12:35 PM EDT, 06/24/2025 (MT Newswires) -- Cidara Therapeutics ( CDTX ) is "potentially transforming the space" in flu prevention with its lead candidate CD388, RBC Capital Markets said following the company's phase 2b results on Monday.

The mid-stage Navigate trial showed that single doses of CD388 reduced symptomatic influenza by about 58% to 76% over 24 weeks, with statistically significant results across all primary and secondary endpoints. The brokerage said in a Monday note that the efficacy appeared to exceed traditional flu vaccine benchmarks and noted a clean safety profile.

The firm expects CD388 to initially target high-risk populations, such as immunocompromised individuals, estimating a global opportunity near $3 billion. It also said the drug could eventually be used in broader populations or for pandemic stockpiling, citing its once-per-season protection and immune-independent mechanism.

Cidara has requested an end-of-phase 2 meeting with the FDA and plans to begin a phase 3 trial in 2026. RBC said the pivotal study could enroll 5,000 to 7,000 subjects over two to three flu seasons, based on a 1.5% placebo attack rate and a 60% efficacy effect size. The firm said these assumptions look reasonable given the current data.

The firm added that while the highest 450 mg dose may require formulation adjustments for commercial delivery, lower doses could remain viable. It expects Cidara to prioritize the 450 mg dose in phase 3 development given its superior efficacy.

RBC raised its price target on Cidara Therapeutics ( CDTX ) to $75 from $35, with an outperform rating.

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