Cidara Therapeutics Awaits Phase 3 Flu Trial Data Ahead of Planned BLA Submission

Cidara Therapeutics is approaching a pivotal moment as it awaits an interim analysis from its Phase 3 ANCHOR trial for CD388, an influenza prophylactic candidate. The data review, anticipated before the end of the current quarter, represents the most significant near-term catalyst for the company. A successful outcome from this analysis is an absolute prerequisite for the company to proceed with its planned Biologics License Application (BLA) for CD388.

The findings will directly guide decisions on patient recruitment adjustments for the upcoming influenza season in the Southern Hemisphere. The performance of this study is currently viewed as the primary benchmark for assessing the potential of the broader Drug-Fc Conjugate (DFC) platform within the long-acting antiviral treatment sector.

In September, Cidara initiated the Phase 3 ANCHOR trial evaluating a single 450mg subcutaneous dose for pre-exposure prophylaxis of seasonal influenza. The trial followed positive results from the Phase 2b NAVIGATE study, which met its primary and secondary endpoints across all doses in June.

Following an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), the company expanded the ANCHOR study population and confirmed its intention to seek biologics license application (BLA) approval based on a single Phase 3 study.

Cidara entered a BARDA agreement that can total $339.2M, with an initial investment of approximately $58.1M to begin in September 2025 and run through September 2027. The initial funds will support the onshoring of CD388 manufacturing to U.S. contractors, a clinical trial to show comparability of a higher-concentration formulation and different presentations, additional non-clinical characterization against pandemic influenza strains, and development of protocols for expanded studies.

The company reported Q3 2025 results showing a net loss of $83.2 million, driven by $45.0 million of acquired in-process R&D and higher R&D spending. Liquidity strengthened following capital raises. As of September 30, cash and cash equivalents were $293.7 million, with $126.4 million in short-term and $50.2 million in long-term available-for-sale investments; restricted cash was $6.3 million. In June, the company completed an underwritten offering of 9,147,727 shares at $44.00 per share for net proceeds of $376.9 million.

Following its acquisition and integration as a subsidiary of Merck & Co., observers are monitoring how Cidara's Cloudbreak platform is leveraged within the larger corporate infrastructure. A key question is whether the accelerated development timeline for CD388 can be maintained despite the organizational transition. Financial updates scheduled for release in early March are expected to provide the first detailed insights into the progress of this corporate integration.