Cidara Therapeutics (CDTX) Soars 20.53% on Strategic Advances, FDA-Backed Trial Expansion for CD388

Cidara Therapeutics (CDTX) surged 20.53% on Tuesday, marking its highest level since September 2025, with intraday gains reaching 23.34%. The rally reflects investor optimism over the company’s strategic advancements in its lead candidate, CD388, a long-acting antiviral for influenza prevention.

Key developments include the acceleration of its Phase 3 trial timeline, with enrollment set to begin by late September 2025, aligning with the Northern Hemisphere flu season. The trial’s global scope, targeting 6,000 participants across both hemispheres, aims to strengthen data generalizability. An interim analysis during the Northern Hemisphere season will allow for adaptive adjustments, potentially streamlining the trial’s efficiency.

The FDA’s feedback has expanded the trial’s eligibility criteria to include adults over 65 without comorbidities, doubling the U.S. potential patient population to over 100 million. This broader demographic aligns with CD388’s unique value proposition as a non-vaccine alternative for high-risk groups, addressing a critical unmet need in older adults with compromised immune function.

Regulatory clarity further boosted investor confidence, as the FDA indicated a single Phase 3 trial may suffice for Biologics License Application (BLA) approval. This streamlined pathway reduces development costs and timelines, contrasting with traditional multi-trial requirements. Positive Phase 2b NAVIGATE trial results and Fast Track Designation from 2023 underscore the drug’s robust clinical foundation.

Cidara’s financial readiness, supported by secured 2025 financing, ensures the trial’s full funding, mitigating risks of delays. CEO Jeffrey Stein emphasized the company’s preparedness to advance CD388 toward a universal flu prevention option, reinforcing leadership’s confidence in the program’s commercial potential.

While CD388 remains the flagship asset, the company’s pipeline diversification into oncology—recently advancing CBO421 for CD73-targeted solid tumors—highlights the Cloudbreak® platform’s adaptability. This strategic expansion reduces reliance on a single therapeutic area, enhancing long-term resilience.