This section highlights FDA-related milestones and regulatory updates for drugs developed by Cidara Therapeutics (CDTX).
Over the past two years, Cidara Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
CD388 and Cloudbreak. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
CD388 - FDA Regulatory Timeline and Events
CD388 is a drug developed by Cidara Therapeutics for the following indication: Universal Prevention and Treatment of Influenza.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CD388
- Announced Date:
- June 23, 2025
- Indication:
- Universal Prevention and Treatment of Influenza
Announcement
Cidara Therapeutics, Inc. announced positive topline results from its randomized, double-blind, placebo-controlled Phase 2b NAVIGATE trial evaluating CD388 for the prevention of seasonal influenza in healthy unvaccinated adults aged 18 to 64.
AI Summary
Cidara Therapeutics, Inc. recently announced positive topline results from its Phase 2b NAVIGATE trial evaluating CD388 as a once-per-season approach to prevent seasonal influenza. In this randomized, double-blind, placebo-controlled study, healthy unvaccinated adults aged 18 to 64 received a single dose of CD388 at 150 mg, 300 mg, or 450 mg at the start of the flu season. Over 24 weeks, the trial showed that CD388 provided 58%, 61%, and 76% protection against symptomatic influenza for the 150 mg, 300 mg, and 450 mg doses, respectively, compared to placebo. All primary and secondary endpoints were met, with efficacy maintained up to 28 weeks at key temperature thresholds. Additionally, CD388 was well-tolerated, with no safety signals or serious adverse events reported across any dose groups.
Read Announcement- Drug:
- CD388
- Announced Date:
- March 18, 2025
- Indication:
- Universal Prevention and Treatment of Influenza
Announcement
Cidara Therapeutics, Inc. announced two upcoming presentations at the 38th International Conference on Antiviral Research (ICAR).
AI Summary
Cidara Therapeutics, Inc. announced two upcoming presentations at the 38th International Conference on Antiviral Research (ICAR), held in Las Vegas, Nevada from March 17-21, 2025.
The first presentation, titled "NAVIGATE: A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multicenter Dose-ranging Study to Evaluate the Efficacy and Safety of CD388," will share the trial’s study design, participant demographics, and preliminary safety information from the ongoing trial involving more than 5,000 participants. The second presentation, "Real World Data-Based Modeling of Seasonal Influenza Variations to Support Clinical Dose Selection of CD388," will discuss how advanced modeling helps improve clinical dose selection. Both presentations, scheduled during specific poster sessions on March 18 and 20, aim to provide key insights into the trial results and dose optimization for future Phase 3 studies.
Read Announcement- Drug:
- CD388
- Announced Date:
- March 17, 2025
- Indication:
- Universal Prevention and Treatment of Influenza
Announcement
Cidara Therapeutics, Inc. announced the publication of preclinical data assessing CD388, the company's influenza DFC, in the peer-reviewed scientific journal Nature Microbiology.
AI Summary
Cidara Therapeutics recently published preclinical data in Nature Microbiology assessing its investigational drug-Fc conjugate, CD388. The study shows that CD388 has the potential to work as a potent, universal antiviral against influenza A and B viruses in both healthy and high-risk populations. Researchers demonstrated that CD388’s intrinsic antiviral activity can protect against various influenza strains, including severe and resistant types, regardless of the immune status of the subjects. The findings in mice indicate that the drug is effective even in immune-compromised models, suggesting broad protection without relying on a strong immune response.
The publication supports the promise of CD388 as a single-dose preventive treatment for influenza. This breakthrough could offer an alternative to vaccines, providing season-long protection that may be particularly beneficial during both seasonal and pandemic flu outbreaks.
Read Announcement- Drug:
- CD388
- Announced Date:
- December 4, 2024
- Indication:
- Universal Prevention and Treatment of Influenza
Announcement
Cidara Therapeutics, Inc. announced it has reached full planned enrollment of 5,000 subjects in the Phase 2b NAVIGATE trial across clinical sites in the US and UK.
AI Summary
Cidara Therapeutics has reached a major milestone by enrolling 5,000 subjects in its Phase 2b NAVIGATE trial at clinical sites in the United States and United Kingdom. This trial is designed to evaluate the safety, proper dosing, and effectiveness of CD388, a novel drug-Fc conjugate intended to prevent seasonal influenza. The investigational treatment aims to serve as a long-acting, universal influenza preventive through a single dose given at the start of the flu season.
The study targets healthy, unvaccinated adults, who will be monitored throughout the flu season for any breakthrough cases of influenza. Achieving this enrollment at the beginning of the northern hemisphere’s flu season positions Cidara Therapeutics to thoroughly assess CD388’s potential as a one-dose treatment, marking a significant development in the fight against seasonal influenza.
