Cogent Biosciences, Inc. (COGT), a clinical-stage biotechnology company, announced the completion of the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Bezuclastinib in patients with Gastrointestinal Stromal Tumours (GIST) who have received prior treatment with Imatinib.
This follows the firm's recent FDA acceptance of the NDA submitted for Bezuclastinib in Non-Advanced Systemic Mastocytosis (Non-AdvSM). The NDA submission for GIST was based on the positive results from the Phase 3 clinical trial dubbed PEAK, and the NDA was submitted under the FDA's Real-Time Oncology Review (RTOR) program, which is intended to enable a more streamlined review process. PEAK is a global, randomised Phase 3 trial evaluating Bezuclastinib in combination with Sunitinib versus Sunitinib monotherapy in patients with GIST who have received prior treatment with Imatinib. Pivotal data from the PEAK trial demonstrated a substantial, highly statistically significant clinical benefit on the primary endpoint of progression-free survival (PFS), reducing the risk of disease progression or death compared with the current standard of care by 50%. Notably, Bezuclastinib combination demonstrated 16.5 months median PFS and 46% Overall Response Rate ORR in imatinib-resistant GIST patients according to the firm. Cogent develops precision therapies for the treatment of genetically defined diseases. Its lead program, Bezuclastinib, is in clinical trials for GIST, Advanced Systemic Mastocytosis (AdvSM), and indolent Systemic Mastocytosis. Recent Highlights On March 16, 2026, the FDA accepted another NDA for Bezuclastinib in patients with Non-Advanced Systemic Mastocytosis (Non-AdvSM) and assigned a Prescription Drug User Fee Act of December 30, 2026. This NDA was submitted based on results from a pivotal SUMMIT trial in December 2025. Wedbush Analyst Rating On March 1, 2026, Wedbush Analyst David Nierengarten reiterated an OUTPERFORM rating for Cogent and maintained its price target at $55. Upcoming Milestones for Cogent Cogent plans to present full results from the PEAK trial at a major medical meeting during the first half of 2026. Another NDA submission for Bezuclastinib in Advanced Systemic Mastocytosis (AdvSM) is also planned for the first half of 2026. In addition, Cogent said it is on track this quarter to initiate a Phase 2 trial evaluating the benefit of the Bezuclastinib plus sunitinib combination in first-line GIST patients with exon 9 mutations who are naive to, or have recently initiated treatment with, imatinib. As of December 30, 2025, Cogent had cash, cash equivalents and marketable securities of $900.8 million, expected to be sufficient to fund operations into 2028. "We believe the Bezuclastinib combination has the potential to meaningfully change the treatment landscape ", said Andrew Robbins, President and Chief Executive Officer. COGT has traded between $3.72 and $43.73. The stock closed Wednesday's trade at $35.24, down 8.47%. In the after-hours market, COGT is up 1.48%, $35.76.
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