Will Cogent Biosciences' (COGT) Breakthrough Therapy Transform GIST Treatment? Analysts Think So

Cogent Biosciences Inc. (NASDAQ:COGT) is among the hottest SMID-cap stocks so far in 2025. On November 13, H.C. Wainwright made a notable upward revision to its outlook on the company, more than doubling its price target from $21 to $50 while reaffirming a Buy rating, according to TheFly.

The investment firm’s increased confidence was driven by positive data from the company’s Phase 3 PEAK trial, which studied the combination of its therapy, bezuclastinib, with sunitinib. Following the announcement, the analysts believe that bezuclastinib plus sunitinib could emerge as the second-line standard of care in gastrointestinal stromal tumors (GIST).

Cogent Biosciences Inc. (NASDAQ:COGT) announced the trial results on November 10, and several analysts saw them as highly positive for the company’s outlook. The company said it plans to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in GIST in the first half of 2026.

Cogent Biosciences Inc. (NASDAQ:COGT) shares skyrocketed 119% on the day of the announcement.

Sara Rothschild, Executive Director at the non-profit organization, The Life Raft Group, which supports GIST patients, stated:

“Imatinib-resistant or intolerant GIST patients have waited nearly 20 years for a new second-line treatment option. The remarkable results of the PEAK study suggest that wait has come to an end.”

Andrew Robbins, Cogent’s President and Chief Executive Officer, called it a historic day for Cogent Biosciences and the GIST patient community. He further stated:

“We are extremely excited to announce positive results from the Phase 3 PEAK trial of bezuclastinib plus sunitinib, which have far surpassed our expectations for the activity of this combination in patients with imatinib-resistant or intolerant GIST. With these incredible results, including a greater than seven-month improvement on mPFS – reducing the rate of progression or death by half – the bezuclastinib combination is poised to become the new standard of care for treatment of second-line GIST patients.”

Cogent Biosciences Inc. (NASDAQ:COGT) is a biotechnology company that develops precision therapies for patients with genetically defined diseases. Their primary focus is on targeting various forms of mastocytosis and gastrointestinal stromal tumors (GIST).

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Disclosure: None. This article is originally published at Insider Monkey.