. The MAST trial will assess whether a single dose of pre-emptive orally administered EBX-102-02 can enhance and preserve microbial diversity during the transplantation period. Exploratory outcomes evaluate clinical transplant outcomes. Topline data are expected in H1 2027.

MAST builds on EnteroBiotix’s broader clinical programme, following previously announced positive Phase 2a data in irritable bowel syndrome (IBS) and Phase 1b data in liver cirrhosis, and supports the Company’s strategy to develop full-spectrum microbiome therapeutics across major disease areas supported by a strong biological rationale.

Professor Julian Marchesi said:

“Profound disruption of the intestinal microbiome is common during allogeneic stem cell transplantation and has been strongly associated with adverse outcomes. MAST builds on prior promising work from the Imperial team utilising traditional FMT approaches and has been designed to assess whether pre-emptive microbiota restoration using EBX-102-02 can preserve microbiome diversity during the transplant period and potentially improve post-transplant outcomes. We are pleased to have completed enrolment and thank the patients and clinical teams involved.”

Dr James McIlroy, Chief Executive Officer of EnteroBiotix, said:

“Completion of enrolment in MAST builds on our recent progress in IBS and cirrhosis and marks another step in evaluating the potential of EBX-102-02 across multiple indications with high unmet medical need. We are excited about the potential of our platform and technology for supporting the treatment of oncology patients. We thank the Imperial investigators for their collaboration and look forward to topline data in H1 2027.”

Trial Design

MAST (NCT06355583) is a multicentre, randomised (1:1), double-blind, placebo-controlled Phase 2a trial enrolling approximately 50 adult patients undergoing allo-HSCT for certain haematological malignancies. Participants receive EBX-102-02 or matched placebo prior to initiation of conditioning chemotherapy and are followed longitudinally for 12 months after allo-HSCT.

The primary endpoint evaluates change in gut microbiota alpha diversity from baseline to post-transplant timepoints. Secondary and exploratory endpoints include safety, tolerability, clinical transplant outcomes, and translational microbiome and immune analyses.

About EBX-102-02

EBX-102-02 is EnteroBiotix’s next-generation full-spectrum investigational microbiome therapeutic, manufactured using proprietary processing technologies designed to enable safe, stable and orally delivered microbial ecosystem restoration. The product is formulated to deliver consistently high microbial diversity with a robust stability profile.

About EnteroBiotix

EnteroBiotix is a clinical-stage biopharmaceutical company developing microbiome-based therapies for gastrointestinal and systemic diseases. Using proprietary manufacturing and analytical technologies, the Company aims to create best-in-class orally delivered products that restore microbial ecology and function. EnteroBiotix is headquartered in Glasgow, Scotland.

About Imperial College London

We are Imperial – a world-leading university for science, technology, engineering, medicine and business (STEMB), where scientific imagination leads to world-changing impact.

As a global top ten university in London, we use science to try to understand more of the universe and improve the lives of more people in it. Across our nine campuses and throughout our Imperial Global network, our 22,000 students, 8,000 staff, and partners work together on scientific discovery, innovation and entrepreneurship. Their work navigates some of the world’s toughest challenges in global health, climate change, AI, business leadership and more.

Founded in 1907, Imperial’s future builds on a distinguished past, having pioneered penicillin, holography and fibre optics. Today, Imperial combines exceptional teaching, world-class facilities and a habit of interdisciplinary practice to unlock scientific imagination. https://www.imperial.ac.uk

Media contacts

EnteroBiotix
Dr James McIlroy, CEO
info@enterobiotix.com 

Scius Communications 
Katja Stout
+44 778 943 5990
katja@sciuscommunications.com

Daniel Gooch
+44 7747 875479
daniel@sciuscommunications.com

Kainova Therapeutics Announces Positive Phase I Results for DT-9081, an Oral EP4 Receptor Antagonist, in Advanced Solid Tumors

Posted on by

Kainova Therapeutics Announces Positive Phase I Results for DT-9081, an Oral EP4 Receptor Antagonist, in Advanced Solid Tumors




Kainova Therapeutics Announces Positive Phase I Results for DT-9081, an Oral EP4 Receptor Antagonist, in Advanced Solid Tumors

  • Phase I results demonstrate favorable safety, sustained target engagement, and early signs of anti-tumor activity
  • Reinforce EP4 receptor antagonism as a validated, high-value strategy to overcome immunotherapy resistance

MONTREAL and STRASBOURG, France and BOSTON, March 10, 2026 (GLOBE NEWSWIRE) — Kainova Therapeutics (“the Company”), a key player for breakthrough treatments in immuno-oncology and inflammation, today announced positive topline results from its Phase I EPRAD study evaluating DT-9081, a proprietary, oral small molecule EP4 receptor (EP4R) antagonist in patients with advanced, recurrent, and metastatic solid tumors.

The study, conducted across four sites in France and Belgium, met all primary objectives. Results demonstrated a favorable safety profile, robust pharmacokinetic (PK) and pharmacodynamic (PD) characteristics with dose-proportional exposure, and sustained EP4 receptor engagement across all tested doses, with early signs of anti-tumor activity.

No dose-limiting toxicities were reported at any dose level, confirming DT-9081’s clinical tolerability and validating its mechanism of action. The Phase I findings further support DT-9081’s potential to improve responses to immune checkpoint inhibitors (ICIs). Full Phase I study details are available on clinicaltrials.gov under identifier NCT05582850.

Professor Jean-Pascal Machiels, Principal Investigator of the EPRAD study, commented: “The results of the study not only validate EP4 receptor antagonism as a powerful mechanism to counteract PGE2-driven immune suppression, but also demonstrate the clinical potential of DT-9081 across a range of tumor types. Since chemotherapy and other standard treatments often trigger PGE2 production by cancer cells, restoring competence through selective EP4 inhibition offers a rational and versatile strategy to overcome resistance. It was my honor to contribute to the advancement of DT-9081 through the clinic.”

Dr Jean-Marie Cuillerot, Chief Medical Officer of Kainova Therapeutics, said: “The Phase I EPRAD study generated a clear and coherent dataset that precisely characterizes DT-9081’s clinical profile. Across all dose levels, we observed consistent safety findings together with robust PK/PD readouts. The high-quality clinical and translational data obtained in this study are essential for understanding how EP4 antagonism behaves in patients with advanced solid tumors in a clinical setting.”

Sean A. MacDonald, Chief Executive Officer of Kainova Therapeutics, added: “The successful completion of this Phase I study represents an important step for Kainova Therapeutics, highlighting the strength of our innovative approach to targeting the EP4 receptor to overcome tumor-induced immunosuppression. The favorable safety and early efficacy signals observed with DT-9081 provide meaningful insight into EP4 biology and its role in immuno-oncology. These findings reflect the depth of expertise within our team and reinforce the relevance of GPCR-modulating strategies in addressing complex immune pathways.”

