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VIVUS Confirms QSIVA® Price Reduction Is Now Effective Across Nordics and Poland

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VIVUS Confirms QSIVA® Price Reduction Is Now Effective Across Nordics and Poland




VIVUS Confirms QSIVA® Price Reduction Is Now Effective Across Nordics and Poland

— The lowered pricing structure is now available for 101.82 EUR per bottle at pharmacies throughout Finland

AMSTERDAM, March 18, 2026 (GLOBE NEWSWIRE) — VIVUS BV, a subsidiary of VIVUS LLC, a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious medical conditions and life-limiting diseases, today announced the new price reduction of QSIVA® hard modified-release capsules phentermine/topiramate, is now in effect in Finland. The updated pricing reflects an average cost of 3.39 EUR per day, or considering the completer results on the top dose from the pivotal clinical trials, it is approximately 98 EUR per kilogram of weight loss. An individual’s results may vary.

“The price reduction of QSIVA is genuinely welcome. Too often, I see patients forced to stop a medication that is working for them simply because the cost is too high. Lowering the price is a step toward more equitable access to effective obesity care—regardless of income. Obesity is a chronic disease and, for many people, requires long-term treatment and follow-up. Medication can be an important and effective part of care, alongside lifestyle support. Just as importantly, patients benefit from structured, multidisciplinary follow-up so treatment can be individualized—choosing the right option, adjusting the dose when needed, and supporting sustainable health behaviours in the long run,” said Emilia Huvinen, Naistentautien ja synnytysten erikoislääkäri, LT.

According to the 2025 World Obesity Atlas, 22% of Finnish adults live with obesity, and 57% of adults have a high body mass index (BMI). Excess body weight is associated with an increased risk of serious health conditions, including cardiovascular disease, stroke, and diabetes, which are among the leading causes of mortality. Effective treatment options such as QSIVA can support patients in achieving and maintaining clinically meaningful weight loss, helping to improve long-term health outcomes and overall well-being.

“Obesity remains a significant public health challenge in Finland, affecting millions of people and increasing the risk of serious, chronic diseases,” said John Amos, Chief Executive Officer at VIVUS LLC. “With this price reduction now in effect, we aim to improve access to QSIVA and support healthcare professionals and patients in addressing obesity through evidence-based treatment options.”

In the Phase III CONQUER trial, a 56-week clinical study, QSIVA demonstrated that subjects assigned to treatment achieved 7.8 – 10.9 percent weight reduction (ITT analysis) and 7.6 – 10.9 cm reduction of waist circumference after 56 weeks of treatment. Subjects who were treated with QSIVA for the full 56-week study period (completer on drug analysis) achieved 9.6 – 14.4 percent weight reduction and 9.4 – 13.6cm reduction of waist circumference after completion of treatment. These clinical trials also demonstrated that phentermine/topiramate in combination with a weight-loss diet and exercise program resulted in statistically significant and clinically important reductions vs. placebo in weight and waist circumference, coupled with improvements in important risk markers indicative of weight-related comorbidities, such as systolic and diastolic BP, triglycerides, fasting glucose and progression towards type 2 diabetes. QSIVA is available in the mid and top dose strengths evaluated in the Phase III CONQUER trial along with 2 other dose strengths. Dose selection should be individualized and determined by the treating physician based on patient characteristics, treatment response, and tolerability, in accordance with the approved prescribing information.

About VIVUS
VIVUS is a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs. For more information about the Company, please visit https://vivus.com/.

About QSIVA
QSIVA (the European brand name for QSYMIA) is approved in Sweden, Denmark, Finland, Iceland, and Poland. QSIVA is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol. The effect of QSIVA on reducing cardiovascular morbidity and mortality has not been established. The safety and effectiveness of QSIVA in combination with other products intended for weight loss, including prescription and over-the-counter drugs and herbal preparations, have not been established. For more information on QSIVA, please visit QSIVA.eu. The website is accessible for healthcare professionals only through registration.

Important Safety Information for QSIVA

QSIVA® hard modified-release capsules phentermine/topiramate is contraindicated in pregnancy and in women of childbearing potential not using highly effective contraception; in patients with glaucoma; in hyperthyroidism; in patients receiving treatment or within 14 days following treatment with monoamine oxidase inhibitors (MAOIs); in patients with hypersensitivity to sympathomimetic amines, to the active substances, or to any of the excipients in QSIVA.

QSIVA can cause foetal harm. It is recommended that patients who can become pregnant obtain a negative pregnancy test result before starting QSIVA treatment, perform monthly pregnancy testing, and use highly effective contraception while taking QSIVA. If a patient becomes pregnant while taking QSIVA, treatment should be discontinued immediately, and the patient should consult promptly with their doctor. The most common adverse reactions in adults are paraesthesia, dizziness, an altered or impaired sense of taste, insomnia, depression, constipation, and dry mouth.

Forward-Looking Statements

Important Information and Cautionary Note Regarding Forward-Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and/or covered by the “Bespeaks Caution” doctrine applied by the courts under the antifraud provisions of the federal securities laws, and other applicable provisions of the federal securities laws. Such forward-looking statements are based on current expectations, management’s beliefs, and certain assumptions made by the Company’s management. These statements may be identified by the use of forward-looking words such as “will,” “shall,” “may,” “believe,” “expect,” “forecast,” “intend,” “anticipate,” “predict,” “should,” “plan,” “likely,” “opportunity,” “estimated,” and “potential,” and/or the negative use of these words or other similar words. All forward-looking statements included in this document are based on the Company’s current expectations, and the Company assumes no obligation to update any such forward-looking statements except to the extent otherwise required by law.

Forward-looking information about QSIVA, including statements regarding its clinical efficacy, safety profile, the anticipated impact of the price reduction on patient access and commercial performance, and its role in long-term obesity management, involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied in this press release.

Risks related to QSIVA include the potential benefits of the price reduction on patient access and uptake, the impact of revised pricing strategies on revenue and commercial performance, the continued success of pharmacy partnerships across the Nordics and Poland, competitive developments in the weight management market including injectable medications, and whether QSIVA will continue to be commercially successful in approved markets.

General risks include the ability to successfully manage commercial programs across multiple international markets; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of QSIVA; supply chain challenges; and competitive developments in the obesity and weight management therapeutic area.

The above factors, risks, and uncertainties are difficult to predict, contain uncertainties that may materially affect actual results, and may be beyond the Company’s control. New factors, risks, and uncertainties emerge from time to time, and it is not possible for management to predict all such factors, risks, and uncertainties. Although the Company believes that the assumptions underlying the forward-looking statements contained herein are reasonable, any of the assumptions could be inaccurate, and therefore any of these statements may prove to be inaccurate. In light of the significant uncertainties inherent in the forward-looking statements included herein, the inclusion of such information should not be regarded as a representation or warranty by the Company or any other person that the Company’s objectives and plans will be achieved. These forward-looking statements speak only as of the date such statements were made or any earlier date indicated, and the Company does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events, changes in underlying assumptions, or otherwise, unless otherwise required by law. This announcement is made in accordance with applicable securities regulations including the EU Market Abuse Regulation.

