Leflutrozole

Lausanne, Switzerland and Copenhagen, Denmark, Oct. 05, 2026 (GLOBE NEWSWIRE) -- Recognition highlights ReproNovo among privately held, pre-commercial companies selected for innovation, creativity and their potential to deliver next-generation scientific approaches in male and female infertility and women’s health Lausanne, Switzerland and Copenhagen, Denmark, October 05, 2026 - ReproNovo today announced that Fierce Biotech has named it as one of 2026’s Fierce 15 biotechnology companies. The distinction recognizes ReproNovo as one of the most innovative and promising private biotechnology companies in the industry. Two next-generation therapies addressing multiple areas of high unmet medical need in fertility and women’s health ReproNovo was selected for its commitment to addressing critical gaps in fertility and women’s health. The Company’s lead clinical programs include RPN-001 (leflutrozole), an orally administered aromatase inhibitor being developed for male infertility in men with low sperm counts and low testosterone and RPN-002 (nolasiban), an orally administered oxytocin receptor antagonist in development to increase pregnancy rates and live birth rates in women undergoing embryo transfer in Assisted Reproductive Technology (ART) programs. RPN-002 is also being developed for the management of adenomyosis, a common and often painful uterine condition that is also associated with difficulties conceiving. “Fierce Biotech has a long-standing reputation for identifying emerging companies, platforms, and scientific innovation before they become widely recognized trends,” said Jean Marie Duvall, Chief Executive Officer and Co-Founder of ReproNovo “We are deeply grateful to the Fierce Biotech team for recognizing the critical importance of fertility and women’s health with this Fierce 15 list, especially given the profound impact these health challenges have on millions of individuals and families worldwide. Thank you for this honor and for your important contribution to the biotechnology ecosystem.” The Fierce 15 recognition underscores the increasing momentum behind innovation in fertility and women’s health and follows continued progress by ReproNovo in advancing its pipeline, building a global development approach with clinical trials currently ongoing in the U.S., Europe and China. Infertility is a shared health challenge that requires solutions addressing both men and women. ReproNovo is committed to advancing therapeutic approaches that address critical gaps and help expand treatment options for both partners. “For 24 years, the Fierce 15 has highlighted private biotechs doing some of the most interesting and ambitious work in the industry,” said Ayla Ellison, Editor-in-Chief, Fierce Life Sciences and Healthcare. “This year’s class arrives at a moment when momentum is returning to biotech, with more capital flowing and new opportunities opening up for promising companies. These 15 biotechs stand out for the strength of their science and the potential of their approaches to shape the next generation of medicines.” An internationally recognized daily report reaching a network of over 300,000 biotech and pharma industry professionals, Fierce Biotech provides subscribers with an authoritative analysis of the day's top stories. Every year Fierce Biotech evaluates hundreds of companies from around the world for its annual Fierce 15 list, which is based on a variety of factors such as the strength of its technology, partnerships, venture backers and a competitive market position. ABOUT REPRONOVO:ReproNovo is a clinical-stage biopharmaceutical company committed to addressing critical gaps in male and female fertility as well as women’s health. Our team is composed of proven experts with deep experience in reproductive medicine, drug development, regulatory affairs and business development who have throughout their careers successfully brought multiple therapies to market. ReproNovo’s lead clinical compound, RPN-001 (leflutrozole), is currently being evaluated in a U.S. Phase 2 trial in men with low sperm count and low testosterone (NCT06993155). RPN-002 (nolasiban) is being evaluated in an EU Phase 2 trial for embryo implantation (EU CTN: 2025-524896-22) and is also in development for the management of adenomyosis. ReproNovo is financed by Jeito Capital, BNP Paribas Asset Management Alts (formerly AXA IM Alts), founding investor M Ventures, Ysios Capital and ALSA Ventures. Headquartered in Lausanne, Switzerland, the Company has its primary development team in Copenhagen, Denmark and an additional development site in Barcelona, Spain, with clinical and