For more information, please contact:

Optimum Strategic Communications
Mary Clark, Zoe Bolt, Elena Bates, Nellie Stephens
+44 (0) 203 882 9621
Kainova@optimumcomms.com

For French media:
communication@kainovatx.com

About Kainova Therapeutics

Kainova Therapeutics is a clinical-stage biopharmaceutical company, headquartered in Montreal, Canada, driving a robust pipeline of breakthrough therapies that precisely modulate G protein-coupled receptors (GPCRs) with a focus on immuno-oncology and inflammation. Kainova Therapeutics’ key programs include a unique clinical-stage Treg-depleting anti-CCR8 antibody with differentiated competitive features and a first-in-modality pre-IND stage biased antagonist of PAR2.

By unlocking challenging and unexploited GPCR targets through its integrated discovery-to-clinic approach that integrates deep biological knowledge, Kainova Therapeutics delivers highly differentiated therapies grounded in rigorous science and designed to improve therapeutic efficacy. Recognized for a solid track record of collaborations with major pharma, physicians and KOLs worldwide, Kainova Therapeutics brings scientific excellence to the development of GPCR-modulating therapies.

Operating in North America, France, and Australia, Kainova Therapeutics applies smart trial designs, capital efficiency, and operational rigor across its programs. As GPCRs gain renewed attention as next-generation drug targets, Kainova Therapeutics is uniquely positioned to lead this evolving field. For more information, please visit https://www.kainovatx.com

About DT-9081
DT-9081 is a best-in-class oral EP4 receptor antagonist designed to reverse Prostaglandin E2 (PGE2)-mediated immunosuppression within the tumor microenvironment. Preclinical studies have shown significant anti-tumor effects in triple-negative breast cancer, sarcoma, and colorectal cancer models, both as a monotherapy and in combination with chemotherapy or immune checkpoint inhibitors. PGE2, produced by COX-2 positive tumors, promotes tumor progression. By selectively inhibiting EP4 receptor, DT-9081 aims at restoring an immunocompetent environment and supporting immune reactivation, with the goal of improving the effectiveness of anticancer treatments, including chemotherapy and certain ICIs. The candidate is supported by a comprehensive biomarker strategy, enabling precise monitoring of EP4 receptor engagement during treatment and helping inform clinical positioning, de-risk development, and ensure an efficient, informative clinical trial strategy.

About GPCRs
G Protein-Coupled Receptors (GPCRs) are at the top of complex signaling cascades and are responsible for translating extracellular messages into intracellular actions, making them critical for various biological processes and attractive for therapeutic intervention. Despite being the most validated drug target family, with 30-35% of all marketed drugs acting on them, they remain challenging to drug, with existing drugs targeting only 10% of the total potential GPCR targets. While most efforts in GPCR drug discovery and development have traditionally focused on central nervous system and cardio-metabolic disorders, Kainova Therapeutics recognizes the substantial untapped potential of GPCRs in immuno-oncology and inflammatory diseases, areas where GPCRs have not been as extensively explored.

Press Release Biocartis NV: Biocartis Receives European IVDR Certification for the Idylla™ CDx MSI Test

Posted on by

Press Release Biocartis NV: Biocartis Receives European IVDR Certification for the Idylla™ CDx MSI Test




Press Release Biocartis NV: Biocartis Receives European IVDR Certification for the Idylla™ CDx MSI Test

PRESS RELEASE  10/03/2025, 08:00 CET

Biocartis Receives European IVDR Certification for the Idylla™ CDx MSI Test

Idylla™ CDx MSI Test is the Second Fully Automated Companion Diagnostic Test Approval for Biocartis under IVDR


Mechelen, Belgium, 10 March 2026 – Today, Biocartis announced that its Idylla™ CDx MSI Test has received Class C companion diagnostic (CDx) certification under the EU’s IVDR1 as a CDx for colorectal cancer (CRC).

The Test is indicated as an aid to identify adult patients with microsatellite instability-high (MSI-H) metastatic CRC patients, who may benefit from treatment with nivolumab in combination with ipilimumab.

Designed for use on the Idylla™ Platform, the Idylla™ CDx MSI Test qualitatively detects MSI-H/MSS in CRC tissue samples within a single-use cartridge, requiring less than three minutes of hands-on-time and delivering straightforward results in under three hours. For more information about the test, please visit the Biocartis website or contact the Biocartis team.

Roger Moody, Chief Executive Officer of Biocartis, commented: “In May 2025, we received IVDR certification for the Idylla™ EGFR Mutation Test and have now expanded our IVDR-approved portfolio with the Idylla™ CDx MSI Test. Building on its FDA approval in the United States, the Idylla™ CDx MSI Test is now also empowering clinicians across Europe with rapid and reliable results that support groundbreaking therapy selection for CRC patients, enabling timely and informed treatment decisions when every moment counts.”

The IVDR-certified Idylla™ CDx MSI Test will be available soon to customers across Europe and additional regions where IVDR regulations apply. The Idylla™ CDx MSI Test is already commercially available in the US.

—– END —–

More information:

Biocartis NV. Generaal De Wittelaan 11B, 2800 Mechelen, Belgium

Biocartis US Inc. 2 Pierce Place, Suite 1510, Itasca, IL 60143, US

www.biocartis.com | info@biocartis.com

About Biocartis

Biocartis is committed to helping cancer patients worldwide access the right treatment faster. With our proprietary Idylla™ Platform, we deliver in-house molecular biomarker results in only 3 hours, enabling healthcare professionals to make timely, informed decisions that guide personalized therapy. Our expanding portfolio of diagnostic tests and research assays addresses key unmet clinical needs across multiple cancers, including lung, skin, thyroid, colorectal, endometrial, blood, brain, and breast cancer.

Learn more at www.biocartis.com and follow us on LinkedIn, Facebook and X (Twitter).

Disclaimers

Idylla™ Platform is CE-marked in Europe in compliance with EU IVD Regulation 2017/746, listed as a class II device in the US under establishment registration 3009972873, and registered in many other countries. Idylla™ CDx MSI Test (A0220/6) is CE-marked in Europe in compliance with the EU IVD Regulation 2017/746 (IVDR) and is approved in the US under P250005. Biocartis and Idylla™ are registered trademarks in Europe, the US and many other countries. The Biocartis and Idylla™ trademarks and logos are used trademarks owned by Biocartis NV. © March 2026, Biocartis NV. All rights reserved.

1 European In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR).

OSE Immunotherapeutics Confirms Marc Le Bozec as Chief Executive Officer to Lead Next Phase of Strategic Growth

Posted on by

OSE Immunotherapeutics Confirms Marc Le Bozec as Chief Executive Officer to Lead Next Phase of Strategic Growth




OSE Immunotherapeutics Confirms Marc Le Bozec as Chief Executive Officer to Lead Next Phase of Strategic Growth

Nantes, France, March 10, 2026 – 7:30am CET – OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), today announced the transition of Marc Le Bozec from interim to permanent Chief Executive Officer, effective immediately. Mr. Le Bozec had served as interim CEO since October 2, 2025.  

