Shares of Cogent Biosciences, Inc. (COGT) are soaring 103.10% in pre-market trading on Monday following the announcement of positive results from its Phase 3 PEAK trial for bezuclastinib in combination with sunitinib for the treatment of Gastrointestinal Stromal Tumors (GIST).

The company reported that the combination therapy of bezuclastinib and sunitinib achieved a median progression-free survival (mPFS) of 16.5 months, compared to 9.2 months for sunitinib monotherapy in patients with imatinib-resistant or intolerant GIST. Additionally, the objective response rate (ORR) for the combination was 46%, significantly higher than the 26% observed with sunitinib alone. Importantly, the safety profile of the combination was consistent with the known profile of sunitinib.

Following these encouraging results, Cogent Biosciences plans to submit a new drug application (NDA) for bezuclastinib in GIST in the first half of 2026. The company also intends to present detailed results from the PEAK trial at a major scientific conference during the same period. This positive development has sparked investor enthusiasm, potentially positioning Cogent Biosciences as a strong contender in the GIST treatment market.