Cogent Biosciences Announces Q3 Net Loss of $80.9 Million, Up from $70.6 Million Last Year
Third Quarter Progress: Cogent has had a productive third quarter, preparing to report results from the Phase 3 PEAK trial for bezuclastinib in Gastrointestinal Stromal Tumor patients and the APEX trial in Advanced Systemic Mastocytosis patients.
ASH 2025 Presentations: The company will present three bezuclastinib studies at ASH 2025, including two oral presentations on the SUMMIT trial results for NonAdvanced Systemic Mastocytosis patients.
Research Pipeline Updates: Cogent has shared updated preclinical data showcasing the potential of its pan-KRAS inhibitor and plans to introduce a selective JAK2 V617F mutant inhibitor at ASH 2025, with both programs on track for IND in 2026.
Financial Discipline and NDA Filing: The company emphasizes its financial discipline and business execution as it approaches pivotal data readouts and prepares for its first NDA filing for NonAdvSM later this year.
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Pfizer Shares Rise on Upgraded Price Forecast
- Forecast Upgrade: Cantor Fitzgerald raised Pfizer's price forecast from $24 to $27, providing a positive catalyst for the pharmaceutical giant despite a 1.6% decline in the broader healthcare sector.
- Licensing Agreement: Pfizer entered a non-exclusive licensing agreement with Novavax for its Matrix-M adjuvant technology, granting Novavax a $30 million upfront payment and potential milestones up to $500 million, indicating Pfizer's proactive approach in product development.
- FDA Breakthrough Therapy: Pfizer's Sutent, in combination with Cogent Biosciences' bezuclastinib, received FDA Breakthrough Therapy Designation after showing a 50% reduction in disease progression risk, enhancing Pfizer's competitive edge in oncology treatments.
- Leadership Warning: At the World Economic Forum, CEO Albert Bourla warned that reduced funding for U.S. universities has weakened America's position in global health research, highlighting China's dominance in health research rankings.

Cogent Biosciences Receives FDA Breakthrough Therapy Designation
- Breakthrough Therapy Designation: The FDA granted Cogent Biosciences Breakthrough Therapy Designation for bezuclastinib in combination with sunitinib for Gastrointestinal Stromal Tumors, marking a significant advancement in cancer treatment.
- Clinical Trial Results: The PEAK trial demonstrated a median progression-free survival of 16.5 months for the bezuclastinib combination compared to 9.2 months for sunitinib monotherapy, reducing the risk of disease progression or death by 50%, indicating substantial clinical benefits.
- NDA Progress: The FDA agreed to accept Cogent's New Drug Application for the bezuclastinib and sunitinib combination under the Real-Time Oncology Review program, with submission completion expected in April 2026, accelerating the drug's path to market.
- Future Trial Plans: Cogent plans to initiate a Phase 2 trial for first-line GIST patients in mid-2026, showcasing the company's ongoing investment in cancer treatment research and market expansion potential.






