Cogent Biosciences (COGT) Advances Bezuclastinib-Sunitinib Combination With Breakthrough Therapy Designation (BTD) [Yahoo! Finance]
Cogent Biosciences, Inc. (COGT)
Last cogent biosciences, inc. earnings: 11/8 04:05 pm
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Source: Yahoo! Finance
On January 26, 2026, Cogent Biosciences, Inc. (NASDAQ:COGT) announced a major milestone, receiving a Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration. The designation came for bezuclastinib in combination with sunitinib for patients with Gastrointestinal Stromal Tumors (GIST) previously treated with imatinib. This win reflects the combination's potential to significantly improve outcomes in this patient population. The designation follows the PEAK trial that featured a 50% reduction in risk of disease progression or death compared to sunitinib monotherapy (hazard ratio 0.50, 95% CI: 0.39-0.65). Meanwhile, median progression-free survival stood at 16.5 months compared to 9.2 months for sunitinib alone, while reporting no new safety signals. Earlier in January, under its Real-Time Oncology Review (RTOR), the FDA agreed to accept Cogent Biosciences, Inc. (NASDAQ:COGT)'s New Drug Application (NDA). This acceptance will accelerate the review, increasing
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News
- Cogent Biosciences FDA Milestones Put Bezuclastinib And Valuation In Focus [Yahoo! Finance]Yahoo! Finance
- Large Biotech Fund Sells Shares of Cogent Biosciences for Over $120M [Yahoo! Finance]Yahoo! Finance
- Cogent Biosciences (NASDAQ:COGT) was downgraded by analysts at <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=COGT&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall StreMarketBeat
- Cogent Biosciences announcse U.S. BTD for bezuclastinib [Yahoo! Finance]Yahoo! Finance
- Cogent Biosciences Announces Breakthrough Therapy Designation for Bezuclastinib in Combination with Sunitinib for Patients with Gastrointestinal Stromal Tumors (GIST)GlobeNewswire
COGT
Sec Filings
- 1/30/26 - Form SCHEDULE
- 1/22/26 - Form 4
- 1/22/26 - Form 144
- COGT's page on the SEC website