Contacts

VIVUS BV
T: +31 20 262 0959

Media – FINN Partners
Julian Tyndale-Biscoe
julian.tyndale-biscoe@finnpartners.com
T: +44 20 7046 8280

Niagen Bioscience to Present at the 38th Annual ROTH Conference

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Niagen Bioscience to Present at the 38th Annual ROTH Conference




Niagen Bioscience to Present at the 38th Annual ROTH Conference

LOS ANGELES–(BUSINESS WIRE)–$NAGE #Biotech—Niagen Bioscience, Inc. (NASDAQ: NAGE), the global authority on NAD+ (nicotinamide adenine dinucleotide) with a focus on the science of healthy aging, today announces that senior management will participate at the 38th Annual ROTH Conference, taking place at The Ritz-Carlton Laguna Niguel in Dana Point, California, from March 22 to 24, 2026.


Niagen Bioscience CEO, Rob Fried, will participate in the Technologies Advancing Healthy Aging Panel on Monday, March 23, at 2:00 PM PT (5:00 PM ET). The panel will be livestreamed and available at www.event.summitcast.com. Additionally, Niagen Bioscience’s CEO, Rob Fried, and CFO, Ozan Pamir, will attend one-on-one meetings with institutional investors in person throughout the day.

This year’s event will consist of one-on-one and small-group meetings, analyst-selected fireside chats, industry keynotes, and panels, with executive management from hundreds of private and public companies across a variety of growth sectors in attendance.

Investors interested in arranging one-on-one meetings should contact their ROTH representative. To learn more and submit a registration request, click here.

The Technologies Advancing Healthy Aging Panel will be livestreamed and available at www.event.summitcast.com.

For additional information on Niagen Bioscience, visit www.niagenbioscience.com.

About Niagen Bioscience:

Niagen Bioscience, Inc. (NASDAQ: NAGE) is the global leader in NAD+ (nicotinamide adenine dinucleotide) science and healthy-aging research. As a trusted pioneer of NAD+ discoveries, Niagen Bioscience™ is dedicated to advancing healthspan through precision science and innovative NAD+-boosting solutions.

The Niagen Bioscience team, composed of world-renowned scientists, works with independent investigators from esteemed universities and research institutions around the globe to uncover the full potential of NAD+. A vital coenzyme found in every cell of the human body, NAD+ declines with age and exposure to everyday lifestyle stressors. NAD+ depletion is a key contributor to age-related changes in health and vitality.

Distinguished by state-of-the-art laboratories, rigorous scientific and quality protocols, and collaborations with leading research institutions worldwide, Niagen Bioscience sets the gold standard for research, quality, and innovation. There’s a better way to age.

At the heart of its clinically proven product portfolio is Niagen® (patented nicotinamide riboside, or NR), the most efficient, well-researched, and high-quality NAD+ booster available. Niagen powers the Company’s consumer supplement, Tru Niagen®, the number one NAD+ boosting oral supplement in the United States† (available at www.truniagen.com), and Niagen Plus™, featuring pharmaceutical-grade intravenous (IV) and injectable Niagen products (www.niagenplus.com). Pharmaceutical-grade Niagen IV and injections are compounded and distributed by U.S. FDA-registered 503B outsourcing facilities and are available exclusively at clinics with a prescription.

Niagen Bioscience’s robust patent portfolio protects NR and other NAD+ precursors. Niagen Bioscience maintains a website at www.niagenbioscience.com, where copies of press releases, news, and financial information are regularly published.

†Based on revenue per largest U.S. e-commerce marketplace (Jan. 2025 – Dec. 2025)

About ROTH:

ROTH is a relationship-driven investment bank focused on serving growth companies and their investors. Their full service platform provides capital raising, high impact equity research, macroeconomics, sales and trading, technical insights, derivatives strategies, M&A advisory, and corporate access. Headquartered in Newport Beach, California, ROTH is a privately-held, employee owned organization and maintains offices throughout the U.S. For more information, please visit www.roth.com.

Contacts

Niagen Bioscience Media Contact:
Kendall Knysch, Senior Director of Media Relations & Partnerships

310.405.5227

kendall.knysch@niagenbio.com

Niagen Bioscience Investor Relations Contact:
Valter Pinto, Managing Director

KCSA Strategic Communications

212.896.1254

Niagen@kcsa.com

Crossbow Therapeutics Raises $77 Million in Series B Financing to Advance Development of TCR-mimetic Antibody Therapies to Treat Cancer

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Crossbow Therapeutics Raises $77 Million in Series B Financing to Advance Development of TCR-mimetic Antibody Therapies to Treat Cancer




Crossbow Therapeutics Raises $77 Million in Series B Financing to Advance Development of TCR-mimetic Antibody Therapies to Treat Cancer

Financing co-led by Taiho Ventures and Arkin Bio Capital with significant participation from other new and existing investors

Investment enables continued clinical development of T-Bolt™ therapies, including completion of CBX-250 Phase 1 trial and initiation of CBX-663 clinical trial

Preclinical and translational updates on both programs to be presented at the American Association for Cancer Research (AACR) 2026 Annual Meeting

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Crossbow Therapeutics, Inc., a biotechnology company developing a novel class of potent and precise antibody therapies to treat a broad range of cancers, today announced it has raised $77 million in a Series B financing that will support the completion of the CROSSCHECK-001 Phase 1 clinical trial of the company’s lead program, CBX-250, and accelerate development of additional T-Bolt™ immunotherapies designed to extend the reach of antibody therapy across a broad range of cancers.


This Series B financing was co-led by Taiho Ventures and Arkin Bio Capital, with participation from new investors Sixty Degree Capital, Hamilton Square Partners Management LP, LifeLink Ventures, Libbs Ventures, and Blood Cancer United’s Therapy Acceleration Program® (TAP), as well as existing investors MPM BioImpact, Pfizer Ventures, BVF Partners, Polaris Partners, Eli Lilly and Company, and Mirae Asset Venture Investment. As part of the financing, Sakae Asanuma, President & CEO of Taiho Ventures, and Pini Orbach, Managing Partner of Arkin Bio Capital, have joined Crossbow’s Board of Directors.

Crossbow is developing a broad portfolio of novel T-cell engager (TCE) therapies that potently target peptide human leukocyte antigen (pHLA) on cancer cells, using antibodies that mimic T-cell receptors (TCR-mimetics). These investigational products, known as T-BoltTM molecules, can be adapted to address a broad range of malignancies, potentially targeting the entire universe of cancer proteins.

“This financing not only strengthens our ability to advance CBX-250 through clinical development but also accelerates our mission to bring next-generation TCR-mimetic immunotherapies to patients who urgently need new options,” said Briggs Morrison, M.D., Chief Executive Officer of Crossbow Therapeutics. “We greatly appreciate our investors for sharing our conviction in the transformative potential of our T-BoltTM platform. We look forward to efficiently expanding our pipeline to address cancers that remain beyond the reach of today’s therapies.”

The Series B financing will allow Crossbow to complete a Phase 1 clinical trial of CBX-250, Crossbow’s first-in-class TCE therapy, which targets a pHLA specific to myeloid cancer cells. The ongoing Phase 1 study (CROSSCHECK-001) is evaluating CBX-250 in patients with relapsed and refractory myeloid malignancies including acute myeloid leukemia (AML), chronic myeloid leukemia (CML), myelodysplastic syndromes (MDS), and chronic myelomonocytic leukemia (CMML). Initial clinical data from the CROSSCHECK-001 trial are expected around the end of 2026.

