Welcome to our dedicated page for Cidara Theraptcs news (Ticker: CDTX), a resource for investors and traders seeking the latest updates and insights on Cidara Theraptcs stock.
Cidara Therapeutics, Inc. (CDTX) generates news primarily as a clinical-stage biotechnology company developing drug-Fc conjugate (DFC) therapeutics through its proprietary Cloudbreak platform. Most recent coverage focuses on CD388, a long-acting antiviral DFC designed as a non-vaccine preventative for seasonal and pandemic influenza, as well as on corporate transactions and government collaborations.
News about Cidara frequently highlights clinical trial milestones for CD388. This includes updates on the Phase 2b NAVIGATE trial in healthy unvaccinated adults and the Phase 3 ANCHOR trial in adults and adolescents at higher risk of influenza complications, including individuals with immune-compromised conditions, certain comorbidities, and adults over 65 years of age. Articles often describe trial design, enrollment progress, interim analysis plans, and safety and efficacy results reported by the company.
Investors following CDTX news will also see disclosures on regulatory interactions and designations, such as Fast Track and Breakthrough Therapy designations granted by the U.S. Food and Drug Administration (FDA) for CD388, and company commentary on plans to seek biologics license application (BLA) approval based on a single Phase 3 study. Additional coverage includes Cidara’s BARDA agreement to support expanded manufacturing and clinical development of CD388, detailing federal funding for onshoring manufacturing and additional clinical and non-clinical work.
Another major theme in Cidara’s news flow is its acquisition by Merck. Releases describe Merck’s definitive agreement to acquire Cidara through a cash tender offer and subsequent merger, the tender offer terms, and Merck’s statements about integrating CD388 into its respiratory portfolio. Updates from Merck note the successful completion of the tender offer, the planned merger to make Cidara a wholly owned subsidiary, and the expected delisting of Cidara’s common stock from the Nasdaq Global Market.
On this CDTX news page, readers can review historical and transaction-related announcements, clinical data presentations at scientific conferences, investor conference participation, and quarterly corporate updates. For those researching Cidara’s development of CD388, its Cloudbreak platform, and the transition of Cidara into Merck’s portfolio, this news feed provides a centralized view of key public communications over time.
Cidara Therapeutics (Nasdaq: CDTX) announced the U.S. FDA has granted Breakthrough Therapy designation for CD388 for prevention of influenza A and B in adults and adolescents at higher risk of complications or for whom vaccines are contraindicated. The designation follows a statistically significant Phase 2b NAVIGATE result in healthy unvaccinated adults and complements an existing Fast Track designation. Cidara initiated the Phase 3 ANCHOR trial at the end of September, six months ahead of schedule, and expanded enrollment to include generally healthy adults >65 based on FDA feedback. Benefits include priority review and rolling submission eligibility.
Cidara Therapeutics (Nasdaq: CDTX) announced a multi‑year award from BARDA valued up to $339M on Oct 2, 2025. The agreement includes a Base period providing $58M over 24 months to onshore CD388 manufacturing in the U.S., run a clinical comparability trial for a higher‑concentration formulation and alternate presentations, further non‑clinical characterization against pandemic influenza strains, and begin protocol development for expanded populations. Option periods could provide up to $281M if requested by Cidara and exercised by the U.S. government to support additional clinical and non‑clinical studies and complement plans for a potential BLA to FDA. Contract number: 75A50125C00017.
Cidara Therapeutics (Nasdaq: CDTX) has initiated dosing in its Phase 3 ANCHOR trial evaluating CD388, a novel non-vaccine preventative treatment for seasonal influenza. The trial aims to enroll 6,000 participants across high-risk populations, including adults over 65 and individuals with compromised immune systems or co-morbidities.
CD388 is administered as a one-time 450-milligram subcutaneous dose and, unlike traditional vaccines, does not rely on an immune response for effectiveness. The study follows positive Phase 2b NAVIGATE trial results and will include an interim analysis after the Northern Hemisphere flu season. The company has over $500 million in cash to fund the Phase 3 program through completion.
Cidara Therapeutics (Nasdaq: CDTX) announced significant updates to its Phase 3 trial plans for CD388, a non-vaccine flu preventative, following FDA End-of-Phase 2 meeting. The company will accelerate the Phase 3 study by six months, starting in September 2025 for the Northern Hemisphere.