Following a thorough review of internal and external candidates and upon recommendation of the Nomination and Compensation Committee, the Board of Directors unanimously confirmed Marc Le Bozec’s transition from interim to permanent CEO.

Dr. Markus Cappel, Chairman of the Board of OSE Immunotherapeutics, commented:
“I am thrilled to announce Marc’s permanent appointment as CEO. Since stepping into the interim role, Marc has demonstrated the strategic ‘grit’ and visionary leadership required to navigate the complexities of our sector. His deep understanding of our pipeline and his ability to unite the team behind a common mission have been exemplary. The Board is fully aligned with Marc’s vision to scale our current assets into commercial successes, and we are confident that his leadership will drive significant value for our shareholders and, most importantly, for the patients who depend on our innovation.”

Marc Le Bozec, Chief Executive Officer of OSE Immunotherapeutics, added:
“I am deeply honored and energized to lead OSE Immunotherapeutics at such a pivotal moment in our journey. We are at a transition point where our scientific excellence is meeting critical clinical and commercial milestones. My focus is clear: to accelerate our breakthrough therapies and ensure that our novel medicines reach the patients in need as quickly as possible. OSE possesses a world-class R&D engine and a pipeline with transformative potential, and I am eager to work alongside Markus, the Board and our talented team to unlock the full value of these assets.”

A Renewed Commitment to Patients
This appointment reinforces OSE’s core mission of bringing life-changing treatments to patients facing high unmet medical needs. The Company remains steadfast in its goal to deliver novel immunotherapies in the fields of immuno-oncology and immuno-inflammation, with a focus on precision medicine and patient-centric clinical development.

The compensation policy of Mr. Le Bozec for his position as Chief Executive Officer, as determined by the Board of Directors on the recommendation of the Nomination and Compensation Committee, will be published in the Company’s 2025 Universal Registration Document and submitted to the vote of the Company’s Annual Shareholders’ Meeting, which will be called upon to approve the financial statements for the fiscal year ending December 31, 2025.

ABOUT OSE IMMUNOTHERAPEUTICS
OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I) that address the unmet patient needs of today and tomorrow. We partner with leading academic institutions and biopharmaceutical companies in our efforts to develop and bring to the market transformative medicines for people with serious diseases. OSE Immunotherapeutics is based between Nantes and Paris and is listed on Euronext. Additional information about OSE Immunotherapeutics assets is available on the Company’s website: www.ose-immuno.com. Follow us on LinkedIn.

Contacts

OSE Immunotherapeutics: investors@ose-immuno.com

FP2COM: Florence Portejoie: fportejoie@fp2com.fr I +33 6 07 768 283

 

Forward-looking statements
This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management considering its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. 

These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on April 30, 2025, including the annual financial report for the fiscal year 2024, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.

Attachment

Idorsia expands QUVIVIQ’s global footprint through new partnership with Pharmalink

Posted on by

Idorsia expands QUVIVIQ’s global footprint through new partnership with Pharmalink




Idorsia expands QUVIVIQ’s global footprint through new partnership with Pharmalink

  • Idorsia and Pharmalink enter into an exclusive distribution and commercialization agreement for QUVIVIQ™ (daridorexant) in the United Arab Emirates (UAE), Kuwait, Qatar, Oman, and Bahrain

Allschwil, Switzerland – March 10, 2026
Idorsia Ltd (SIX: IDIA) has entered into an exclusive agreement with Pharmalink Drug Store L.L.C for the distribution and commercialization of QUVIVIQ™ (daridorexant) – its treatment for adults with insomnia – across the United Arab Emirates (UAE), Kuwait, Qatar, Oman, and Bahrain.

Srishti Gupta, MD, Chief Executive Officer of Idorsia, commented:
“We are delighted to partner with Pharmalink, a leading healthcare provider that shares our bold vision for QUVIVIQ‘s growth across the UAE and other Gulf states. I am confident that this partnership will ensure that many patients gain access to our innovative treatment for insomnia – the only medication to have shown improvement on daytime functioning and treat insomnia as a 24-hour disorder.”

Abdul Rauf Jabour, MD, Chief Executive Officer of Pharmalink, commented: 
“We are extremely pleased to partner with Idorsia to introduce QUVIVIQ to the UAE and the wider Gulf Cooperation Council (GCC) region. Insomnia is highly prevalent in the GCC region and an innovative brand like QUVIVIQ would rightly address the patient’s needs.”

Under the terms of the agreement, Idorsia will receive an upfront payment and hold the Marketing Authorizations for the countries. Upon regulatory approval, Idorsia will supply to Pharmalink finished drug product at an agreed price. Pharmalink will be responsible for distribution, promotion and sale of the product in the specified territory.

QUVIVIQ – a different kind of insomnia treatment
Insomnia affects millions worldwide, yet commonly used treatments can lead to next-day drowsiness, dependence, and withdrawal symptoms – leaving a clear unmet need for safer, effective alternatives.

Discovered by Idorsia, QUVIVIQ works differently from traditional hypnotics. As a dual orexin receptor antagonist, it selectively targets the orexin system, helping to regulate overactive wake signaling without broadly suppressing brain activity. Its optimized pharmacokinetics promote restorative sleep throughout the entire night, reducing morning sleepiness and improving daytime functioning.

Clinical trials published in The Lancet Neurology demonstrated that daridorexant significantly improved sleep onset, sleep maintenance, and self-reported total sleep time at 25mg and 50mg doses compared to placebo. Daridorexant 50 mg also demonstrated a highly significant improvement in daytime functioning compared to placebo.

Global availability
QUVIVIQ is marketed by Idorsia in the US, Canada, and multiple European countries, and is available in Japan, Hong Kong, and China through commercial partnerships. Idorsia also has license and supply agreements with EMS in Latin America and CTS in Israel. This collaboration with Pharmalink further strengthens Idorsia’s commitment to building QUVIVIQ into a global brand.

Notes to the editor

About insomnia
Insomnia is defined as a combination of dissatisfaction with sleep and a significant negative impact on daytime functioning. Dissatisfaction with sleep refers to the difficulty to initiate and/or maintain sleep on at least three nights per week for at least three months, despite adequate opportunity to sleep.

Insomnia is a condition of overactive wake signaling and studies have shown that areas of the brain associated with wakefulness remain more active during sleep in patients with insomnia.

Insomnia as a disorder is quite different from a brief period of poor sleep, and it can take its toll on both physical and mental health. It is a persistent condition with a negative impact on daytime functioning. Idorsia’s research has shown that poor-quality sleep can affect many aspects of daily life, including the ability to concentrate, mood, and energy levels.

The goals of managing insomnia are to improve sleep quality and quantity, as well as daytime functioning. Current recommended treatment of insomnia includes sleep hygiene recommendations, cognitive behavioral therapy and pharmacotherapy.

About Pharmalink
Pharmalink is a trusted partner for innovative therapies commercialization in the Gulf region, a success story that is more than three decades in the making. The group operates with more than 1800 employees with fully integrated own commercialization set up including registration, marketing, distribution and more than 200 pharmacies to support in-licensed brands growth. Today, Pharmalink supplies a wide range of product categories that address all age groups and specialties. These medications include lifesaving & emergency drugs to consumables and OTC medications that can be purchased without prescriptions.

