Nov 14, 2025 6:45 AM Eastern Standard Time Merck to Acquire Cidara Therapeutics, Inc., Diversifying Its Portfolio to Include Late-Phase Antiviral Agent Share CD388 is an investigational long-acting, strain-agnostic antiviral agent currently in Phase 3, designed to prevent influenza infection in individuals at higher risk of influenza complications Acquisition aligns with Merck's science-led business development strategy, diversifying and expanding the company's pipeline RAHWAY, N.J. & SAN DIEGO, Calif.--(BU ...

Core Insights - Cidara Therapeutics presented late-breaking Phase 2b clinical data on its influenza preventative candidate, CD388, at ID Week 2025, indicating its potential as a once-per-season preventative option against influenza A and B [1][2] Company Overview - Cidara Therapeutics is a biotechnology company utilizing its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) therapeutics, with CD388 being its lead candidate aimed at universal prevention of seasonal and pandemic influenza [3] - CD388 has received Fast Track Designation from the FDA and has progressed through clinical trials, with positive results from the Phase 2b NAVIGATE trial announced in June 2025 and the initiation of the Phase 3 ANCHOR trial in September 2025 [3] Clinical Data Summary - The Phase 2b NAVIGATE study demonstrated that CD388 provided significant prevention efficacy against influenza A and B in healthy, unvaccinated adults, with efficacy rates of 57.7% for 150 mg, 61.3% for 300 mg, and 76.1% for 450 mg doses [2] - CD388 was well tolerated with no apparent safety issues reported, suggesting its potential for season-long prevention of influenza illness in individuals not adequately protected by existing vaccines [2]

Core Insights - Cidara Therapeutics has received a funding award of up to $339 million from BARDA to support the development of its investigational drug CD388 for influenza prevention [1][2][3] Funding Details - The agreement includes a Base contract of $58 million over 24 months for onshoring CD388 manufacturing to the U.S. and conducting clinical trials [2] - Option periods funding could provide an additional $281 million for further clinical and non-clinical studies of CD388, contingent on requests from Cidara and government approval [2] Product Overview - CD388 is a drug-Fc conjugate designed to provide long-acting protection against all known strains of seasonal and pandemic influenza [4][5] - It is not a vaccine and is expected to be effective regardless of the immune status of individuals, making it suitable for vulnerable populations [4][5] Clinical Development - CD388 has shown potential as a non-vaccine preventative for both pandemic and seasonal influenza, with positive results from the Phase 2b NAVIGATE trial reported in June 2025 [3][5] - The drug has received Fast Track Designation from the FDA, indicating its potential to address unmet medical needs [5]

Core Insights - Cidara Therapeutics, Inc. is recognized as one of the 12 best performing healthcare stocks, focusing on its proprietary Cloudbreak® platform for drug-Fc conjugate therapeutics [1] - The company’s lead candidate, CD388, aims to provide universal prevention of seasonal and pandemic influenza with a single dose [1] Group 1: Clinical Development - In September 2025, Cidara announced an accelerated and expanded Phase 3 trial for CD388, moving the study start up by six months to align with the fall flu season [2] - The participant pool for the trial now includes adults over 65 and high-risk individuals aged 12 and older, effectively doubling the potential U.S. patient market to over 100 million [2] - The FDA indicated that a single successful Phase 3 trial may suffice for biologics license application approval, streamlining CD388's path to market [2] Group 2: Market Performance - Dosing for the Phase 3 ANCHOR trial began in September 2025, enrolling 6,000 participants to prevent seasonal influenza in high-risk populations [3] - Positive results from the Phase 2b NAVIGATE study and encouraging preclinical data against H5N1 influenza have bolstered investor confidence, leading analysts to raise the company's price targets up to $167 [3] - The stock recently surged over 19% amid strong market anticipation [3] Group 3: Diversification and Growth Potential - Beyond influenza, Cidara is advancing other DFC programs, including CBO421 for oncology, which targets CD73 in solid tumors and has received investigational new drug clearance [4] - This diversification underscores the company's growth potential across multiple therapeutic areas, positioning Cidara as a notable player in innovative biotech development [4]

