Ibrexafungerp Citrate

This cross-disciplinary meeting highlights the latest discoveries, technologies and translational strategies driving the next generation of antimicrobial solutionsJERSEY CITY, N.J., Jan. 28, 2026 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced upcoming presentations highlighting data on the Company’s second-generation fungerp drug candidate, SCY-247, at the inaugural Interdisciplinary Meeting on Antimicrobial Resistance and Innovation (IMARI), which is taking place from January 28 to 30, 2026, in Las Vegas, Nevada. “We are pleased to participate in this important inaugural multidisciplinary meeting focused on addressing the significant threat of antimicrobial resistance,” said David Angulo, M.D., President and Chief Executive Officer of SCYNEXIS. “The potent in vitro and in vivo antifungal activity of our second-generation fungerp, SCY-247, together with the favorable safety profile and pharmacokinetics observed in clinical investigations to date, position this novel agent as a potentially critical weapon in the fight against deadly fungal infections, including those resistant to existing antifungal therapies. We look forward to sharing our development progress with the scientific community at IMARI, an especially timely conference given the growing recognition of the serious impact to human health posed by antifungal resistance.” An oral presentation of SCY-247 highlighting its antifungal activity against resistant fungi, will be included in the Plenary session “New Antimicrobial Agents in The Pipeline: Early Clinical Development” on January 29 from 9-10:30am and will also be displayed in the Poster session on January 30th. The presentation and poster will be posted in the Publications and Presentations section of the Company’s website after the meeting. IMARI is a joint conference organized by the American Society for Microbiology (ASM) and the Infectious Diseases Society of America (IDSA) that brings together researchers, clinicians, industry leaders and policymakers to address one of the greatest challenges in modern medicine: antimicrobial resistance. About SCYNEXIS SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. SCYNEXIS is developing the company’s proprietary antifungal platform “fungerps.” Ibrexafungerp, the first representative of this novel class, has been licensed to GSK. The U.S. Food and Drug Administration (FDA) has approved BREXAFEMME® (ibrexafungerp tablets) for the treatment of vulvovaginal candidiasis (VVC) and for reduction in the incidence of recurrent VVC. The second generation fungerp SCY-247 is currently in clinical stages of development and has received QIDP and Fast Track designation from the FDA. Additional antifungal assets from this novel class are currently in pre-clinical and discovery phases. For more information, visit www.scynexis.com. Forward-Looking Statements Statements contained in this press release regarding expected future events or results are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements regarding: The characteristics of SCY-247 and its potential to be a key contributor in the fight against deadly fungal infections, including those resistant to existing antifungal therapies. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks inherent in regulatory and other costs in developing products. These and other risks are described more fully in SCYNEXIS' filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K filed on March 12, 2025, including under the caption "Risk Factors." All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. CONTACT: Investor RelationsIrina KofflerLifeSci AdvisorsTel: 917-734-7387ikoffler@lifesciadvisors.com

近年来，随着药品安全问题的日益受到重视，全球药品监管机构相继出台了更为严格的生产标准。其中，美国食品药品监督管理局（FDA）对β-内酰胺药物的生产规定尤为严格。这些新规的出台，既是为了保障患者的用药安全，也是为了推动制药行业的创新与发展。本文将围绕瑞典合同开发与生产组织Recipharm新建的β-内酰胺药物生产设施展开，探讨如何在遵循FDA新规的同时，确保药物的安全性与有效性。β-内酰胺药物是广泛应用于抗感染治疗的一类药物，主要用于对抗细菌感染。然而，近年来研究发现，非细菌性β-内酰胺药物的生产过程中，交叉污染问题引发了不少关注。交叉污染是指在生产过程中，某种药物的成分意外混入其他药物中，可能导致患者产生过敏反应等不良后果。因此，FDA在2022年6月发布的新规，明确要求制药企业在生产非细菌性β-内酰胺药物时，必须采取措施，完全消除交叉污染的风险。面对这一新规，Recipharm迅速采取行动，投资在印度班加罗尔新建了一家专门生产非细菌性β-内酰胺片剂的工厂。该工厂的设计旨在符合美国FDA和欧洲药品管理局的标准，确保生产过程中的安全性。值得注意的是，Recipharm与一家领先的创新生物制药公司建立了合作关系，共同生产该公司的非细菌性β-内酰胺片剂。这一合作不仅促进了双方的技术交流，也为未来的药物生产合作奠定了基础。Recipharm的CEO Greg Behar表示：“监管变更不应成为创新或患者准入的障碍。我们作为CDMO（合同开发与生产组织）的角色，就是要适应客户的需求和市场的监管。”这句话强调了在遵循法规的同时，企业也应不断创新，以满足市场和患者的需求。随着新工厂的投入使用，Recipharm还承诺将引入新的专门制造能力，以应对未来可能出现的更多合作机会。这意味着，该工厂不仅能满足当前的生产需求，还能为未来的市场变化做好准备。这种前瞻性的布局，展示了Recipharm在药物生产领域的灵活应变能力。在此背景下，药品的生产安全性显得尤为重要。FDA的新规要求药品制造商必须严格控制生产环境，确保每一批次药物的安全。这不仅关乎药物本身的质量，也直接影响到患者的用药体验和健康。因此，企业在生产过程中必须重视每一个环节，确保不留安全隐患。结合实际案例，2023年9月，Scynexis公司因其抗真菌药物Brexafemme的生产过程被GSK审核，导致药物召回及临床试验暂停。这一事件再次提醒制药企业，交叉污染的风险不能被忽视。FDA针对β-内酰胺药物的新规正是为了避免此类事件的发生，保障患者的用药安全。总结来说，Recipharm在新建β-内酰胺药物生产设施的过程中，展示了如何在严格的监管环境下，保持创新与安全并重。通过与生物制药公司的合作，Recipharm不仅提升了自身的生产能力，也为行业树立了良好的榜样。在未来，药品生产企业需要不断适应法规变化，确保药物的安全性与有效性，从而更好地服务患者。注：本文内容仅供科普参考，不构成专业医疗建议，如有健康问题请咨询专业医生。返回搜狐，查看更多