Key Takeaways CDTX secured FDA Breakthrough Therapy designation for CD388 to prevent seasonal influenza.The FDA decision follows phase IIb data showing CD388's significant prevention of seasonal influenza.CDTX's ANCHOR phase III study began ahead of schedule and may support regulatory filing if successful.Cidara Therapeutics (CDTX) announced that the FDA has granted a Breakthrough Therapy designation to its lead pipeline candidate, CD388, for the prevention of seasonal influenza.Shares of the company were u ...

SAN DIEGO, Oct. 10, 2025 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, today announced it will have a late-breaking presentation at the European Scientific Working Group on Influenza (ESWI)’s 10th Influenza Conference taking place October 20-23, 2025 in Valencia, Spain. Presentation details are summarized below: Late-Breaking Abstract Title: Translational efficacy of CD388, a ...

On Thursday, October 9, a wave of strength swept across the biotech and healthcare sectors, with several stocks reaching 52-week highs. The rally was driven by a mix of regulatory milestones, strategic announcements, and investor enthusiasm around clinical progress.Aquestive Therapeutics Inc. (AQST) reached a 52-week high of $6.86 before closing at $6.69 on Thursday. The move followed the company's announcement of a newly issued U.S. patent for its PharmFilm , reinforcing its sway in oral drug delivery pla ...

Key Points It reported some highly encouraging news about its leading drug candidate. This is a flu treatment aimed at folks who can't or won't take vaccines. 10 stocks we like better than Cidara Therapeutics › The leading pipeline drug being developed by Cidara Therapeutics (NASDAQ: CDTX) got a real boost from a regulator on Thursday, and the biotech's share price moved accordingly. Cidara's stock closed the day more than 12% higher, during a session in which the bellwether S&P 500 (SNPINDEX: ^GSP ...

Breakthrough Therapy designation comes in addition to previously awarded Fast Track designationSAN DIEGO, Oct. 09, 2025 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for CD388 for prevention of influenza A and B in adults and adolescents who are at higher risk of influe ...

SAN DIEGO, Oct. 02, 2025 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, today announced it has received an award valued up to $339M from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). The multi-year agreement consists of a ...

公司概况与核心技术 - 公司是一家生物技术公司，利用其专有的Cloudbreak®平台开发药物-Fc偶联物疗法 [1] - 主要候选药物CD388是一种长效抗病毒药物，旨在通过单次给药直接抑制病毒复制，从而实现对季节性和大流行性流感的普遍预防 [1] 核心产品CD388的临床进展 - 2025年9月，公司与FDA举行了第二阶段结束会议后，宣布加速并扩大CD388的第三阶段试验 [2] - 研究开始时间提前了六个月，以配合秋季流感季节，参与者范围现在包括65岁以上成人、高风险人群以及12岁及以上的免疫功能低下个体，使美国潜在患者市场翻倍至超过1亿人 [2] - FDA表示，一次成功的第三阶段试验可能就足以支持生物制品许可申请的批准，简化了CD388的上市路径 [2] - 2025年9月，针对高风险人群预防季节性流感的第三阶段ANCHOR试验开始给药，计划招募6000名参与者 [3] 积极数据与市场反应 - 积极的第二阶段b期NAVIGATE研究结果以及针对H5N1流感的临床前数据增强了投资者信心，分析师将公司目标股价上调至最高167美元 [3] - 在市场强烈预期下，公司股价近期飙升超过19% [3] 产品管线多元化 - 除流感项目外，公司正在推进其他药物-Fc偶联物项目，包括用于肿瘤学的CBO421，该药物靶向实体瘤中的CD73，并已获得新药临床试验申请批准 [4] - 这种多元化凸显了公司在多个治疗领域的增长潜力 [4]

Key Points The biotech launched a late-stage trial of a non-vaccine flu preventative. There is a vast addressable market for such a product. 10 stocks we like better than Cidara Therapeutics › Cidara Therapeutics (NASDAQ: CDTX) had some encouraging news to deliver at the end of the trading week, and investors traded the biotech's stock up as a result. It closed Friday nearly 7% higher in price, easily outpacing the 0.6% increase of the bellwether S&P 500 index. Phase 3 trial begins for investigatio ...

Key Takeaways Cidara shares have jumped 217.8% in 2025 so far on progress with its influenza drug candidate CD388.The phase IIb NAVIGATE study met all primary and secondary endpoints across multiple dose levels.The phase III ANCHOR study began ahead of schedule and could support regulatory filing if successful.Shares of Cidara Therapeutics (CDTX) have skyrocketed 217.8% in the year so far, driven by positive updates from the development program of its only clinical-stage pipeline candidate, CD388, for the p ...

- Phase 3 study expected to enroll 6,000 participants starting in the Northern Hemisphere - Participants will include adults over 65 years of age in addition to individuals with high-risk co-morbidities and immune compromised status SAN DIEGO, Sept. 25, 2025 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, today announced that the first participants have been dosed in its Phase 3 ...