Cogent Biosciences Inc. (NASDAQ:COGT) is one of the best emerging technology stocks to invest in. On December 19, JPMorgan raised the firm’s price target on Cogent Biosciences to $67 from $65 with an Overweight rating on the shares. This sentiment was announced as the firm broadly updated models in its smid-cap biotech group.
In other news, on December 8, Cogent Biosciences announced positive top-line results from the registration-directed APEX Part 2 clinical trial. The study evaluated bezuclastinib, which is a highly selective and potent KIT D816V inhibitor, in 81 patients with advanced systemic mastocytosis/AdvSM, a rare and aggressive blood disorder. The primary efficacy analysis focused on 68 evaluable patients, demonstrating an Objective Response Rate/ORR of 57% based on modified IWG/mIWG criteria, which account for the reversal of organ damage. When measured by Pure Pathological Response criteria, the ORR reached 80%.
Bezuclastinib was reported to be well-tolerated, with no patients discontinuing the study due to treatment-related adverse events/TRAEs. The most common side effects included hair color change (30.9%), neutropenia (29.6%), and altered taste (28.4%). Dose reductions were infrequent, required by only 14.8% of the participants. These safety results are particularly notable as the drug is designed to avoid the central nervous system and off-target toxicities, such as intracranial bleeding, often seen with other treatments in this class.
This announcement marks the third successful pivotal trial for bezuclastinib in 2025, following the SUMMIT/NonAdvSM and PEAK/GIST trials. Cogent Biosciences expects to submit an NDA to the FDA in H1 2026, with plans for multiple commercial launches in H2 of that year. Detailed data from the APEX trial will be presented at a major medical conference in early 2026.
Cogent Biosciences Inc. (NASDAQ:COGT) is a biotechnology company that develops precision therapies for genetically defined diseases.
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Disclosure: None. This article is originally published at Insider Monkey.
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