As a well-known name in the market, Pharmalink in-licenses innovative therapies across therapeutic segments from reputed global biotech and pharmaceutical companies for commercialization in the GCC countries thereby ensuring their availability to the patients across the Gulf countries.

Pharmalink effectively covers the entire market through own resources, capabilities and infrastructure catering to private as well as public markets in the region.

The group operates fully-owned pharmacy chains – Medicina and Al Manara with a total of more than 200 pharmacies ensuring retail penetration for brands in-licensed from partners globally.

About Idorsia
The purpose of Idorsia is to challenge accepted medical paradigms, answering the questions that matter most. To achieve this, we will discover, develop, and commercialize transformative medicines – either with in-house capabilities or together with partners – and evolve Idorsia into a leading biopharmaceutical company, with a strong scientific core.

Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients.

Idorsia is listed on the SIX Swiss Exchange (ticker symbol: IDIA).

For further information, please contact:
Investor & Media Relations
Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil
+41 58 844 10 10
investor.relations@idorsia.com – media.relations@idorsia.com – www.idorsia.com

The above information contains certain “forward-looking statements”, relating to the company’s business, which can be identified by the use of forward-looking terminology such as “intend”, “estimates”, “believes”, “expects”, “may”, “are expected to”, “will”, “will continue”, “should”, “would be”, “seeks”, “pending” or “anticipates” or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company’s investment and research and development programs, business development activities and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company’s existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.

Attachment

ViruSure Launches First GMP-Validated Viral Safety Test Based on Oxford Nanopore Sequencing

Posted on by

ViruSure Launches First GMP-Validated Viral Safety Test Based on Oxford Nanopore Sequencing




ViruSure Launches First GMP-Validated Viral Safety Test Based on Oxford Nanopore Sequencing

First-in-class solution consolidates multiple assays into a single test, enabling broader viral detection, faster time-to-result and more confident decision-making in regulated biopharmaceutical quality control


OXFORD, England & VIENNA–(BUSINESS WIRE)–#Nanopore–ViruSure, an Asahi Kasei company and global leader in pathogen safety testing for biopharmaceuticals, today announced the launch of the world’s first GMP-validated adventitious viral agent (AVA) detection test based on Oxford Nanopore sequencing. Designed for use in regulated biopharmaceutical quality control (QC) environments, this process is designed to ensure biologics medicines are free from viral contamination.

The first-in-class solution combines Oxford Nanopore’s rapid, information-rich molecular sensing technology with ViruSure’s GMP expertise, delivering broader viral detection and a more streamlined approach to viral safety testing in commercial biologics manufacturing. This has the potential to enable rapid testing and support confidence in batch release, thus strengthening supply chain resilience.

The launch follows the industry’s first GLP-validated (Good Laboratory Practice) AVA detection test using Oxford Nanopore sequencing in August 2025. Progression to GMP (Good Manufacturing Practice) validation, the standard required for routine use in commercial biopharmaceutical manufacturing, demonstrates the regulatory readiness of Oxford Nanopore sequencing-based approaches for viral safety testing and marks an important step toward wider adoption in regulated environments.

Francis Van Parys, CEO of Oxford Nanopore Technologies, said:

“Rapid Oxford Nanopore sequencing offers a fundamentally different level of resolution for detecting viral contaminants. Through this collaboration with ViruSure, that capability is now available in a GMP-validated format, making advanced sequencing accessible for routine safety testing across biologics manufacturing.”

Faster and boarder AVA detection from a single, comprehensive test

Biopharmaceutical manufacturing underpins the supply of many critical medicines used worldwide. With the global biologics market estimated in excess of £300 billion, and a biosafety testing market alone valued at approximately £3.2 billion, even isolated viral contamination events can have cascading effects across healthcare systems, resulting in patient safety concerns, drug shortages, and substantial financial impact.

Quality control is central to ensuring safe, reliable biologics manufacturing, and new technologies are creating opportunities to make this process more reliable and efficient. While traditional AVA testing has long supported the industry with a broad panel of established assays, the ViruSure and Oxford Nanopore approach brings the benefit of consolidating multiple steps into a single, information-rich test.

Traditional AVA testing relies on numerous parallel and sequential assays to complete a full viral safety panel. Individual tests can take more than 28 days and depending on the level of characterisation can cost tens to hundreds of thousands of pounds, with full panels often taking months. As a result, viral safety testing represents a significant operational component of biologics production, and quality control can account for up to half of the total manufacturing timeline.

Despite their complexity, these approaches can still produce false negatives and false positive results. False positives can trigger unnecessary manufacturing pauses and emergency investigations, creating additional cost and potential supply disruption.

The ViruSure and Oxford Nanopore solution introduces a sequencing-based alternative capable of consolidating many of these individual assays into a single, integrated test that has been demonstrated to have the required sensitivity and specificity necessary to provide assurances around the absence of adventitious agents. By generating a comprehensive and information-rich dataset in one run, manufacturers have the potential to reduce the number of required tests from multiple assays to one, shorten overall testing timelines by weeks, and simplify laboratory workflows within GMP-regulated environments.

Oxford Nanopore’s unique ability to sequence reads of any length enables broader AVA detection and clearer differentiation between background noise, false positives, and true viral contaminants. This supports more confident, data-driven decision-making while reducing the need for unnecessary follow-up investigations, helping to maintain continuity in manufacturing operations.

Dr Andy Bailey, CEO of ViruSure, said:

“Manufacturers need viral safety tests that detect the whole range of potential contaminants, are fast and practical for GMP environments with a low rate of false positives. By validating nanopore sequencing for adventitious viral agent detection, our workflow has demonstrated that we can provide a robust and sensitive solution, with a low risk of false positives, that can strengthen safety assurances for the whole range of biological products.”

About Oxford Nanopore Technologies

Oxford Nanopore Technologies’ goal is to bring the widest benefits to society through enabling the analysis of anything, by anyone, anywhere. The company has developed a new generation of nanopore-based sensing technology for real-time, high-performance, accessible and scalable analysis of DNA and RNA. The technology is used in more than 120 countries to understand the biology of humans and diseases such as cancer, plants, animals, bacteria, viruses and whole environments. Oxford Nanopore Technologies products are intended for molecular biology applications and are not intended for diagnostic purposes.

For more, visit: https://nanoporetech.com/

About ViruSure

With over 20 years of experience, ViruSure is a leading global Contract Research Organization specializing in virus and prion biosafety testing for the life sciences industry. Located in Vienna, Austria, ViruSure offers analytical testing solutions, virus and prion validation services covering a broad portfolio of tests necessary to support drug development and ensure the safety of biopharmaceuticals, cell & gene therapies, and vaccines. ViruSure is integral to the Biosafety Testing Services Unit of Asahi Kasei Bioprocess. To learn more about ViruSure, visit www.virusure.com.