Core Insights - Cidara Therapeutics presented promising efficacy and safety results for CD388, a non-vaccine influenza preventative, during the ISRV conference, highlighting its potential for long-term protection against influenza and H5N1 strains [1][2] Group 1: CD388 Efficacy and Safety - The Phase 2b NAVIGATE study involved over 5,000 healthy adults aged 18-64, randomized to receive either CD388 (150mg, 300mg, or 450mg) or placebo, demonstrating statistically significant protection against influenza illness over 24 weeks [1][3] - CD388 was well tolerated, with the primary endpoint focusing on preventative efficacy against laboratory-confirmed influenza [1][3] Group 2: Preclinical Data on H5N1 - Preclinical studies in ferrets showed that a single subcutaneous dose of CD388 at 3 mg/kg provided 75% protection against lethal H5N1 infection, while a 10 mg/kg dose resulted in 100% survival [3] - CD388-treated ferrets exhibited reduced weight loss and clinical symptoms compared to untreated controls, indicating its potential effectiveness against highly pathogenic strains [3] Group 3: Future Plans and Presentations - Cidara plans to disclose additional safety, pharmacokinetics, and virology data from the Phase 2b NAVIGATE study at upcoming conferences [2] - The company will host a lunch symposium at the conference to discuss CD388's broad influenza protection capabilities [5]

Company Overview - Cidara Therapeutics is a biotechnology company utilizing its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) therapeutics [2] - The lead DFC candidate, CD388, is designed for universal prevention of seasonal and pandemic influenza with a single dose by inhibiting viral proliferation [2] - Cidara received Fast Track Designation from the FDA for CD388 in June 2023 and announced positive top-line results from its Phase 2b NAVIGATE trial in June 2025 [2] - Additional DFCs are being developed for oncology, with Cidara receiving investigational new drug application clearance for CBO421 in July 2024, targeting CD73 in solid tumors [2] Upcoming Events - Cidara management will participate in the H.C. Wainwright 27th Annual Global Investment Conference on September 8, 2025, at 4:00 PM ET in a corporate presentation format [1] - The company will also take part in the Morgan Stanley 23rd Annual Global Healthcare Conference on September 9, 2025, at 7:00 AM ET in a fireside chat format [1] - Cidara will engage in one-on-one investor meetings during these conferences [1]

Core Insights - Cidara Therapeutics will present two oral presentations, including a late-breaking abstract, at the ISRV 8th AntiViral Group Meeting and 3rd International Meeting on Respiratory Pathogens in Singapore from September 17-20, 2025 [1][2] Group 1: Presentation Details - The late-breaking abstract titled "NAVIGATE: A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multicenter Dose-ranging Trial to Evaluate the Efficacy and Safety of CD388 for Prevention of Influenza Illness in Healthy Adults" will be presented by Dr. Rick Bright on September 17, 2025, from 3:50 – 4:05 p.m. SGT [2] - Another abstract titled "A Single Prophylactic dose of CD388 Provides Protection Against Highly Pathogenic Bovine-Origin Influenza A (H5N1) Virus in the Ferret Model" will be presented by Dr. Andreev Konstantin on September 19, 2025, from 10:30 a.m. – 12:30 p.m. SGT [2] Group 2: Company Overview - Cidara Therapeutics utilizes its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, with its lead candidate CD388 designed for universal prevention of seasonal and pandemic influenza with a single dose [3] - CD388 received Fast Track Designation from the FDA in June 2023 and positive top-line results from its Phase 2b NAVIGATE trial were announced in June 2025 [3]