Key developments include: expansion of the study population to include adults over 65 years alongside high-risk patients aged 12+, increasing eligible U.S. patients from 50 million to over 100 million; potential for BLA approval based on a single Phase 3 trial; and a target enrollment of 6,000 subjects. The study will evaluate a single 450mg dose of CD388 administered subcutaneously at the start of flu season.
Cidara Therapeutics (NASDAQ:CDTX) presented significant data on CD388, its non-vaccine influenza preventative, at the International Society for Respiratory Viruses conference in Singapore. The company showcased two key presentations: results from the Phase 2b NAVIGATE trial and preclinical studies against H5N1.
The NAVIGATE study, involving over 5,000 healthy adults, demonstrated that a single subcutaneous dose of CD388 provided statistically significant protection against influenza illness over 24 weeks. The trial tested three dosage levels (150mg, 300mg, and 450mg) against placebo.
In preclinical studies, CD388 showed promising results against H5N1 (bird flu) in ferret models, with a 10 mg/kg dose achieving 100% survival rate and a 3 mg/kg dose protecting 75% of ferrets from death. The treatment significantly reduced viral titers and prevented viral spread to other organs.
Cidara Therapeutics (NASDAQ:CDTX), a biotechnology company specializing in drug-Fc conjugate therapeutics through its Cloudbreak® platform, has announced its participation in two upcoming investor conferences in September 2025.
The company will present at the H.C. Wainwright 27th Annual Global Investment Conference on September 8 at 4:00 PM ET, and participate in a fireside chat at the Morgan Stanley 23rd Annual Global Healthcare Conference on September 9 at 7:00 AM ET. Management will also conduct one-on-one meetings with investors during both events.
Cidara Therapeutics (Nasdaq: CDTX) announced two upcoming oral presentations at the International Society for Respiratory Viruses (ISRV) conference in Singapore, September 17-20, 2025. The presentations will feature clinical and preclinical data for their drug candidate CD388.
The first presentation is a late-breaking abstract showcasing Phase 2b clinical trial results (NAVIGATE study) evaluating CD388's efficacy and safety for influenza prevention in healthy adults. The second presentation will discuss preclinical data demonstrating CD388's protective effects against H5N1 influenza virus in ferret models.
Cidara Therapeutics (Nasdaq: CDTX) reported significant Q2 2025 developments, highlighted by positive Phase 2b NAVIGATE trial results for CD388, their influenza prevention drug. The trial met all primary and secondary endpoints, with the highest dose (450mg) showing 76.1% protection against symptomatic influenza over 24 weeks.
The company substantially strengthened its financial position by closing an upsized public offering of $402.5 million, pricing 9.1 million shares at $44.00 each. As of June 30, 2025, Cidara reported cash and equivalents of $516.9 million. The company has submitted an End of Phase 2 meeting request to the FDA and plans to initiate Phase 3 trials by spring 2026.
Q2 financial results showed increased R&D expenses of $24.8 million, up from $6.7 million in Q2 2024, primarily due to CD388 development. The company reported a net loss of $25.7 million for Q2 2025, compared to $91.2 million in Q2 2024.
Cidara Therapeutics (Nasdaq: CDTX), a biotechnology company specializing in drug-Fc conjugate (DFC) immunotherapies through its Cloudbreak® platform, has scheduled its second quarter 2025 financial results announcement for August 7, 2025.
The company will release its financial results and operational highlights after U.S. market close, followed by a conference call and webcast at 5:00 PM Eastern Time. Investors can access the call via U.S. toll-free (1-844-825-9789) or international (1-412-317-5180) numbers using Conference ID 10200740.
Cidara Therapeutics (Nasdaq: CDTX), a biotechnology company focused on developing drug-Fc conjugate therapeutics through its Cloudbreak® platform, has announced new equity grants to two employees. The Compensation Committee approved non-qualified stock options and restricted stock units (RSUs) totaling 12,100 shares of common stock under the company's 2020 Inducement Incentive Plan.
The stock options were granted at an exercise price of $48.71 per share, matching Cidara's closing price on June 30, 2025. The options will vest over four years, with 25% vesting after one year and the remainder vesting monthly over 36 months. The RSUs will vest in four equal annual installments on specified quarterly vesting dates.