Eric Schmidt

Roy Buchanan

Seamus Fernandez

Edward Marks

Gregory Renza

Joseph Stringer

Sara Nik

- Cidara Therapeutics (CDTX) will present **late-breaking Phase 2 clinical data** on its antiviral influenza candidate, **CD388**, at ID Week 2025 on **Monday, October 20, 2025**.  **[1610618_39311b6c42fa4a69b09f9849e544f1cd_0]** 
- CD388, a long-acting antiviral designed for universal influenza prevention, was granted **FDA Fast Track Designation in June 2023**.  **[1610618_39311b6c42fa4a69b09f9849e544f1cd_0]** 
- The company announced **positive top-line results from its Phase 2b NAVIGATE trial in June 2025** and subsequently **initiated its Phase 3 ANCHOR trial in September 2025**.  **[1610618_39311b6c42fa4a69b09f9849e544f1cd_0]**

Cidara Therapeutics to Present Late-Breaking Phase 2 Data for CD388

- Cidara Therapeutics (Nasdaq: CDTX) will deliver a **late-breaking presentation** on its lead drug candidate, **CD388**, at the 10th European Scientific Working Group on Influenza (ESWI) Conference in Valencia, Spain, on **October 23, 2025**.  **[1610618_f0a818de5074400aacc438c795bf76a3_0]** 
- The presentation will detail the translational efficacy of CD388 in mouse influenza models and its prevention efficacy from the recently completed **Phase 2b NAVIGATE clinical study**.  **[1610618_f0a818de5074400aacc438c795bf76a3_0]** 
- CD388, a long-acting antiviral, is designed for universal prevention of seasonal and pandemic influenza with a single dose.  **[1610618_f0a818de5074400aacc438c795bf76a3_0]** 
- Cidara announced **positive top-line results from its Phase 2b NAVIGATE trial in June 2025** and initiated its **Phase 3 ANCHOR trial in September 2025**.  **[1610618_f0a818de5074400aacc438c795bf76a3_0]**

Cidara Therapeutics to Present CD388 Clinical Data

- **Cidara Therapeutics** received **Breakthrough Therapy designation from the FDA** for its drug **CD388**, designed to prevent influenza A and B, following positive Phase 2b trial results.  **[1610618_502abc3a1c46431986d8f7342db5109e]** 
- The company initiated a **Phase 3 study (ANCHOR)** for CD388 in late September and secured **up to $339 million in funding from BARDA** for its development and manufacturing.  **[1610618_502abc3a1c46431986d8f7342db5109e]** 
- CD388 is a **drug-Fc conjugate**, distinguishing it from traditional vaccines by offering protection without relying on an immune response.  **[1610618_502abc3a1c46431986d8f7342db5109e]** 
- Despite these positive regulatory and development milestones, **Cidara Therapeutics faces financial challenges**, including declining revenue and negative profitability margins.  **[1610618_502abc3a1c46431986d8f7342db5109e]**

Cidara Therapeutics' CD388 Receives FDA Breakthrough Therapy Designation

- Cidara Therapeutics (CDTX) has been granted **Breakthrough Therapy designation** by the U.S. FDA for its lead drug candidate, **CD388**, for the prevention of influenza A and B in high-risk adults and adolescents.  **[1610618_dbf092570c3f48f39530ab4478c818ac_0]** 
- This designation, which follows a **Fast Track designation** in June 2023, aims to expedite the review of CD388, which has shown preliminary clinical evidence of substantial improvement over available therapies based on positive **Phase 2b NAVIGATE trial results** announced in June 2025.  **[1610618_dbf092570c3f48f39530ab4478c818ac_0]** **[1610618_dbf092570c3f48f39530ab4478c818ac_1]** 
- The company initiated its **Phase 3 ANCHOR trial** for CD388 in September 2025, six months ahead of schedule, expanding the study population to include high-risk individuals and healthy adults over 65.  **[1610618_dbf092570c3f48f39530ab4478c818ac_0]** **[1610618_dbf092570c3f48f39530ab4478c818ac_1]**

Cidara Therapeutics Receives FDA Breakthrough Therapy Designation for CD388

- Cidara Therapeutics, Inc. has received an award valued up to **$339 million** from the Biomedical Advanced Research and Development Authority (BARDA) to support the manufacturing and clinical development of its non-vaccine influenza preventative therapeutic, CD388.  **[1610618_c8b74916dd1a4421b2eaf5651cb00b9f_0]** 
- The multi-year agreement includes a Base period funding of **$58 million** over **24 months** to onshore CD388 manufacturing to the United States, conduct a clinical trial for a higher-concentration formulation, and initiate development of clinical trial protocols for expanded populations.  **[1610618_c8b74916dd1a4421b2eaf5651cb00b9f_0]** 
- Option periods, if requested by Cidara and exercised by the U.S. government, could provide up to **$281 million** for additional clinical and non-clinical studies of CD388, complementing the company's plans for a potential Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA).  **[1610618_c8b74916dd1a4421b2eaf5651cb00b9f_0]** 
- CD388 is an investigational drug-Fc conjugate (DFC) designed to provide universal protection against influenza, which received FDA Fast Track Designation in June 2023 and showed positive top-line results from its Phase 2b NAVIGATE trial in June 2025.  **[1610618_c8b74916dd1a4421b2eaf5651cb00b9f_1]**

Cidara Therapeutics Receives BARDA Award for CD388 Development

- Cidara Therapeutics, Inc. is proceeding with an **expanded and accelerated development plan** for its CD388 Phase 3 registrational trial, aiming for biologics license application (BLA) approval based on a single study.  **[1610618_0001193125-25-214001_d159459d8k.htm:1]** 
- The study population for CD388 will be expanded to include adults over 65 years of age without specific co-morbidities, in addition to subjects over 12 years of age with high-risk comorbidities or immune-compromised status, significantly increasing the **potential U.S. patient pool from approximately 50 million to over 100 million people**.  **[1610618_0001193125-25-214001_d159459d8k.htm:1]** 
- Enrollment for the global Phase 3 study, targeting **6,000 subjects**, is set to begin by the **end of September 2025** in the Northern Hemisphere, representing a **six-month acceleration** from the prior plan.  **[1610618_0001193125-25-214001_d159459d8k.htm:1]** 
- The company believes its **existing cash, cash equivalents, and restricted cash will be sufficient to fully fund the planned Phase 3 development program through completion**.  **[1610618_0001193125-25-214001_d159459d8k.htm:1]**