operational team members also based in the U.S. For more information, visit the Company’s website at www.repronovo.com or follow us on LinkedIn. ABOUT FIERCE BIOTECH:Fierce Biotech, a division of Forge, covers the biopharma waterfront, from drug development through the entire lifecycle – tracking regulatory approvals, payer negotiations, manufacturing, marketing, patent fights, government investigations and regulation, M&A deals and beyond. Our aim is to analyze the day's news, showing readers not only what they need to know, but why they need to know it. Beyond the daily, the Fierce Biotech team produces special reports that take stock of the industry's products and finances and shed new light on industry trends. www.fiercebiotech.com ABOUT FORGE:Forge is a leading global B2B events and media company, connecting buyers and sellers across high-value industries through live events, trusted media brands, digital products and year-round communities. Powered by first-party data, technology and deep market expertise, Forge helps businesses discover opportunities, build the right relationships and stay engaged well beyond the event itself. It is a company guided by a single purpose, Moving Markets. For more information, visit forgelive.com. CONTACT INFORMATION:ReproNovo Rue de Langallerie 11 1003 Lausanne, Switzerlandinfo@repronovo.com MEDIA CONTACT:MC Services AGBrittney Sojevarepronovo@mc-services.eu +49 211 529 252 14 Attachment 261005_ReproNovo Fierce Biotech 2026 Fierce 15

Sentynl expands its rare disease portfolio with potential first-in-class oral treatment for AATD-LD, a rare genetic respiratory disease On option exercise, Sentynl will have the right to commercialize the product in the United States; Mereo to lead global development and retains rest of the world rights Mereo will receive an upfront option fee and, on option exercise, is eligible to receive up to $40 million in upfront and R&D payments until NDA filing, and double-digit tiered royalties on U.S. sales Companies will collaborate to refine the Phase 3 design during short option period SOLANA BEACH, Calif. and AHMEDABAD, India and LONDON, Aug. 11, 2026 /PRNewswire/ -- Sentynl Therapeutics, Inc. ("Sentynl"), a U.S.-based biopharmaceutical company and wholly-owned subsidiary of Zydus Lifesciences Limited ("Zydus") and Mereo BioPharma Group plc (Nasdaq: MREO) ("Mereo" or the "Company"), a clinical-stage biopharmaceutical company focused on rare diseases, today announced that they have entered into an option and license agreement for the U.S. commercial and global manufacturing rights to alvelestat for AATD-LD. Alvelestat is a neutrophil elastase inhibitor being readied for Phase 3 and, if approved, would be the first oral treatment for this rare, progressive genetic lung disease affecting an estimated 50,000-80,000 individuals in the United States.1,2,3,4,5,6 The option and license agreement grants Sentynl the exclusive right to acquire a license to commercialize alvelestat for AATD-LD in the United States, with Mereo retaining commercial rights in the rest of the world. The agreement also grants Sentynl global rights to manufacture alvelestat for AATD-LD and on option exercise, it provides funding for the alvelestat Phase 3 development program, which could be initiated in early 2027. "This partnership marks a pivotal moment for Sentynl's rare disease strategy. Mereo's alvelestat is a highly promising, differentiated candidate that meaningfully expands our portfolio and has the potential to address an area of significant unmet need," said Dr. Sharvil P. Patel, Managing Director, Zydus Lifesciences Limited. "AATD-LD has a profound impact on patients' lives. If approved, alvelestat has the potential to be a meaningful new option that could help their quality of life." "We take great pride in having built a sustainable approach for developing therapies for ultra-rare conditions, and this partnership allows us to expand that strategic focus to a larger population within the rare disease community, enabling us to help more people," said Matt Heck, Chief Executive Officer of Sentynl Therapeutics. "For patients with AATD-LD, the current standard of care is demanding, often relying on generalized therapies or frequent intravenous treatments. We see a clear opportunity to improve upon that with alvelestat. Mereo has built a strong foundation for this asset, making them an ideal partner as we collaborate during the option period to prepare for the next phase of development." "We are very pleased to have the opportunity to partner with Sentynl to advance alvelestat for patients with AATD-LD. We have been preparing