Contacts

Oxford Nanopore
media@nanoporetech.com

Dermapharm Holding SE records decline in consolidated revenue, adjusted consolidated EBITDA improves

Posted on by

Dermapharm Holding SE

/ Key word(s): Annual Results/Preliminary Results

Dermapharm Holding SE records decline in consolidated revenue, adjusted consolidated EBITDA improves

10.03.2026 / 07:30 CET/CEST

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

Dermapharm Holding SE records decline in consolidated revenue, adjusted consolidated EBITDA improves

 

  • In 2025, consolidated revenue decreases to EUR 1,165.0 million (-1.3%) following phase-out of low-margin products in “Parallel import business” segment
  • Adjusted EBITDA increases by 2.9% to EUR 324.8 million; adjusted EBITDA margin at 27.9% (up 1.2 percentage points year on year)
  • Unadjusted EBITDA rises by 2.8% to EUR 317.6 million, margin improves by 1.1 percentage points to 27.3%
  • Earnings and margin development remains heavily dependent on structural measures

 

Grünwald, 10 March 2026 – Dermapharm Holding SE (“Dermapharm”), an innovative and rapidly growing manufacturer of branded pharmaceuticals and other healthcare products, today published its unaudited preliminary consolidated figures (IFRS) for the 2025 financial year.

Consolidated revenue decreased to EUR 1,165.0 million in the reporting period (previous year: EUR 1,180.8 million). The 1.3% decline was due primarily to portfolio adjustments in the Parallel import business in the wake of the systematic phase-out of low-margin products. The organic growth in the “Branded pharmaceuticals” segment did not fully offset this decline.

Adjusted earnings before interest, taxes, depreciation and amortisation (EBITDA) rose by 2.9% to EUR 324.8 million (previous year: EUR 315.6 million), with the adjusted EBITDA margin amounting to 27.9% (previous year: 26.7%). Prior to adjustment, EBITDA increased by 2.8% to EUR 317.6 million (previous year: EUR 308.9 million). The EBITDA margin thus improved from 26.2% in the previous year to 27.3%.

“In 2025, we once again increased our earnings year on year. The systematic focus of our portfolio and the robust development of our core segments underscore the stability and profitability of our Company,” said Dr Hans-Georg Feldmeier, CEO of Dermapharm Holding SE.
 

Branded pharmaceuticals

The segment recorded growth in revenue as well as EBITDA. Organic growth remains solid on the back of a broadly diversified product portfolio. The acquisition of the Austrian pharmaceuticals company F. Trenka expands the Company’s international footprint in the MENA region.

Other healthcare products

The segment’s revenue trend in the reporting year remained on par with the prior-year level. Growth at Euromed and Anton Hübner did not fully offset the decline at Arkopharma. Currency-related effects resulting from the depreciation of the US dollar also weighed on earnings.

Parallel import business

In financial year 2025, Dermapharm continued to restructure its product portfolio with the aim of increasing its focus on high-margin products. Lucrative but low-margin products were gradually phased out. This restructuring led to a significant decline in revenue and earnings.

 

IFRS figures for 2025 and the previous year

EUR million 2025   2024   Change
       
Consolidated revenue     1,165.0     1,180.8  -1.3%
Adjusted consolidated EBITDA* 324.8 315.6 2.9%
Adjusted EBITDA margin* (%) 27.9 26.7 1.2 pp
Consolidated EBITDA 317.6 308.9 2.8%
EBITDA margin (%) 27.3 26.2 1.1 pp

 * 2025 EBITDA was adjusted for non-recurring items amounting to EUR 7.2 million.
   2024 EBITDA was adjusted for non-recurring items amounting to EUR 6.7 million.

 

Company profile:

Dermapharm – Pharmaceutical Excellence “Made in Europe”

Dermapharm is an innovative and rapidly growing manufacturer of branded pharmaceuticals and other healthcare products. Founded in 1991, the Company is based in Grünwald near Munich. In addition to its main location in Brehna near Leipzig, Dermapharm also operates other production, development and distribution locations, including in Germany, the rest of Europe and the United States.

In the “Branded pharmaceuticals” segment, Dermapharm has more than 1,400 marketing authorisations with more than 400 active pharmaceutical ingredients. Dermapharm’s portfolio of pharmaceuticals is tailored to selected therapeutic areas in which the Company is a market leader, especially in Germany. The Company’s integrated business model extends from in-house product development and production through quality management and logistics to the distribution of branded pharmaceuticals by a trained pharmaceutical sales force.

Dermapharm bundles food supplements, herbal pharmaceuticals, cosmetics, medical devices, herbal extracts and medicinal cannabis in its “Other healthcare products” segment. In this segment, Dermapharm can tap the expertise of Arkopharma, the market leader for phytotherapeutic food supplements in France, and the Spanish company Euromed S.A., a leading global manufacturer of herbal extracts and plant-based active ingredients for the pharmaceuticals, nutraceuticals, foodstuffs and cosmetics industries.

Dermapharm also operates the “Parallel import business” segment under the axicorp brand. axicorp imports originator pharmaceuticals from other EU Member States and resells them to pharmaceuticals wholesalers and pharmacies in Germany. This enables axicorp to benefit from the different pricing structures in the individual EU member states. Based on revenue, axicorp is currently the seventh largest parallel importer in Germany.

With a consistent R&D strategy and numerous successful product and company acquisitions and by stepping up its internationalisation efforts, the Group is continuously optimising its business activities and seeks external growth opportunities in addition to organic growth.

 

 

Contact

Investor Relations & Corporate Communications
Britta Hamberger
Tel.: +49 (0)89 – 64186-233
E-mail: ir@dermapharm.com

 

10.03.2026 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: Dermapharm Holding SE
Lil-Dagover-Ring 7
82031 Grünwald
Germany
Phone: +49 (0)89 64 86-0
E-mail: ir@dermapharm.com
Internet: ir.dermapharm.de
ISIN: DE000A2GS5D8
WKN: A2GS5D
Indices: SDAX
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Dusseldorf, Hamburg, Stuttgart, Tradegate BSX
EQS News ID: 2288158

 
End of News EQS News Service

2288158  10.03.2026 CET/CEST

Evotec Announces ‘Horizon’ – Next Inflection in Its Strategic Transformation to Accelerate Growth and Promote Agility

Posted on by

Evotec SE

/ Key word(s): Preliminary Results/Restructure of Company

Evotec Announces ‘Horizon’ – Next Inflection in Its Strategic Transformation to Accelerate Growth and Promote Agility

10.03.2026 / 07:30 CET/CEST

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

Evotec Announces ‘Horizon’ – Next Inflection in Its Strategic Transformation to Accelerate Growth and Promote Agility

