On Monday, Cogent Biosciences, Inc. ( COGT ) said bezuclastinib showed meaningful clinical benefit for patients with non-advanced systemic mastocytosis.

The company said that its experimental drug reduced the symptoms of a chronic immune disorder called non-advanced systemic mastocytosis.

The latest study demonstrated meaningful and highly statistically significant improvements across the primary and all key secondary endpoints, including patient-reported symptoms and objective measures of mast cell burden.

Also Read: Why Is Cogent Biosciences Stock Trading Higher On Monday?

The SUMMIT trial achieved its primary endpoint with a statistically significant difference in the mean change in total symptom score (TSS) at 24 weeks.

The bezuclastinib arm had a mean reduction of 24.3 points in TSS at 24 weeks, versus the placebo arm, which had a mean reduction of 15.4 points, resulting in a placebo-adjusted TSS improvement of 8.91 points.

Based on these data, Cogent is on track to submit its first new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in NonAdvSM by the end of 2025.

Further underscoring the drug’s potential, JP Morgan views the asset as very strategically attractive. “We believe the SUMMIT Part 2 bezuclastinib results were near a best-case outcome on the emerging clinical profile in NonAdvSM, particularly on the safety side (removing a key overhang on the program),” wrote analyst Anupam Rama in an investor note on Monday.

Consequently, JP Morgan maintains its overweight rating on Cogent with a price forecast of $25. In fact, JPMorgan believes Cogent’s bezuclastinib for systemic mastocytosis (SM) has strong potential to become a blockbuster drug and could set a new standard for future treatments.

From a market perspective, Cogent estimates the U.S. market worth over $2 billion for non-advanced SM and $300 million for advanced SM.

To provide context, Blueprint previously suggested the overall SM market could reach around $4 billion in peak sales, with its own drug Ayvakit projected to generate about $2 billion by 2030. Overall, the SM market is considered large and full of opportunity.

The analyst says the strategic attractiveness of the systemic mastocytosis market was recently validated by Sanofi SA’s acquisition of Blueprint Medicines Corporation ( BPMC ) for over $9 billion.

Beyond SM, JP Morgan also sees bezuclastinib’s potential in gastrointestinal stromal tumors (GIST) as underappreciated. The analyst adds, “We have been asked if a potential strategic interest in the asset would require positive data in GIST…and we do not believe so (SM is attractive on its own and GIST would be another lever of upside).

Looking ahead, Cogent remains on track to provide topline results from both PEAK, a Phase 3 trial of bezuclastinib in combination with sunitinib in patients with gastrointestinal stromal tumors, and APEX, a registration-directed trial of bezuclastinib in advanced systemic mastocytosis patients, during the second half of 2025.

Price Action: At the last check on Tuesday, COGT stock was up 6% at $9.911.

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