The financing will also enable submission of an Investigational New Drug (IND) application and initiation of a Phase 1 trial of CBX-663, a first-in-class TCE targeting a telomerase reverse transcriptase (TERT)-derived pHLA for the treatment of multiple hematologic and solid tumors. The initiation of the Phase 1 study evaluating CBX-663 is projected for Q3 2026.

Crossbow researchers will present preclinical findings for CBX-250 in myeloid malignancies as well as the characterization of CBX-663 in models of solid tumors at the upcoming American Association for Cancer Research (AACR) 2026 Annual Meeting in San Diego, Calif., which takes place April 17-22, 2026.

“Crossbow’s arsenal of T-cell engagers represents a differentiated and promising approach to anti-cancer immunotherapy by addressing the wide variety of intra-cellular targets and broadens the potentials of TCE modality,” commented Sakae Asanuma, President & CEO of Taiho Ventures and Crossbow board member. “The company’s experienced team and versatile platform position it to overcome the limitations of current treatments and deliver impact for patients in need. We are excited to continue supporting Crossbow as it advances its lead programs into the clinic.”

About Crossbow Therapeutics, Inc.

Crossbow Therapeutics, Inc., is a biotechnology company determined to improve the lives of people with cancer by unlocking the therapeutic potential of T-cell receptor (TCR)-mimetic antibodies. The company’s T-BoltTM therapies are next-generation, easily assembled immunotherapies directed with high precision at previously unreachable cancer cell targets. Crossbow’s efficient and selective approach is designed to target the entire universe of cancer proteins, dramatically expanding the potential of antibody therapy to address many types of cancer.

AACR 2026 Annual Meeting presentation details:

CBX-250 (Oral Presentation)

  • Title: Preclinical evaluation and safety of CBX-250 in acute myeloid leukemia: A bispecific T cell engager targeting Cathepsin-G peptide/HLA Complex (abstract #4056)
  • Presenting Author: Jennifer Helble, PhD
  • Session Title: Advances in Therapeutic Antibodies
  • Presentation Date/Time/Location: Monday Apr. 20, 2026, 3:50PM-4:05PM PDT, San Diego Convention Center – Ballroom 20 CD (Upper Level)
  • Full text of the abstract is available here.

CBX-663 (Poster Presentation)

  • Title: CBX-663, a first-in-class TCR-mimetic T-Cell Engager targeting the TERT peptide-HLA complex, mediates potent cytotoxicity in vitro and tumor inhibition in vivo in preclinical models of solid malignancies (abstract #1635)
  • Session Title: T Cell Engagers 1
  • Session Date/Time/Location: Monday Apr. 20, 2026, 9:00AM-12:00PM PDT, San Diego Convention Center, Poster Section 10, Poster Board Number 27
  • Full text of the abstract is available here.

For additional details on the CROSSCHECK-001 Phase 1 trial, visit https://clinicaltrials.gov/study/NCT06994676.

For more information about Crossbow Therapeutics, visit www.crossbowtx.com.

About Taiho Ventures, LLC

Taiho Ventures, LLC is a strategic corporate venture capital arm of Taiho Pharmaceutical Co., Ltd., a Japanese specialty pharma focusing on oncology, allergy and immunology. Taiho Ventures is looking at early-stage preclinical oncology companies as well as platform technology companies for our core therapeutic areas. Taiho Ventures will review a wide variety of modalities, including both biologics and small molecules. The company will also consider option-type investments and spin-outs, in addition to the pure equity investments. For more information about Taiho Ventures, please visit https://www.taihoventures.com/.

About Arkin Bio Capital

Arkin Bio Capital is a global biotech fund dedicated to supporting clinical stage biotech companies approaching proof of concept in patients. Arkin Bio Capital leads investments alongside top global partners, driving robust growth and impactful advancements. Our team has a strong background in biopharmaceuticals, drug development, business development, and management, with a proven track record. Arkin Bio Capital seeks to invest in companies with innovative therapeutic candidates and experienced managements and is committed to nurturing promising opportunities and ensuring the success of each investment. For more information about Arkin Bio Capital, please visit https://arkin-capital.com/bio/.

Contacts

Investor Contact:
Crossbow Therapeutics, Inc.

Geraldine Paulus, Co-Founder, Senior Vice President and Head of Corporate Development and Business Operations

Geraldine.Paulus@crossbowtx.com

Media Contact:
SmithSolve

Alex Van Rees

Alex.VanRees@smithsolve.com

Darwin AG launches commercialization of Multi-Cancer Check — a blood test for early detection of 13 types of cancer

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Darwin AG

/ Key word(s): Alliance/Product Launch

Darwin AG launches commercialization of Multi-Cancer Check — a blood test for early detection of 13 types of cancer

18.03.2026 / 10:00 CET/CEST

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

Corporate News

Darwin AG launches commercialization of Multi-Cancer Check — a blood test for early detection of 13 types of cancer

Munich, March 18, 2026 – Darwin AG (ISIN DE000A3C35W0) today announced the launch of its innovative Multi-Cancer Check blood test for early cancer detection. The test was developed in collaboration with Wholomics GmbH and will initially be sold primarily through the Company’s 70% subsidiary NovoMedic GmbH. The Multi-Cancer Check is based on innovative liquid biopsy technology and multi-omics analysis with its performance data setting new standards in preventive oncology.

The Multi-Cancer Check is a non-invasive and highly specific blood test for cancer diagnosis that can detect molecular signals from several types of tumors simultaneously. Unlike many currently available liquid biopsy tests that focus on individual types of cancer, the Multi-Cancer Check allows for broad pre-screening for a total of 13 common types of cancer, including colon, uterus, ovarian, lung, and bladder cancer, thus enabling the detection of a particularly wide range of solid tumors.

In a validation study, the Multi-Cancer Check demonstrated very high sensitivity, especially in early stages of cancer, combined with excellent specificity. The test thus sets a new standard in non-invasive, blood-based early cancer detection. A total of 862 samples, including 440 confirmed cancer cases, were analyzed. The test achieved a sensitivity of 80.7% with a specificity of 99.1% and showed a sensitivity of 82.5% even in stage I. The Multi-Cancer Check produced only three false positive results.

“We are very pleased to introduce the Multi-Cancer Check, a first-class test for early cancer detection, to the market,” says CEO Dr. Daniel Wallerstorfer. “Cancer survival rates depend largely on how early the disease is detected. Our test was developed precisely for this purpose, to identify cancer with high accuracy even before symptoms appear. We are convinced that the Multi-Cancer Check, with its combination of high sensitivity in early stages and very high specificity, as well as its ability to detect different types of cancer, can make a decisive contribution to preventive medicine.”

The Multi-Cancer Check is based on a sophisticated multi-omics analysis in which more than 150 metabolites, lipoproteins, and other biomarkers are examined using nuclear magnetic resonance. The molecular signatures are evaluated using an artificial intelligence (AI) algorithm developed by cooperation partner Wholomics GmbH. The test detects common molecular signals from various solid tumors without clearly localizing the organ of origin. Positive test results should therefore be confirmed by diagnostic imaging procedures.