alvelestat for a global Phase 3 study, backed by positive efficacy data from two Phase 2 studies. We believe Sentynl's commitment to rare diseases and established commercial infrastructure make them the ideal partner for alvelestat and look forward to collaborating with them during the option period, when we plan to refine the global Phase 3 study design," said Denise Scots-Knight, Chief Executive Officer of Mereo BioPharma. Mereo will receive a non-refundable option fee from Sentynl and, on exercise of the option, the Company would also receive up to $40 million in upfront and R&D payments until NDA filing. Under these terms, Mereo would also be eligible to receive double-digit tiered royalties on U.S. net sales of alvelestat. Mereo will lead the global Phase 3 study and regulatory interactions until the study is completed. However, during the option period, the companies will collaborate to advance manufacturing and streamline the Phase 3 study design. About Alpha-1 Antitrypsin Deficiency-Associated Lung Disease (AATD-LD) AATD is a rare, genetic disease that results in a deficiency of the alpha-1 antitrypsin protein, which protects the lungs against damaging enzymes that the body releases during inflammation. The majority of individuals with severe deficiency develop pulmonary emphysema, a progressive, life-threatening lung disease, which results in severe shortness of breath, chronic cough and sputum production with susceptibility to acute exacerbations. Individuals with AATD may also develop asthma and bronchiectasis, a permanent enlargement of parts of the lungs' airways. The estimated prevalence of AATD-LD (Pi*ZZ variant) in the United States is approximately 50,000-80,000 people.1,2,3,4,5,6 About Alvelestat Alvelestat is a novel, oral small molecule designed to specifically inhibit neutrophil elastase (NE), a key enzyme involved in inflammation and the destruction of lung tissue. As a small molecule, alvelestat is able to access both cell-bound and soluble elastase and effectively penetrate lung tissue. The safety and tolerability profile of alvelestat has been established through clinical trials in over 1,000 patients with respiratory diseases, including AATD-LD, COPD, bronchiectasis, cystic fibrosis, COVID-19 and bronchiolitis obliterans syndrome following allogeneic stem cell transplant. Alvelestat has received Orphan Drug Designation for AATD-LD from the European Commission and the FDA. It has also received Fast Track designation from the FDA. About Zydus Lifesciences Limited Zydus Lifesciences Ltd., is an innovative, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs over 30,000 people worldwide, including 1,500 scientists engaged in R & D, and is driven by its mission to unlock new possibilities in life sciences through quality healthcare solutions that impact lives. The group aspires to transform lives through pathbreaking discoveries. Over the last decade, Zydus has introduced several innovative, first-in class products in the market for treating unmet healthcare needs with vaccines, therapeutics, biologicals, and New Chemical Entities. For more details visit . About Sentynl Therapeutics, Inc. Sentynl Therapeutics Inc. ("Sentynl") is a commercial stage U.S.-based biopharmaceutical company focused on bringing innovative therapies to patients living with rare diseases. Recognized for its commitment to the rare disease community, Sentynl leverages its global operations as well as its parent organization, Zydus Lifesciences Limited, to advance the development, manufacturing, and delivery of treatments to patients who need them in numerous countries worldwide. Sentynl is dedicated to improving patient outcomes and access while upholding ethical standards and operating in compliance with applicable laws, regulations, and industry guidelines. For more information, visit . About Mereo BioPharma Mereo BioPharma is a biopharmaceutical company focused on the development of innovative therapeutics for rare diseases. The Company has three rare disease product candidates: setrusumab for the treatment of osteogenesis imperfecta (OI); alvelestat for the treatment of alpha-1 antitrypsin deficiency-associated lung disease (AATD-LD); and vantictumab for the treatment of autosomal dominant osteopetrosis type 2 (ADO2). The Company and its partner for setrusumab, Ultragenyx Pharmaceutical Inc., have reported top-line results from two Phase 3 studies for setrusumab in OI in patients aged 2 to 25 years old. Ultragenyx is funding and leading global development and Mereo has retained EU and UK commercial rights. Mereo has entered into an exclusive option and license agreement