Cogent Biosciences to Initiate New Drug Application (NDA) Submission for Bezuclastinib Under Real-Time Oncology Review (RTOR)
Cogent Biosciences, Inc. (COGT)
Last cogent biosciences, inc. earnings: 11/8 04:05 pm
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Source: GlobeNewswire
- PEAK trial first ever study to demonstrate statistical significance over an active comparator in GIST patients, with bezuclastinib plus sunitinib combination demonstrating mPFS of 16.5 months and ORR of 46% in patients who had received prior treatment with imatinib - Cogent is expected to initiate the RTOR process immediately; completion of the PEAK NDA submission expected in April 2026 WALTHAM, Mass. and BOULDER, Colo., Jan. 20, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc.?(Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced that the U.S. Food and Drug Administration (FDA) has agreed to accept its New Drug Application (NDA) for bezuclastinib in combination with sunitinib for patients with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment with imatinib under the Real-Time Oncology Review (RTOR) program. “This milestone reflects the FDA’s recognition of the significant
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News
- Cogent Biosciences (COGT) Is Up 13.1% After FDA RTOR Nod For Bezuclastinib Combo - Has The Bull Case Changed? [Yahoo! Finance]Yahoo! Finance
- Cogent Biosciences (NASDAQ:COGT) had its "outperform" rating reaffirmed by analysts at Wedbush. They now have a $55.00 price target on the stock.MarketBeat
- Cogent Biosciences Announces Anticipated 2026 Commercial and Clinical Milestones for Bezuclastinib and Precision Therapies PortfolioGlobeNewswire
- Cogent Insider Sells $2.5 Million in Stock Amid Staggering 300% Price Surge [Yahoo! Finance]Yahoo! Finance
- H.C. Wainwright is Bullish on Cogent Biosciences, Inc. (COGT) [Yahoo! Finance]Yahoo! Finance
COGT
Sec Filings
- 1/21/26 - Form SCHEDULE
- 1/21/26 - Form SCHEDULE
- 1/5/26 - Form 4
- COGT's page on the SEC website