The global market for liquid biopsies, i.e., non-invasive biopsies or blood tests for early cancer detection and therapy monitoring, is currently estimated at around USD 7 billion and, according to market studies, is expected to grow to over USD 22 billion by 2034, corresponding to an annual growth rate of around 14%.[1] Growth is being driven in particular by the increasing use of minimally invasive or non-invasive diagnostic procedures such as liquid biopsies, which offer significant advantages over traditional tissue biopsies and are therefore increasingly being used in cancer detection and treatment. Compared to traditional tissue biopsies, non-invasive liquid biopsies offer the advantage of fewer complications, ease of repetition, and the ability to map tumor changes in real time. They can provide important molecular information about a tumor, especially in cases of hard-to-reach cancers, making the different biological characteristics of tumors more visible and enabling physicians to make more targeted, personalized treatment decisions.

 

About Darwin AG

The “Darwin Group” (i.e. Darwin AG including its subsidiaries), headquartered in Munich (Germany), is a European healthcare company, particularly active in the field of human genetics and the development of personalized products based on genetic analysis. The genetic analyses conducted in the company’s own laboratory are used in the diagnosis, treatment, and prevention of diseases, as well as in the production of individually tailored nutritional supplements and cosmetics. Darwin also acts as a partner to physicians, therapists, pharmacists, nutritionists, and fitness trainers, helping to ensure treatment or support that is as optimal as possible for the patient’s or client’s needs by analyzing their respective genetic predispositions. In addition, Darwin holds investments in innovative companies in the biotech, healthcare, and life sciences sectors. More information: https://darwin-biotech.com/

[1] Precedence Research, Liquid Biopsy Market Size, Share and Trends 2025 to 2034

Contact:

Darwin AG
Brienner Str. 7
80333 Munich
Phone: +49 89 – 20 500 450
investor.relations@darwin-biotech.com		 Media contact
MC Services AG
Katja Arnold, Pamela Keck
Phone.: +49 89 – 210 228-0
darwin@mc-services.eu
 
 

18.03.2026 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.

2292778  18.03.2026 CET/CEST

Sandoz announces partnership agreement with Samsung Bioepis on up to five biosimilars, further expanding its leading pipeline to up to 32 assets

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MEDIA RELEASE
 

  • Agreement for up to five biosimilar assets, with potential for further collaboration; first asset to be vedolizumab biosimilar
  • Collaboration builds on successful existing partnership; further strengthens Sandoz global position in biosimilars and could expand industry-leading pipeline to up to 32 assets
  • Reinforces commitment to capture significant share of projected ~USD 320 billion biosimilar loss-of-exclusivity market opportunity over next decade¹

 

Basel, March 18, 2026 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in affordable medicines, today announced a major license, development and commercialization partnership agreement with Samsung Bioepis Co., Ltd., marking a significant step to broaden patient access to high-quality biosimilar medicines worldwide.

The agreement paves the way for the two companies to partner on up to five biosimilar assets. The first asset will be a vedolizumab biosimilar, which is in early-stage development. The reference medicine, Entyvio®* (vedolizumab), is used to treat adult patients with Crohn’s disease, ulcerative colitis or pouchitis2,3.

Under the terms of the agreement, Sandoz will have exclusive rights to commercialize globally, except in China, Hong Kong, Taiwan, Macau and Republic of Korea. Samsung Bioepis will be responsible for development, regulatory submissions in key markets and manufacturing. Both companies have agreed to keep the financial details of the agreement confidential.

The partnership could expand the leading Sandoz pipeline to up to 32 assets and reinforces its commitment to capturing a significant share of the projected global biosimilar loss-of-exclusivity market opportunity, estimated at around USD 320 billion over the next decade1.

Richard Saynor, Chief Executive Officer, Sandoz, said: “This partnership underscores our unwavering commitment to expanding access to affordable, high-quality medicines for patients worldwide. It is another important step toward capitalizing on the unprecedented biosimilar market opportunity over the next decade while also strengthening our partnership with Samsung Bioepis.”

Today’s news builds on the successful global partnership between the two companies first established in September 2023 for Pyzchiva® (ustekinumab), which Sandoz launched in Europe in July 2024 and in the US in February 2025. The Pyzchiva collaboration is unaffected by the partnership announced today. In December 2025, the companies also signed an agreement for the commercialization of Epysqli™, a biosimilar to eculizumab (Soliris®**), for the Middle East and Africa region.

Sandoz continues to develop its leading pipeline of biosimilar medicines, building on its experience as the pioneer and global leader with a portfolio of 13 molecules available in nearly 100 countries.

*Entyvio® is a registered trademark of Takeda.
**Soliris® is a registered trademark of Alexion.

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.

REFERENCES
1 Covers US and EU markets (2026–2035). Originator sales and LoE based on internal analysis of data from multiple subscription databases. Biosimilar data accessed in September 2025.
2 European Medicines Agency (EMA). Entyvio. Summary of Product Characteristics. Available at: Entyvio, INN-vedolizumab. [Last accessed March 2026]
3 FDA. Entyvio. Prescribing Information. Available at: ENTYVIO. [Last accessed March 2026]

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 colleagues of 100 nationalities work together to ensure over one billion patients are reached by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 medicines 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
+41 792 790285

Craig Marks

+44 7818 942 383

Chris Lewis

+49 174 244 9501

Tamara Hackl

+41 79 790 5217

Gregor Rodehueser

+49 170 574 3200

Silvia Siegfried

+41 79 795 9061

 

Global survey reveals pet owners lack awareness of parasite risks and seek clearer prevention advice

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Global survey reveals pet owners lack awareness of parasite risks and seek clearer prevention advice




Global survey reveals pet owners lack awareness of parasite risks and seek clearer prevention advice

  • 43% of pet owners report that their pets experienced parasite infections, with 75% looking for clearer parasite prevention advice.
  • Veterinarians are seen as the most trusted source of pet health advice.
  • “Small acts of love. Big moments of life” campaign is launching on World Parasite Awareness Day to increase understanding of how a simple act such as preventing parasites can have a big impact on keeping our cats and dogs healthy. 

World Parasite Awareness Day, held annually on March 20, is an important reminder that parasites such as fleas, ticks and worms are among the most common health threats for pets around the world, yet they can easily be prevented.   

 A global survey among 6,500 pet owners1 shows that, despite frequent exposure to parasites, there is a significant need for greater awareness, clearer guidance and education, and stronger preventative habits among pet owners worldwide. 27% state that they are only slightly familiar with parasite risks or not familiar at all, and a large majority of respondents (75%) said they would value clearer advice on prevention. At the same time, 43% report that their pet had already experienced a parasite infection, with one in five cases occurring within the last year. These findings expose a critical gap between experience and understanding and demonstrate the need for stronger awareness and more consistent preventative action.

In the United States alone, more than 1.2 million dogs are estimated to be heartworm-positive2. In Europe, the same disease has spread to new countries, while in parts of Latin America, Africa, and Asia, heartworm prevalence remains high due to regional conditions. Among external parasites, ticks are commonly found in pets worldwide. For instance, a recent survey in Italy showed that more than 47% of dogs could be infested3, while in a similar study across Southeast Asia up to 67% of owned dogs were found with at least one tick4. These blood-feeding parasites can transmit severe and in some cases life‑threatening diseases such as Lyme borreliosis (causing joint pain and in some cases kidney damage), babesiosis (a protozoan infection that destroys red blood cells) or ehrlichiosis (a bacterial infection that leads to fever and bleeding tendencies).   

