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| Cogent Biosciences, Inc.: Cogent Biosciences Announces Breakthrough Therapy Designation for Bezuclastinib in Combination with Sunitinib for Patients with Gastrointestinal Stromal Tumors (GIST) | - Cogent will submit the PEAK New Drug Application (NDA) under previously announced RTOR designation; on track to complete NDA submission in April 2026 WALTHAM, Mass. and BOULDER, Colo., Jan. 26... ► Artikel lesen |
| Cogent Biosciences, Inc.: Cogent Biosciences Announces Anticipated 2026 Commercial and Clinical Milestones for Bezuclastinib and Precision Therapies Portfolio | New Drug Application (NDA) for NonAdvSM submitted in December 2025, NDA submission for AdvSM on track for 1H 2026NDA submission for GIST on track for April 2026; bezuclastinib has the potential to... ► Artikel lesen |
| Cogent Biosciences, Inc.: Cogent Biosciences Announces Submission of New Drug Application for Bezuclastinib in NonAdvanced Systemic Mastocytosis | WALTHAM, Mass. and BOULDER, Colo., Dec. 30, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined... ► Artikel lesen |
| Mineralys Therapeutics, Inc.: Mineralys Therapeutics' Phase 3 Launch-HTN Trial of Lorundrostat Recognized in Inaugural Journal of the American Medical Association (JAMA) "Research of the Year" Roundup | - Launch-HTN, the largest trial of an aldosterone synthase inhibitor conducted among participants with uncontrolled or treatment-resistant hypertension, was one of nine studies selected as most impactful... ► Artikel lesen |
| Mineralys Therapeutics, Inc.: Mineralys Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update | - Submission of New Drug Application (NDA) for lorundrostat planned for late-2025/Q1 2026 - - Completed enrollment in Explore-OSA trial; topline results anticipated in Q1 2026 - - Conference call... ► Artikel lesen |
| CG Oncology Inc.: CG Oncology Provides Updated Timeline for PIVOT-006 Phase 3 Topline Data in Intermediate-Risk NMIBC | - PIVOT-006 Phase 3 topline data evaluating cretostimogene monotherapy for intermediate-risk NMIBC now expected in 1H 2026, nearly one year ahead of schedule - First randomized registrational trial... ► Artikel lesen |
| CG Oncology Inc.: CG Oncology Reports Third Quarter 2025 Financial Results and Provides Business Updates | Initiated rolling Biologics License Application (BLA) submission to U.S. FDA for cretostimogene monotherapy in high-risk (HR) BCG-unresponsive non-muscle invasive bladder cancer (NMIBC)Demonstrated... ► Artikel lesen |
| CG Oncology Inc.: CG Oncology Completes Enrollment in PIVOT-006 | - Rapid enrollment underscores high unmet need in intermediate-risk non-muscle invasive bladder cancer (NMIBC) -- One of the largest randomized phase 3 studies in this patient population will encompass... ► Artikel lesen |
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