  • Horizon advances multi-stage transformation initiated with Priority Reset in 2024 and establishes new operating model across three pillars: operations, science and commercial execution
  • Operations: Global footprint further streamlined to 10 sites to simplify organizational structures and improve cost base
  • Science: Centers of Excellence concentrate key expertise and innovation infrastructure to deepen scientific leadership and strengthen competitiveness in high-value segments
  • Commercial execution: Upgraded commercial organization enables faster execution, clearer ownership and improved customer responsiveness
  • New operating model designed to deliver greater agility and sustainable growth, enabling improved value creation
  • Structural Horizon measures expected to generate ~€75 million run-rate savings by end of 2027
  • New phased 2026-2030 mid-term framework introduced, aligned with transformation roadmap
  • Investor and analyst webcast and conference call today at 3 p.m. CET / 2 p.m. GMT / 10 a.m. EDT; details can be found below or under this link
 

Hamburg, Germany, March 10, 2026 – Evotec SE (NASDAQ: EVO; Frankfurt Prime Standard: EVT) today announced ‘Horizon’, the next phase in its multi-stage transformation initiative. Horizon advances the company’s evolution by implementing a new and focused operating model built across the three pillars of operations, science and commercial execution. This model is designed to generate above market growth and enhance operating leverage in an environment of normalized demand and increased expectations on scientific and operational performance, building on the Priority Reset in 2024 and the articulation of strategic levers for mid-term value creation in 2025.

Horizon will simplify organizational structures, reorganize Evotec’s global expertise into new, focused Centers of Excellence and align the company footprint to support more disciplined execution in high-value segments of the drug discovery and preclinical development market.

Dr. Christian Wojczewski, Chief Executive Officer of Evotec, said:

“Horizon represents the next step in Evotec’s structured transformation to position the company for sustainable, high-quality growth. Following the disciplined cost actions implemented over the past two years and the strategic priorities we set in 2025, we are now transforming our operating model. This will enable deeper integration, faster decision making and greater agility for our customers and partners. Horizon positions Evotec for stronger performance through 2027 and lays the foundation for further optimization and intelligent scaling toward 2030.”

Strategic Rationale

Horizon marks an important step to position Evotec for the next phase in the evolution of the global drug discovery and pre-clinical development market, driven by deeper scientific excellence and advances in data science, automation and AI. It represents a building phase after which the company will operate with a more disciplined cost base, a higher-value technology-driven revenue mix, improved operating margins and a platform capable of delivering sustainable and profitable growth. Operational streamlining will increase agility and responsiveness and will enable faster execution, particularly within Evotec’s drug and preclinical development (D&PD) business.

Horizon accelerates delivery on Evotec’s four strategic levers for mid-term value creation:

  1. Above market growth rates at better-quality earnings
  2. Commitment to operational excellence
  3. Better monetization of technology and assets of Just – Evotec Biologics
  4. Upside through returns on partnered asset pipeline

Implementation Plan

As part of the transformation, Evotec plans to further optimize its global footprint, reduced from 19 to 14 sites between 2024 and 2025, to 10 sites over the next two years. The footprint optimization will be accompanied by a workforce adjustment affecting up to 800 positions across all locations. Centers of Excellence will enable a centralized innovation infrastructure by concentrating key areas of expertise. This focused model is designed to strengthen scientific depth, enhance cross-disciplinary collaboration and support growth in high-value therapeutic and technology-driven areas.

Implementation of these measures has been initiated, with first operational effects anticipated in the second half of 2026. Horizon is expected to be substantially implemented by the end of 2027, taking into account phased workforce adjustments in accordance with local legal requirements. The organizational changes and associated charges that Evotec expects to incur are subject to a number of assumptions, including local legal requirements. The company is committed to a transparent process and does not expect material disruption to ongoing customer programs.

Paul Hitchin, Chief Financial Officer of Evotec, said:

“From a financial perspective, Horizon represents a fundamental realignment of our operating model and cost structure. We are simplifying our cost base, reallocating resources toward higher-value, intellectual property-driven programs and improving operating leverage across the business to create value for our stakeholders. While 2026 will be a transition year, our objective is a structurally more focused organization with enhanced long-term profitability and strengthened cash generation through 2027 and beyond.”

Financial Framework and Medium-Term Outlook

Considering the start of Horizon and the transition year expected in 2026, Evotec is revising its medium-term financial framework to reflect a phased trajectory from 2026 through 2030.

The revised framework incorporates the timing of restructuring measures and the continued development of the revenue mix across Evotec’s two business segments.

Preliminary FY 2025 Performance (Unaudited)

To provide transparency as part of the updated framework, Evotec is sharing preliminary, unaudited full-year 2025 financial figures, subject to completion of year-end closing and audit procedures.

For full-year 2025, Evotec expects results to fall within its previously communicated guidance ranges:

  • Group revenues of approximately €788 million at the high end of the €760-800 million guidance (€811 million at constant exchange rates (CER))
  • Adjusted Group EBITDA of approximately €41 million versus guidance of €30-50 million
    (€52 million CER)

Evotec will report final fourth quarter and full-year 2025 results on April 8, 2026.

Discovery & Preclinical Development (D&PD)

Preliminary unaudited revenues for the D&PD segment are expected to amount to approximately €529 million (€540 million CER), representing a year-on-year decrease of 13 %. Adjusted EBITDA for the segment is expected to amount to approximately -€12 million (-€5 million CER).

Just – Evotec Biologics (JEB)

Preliminary unaudited revenues for the JEB segment are expected to amount to approximately €259 million (€271 million CER), representing a year-on-year increase of 40 %. Adjusted EBITDA contribution from JEB is expected to amount to approximately €53 million (€57 million CER).

Horizon Financial Impact and 2026 Guidance

Horizon is expected to be substantially completed by the end of 2027. 2026 will represent a transition year, with meaningful operational improvements anticipated to become increasingly visible in the second half.

Evotec expects total run-rate cost savings of approximately €75 million from the structural Horizon measures by the end of 2027 of which a positive contribution will be already realized in 2026.

To implement Horizon, Evotec expects total cash restructuring charges of approximately €100 million over the 2026–2028 period. There are also expected to be non-cash components related to asset impairments.

Evotec enters 2026 with annualized savings of approximately €60 million realized in 2025, fully embedded in its structurally lower operating cost and driven by improved capital discipline and a progressively more technology-driven revenue mix and base. These structural cost reductions, combined with improved utilization and a shift toward higher-margin technology and platform-based activities, are expected to enhance operating leverage and support sustained margin expansion from 2027 onward.

For full-year 2026, Evotec expects:

  • Group revenues of approximately €700-780 million (€730-810 million CER)
  • Adjusted Group EBITDA of approximately €0-40 million (€10-50 million CER)

Medium-Term Framework 2026–2030

Evotec is providing a new medium-term framework for 2026-2030 to consider the timing and impact of Horizon while maintaining its growth ambition. The framework reflects a phased trajectory.