Read Announcement- Drug:
- CD388
- Announced Date:
- September 25, 2024
- Indication:
- Universal Prevention and Treatment of Influenza
Announcement
Cidara Therapeutics, Inc. announced two presentations at OPTIONS XII for the Control of Influenza conference, to be held September 29 through October 2, 2024 in Brisbane, Australia.
AI Summary
Cidara Therapeutics, Inc. announced that it will present two key sessions on its influenza drug candidate, CD388, at the upcoming OPTIONS XII for the Control of Influenza conference in Brisbane, Australia from September 29 to October 2, 2024. One session is an oral presentation scheduled for October 1, where Dr. Taylor Sandison will share safety data from Phase 1 and Phase 2a studies involving 108 subjects. The study reported that CD388, given by subcutaneous or intramuscular injection, was safe and well-tolerated across various doses. The second session, which is a poster presentation on September 29, will cover pharmacokinetic (PK) and safety results from a study involving 27 healthy Japanese participants. These findings reinforce the potential of CD388 to offer season-long protection against influenza A and B in both immune-compromised and immune-competent individuals.
Read Announcement- Drug:
- CD388
- Announced Date:
- September 23, 2024
- Indication:
- Universal Prevention and Treatment of Influenza
Announcement
Cidara Therapeutics, Inc. announced the first subjects dosed in the Phase 2b NAVIGATE trial to evaluate the efficacy and safety of CD388 for the pre-exposure prophylaxis of influenza during the current flu season.
AI Summary
Cidara Therapeutics, Inc. has begun dosing the first subjects in its Phase 2b NAVIGATE trial to test CD388 for preventing influenza before exposure. The trial is designed to study how effective and safe CD388 is during the current flu season. It will involve about 5,000 healthy adults who have not been vaccinated and are not at high risk from the flu. Participants will receive either one of three single doses of CD388 or a placebo at the start of the season. Researchers will follow the subjects throughout the flu season to compare rates of laboratory and clinically confirmed influenza cases. According to the company’s CEO, CD388 may offer a new way to prevent both seasonal and pandemic flu strains, especially for those who do not benefit as much from traditional vaccines.
Read Announcement- Drug:
- CD388
- Announced Date:
- September 12, 2024
- Indication:
- Universal Prevention and Treatment of Influenza
Announcement
Cidara Therapeutics, Inc. announced a reduction in its workforce to focus on the clinical development of CD388, the Company's novel DFC candidate for influenza A and B.
AI Summary
Cidara Therapeutics, Inc. has announced a strategic decision to reduce its workforce by around 30% to focus on the clinical development of CD388, its innovative drug-Fc conjugate (DFC) candidate for influenza A and B. This move is aimed at reducing capital needs and streamlining operations, allowing the company to concentrate resources on the upcoming Phase 2b trial of CD388. The candidate is designed to provide universal prevention against seasonal and pandemic influenza with just a single dose, potentially setting a new standard for flu prevention.
By making these changes, Cidara aims to speed up the advancement of CD388 while improving overall efficiency. The workforce reduction was a difficult but necessary choice to help ensure long-term success and the proper allocation of resources to this promising immunotherapy candidate.
Read Announcement
Cloudbreak - FDA Regulatory Timeline and Events
Cloudbreak is a drug developed by Cidara Therapeutics for the following indication: Novel Drug-Fc Conjugate Candidates.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Cloudbreak
- Announced Date:
- April 5, 2024
- Indication:
- Novel Drug-Fc Conjugate Candidates
Announcement
Cidara Therapeutics, Inc , announced the company will deliver four poster presentations, including one late-breaking poster presentation, at this year's American Association for Cancer Research (AACR) Annual Meeting being held April 5-10, 2024 at the San Diego Convention Center in San Diego, California. .
AI Summary
Cidara Therapeutics, Inc. announced that it will present four posters, including one late-breaking presentation, at the American Association for Cancer Research (AACR) Annual Meeting from April 5-10, 2024 at the San Diego Convention Center. These presentations highlight preclinical data from its leading drug-Fc conjugate programs, with a focus on innovative cancer immunotherapies.
One featured study details a multispecific CD73/PD-1 targeting DFC that showed improved tumor reduction compared to PD-1 monotherapy in a humanized mouse model. Additionally, data will be shared on a CCR5-targeting DFC, which demonstrated potent efficacy in a colorectal cancer mouse model, as well as new findings on CBO421, the company’s lead CD73-targeting candidate in triple-negative breast cancer cell lines. These sessions emphasize the potential of Cidara’s Cloudbreak platform to develop therapies that better engage the immune system to fight cancer.
Read Announcement
Free CDTX Stock Alerts