Cidara Therapeutics' Q1 2025: Unpacking Contradictions in CD388's Opportunity and Pricing Dynamics

Opportunity expansion for CD388, pricing dynamics for CD388 are the key contradictions discussed in Cidara Therapeutics' latest 2025Q1 earnings call.



CD388 Clinical Advancements:
- Cidara's Phase IIb NAVIGATE study evaluating CD388 for seasonal influenza prevention completed dosing of 5,041 subjects across 3 CD388 dose groups (150 mg, 300 mg, 450 mg) and 1 placebo group by December 2024.
- Top line data is expected by the end of June 2025, with potential statistical significance evaluation due to the severity of the 2024-2025 flu season.
- The study aims to determine dose selection for Phase III trials and is designed to evaluate efficacy and safety in healthy adults.

Target Population and Market Opportunity:
- Cidara is initially focusing on high-risk comorbid and immune-compromised patients due to their higher hospitalization and death rates from influenza.
- The market research indicates broader physician interest in treating moderate forms of conditions, leading to an expanded potential patient population beyond the initial 20 million estimate.
- The company sees significant value in CD388, suggesting pricing meaningfully above the previously modeled range of $180 to $200.

Regulatory and Collaboration Efforts:
- Cidara has had discussions with the FDA and plans to share updates about the statistical analysis plan at the upcoming R&D Day event on May 22.
- The company is also exploring collaboration opportunities with the Biological Advanced Research and Development Authority (BARDA) for CD388's potential prevention of H5N1.
- CD388's potential as a universal antiviral highlights its role in addressing unmet needs in influenza prevention, especially in immune-compromised individuals.

Primary Endpoint of NAVIGATE Study:
- The primary endpoint of the NAVIGATE study is preventive efficacy, evaluated by centrally confirmed influenza infection, which includes nasopharyngeal PCR positivity, a body temperature of 38 degrees, and two symptoms (respiratory or one respiratory and one systemic).
- CD388 aims to provide substantial protective efficacy compared to placebo, as shown in previous Phase IIa human challenge studies.
- The study is designed to robustly confirm symptomatic and severe flu infections, contributing to CD388's potential as a complement to existing vaccines.