Beyond causing discomfort and illness in pets, some parasites can also infest or spread infections to people. As parasites show up in more places due to warmer temperatures and increased travel, prevention has never been more relevant.  

Veterinarians can play a central role in assessing risk, recommending appropriate protection and supporting responsible care. They remain the most trusted source of pet health information, with 70% of pet owners identifying them as their primary reference for guidance. Because parasite risk varies depending on location, season and lifestyle, tailored advice, regular monitoring and responsible use of preventative solutions are essential to protecting pets and people.  

Boehringer Ingelheim, a global leader in animal health, is marking World Parasite Awareness Day with the launch of “Small acts of love. Big moments of life”, a global campaign aiming to raise awareness about how parasites can easily be prevented. “Parasite prevention is a simple yet meaningful way for pet owners to show how they care for the animals they love, but our survey shows that awareness does not always translate into consistent action,” said Claire Fowler, Head of Global Strategic Marketing for Animal Health at Boehringer Ingelheim. “Through this campaign, we want to encourage pet owners to see prevention as one of the small acts of care that help protect their pets and allow them to enjoy more happy and healthy moments together.”   

As a company dedicated to advancing preventative care, Boehringer Ingelheim continues to invest in research, collaborate closely with veterinarians and support educational initiatives that empower pet owners to make informed decisions. Launched around World Parasite Awareness Day at the start of spring in the Northern Hemisphere, its awareness campaign coincides with a time when parasite activity begins to rise in many regions. By encouraging simple habits of care that help protect the health of pets and strengthen the bond they share with their owners, the campaign puts consumer insights into action.

1Pet owner survey: The survey was conducted among 6,500 pet owners across the UK, the US, France, Germany, Turkey, China, Japan, Mexico and Brazil. The interviews were conducted online by Sapio Research in January 2026 using an email invitation and an online survey.   

2American Veterinary Medical Association (AVMA). Heartworm incidence climbs despite preventive efforts. Published October 08, 2024. https://www.avma.org/news/heartworm-incidence-climbs-despite-preventive-efforts  

3Maurelli, M.P., Pepe, P., Colombo, L. et al. A national survey of Ixodidae ticks on privately owned dogs in Italy. Parasites Vectors 11, 420 (2018). https://doi.org/10.1186/s13071-018-2994-2  

4Colella V, Nguyen VL, Tan DY, Lu N, Fang F, Zhijuan Y, et al. Zoonotic Vectorborne Pathogens and Ectoparasites of Dogs and Cats in Eastern and Southeast Asia. Emerg Infect Dis. 2020;26(6):1221-1233. https://doi.org/10.3201/eid2606.191832  

 

About Boehringer Ingelheim 

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com.   

 

About Boehringer Ingelheim – Animal Health business  

Boehringer Ingelheim provides first-in-class innovation for preventing and treating diseases in animals. The company offers a wide range of vaccines, parasite-control products, and medicines for pets, horses, and livestock to veterinarians, animal owners, farmers, and governments. As a leader in animal health, Boehringer Ingelheim values that the health of humans and animals is deeply connected and strives to make a difference for people, animals, and society. Learn more at boehringer-ingelheim.com/animal-health. For more information, visit www.boehringer-ingelheim.com/animal-health.  

 

About World Parasite Awareness Day   

World Parasite Awareness Day is held each year on March 20 to highlight the risk that parasites pose to pets and the people around them. Fleas, ticks, worms, and other parasites can lead to discomfort, illness, and in some cases life-threatening disease in pets, while certain parasitic infections can also spread to people. The day brings together veterinary associations, animal health organizations, and other groups to promote awareness of parasites and the importance of prevention. It is coordinated through www.parasiteawarenessday.com. 

Peace through well-being: Orion and CMI – Martti Ahtisaari Peace Foundation announce partnership

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Peace through well-being: Orion and CMI – Martti Ahtisaari Peace Foundation announce partnership




Peace through well-being: Orion and CMI – Martti Ahtisaari Peace Foundation announce partnership

ORION CORPORATION
PRESS RELEASE
18 March 2026 at 10:00 EET
      

Peace through well-being: Orion and CMI – Martti Ahtisaari Peace Foundation announce partnership

Orion Corporation (“Orion Pharma”) and CMI – Martti Ahtisaari Peace Foundation (“CMI”) have entered a strategic content partnership for 2026. The partnership channels insights from CMI’s peace mediation experts, turning decades of peace process experience into clear and accessible content for a broad audience.

“At Orion Pharma, we believe that building health is building peace. We continue to strengthen resilient healthcare systems in Europe and beyond, with a strong focus on research and development, and our medicines reaching patients in more than a hundred countries. These are long-term commitments to health and, ultimately, investments in peace for future generations,” says Liisa Hurme, President & CEO of Orion Pharma.

The partnership aims to inspire public discussion about peacebuilding and emphasises that societal health and well-being is fundamental to lasting peace. Instead of focusing on peace only after crises emerge, the cooperation highlights peace as a long-term, everyday practice rooted in skills such as dialogue, mediation and trust.

“We share CMI’s ambition for a more stable, just and healthy future for all, and see the core tenets of peacebuilding as an important part of our work and the broader societal discussion around health. We’re proud to start this partnership with them,” Hurme adds.

Prescriptions for Peace

A central part of the partnership is a nine-part video series titled Prescriptions for Peace. Drawing on insights from CMI’s peace mediation experts, the series distils their experience into short and accessible videos. Each episode focuses on one key condition for sustainable peace, such as trust, dialogue, inclusion, ownership and compromise.

As with effective medical treatments, sustainable peace requires commitment, responsibility and long-term effort. The series encourages reflection rather than offering ready-made answers, presenting peace as a conscious choice and a continuous process. The concept of prescriptions is used metaphorically to refer to expert-informed guidance rather than quick fixes.

“Sustainable peace is about much more than just ending violence and getting to a deal. In mediation processes, we see how trust and dialogue gradually create the foundations for more stable societies. Through the Prescriptions for Peace series, we want to share some of these lessons from peace processes with a wider audience,” says Hanna Klinge, Deputy CEO of CMI.

Read more about the collaboration and watch the Prescriptions for Peace videos: prescriptionsforpeace.fi

About Orion Pharma

Orion Pharma is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years. We develop, manufacture and market human and veterinary pharmaceuticals as well as active pharmaceutical ingredients, combining our trusted expertise with continuous innovation. We have an extensive portfolio of proprietary and generic medicines and consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by us are used to treat cancer, respiratory diseases and neurological diseases, among others. In 2025 our net sales amounted to EUR 1,890 million, and we employ about 4,000 professionals worldwide, dedicated to building well-being.

About CMI
CMI – Martti Ahtisaari Peace Foundation is an independent, non-profit Finnish organisation dedicated to advancing peace through conflict resolution, dialogue, and mediation. The organisation was founded 25 years ago by Nobel Peace Prize laureate President Martti Ahtisaari. CMI is one of the world’s leading peace mediation organisations and has been involved in more than 50 peace processes across the globe.