  • Group revenues are expected to grow to > €1 billion (8-12 % CAGR)
  • Adjusted EBITDA margin is expected to reach 20% by 2028 and exceed that level by 2030

The framework reflects:

  • Anticipated recovery of the early drug discovery and development market
  • Cost reductions from Horizon with positive contributions beginning in 2026
  • Continued shift toward higher-margin, technology-enabled, capital-efficient revenue streams
  • Continued CAPEX-lighter approach to below 10 % of revenues
  • Operating leverage as growth resumes following the 2026 transition year

This phased approach defines a clear trajectory from operational reset, through transition, to sustainable margin expansion and scalable growth by 2030. Further details on the medium-term framework will be provided during the final fourth quarter and full-year 2025 reporting on April 8, 2026.

Webcast Details

Evotec will host a webcast and conference call today at 3 p.m. CET / 2 p.m. GMT / 10 a.m. EDT.

To join the audio webcast and to access the presentation slides, please register via this link.

The on-demand replay of the webcast will be available under the same link after the event and on
our website.

Conference Call Details

To join the conference call, please pre-register via this link. You will receive a confirmation email with dedicated dial-in details such as telephone number, access code and PIN to access the call.
A simultaneous slide presentation for participants dialing in via phone is available under this link.

 

About Evotec SE

Evotec is a life science company that is pioneering the future of drug discovery and development. By integrating breakthrough science with AI-driven innovation and advanced technologies, we accelerate the journey from concept to cure — faster, smarter, and with greater precision.Our expertise spans small molecules, biologics, cell therapies and associated modalities, supported by proprietary platforms such as Molecular Patient Databases, PanOmics and iPSC-based disease modeling. With flexible partnering models tailored to our customers’ needs, we work with all Top 20 Pharma companies, over 800 biotechs, academic institutions, and healthcare stakeholders. Our offerings range from standalone services to fully integrated R&D programs and long-term strategic partnerships, combining scientific excellence with operational agility. Through Just – Evotec Biologics, we redefine biologics development and manufacturing to improve accessibility and affordability. With a strong portfolio of over 100 proprietary R&D assets, most of them being co-owned, we focus on key therapeutic areas including oncology, cardiovascular and metabolic diseases, neurology, and immunology. Evotec’s global team of more than 4,800 experts operates from sites in Europe and the U.S., offering complementary technologies and services as synergistic centers of excellence. Learn more at www.evotec.com and follow us on LinkedIn and X/Twitter @Evotec.

 

Forward-looking statements

This announcement contains forward-looking statements concerning future events, including the proposed offering and listing of Evotec’s securities. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “should,” “target,” “would” and variations of such words and similar expressions are intended to identify forward-looking statements. Such statements include comments regarding Evotec’s expectations for revenues, Group EBITDA and unpartnered R&D expenses. These forward-looking statements are based on the information available to, and the expectations and assumptions deemed reasonable by Evotec at the time these statements were made. No assurance can be given that such expectations will prove to have been correct. These statements involve known and unknown risks and are based upon a number of assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond the control of Evotec. Evotec expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Evotec’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

 

Investor Relations and Media Contact

Dr. Sarah Fakih
EVP Head of Global Communications & Investor Relations
Sarah.Fakih@evotec.com

10.03.2026 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: Evotec SE
Manfred Eigen Campus / Essener Bogen 7
22419 Hamburg
Germany
Phone: +49 (0)40 560 81-0
Fax: +49 (0)40 560 81-222
E-mail: info@evotec.com
Internet: www.evotec.com
ISIN: DE0005664809
WKN: 566480
Indices: SDAX, TecDAX
Listed: Regulated Market in Frankfurt (Prime Standard), Tradegate BSX; Regulated Unofficial Market in Dusseldorf, Hamburg, Hanover, Munich, Stuttgart; Nasdaq
EQS News ID: 2288278

 
End of News EQS News Service

2288278  10.03.2026 CET/CEST

Sandoz creates new global biosimilar development, manufacturing and supply unit, appoints industry veteran Armin Metzger to lead next phase of growth

Posted on by

Ad hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules

  • Key move to drive organizational focus ahead of coming ‘golden decade’ of loss of exclusivity opportunities
  • Supports unique strategic positioning as global leader across both biosimilars and generics
  • Enables Sandoz to unlock significant biosimilar market potential while strengthening high-volume generics business to ensure sustainable competitive edge 

Basel, March 10, 2026 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in affordable medicines, today announces the creation of a new biosimilar development, manufacturing and supply unit. The global unit will be headed by industry veteran Armin Metzger, who will join Sandoz on April 1, 2026, as President, Biosimilar Development, Manufacturing & Supply and become a member of the Sandoz Executive Committee (SEC).

 

Sandoz CEO Richard Saynor says: “We stand today at the start of an unprecedented ‘golden decade’ for patient access, with medicines worth more than USD 650 billion dollars set to lose exclusivity over the next 10 years. As the global leader in affordable medicines and the pioneer of biosimilars, Sandoz is determined to capture this opportunity and deliver strong, sustainable growth.

 

“Today’s announcement marks a concrete step towards achieving that goal. Sandoz is uniquely positioned for success thanks to its leading position across both biosimilar and generic medicines. However, despite their many synergies, the two parts of the business have different development, manufacturing and supply requirements, as well as increasingly divergent market dynamics. This change will enable us to focus our efforts more sharply on accelerating biosimilar growth while further strengthening our generic operations to increase our competitive edge.”

 

Consolidating biosimilar development, manufacturing and supply under one SEC leader will enable clear ownership, fast decision-making and stronger alignment. It will also help to accelerate full vertical integration of biosimilar development, manufacturing and supply at Sandoz.

 

Mr. Metzger joins Sandoz from Swiss-based Ferring Pharmaceuticals, where he has served in senior technological leadership roles since 2016, most recently as Executive Vice President, Chief Technical Operations Officer. Prior to that, he spent nearly 20 years in technological and scientific leadership roles at Merck KGaA and Merck Serono. He holds an MSc and PhD in Biochemistry from the University of Bayreuth.

 

Under the new organizational set-up, Claire D’Abreu-Hayling, currently Chief Scientific Officer, becomes President, Generics Development and Chief Scientific Officer. Glenn Gerecke, currently Chief Manufacturing & Supply Officer, is appointed President, Generics Manufacturing & Supply. Both remain as members of the SEC.

 

Dedicated generics capabilities will enable more tailored approaches and clearer focus on the needs of the lower-cost, higher-volume business. The success of the core generics business remains central to the long-term Sandoz strategy, as the only ‘pure-play’ biosimilars and generics company with a strong leadership position and strategic commitment to the synergies in both segments. Generic medicines represent 70% of Sandoz net sales globally in 2025 and an even higher proportion by volume.

 

Additionally, in a move to simplify and align the overall organizational structure, Thomas Weigold, Country Head, Sandoz Germany, will in future report into Christophe Delenta, President Europe. As of April 1, 2026, Germany’s interests will therefore be represented on the SEC at a European regional level. 

 

These changes have no impact on the Company’s 2026 financial guidance, the medium-term outlook or financial reporting.

 

A portrait of Armin Metzger is available via this link: www.sandoz.com/sandoz-creates-new-global-biosimilar-development-manufacturing-and-supply-unit-appoints-industry

 

DISCLAIMER
This Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly revise any forward-looking statements, except as required by law.

