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Investing.com - Guggenheim has raised its price target on Cidara Therapeutics (NASDAQ:CDTX) to $167.00 from $70.00 while maintaining a Buy rating following positive FDA feedback on the company’s end-of-Phase 2 meeting. The stock, which has surged over 700% in the past year, is currently trading near its 52-week high of $90.64, according to InvestingPro data.
The FDA has allowed Cidara to broaden the population for its imminent ANCHOR Phase 3 study to include participants 65 years and older, in addition to the previously anticipated 12 years plus higher risk non-immunocompromised ages and immunocompromised population.
The Phase 3 study is expected to begin dosing before the end of September and will target approximately 6,000 individuals across both Northern and Southern Hemispheres, with an interim analysis planned following the Northern Hemisphere flu season.
The FDA also confirmed that the NAVIGATE Phase 2b trial is eligible as a pivotal trial, with the ANCHOR Phase 3 study sufficient to support approval, representing strong regulatory support and validation for Cidara’s development program.
Guggenheim has increased its CD388 revenue estimates to include the larger 65 years plus and at-risk patient population, now assuming risk-adjusted peak revenues of approximately $3.4 billion compared to its prior risk-adjusted estimate of approximately $1.6 billion. With analysts maintaining a strong Buy consensus and multiple positive catalysts ahead, investors can access detailed valuation models and 13 additional ProTips through InvestingPro’s comprehensive research report.
In other recent news, Cidara Therapeutics has made significant strides with its CD388 flu prevention treatment. The company announced updates to its planned Phase 3 trial, revealing an accelerated timeline and an expanded study population following feedback from the FDA. The trial is now set to begin by the end of September 2025, targeting 6,000 participants, and will include adults over 65 without specific comorbidities, alongside individuals over 12 with high-risk conditions. This expansion potentially increases the eligible U.S. population from 50 million to over 100 million.
Analysts have responded positively to these developments. H.C. Wainwright reiterated its Buy rating with a $74 price target, while WBB Securities raised its price target from $45 to $123, maintaining a Strong Buy rating. WBB Securities highlighted impressive efficacy data from Cidara’s antiviral treatments, including results from pre-clinical models and the CD388 Topline Phase 2b NAVIGATE trial. These updates reflect a strategic push by Cidara to advance its flu prevention efforts, potentially impacting a broader patient population in the future.
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