Orion Corporation
  
Contact person Orion:
Terhi Ormio, Vice President Communications

tel. +358 10 426 4646

Contact person CMI:
Kaisa Raitio, Head, Communications and Private Fundraising

tel. +358 50 338 92 60
                                         

Publisher:
Orion Corporation
Communications
Orionintie 1A, FI-02200 Espoo, Finland
http://www.orionpharma.com 

UREVO Unveils CyberMega Across the DACH Region: The First Smart Treadmill Engineered for Marathon Training at Home

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UREVO Unveils CyberMega Across the DACH Region: The First Smart Treadmill Engineered for Marathon Training at Home




UREVO Unveils CyberMega Across the DACH Region: The First Smart Treadmill Engineered for Marathon Training at Home

BERLIN, March 18, 2026 (GLOBE NEWSWIRE) — As marathon participation rises, runners increasingly require equipment that replicates the rigor and precision of road racing. To meet this demand, UREVO launched the CyberMega Smart Treadmill across the DACH region on March 5th. Engineered for high-intensity endurance training, it delivers the uncompromising road feel of outdoor running while insulating training plans from unpredictable weather. The treadmill is available now on UREVO’s official German website and Amazon for €999.99.

Native AI Coaching and Localized Support

A key innovation is the integrated AI Smart Marathon Coach, now featuring full support for the German language. Available via the UREVO Wellness Hub app, it acts as a digital training director to bring race-day discipline home. It provides real-time audio guidance, including warm-up reminders, pacing alerts, split-time analysis, and course time-limit tracking, allowing runners to maintain a structured rhythm without the distraction of manually adjusting settings.

Professional Preparation at Your Own Pace

The CyberMega is built for comprehensive endurance development. Runners can select specific distances, from 5K to a full Marathon, following a structured flow that mirrors a real race. Every session is tracked with precision, syncing seamlessly with Apple Health and Google Fit for professional-grade progress tracking and accountability within a centralized ecosystem.

Instant Setup and Space Efficiency

The CyberMega features the one-touch SwiftFold™ system, requiring no installation and ready to use straight out of the box. The console and armrests fold down smoothly for easy, space-saving storage when not in use.

Elite Marathon Performance Metrics

  • Elite 4.0 HP Brushless Motor: Powers speeds up to 20 km/h, unlocking elite marathon pacing so runners of all levels can push their limits and experience professional racing speeds at home.
  • Acoustic Optimization: Whisper-quiet operation below 40 dB, perfect for noise-sensitive German apartment living.
  • Intelligent Incline System: 12% smart incline that dynamically replicates outdoor topography and engages stabilizing muscles.
  • Virtual Racing & Event Ranking: Run iconic global routes and receive an estimated overall ranking, benchmarking finish times against real-world marathon standards.

“We created the CyberMega for runners who demand professional training at home without compromising space or convenience,” says Davis, CEO of UREVO. “By combining premium hardware, intelligent software, and user-centric design, we’ve built a treadmill that embodies our philosophy: Achieve More with Less.”

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/a4708fa7-68ef-4f1a-be5b-93a7f9f68fce

CONTACT: Contact Person:
Vincent Wang
Email: marketing@urevo.com

BioVersys Reports Corporate Highlights and Financial Results for the Full Year 2025

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Basel, Switzerland. March 18, 2026, 7am CET.

  • Significant clinical and regulatory progress across entire pipeline

BV100:

  • Initiated global registrational Phase 3 (RIV-TARGET) in HABP/VABP1 program – US FDA green lights IND
  • Phase 2b (RIV-CARE) to be conducted via Wellcome-funded trial network ADVANCE-ID
  • First participants dosed in Phase 1 in China, preparing onboarding of China into RIV-TARGET
  • BV100 patent granted in China, adding to BV100’s patent coverage in over 25 countries including the US and Europe

Alpibectir:

  • Our partner GSK reported first patient first visit for Phase 2b/c trial in pulmonary TB
  • Phase 2a results published in New England Journal of Medicine
  • Received EMA Orphan Designation

Corporate:

  • BV500: Entered global research collaboration with Shionogi for broad-spectrum non-tuberculous mycobacteria
  • Successful IPO funding operations into 2028 with BV100 Phase 3 read-out by the end of 2027
  • Conference call on March 18, 2026 at 2.00 pm CET (9.00 am EST)

 

BioVersys AG (SIX: BIOV), a multi-asset, clinical stage biopharmaceutical company focusing on research and development of novel antibacterial products for serious life-threatening infections caused by multi-drug resistant (MDR) bacteria, announced today its audited financial results and corporate highlights for the full year 2025, as well as the publication of its 2025 Annual Report.

Dr. Marc Gitzinger, Chief Executive Officer of BioVersys: “Our successful IPO in early 2025 provided us with the funding to progress our entire pipeline of novel antibacterial drugs, including our two lead assets BV100 and alpibectir. 2025 has been a year of substantial clinical and regulatory progress. We initiated a global Phase 3 program for BV100 in HABP/VABP[1] caused by carbapenem resistant Acinetobacter baumanni (CRAB), and entered into strategic partnerships with Shionogi for BV500 in non-tuberculous mycobacteria (NTM) infection, and with the ADVANCE-ID clinical trial network for the BV100 Phase 2b (RIV-CARE) study. These agreements validate our rich pipeline and extend our cash runway well beyond the BV100 Phase 3 read-out. In 2025, we also saw significant progress in policy change and reimbursement reforms for novel antibiotics, particularly in Europe, and we believe that BioVersys is ideally positioned to benefit from these long-awaited changes. 2026 has started very strongly with the publication of pre-clinical and clinical data on BV100 and alpibectir in prestigious journals, as well as the US FDA’s acceptance of the BV100 Phase 3 IND. As we continue to advance our pipeline, I would like to thank our shareholders, stakeholders and colleagues for supporting us in developing the next generation antibiotics.”

 

Pipeline Highlights

BV100:

In 2025, the company’s lead candidate BV100 initiated its planned global Phase 3 registrational trial (RIV-TARGET) in HABP/VABP caused by carbapenem resistant Acinetobacter baumannii (CRAB) and received US FDA green light for its IND. The study aims to enroll approximately 300 HABP/VABP patients with suspected or confirmed CRAB infections. Patients will be randomized 1:1 to receive either [1] BV100 combined with low dose polymyxin B or [2] Colistin combined with high-dose ampicillin-sulbactam, with both arms allowing meropenem as background in case of polymicrobial infections. The primary efficacy endpoint is defined as 28-day all-cause mortality (ACM) in the CRABC microbiological modified intention-to-treat (CRABC m-MITT) population. Secondary efficacy endpoints will include clinical cure status at the test of cure (ToC) in CRABC m-MITT, ventilator free days, time spent in intensive care unit (ICU) and time in hospital. As part of the study protocol, data safety monitoring boards (DSMB)[2] will be convened at regular intervals to review trial progress.

In parallel to the Phase 3 pivotal trial, an open-label Phase 2b differentiation trial (RIV-CARE) will be initiated in H1 2026, comparing BV100 with BAT in multiple geographies. The Phase 2b trial aims to provide real world evidence of clinical practices in settings with very high drug resistance levels. Interim analysis is planned for end of 2026. In November 2025, BioVersys announced that the ADVANCE-ID clinical trial network will support and collaborate with BioVersys in conducting the Phase 2b study. This support has been made possible thanks to the generous contribution of Wellcome who strengthened the ADVANCE-ID network with SGD 22 million (c. USD 17m or CHF 14m).

