Cidara Theraptcs Stock Price, News & Analysis

Cidara Therapeutics (Nasdaq: CDTX) presented a late-breaking abstract on CD388 at the 10th ESWI Influenza Conference (Oct 20-23, 2025) in Valencia, Spain.

The presentation linked preclinical mouse data to clinical outcomes from the Phase 2b NAVIGATE study, reporting that a single CD388 dose protected mice against 12 seasonal and multiple pandemic influenza subtypes and that plasma concentrations at infection time conferred complete protection. Phase 2b results reportedly showed statistically significant prevention efficacy across all dose groups, with lower drug concentrations correlating with higher infection rates. Exposure-response modeling indicated a clear concentration-response alignment between mouse efficacious exposures and Phase 2b prevention efficacy. Cidara said these findings support its ongoing Phase 3 ANCHOR trial targeting vulnerable populations.

Cidara Therapeutics (Nasdaq: CDTX) presented late-breaking Phase 2b data on CD388 at ID Week 2025 (Oct 19-22, 2025). The randomized, double-blind, placebo-controlled NAVIGATE study in healthy, unvaccinated adults reported prevention efficacy (PE) of 57.7% at 150 mg, 61.3% at 300 mg and 76.1% at 450 mg against influenza A and B.

The company reported CD388 was well tolerated with no apparent safety issues and said the virology readouts support dose selection for the ongoing Phase 3 ANCHOR study targeting immunocompromised, high‑risk, and ≥65 populations.

Cidara Therapeutics (Nasdaq: CDTX) will present late-breaking Phase 2 clinical data for its antiviral influenza candidate CD388 at ID Week 2025 in Atlanta on October 20, 2025. The randomized, placebo-controlled trial evaluates safety and efficacy of CD388 for prevention of illness due to Influenza A and B in healthy unvaccinated participants.

Presentation: "A Randomized, Placebo-controlled Trial to Evaluate the Safety and Efficacy of CD388, a Novel Drug-Fc-Conjugate, for Prevention of Illness due to Influenza A and B in Healthy Unvaccinated Participants." Presenter: James Alexander MD, MPH, FIDSA. Session: Extra, Extra! New Info on Treating and Preventing RSV and Influenza. Location B401-B402, Monday, October 20, 2025, 3:15 PM - 4:30 PM ET.

Cidara Therapeutics (Nasdaq: CDTX) will present a late-breaking abstract at the 10th ESWI Influenza Conference in Valencia, Spain, Oct 20-23, 2025.

The presentation, titled "Translational efficacy of CD388, a novel Drug Fc-Conjugate (DFC), in mouse influenza infection models: application to prevention efficacy in the recently completed Ph2b NAVIGATE clinical study," will be delivered by Voon Ong, Ph.D. in the Late Breakers: Novel and Outstanding Discoveries session on Thursday, October 23, 2025, 2:00-3:30 pm CET.

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.