ABOUT SANDOZ
Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in affordable medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure Sandoz reaches one billion patients annually, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. In 2026, Sandoz celebrates 20 years of pioneering biosimilars, 80 years of antibiotics manufacturing and 140 years of heritage. In 2025, Sandoz recorded net sales of USD 11.1 billion.   

 

 

CONTACTS

Global Media Relations contacts

Investor Relations contacts

Global.MediaRelations@sandoz.com

Investor.Relations@sandoz.com

Alexis Kalomparis
+41 79 279 0285

Craig Marks

+44 78 1894 2383

Chris Lewis

+49 174 244 9501

Tamara Hackl

+41 79 790 5217

Gregor Rodehueser

+49 170 574 3200

Silvia Siegfried

+41 79 795 90 61 

 

Galenica achieves strong annual result and increases mid-term guidance

Posted on by

Galenica consistently pursued its growth strategy throughout 2025 and reported a strong result. Adjusted1 EBIT grew significantly, with an increase of 11.3% to CHF 234.8 million. This performance was driven by strong sales growth of 5.5% to CHF 4,135.6 million, to which all business areas contributed. Adjusted1 net profit from continuing operations increased by 3.0% to CHF 188.7 million. Commenting on the pleasing annual result, Marc Werner, CEO of Galenica, says: “In 2025, we consistently implemented our strategic objectives and further strengthened our established position in the Swiss healthcare market. We have successfully developed our network and are focusing on customer focus, efficiency and digitalisation.”

The Group’s adjusted1 ROS increased to 5.7% (previous year: 5.4%), bolstered by an improved gross margin combined with optimisation of personnel costs. The acquisition of Labor Team in September as well as special factors of CHF 6.2 million also had a positive impact on EBIT. At CHF 245.7 million, adjusted1 operating cashflow in the 2025 financial year was well above the previous year’s level. The positive cash flow performance was due to a combination of the strong operating result and a targeted focus on managing net working capital.

Consultation services enhance basic care

Galenica further expanded its role in basic care in 2025. Pharmacies in the Galenica network provided more than 368,000 fee-based healthcare and consultation services, including almost 93,000 vaccinations. Thanks to new partnerships with KPT and Helsana, the costs of these services have been covered under certain insurance models since 1 January 2026. Over the course of 2026, the “Consultation plus” offer will become available nationwide in all pharmacies in the network. The company is also growing in the digital sector: the use of Click & Collect is steadily increasing, and the Prescription Manager, launched in early 2025, simplifies the management of prescriptions and ordering of medications. In addition, with the majority takeover of the online drugstore Puravita, Galenica is strengthening its presence in the digital drugstore and over-the-counter range and expanding its online offering.

Wholesale systems modernised for greater efficiency

In 2025, Galexis reached an important milestone in its long-term investments in efficiency and digitalisation, as its distribution centre in Western Switzerland underwent comprehensive modernisation. Thanks to the introduction of the new warehouse management system at the Lausanne-Ecublens site, the level of automation is now over 70%. The next step will follow in the third quarter of 2026, with plans to transition the systems at the Niederbipp site to SAP too. In doing so, Galexis is laying the foundations for even more efficient logistics and creating new opportunities for innovation, particularly in combination with artificial intelligence.

Foundation laid for further growth

Another key milestone was the entry into the diagnostics business by acquiring the Labor Team Group. In doing so, Galenica expanded its offering, in particular for doctors, while at the same time tapping new potential for innovation and growth. In the year under review, Galenica also laid important foundations for sustainable growth in the home care sector. The common market presence of Bichsel and Lifestage Solutions combines many years of experience in clinical nutrition with a modern, digital ordering and billing platform. In future, Bichsel is to focus on home care services, which already account for around two-thirds of the business. As part of this strategic focus, Galenica announced in February 2026 that it aims to cease manufacturing of pharmaceutical products at Bichsel at the end of 2026. The consultation process is expected to conclude in mid-March 2026. 

Galenica increases mid-term EBIT guidance

In light of the strong result, Galenica is clearly on track to meet both its sales and EBIT forecast for 2025. The Board of Directors will therefore propose to the General Meeting that the dividend be increased to CHF 2.50 per share, which corresponds to an increase of 8.7%. For 2026, Galenica expects sales growth of between 5% and 7%. Galenica expects adjusted1 EBIT to increase by 6% to 8%. Excluding the extraordinary special factors of CHF 6.2 million in 2025, this corresponds to an increase in adjusted1 EBIT of 9% to 11%. The costs of the planned closure of Bichsel’s production division will mainly be incurred in the first half of 2026 and are not reflected in the adjusted1 EBIT. Galenica is pursuing a sustainable dividend policy and plans a dividend for 2026 at least at the previous year’s level.

Galenica is also updating its profitability targets in both segments and raises its mid-term guidance for adjusted1 EBIT for the period up to 2027. The previous target of CHF 250 million has been increased to CHF 270 million. In doing so, Galenica is highlighting its ambitious growth targets as well as the positive development of the company and is now also factoring the successful acquisition of Labor Team into its mid-term guidance.

Key figures for the Galenica Group 2025

(in million CHF)

2025

2024

Change

Net sales

 

 

 

Products & Care segment

1,816.4

1,700.2

6.8%

Pharmacies Omni-Channel

1,473.3

1,404.3

4.9%

Products & Brands

 194.2

190.2

2.1%

Services & Production

119.9

115.2

4.0%

Diagnostics

 40.7

0

 

Logistics & IT segment

3,332.6

3,180.5

4.8%

Wholesale

3,255.3

3,105.2

4.8%

Logistics & IT Services

79.6

77.5

2.8%

 

 

 

 

Corporate and eliminations

-1,013.4

-959.6

 

Galenica Group

4,135.6

3,921.1

5.5%

 

 

 

 

EBIT adjusted1

 

 

 

Products & Care segment1

175.2

160.1

9.4%

Logistics & IT segment1

61.7

53.8

14.8%

 

 

 

 

Corporate and eliminations

-2.1

-2.9

 

Galenica Group1

234.8

211.0

11.3%

 

 

 

 

Net profit from ongoing business activities adjusted1

188.7

183.2

3.0%

1See definition as per section “Alternative performance measures” in the Annual Report 2025.

Further information can be found in the Annual Report 2025.

Media and analyst conference at 10.30 a.m.

Galenica will host its media and analyst conference on the 2025 annual results today, Tuesday, 10 March 2026, at 10.30 a.m. (Central European Time, CET).

 

The conference will be held as a hybrid event.

 

Physical location: National Museum Zurich, Auditorium Willy G.S. Hirzel, Museumstrasse 2, 8021 CH-Zurich

 

Online: Live webcast

 

If you are unable to attend in person, you can follow the conference via webcast in German or English and also submit questions.

 

The conference will be held in German with simultaneous translation into English. The documentation will be available on the website from 7 a.m. on 10  March 2026.

 

The recording will be published after the conference on www.galenica.com.