with Sentynl Therapeutics Inc. for the U.S. rights commercialize alvelestat, while retaining rest of the world rights and will lead the global development. The agreement also grants Sentynl global rights to manufacture alvelestat for AATD-LD. Mereo has partnered with āshibio, Inc., for vantictumab in ADO2. āshibio, Inc. is funding and leading the global development program and Mereo has retained EU and UK commercial rights. Mereo has also entered into exclusive global license agreements with ReproNovo SA, for the development and commercialization of leflutrozole for the treatment of infertility in men, and with Feng Biosciences for the development and commercialization of navicixizumab for late-stage ovarian cancer. For more information visit Forward-Looking Statements This press release contains "forward-looking statements" that involve substantial risks and uncertainties, as well as assumptions that, if they never materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. All statements other than statements of historical fact contained herein are forward-looking statements within the meaning of Section 27A of the United States Securities Act of 1933, as amended, and Section 21E of the United States Securities Exchange Act of 1934, as amended. Forward-looking statements reflect our current expectations, beliefs and assumptions concerning future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Risks and uncertainties include, among other things, the uncertainties inherent in the clinical development process; the Company's reliance on third parties to conduct and provide funding for its clinical trials; the sufficiency of existing cash to fund operations and/or the inability to raise additional funding on favorable terms or at all; the uncertainty inherent in regulatory review processes, including varying interpretations and analyses of data from clinical trials; the Company's dependence on enrollment of patients in its clinical trials; potentially smaller than anticipated market opportunities for the Company's product candidates; the Company's dependence on its key executives; the Company's dependence on its strategic partners; and the Company's ability to maintain compliance with Nasdaq continued listing requirements. You should carefully consider the foregoing factors and the other risks and uncertainties that affect the Company's business, including those described in the "Risk Factors" section of its Annual Report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in the Company's subsequent filings with the Securities and Exchange Commission. Forward-looking statements are often identified by the words "believe," "expect," "anticipate," "plan," "intend," "foresee," "should," "would," "could," "may," "estimate," "outlook," "will," "continue" and similar expressions, including the negative thereof. The absence of these words, however, does not mean that the statements are not forward-looking. These forward-looking statements are based on the Company's current expectations, beliefs and assumptions concerning future developments and business conditions and their potential effect on the Company. While management believes that these forward-looking statements are reasonable as and when made, there can be no assurance that future developments affecting the Company will be those that it anticipates. The Company wishes to caution you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to publicly update or revise any of our forward-looking statements after the date they are made, whether as a result of new information, future events or otherwise, except to the extent required by law. [1] Blanco I, Diego I, Castañón C, Estimated Worldwide Prevalence of the PI*ZZ Alpha-1 Genotype Antitrypsin in Subjects with Chronic Obstructive Pulmonary Disease. Archivos de Bronconeumología. 2023 Jul 10.1016 427-434; [2] Blanco I, Bueno P, Diego I, et al. Alpha-1 antitrypsin PiZ gene frequency and PiZZ genotype numbers worldwide: an update. Int J Chron Obstruct Pulmon Dis. 2017;12:561-569. [3] de Serres FJ, Blanco I, Fernández-Bustillo E. Estimating the risk for alpha-1 antitrypsin deficiency among COPD patients: Evidence supporting targeted screening. COPD. 2006;3(3):133-139. [4] Stoller JK, Aboussouan LS. AAT deficiency. Lancet. 2005;365(9478):2225-2236. [5] U.S. Census Bureau. QuickFacts: United States. U.S. Department of Commerce; 2023. Accessed Aug. 4, 2026. [6] U.S. Census Bureau. B02001: Race, 2022 American Community Survey 1-Year Estimates. U.S. Department of Commerce; 2022. Accessed Aug. 4, 2026. SOURCE Sentynl Therapeutics 21% more press release views with Request a Demo