Core Viewpoint - Cidara Therapeutics, Inc. has announced a public offering of 7,954,546 shares of its common stock priced at $44.00 per share, aiming to raise approximately $350 million in gross proceeds before expenses [1][2]. Group 1: Offering Details - The offering is expected to close on June 26, 2025, subject to customary closing conditions [2]. - Cidara has granted underwriters a 30-day option to purchase an additional 1,193,181 shares at the public offering price [2]. - J.P. Morgan, Morgan Stanley, Guggenheim Securities, and Cantor are acting as joint book-running managers for the offering [3]. Group 2: Regulatory Information - The offering is made pursuant to a shelf registration statement filed with the SEC on May 8, 2025, and declared effective on May 15, 2025 [4]. Group 3: Company Overview - Cidara Therapeutics utilizes its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, with its lead candidate CD388 aimed at universal prevention of influenza [6]. - CD388 received Fast Track Designation from the FDA in June 2023, and the company completed enrollment for its Phase 2b NAVIGATE trial in December 2024 [6]. - Cidara is also developing additional DFCs for oncology, including CBO421, which targets CD73 in solid tumors [6].

Core Insights - Cidara Therapeutics announced positive topline results from its Phase 2b NAVIGATE trial for CD388, demonstrating significant efficacy in preventing symptomatic influenza in healthy adults [1][7] - CD388 showed protection rates of 76%, 61%, and 58% for doses of 450mg, 300mg, and 150mg respectively, compared to placebo [1][2] - The drug was well-tolerated with no safety signals observed, and an end of Phase 2 meeting request has been submitted to the FDA [1][5] Efficacy Results - The primary efficacy analysis indicated that the prevention efficacy for the 450mg group was 76.1%, 61.3% for the 300mg group, and 57.7% for the 150mg group, with p-values of <0.0001, 0.0024, and 0.0050 respectively [2][4] - Key secondary endpoints also showed significant efficacy, with the 450mg group achieving a prevention efficacy of 76.1% for participants with temperatures ≥37.8°C [3][4] Safety and Tolerability - Safety data indicated no unexpected dose-limiting treatment-emergent adverse events across all dose groups, with injection site reactions being similar to placebo [5][6] - The overall safety profile of CD388 was consistent across all treatment arms, reinforcing its potential as a well-tolerated option for influenza prevention [5][6] Future Plans - Cidara plans to present additional results from the NAVIGATE trial at scientific conferences in 2025 and is preparing for a Phase 3 trial [6][7] - The company has engaged with the FDA to discuss the Phase 2b results and the design of the upcoming Phase 3 trial [7][12] About CD388 - CD388 is a drug-Fc conjugate designed to provide long-acting protection against all strains of seasonal and pandemic influenza with a single administration [9][12] - Unlike vaccines, CD388's efficacy is not reliant on an immune response, making it suitable for individuals regardless of their immune status [9][12]

Core Viewpoint - Cidara Therapeutics is hosting a virtual R&D day to discuss its long-acting antiviral drug CD388, aimed at providing universal influenza protection with a single administration [1][2]. Group 1: Event Details - The virtual R&D day is scheduled for May 22, 2025, from 10:00 to 11:30 AM ET [1]. - Key opinion leaders Fred Hayden, MD, and Rick Bright, PhD, will participate alongside company management [2]. Group 2: CD388 Overview - CD388 is a drug-Fc conjugate designed to offer long-lasting protection against all known strains of seasonal and pandemic influenza [7]. - It is not a vaccine but a low molecular weight biologic that does not rely on an immune response, making it effective regardless of an individual's immune status [7]. - The drug aims to provide season-long protection with a single subcutaneous or intramuscular dose [7]. Group 3: Clinical Trials and Commercial Potential - The ongoing Phase 2b NAVIGATE trial is a key focus, with updates on the statistical analysis plan for evaluating efficacy results expected [3]. - The event will also cover the commercial opportunity and competitive landscape for CD388, as well as prospects for pandemic influenza [3]. - CD388 received Fast Track Designation from the FDA in June 2023, and enrollment for the Phase 2b trial was completed in December 2024 [9].