A Phase 1 safety study in China was also initiated in 2025 prior to enrolling Chinese patients in the global Phase 3 study program in H2 2026. The Chinese Patent Office granted crucial IP protection to BV100, adding to BV100’s patent coverage in over 25 countries including the US, Europe and the UK.

 

Alpibectir:

In March 2025, BioVersys announced first patient first visit (FPFV) in part 1 of the alpibectir-ethionamide (AlpE) Phase 2 clinical trial in pulmonary tuberculosis (TB) in combination with 1st line tuberculosis drugs. This part 1 of the study delivered top line data showed that alpibectir is generally safe and well tolerated warranting progression into part 2 of the study. Part 2 of the study is a Phase 2b in which AlpE is given for 2 months in combination with first-line TB drugs, followed by 18 weeks of Rifampicin and Isoniazid treatment. FPFV for the Phase 2b was reported in March 2026.

 

Alongside the development in pulmonary TB, BioVersys has also submitted a Phase 2 trial for AlpE in meningeal TB to regulatory authorities. FPFV is expected in H1 2026.

 

In August 2025, BioVersys received European Medicine Agency Orphan Designation for alpibectir combined with ethionamide for the treatment of tuberculosis. This Designation provides key incentives, including reduced fees, research and clinical protocol support, and 10-year EU market exclusivity, and follows alpibectir ethionamide receiving US FDA Orphan Drug Designation in 2023.

 

Alpibectir is being developed in strategic partnership with GSK, who leads clinical development in Tuberculosis Pneumonia while BioVersys leads development in Tuberculosis Meningitis. Both partners share equal economics.

 

BV500:

In July 2025, BioVersys entered a global research collaboration with Shionogi for its broad-spectrum non-tuberculous mycobacteria (NTM) program BV500.

 

The collaboration provides a research and exclusive license option agreement with Shionogi to jointly develop novel ansamycin leads from BioVersys’ BV500 program into clinical candidates. Under the terms of the agreement, BioVersys is eligible to receive upfront and near-term research payments of CHF 5.0 million and, upon exercise of the license option, regulatory and sales milestones of up to CHF 479 million as well as royalties on future sales.

 

2025 Financial Highlights

For the year ended 31 December 2025, BioVersys recognized revenues of CHF 0.8 million (2024: nil) related to the Research Collaboration Agreement entered with Shionogi in July 2025 as well as CHF 2.5 million in other operating income made of research tax credits, grants and subsidies (2024: CHF 1.2 million) leading to a total operating income of CHF 3.3 million (2024: CHF 1.2 million).

 

As a result of BioVersys pipeline progressing through the stages of development, operating expenses were CHF 23.2 million in 2025 compared to CHF 19.9 million in 2024 and leading to an operating loss of CHF 20 million (2024: CHF 18.7m) for the financial year 2025. Operating expenses in 2025 included CHF 16.5 million in R&D expenses, representing approximately 71% of operating expenses for the year (2024: 64.9%).

 

The net loss in 2025 amounted to CHF 21.8 million (2024: Net loss of CHF 18.7 million). 

 

The net cash used in operating activities in 2025 was CHF 22.0 million (2024: CHF 16.1 million). 

 

The company raised approximately CHF 76.7 million as part of its February 2025 Initial Public Offering. The cash and cash equivalents position increased to CHF 82.5 million as of December 31, 2025 (December 31, 2024: CHF 26.6 million).

Total shareholders’ equity stood at CHF 59.8 million as of December 31, 2025 (December 31, 2024: CHF 10.7 million).

 

As of December 31, 2025, the company employed 33 FTE (full-time equivalents) (end 2024: 27). About 75% of the employees are employed in R&D-related functions.

 

Key Figures as of December 31, 2025

CHF million

 FY 2025

 FY 2024

Change

Operating income

 3.3

 1.2

 2.1

R&D expenses

 (16.5)

 (12.9)

 (3.6)

G&A expenses

 (6.7)

 (7.0)

 0.3

Operating loss

 (20.0)

 (18.7)

(1.3)

Net loss

 (21.8)

 (18.7)

(3.1)

Basic net loss per share (in CHF)

 (3.89)

 (5.62)

 1.73

Net cash used in operating activities

 (22.0)

 (16.1)

 (5.9)

Cash & cash equivalents

 82.5

 26.6

 55.9

Total shareholders’ equity

 59.8

 10.7

 49.1

Number of registered shares

5,848,011

3,692,285

2,155,726

Number of FTE

33

27

6

Initial Public Offering in Q1 2025

On the back of the promising advancement of the company’s pipeline and the related positive clinical data generated, BioVersys successfully completed its IPO on the SIX Swiss Exchange on February 7, 2025. 

 

Hernan Levett, CFO of BioVersys, comments: “In February 2025, we successfully completed an IPO on the Swiss Stock Exchange, which added proceeds of CHF 76.7 million, providing the necessary capital to advance our pipeline through key development milestones. Later in the year, we entered into a research collaboration agreement with Shionogi and added the partnership with ADVANCE-ID financially supported by Wellcome. These partnerships further strengthen our financial position and  are of strategic importance to our pipeline. The accomplishments of 2025 are a testament to the robust clinical data and the strong team at BioVersys demonstrating potential to bring game-changing anti-infectives to market.”

 

Outlook 
Following the initiation of the BV100 global Phase 3 registrational study in 2025, BioVersys plans to initiate the recruitment of patients based on regulatory green lights (e.g. US FDA IND) and the completion of the ongoing Phase 1 study in China, respectively. The study remains on track to report top-line data by the end of 2027, with DSMB reviews planned in H2 2026 and H1 2027. The Phase 2b for BV100 being conducted by the ADVANCE-ID network is expected to initiate recruiting patients in H1 2026 with a planned interim analysis expected to take place by end of this year.

 

For alpibectir, BioVersys’ partner GSK is pursuing the Phase 2 program in pulmonary TB, expecting last patient last visit by end of 2026, while BioVersys is on track to initiate the Phase 2 in meningeal TB in H1 2026.

 

For BV200 and BV500, BioVersys expects to generate additional pre-clinical data in the course of 2026. In addition, the BioVersys team will continue to engage with industry alliances and will be working with global regulatory and political leaders towards a sustainable policy framework ensuring adequate reimbursement and access mechanisms for novel antibiotics.

 

Financial Outlook 2026

For the full year 2026, the company expects total operating loss to be in the range of CHF 40.0 to CHF 45.0 million.

Full Year 2025 Documents

This press release, the Annual Report 2025 as well as the webcast presentation are available under the investors section of www.bioversys.com.

Full Year 2025 Conference Call & Audio Webcast

BioVersys will host a conference call and webcast at 2.00 pm CET (9.00 am EST) to discuss the financial results, provide an update on the company’s performance, outline its strategic outlook, and share insights into BioVersys’ therapeutic pipeline.

Event details for Investors, Media and Interested Parties:

  • Conference Call Registration: Link (Participants will receive dial-in details upon registration)

 

Financial calendar

April 30, 2026

Annual General Meeting

September 3, 2026

Half-year Statement 2026

 

The scheduled events for BioVersys are also available on the investor section of the company’s website.

