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Promising Outlook for Cogent Biosciences: Buy Rating Backed by FDA Breakthrough Designation and Strong Phase 3 Trial Prospects

Promising Outlook for Cogent Biosciences: Buy Rating Backed by FDA Breakthrough Designation and Strong Phase 3 Trial Prospects

Sam Slutsky, an analyst from LifeSci Capital, maintained the Buy rating on Cogent Biosciences. The associated price target remains the same with $20.00.

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Sam Slutsky has given his Buy rating due to a combination of factors, primarily centered around the promising developments with Cogent Biosciences’ drug candidate, bezuclastinib. The recent FDA Breakthrough Therapy Designation for bezuclastinib in treating Non-Advanced Systemic Mastocytosis (Non-AdvSM) underscores its potential efficacy and the unmet need in this patient population, which currently lacks approved standard treatments. This designation not only validates the strong data from the Phase 3 SUMMIT trial but also positions the drug for a Priority Review, expediting its path to market.
Additionally, Cogent Biosciences is on track to release significant topline data from their ongoing Phase 3 trials, including the PEAK study for 2L GIST and the APEX trial for advanced systemic mastocytosis, both expected in late 2025. These upcoming data releases could further bolster the company’s prospects. The strategic timing of these trials and the company’s financial position, with approximately 2.5 years of cash runway, support a positive outlook for Cogent Biosciences, contributing to Slutsky’s Buy recommendation.

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