 

About BioVersys

BioVersys AG is a multi-asset, clinical stage biopharmaceutical company focused on identifying, developing and commercializing novel antibacterial products for serious life-threatening infections caused by multi-drug resistant (“MDR”) bacteria. Derived from the company’s two internal technology platforms (TRIC and Ansamycin Chemistry), candidates are designed and developed to overcome resistance mechanisms, block virulence production and directly affect the pathogenesis of harmful bacteria towards the identification of new treatment options in the antimicrobial and microbiome fields. This enables BioVersys to address the high unmet medical need for new treatments against life-threatening resistant bacterial infections and bacteria-exacerbated chronic inflammatory microbiome disorders. The company’s most advanced research and development programs address nosocomial infections of Acinetobacter baumannii (BV100, Phase 3), and tuberculosis (alpibectir, Phase 2, in collaboration with GlaxoSmithKline (GSK) and a consortium of the University of Lille, France). BioVersys is located in the biotech hub of Basel, Switzerland.

BioVersys contact 
Hernan Levett, CFO, Tel. +41 61 633 22 50; Mail: hernan.levett@bioversys.com
For media: media@bioversys.com Website: www.bioversys.com

 

 

Disclaimer

This communication expressly or implicitly contains certain forward-looking statements, such as “believe”, “assume”, “expect”, “forecast”, “project”, “may”, “could”, “might”, “will” or similar expressions concerning BioVersys and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of BioVersys to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. BioVersys is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

 

[1] HABP: Hospital-Acquired Bacterial Pneumonia; VABP: Ventilator-Associated Bacterial Pneumonia.

[2] The DSMB review is the periodic evaluation of unblinded or partially unblinded clinical trial data by an independent committee of experts to determine whether the study should continue, be modified, or be stopped based on safety, efficacy, or futility considerations.

Newron announces nominations to its Board of Directors at upcoming Annual General Meeting

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Newron Pharmaceuticals S.p.A.

/ Key word(s): Personnel

Newron announces nominations to its Board of Directors at upcoming Annual General Meeting

18.03.2026 / 07:00 CET/CEST

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

Newron announces nominations to its Board of Directors at upcoming Annual General Meeting

  • George Garibaldi and Paolo Zocchi proposed as new independent, non-executive Board members
  • Patrick Langlois and Luca Benatti to step down after long-standing service
  • Full Annual General Meeting agenda to be published on March 24, 2026

Milan, Italy, and Morristown, NJ, USA – March 18, 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, today announced that Patrick Langlois and Luca Benatti, who have served on the Board of Directors for many years, will not be standing for re-election at the upcoming Annual General Meeting (AGM) of shareholders on April 23, 2026. Two highly experienced industry and financial experts, George Garibaldi and Paolo Zocchi, are proposed for election to Newron’s Board as independent and non-executive directors.

Chris Martin, Chairman of the Board of Directors of Newron, commented on the resigning Board members: “We are hugely grateful to Patrick Langlois and Luca Benatti. Patrick has been a Board member of Newron for a total of 18 years, helping the Company to navigate some challenging times as well as some of our greatest successes. We have benefited greatly from his extensive experience in the pharmaceutical and biotech industries, as well as his commitment to creating an enabling working environment. Having been a founder of Newron and its first CEO, Luca was instrumental in the development of our Parkinson’s disease treatment, Xadago®. He has served as non-executive Board member for 14 years. We wish them well for the future.”

On the proposed new Board members, Chris Martin said: “We are delighted to propose two new, highly qualified candidates to shareholders as independent and non-executive members of the Board of Directors. George Garibaldi brings more than 30 years of leadership in CNS drug development across the pharmaceutical and biotech industries, while Paolo Zocchi has more than 35 years of significant expertise in capital markets transactions and complex international operations. George and Paolo’s deep experience will complement the Board’s existing expertise, and we look forward to benefiting from their actionable insights and advice.”

Stefan Weber, CEO of Newron, added: “On behalf of Newron’s management team, I would also like to express our sincere thanks to Patrick and Luca for their many years of expert, constructive, fruitful and successful collaboration. We welcome the appointment of George and Paolo and look forward to working with them both.”

The complete list of agenda items for Newron’s AGM 2026 will be published on March 24, 2026, together with the 2025 Full-Year results and the 2026 Outlook. All documents connected with the agenda, as per applicable laws and regulations, as well as information on how to register and attend the AGM, will be made available on the Company’s website (www.newron.com/investors/shareholders-meeting) on the same day.

About George Garibaldi

  • Dr. George Garibaldi is proposed to join Newron as an independent, non-executive member of the Board of Directors with more than 30 years of leadership in CNS drug development across the pharmaceutical and biotech industry. He most recently co‑founded StutterSenseAI Therapeutics, focused on medicines for neurodevelopmental and speech disorders, and serves as Chief Medical Officer at Synendos Therapeutics.
  • Previously, he co‑founded Noema Pharma, a biotech developing therapies for rare diseases, and led teams at Hoffmann‑La Roche, Janssen, and Novartis that advanced breakthrough treatments, including first approvals in primary progressive multiple sclerosis, schizoaffective disorder, and autism spectrum disorders.
  • Dr Garibaldi earned his MB BCh (MD) from Cairo University’s Faculty of Medicine (Egypt), completed residency training in Child and General Psychiatry at the René Descartes Medical School, pursued statistics and mathematical modeling at the University of Kremlin‑Bicêtre, and specialized in Neuropsychopharmacology at the Pitié Salpêtrière (all in Paris, France).
  • He is Co‑Founder and Past President of the International Society for Central Nervous System Clinical Trials and Methodology (ISCTM), former Chairman of the International Society for CNS Drug Development (ISCDD), and a member of the American Academy of Child and Adolescent Psychiatry (AACAP). He has received multiple honors, including the ISCDD Award for Innovation, has served on the Board of Directors of MedDay Pharmaceuticals and Retrotope Therapeutics, and is currently member of the Scientific Advisory Board of BioHarvest Sciences, a NASDAQ‑listed company and on the Advisory Committee of Redbird Research; he is American.

About Paolo Zocchi

  • Paolo Zocchi is proposed to join Newron as an independent, non-executive member of the Board of Directors. He is a former International Senior Partner at Ernst & Young (EY), where he served for more than 35 years in senior leadership roles at both the Italian and EMEIA levels, including Mediterranean Growth Markets Leader and Markets Clients Leader. He has extensive experience in the pharmaceutical and life sciences sectors, having audited and advised companies including Sanofi, Bayer, Neogen, Pierrel, Gentium, Madaus, and Mediolanum Farmaceutici, as well as several early-stage biotech companies backed by Rottapharm Biotech.
  • Paolo has significant expertise in capital markets transactions and complex international operations. During his career, he coordinated more than 15 IPOs across Italy, the United States and Europe, as well as international bond issuances, M&A transactions, cross-border acquisitions, and joint ventures, supporting companies in raising more than $3 billion on global capital markets.
  • He founded EY’s Center of Excellence for Family Business in collaboration with Bocconi University in Milan (Italy) in the early 2000s. In 2025, he established PZConsulting, where he advises companies and shareholders on transformation, international expansion, and sustainable growth, while also serving as a board member and statutory auditor for numerous private companies.
  • Paolo holds a degree in Economics from Università Cattolica del Sacro Cuore in Milan (Italy). He is a member of the Italian Register of Statutory Auditors and the Italian Register of CSRD professionals; he holds Italian and Swiss citizenship.

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

18.03.2026 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: 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: 2293076

 
End of News EQS News Service

2293076  18.03.2026 CET/CEST