Welcome to our dedicated page for Cogent Biosciences news (Ticker: COGT), a resource for investors and traders seeking the latest updates and insights on Cogent Biosciences stock.
Cogent Biosciences develops precision therapies for genetically defined diseases, with recurring updates centered on bezuclastinib and KIT-driven disorders including Systemic Mastocytosis and Gastrointestinal Stromal Tumors (GIST). News commonly covers bezuclastinib clinical data from the SUMMIT and PEAK programs, U.S. FDA New Drug Application activity, medical-meeting presentations and related business updates.
Company announcements also describe preclinical oncology programs such as CGT1263, a KRAS inhibitor candidate, and CGT4255, a brain-penetrant ErbB2/HER2 inhibitor candidate. Financial-result releases and capital updates address cash resources, at-the-market equity activity and Nasdaq inducement equity awards.
Cogent Biosciences (Nasdaq: COGT) announced that Andrew Robbins, President and CEO, will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on January 13, 2026 at 8:15 a.m. PT / 11:15 a.m. ET.
A live webcast will be available on the company’s Investors & Media page at investors.cogentbio.com, with a replay posted approximately two hours after the event and archived for up to 30 days.
Cogent Biosciences (Nasdaq: COGT) submitted a New Drug Application (NDA) to the FDA on Dec. 30, 2025 for bezuclastinib in NonAdvanced Systemic Mastocytosis based on positive SUMMIT pivotal-trial data.
The filing follows an FDA Breakthrough Therapy designation (Oct 2025) and 48-week SUMMIT results showing statistical significance across all primary and key secondary endpoints, symptom improvements across 11 reported domains, correlated reductions in serum tryptase, and a favorable safety/tolerability profile. Cogent plans two additional NDA submissions for bezuclastinib in GIST and Advanced SM in the first half of 2026 based on PEAK and APEX trial data.
Cogent Biosciences (NASDAQ: COGT) reported positive top-line results from the APEX Part 2 trial of bezuclastinib in advanced systemic mastocytosis (AdvSM) on Dec 8, 2025. Key outcomes: 57% ORR per mIWG criteria and 80% ORR per PPR; 89% of patients achieved ≥50% reductions in bone marrow mast cells and in serum tryptase; 91% achieved ≥50% reduction in KIT D816V VAF (n=43). Median time to response was 2.0 months; median duration of response is not yet mature. Safety: no discontinuations due to treatment-related adverse events and 14.8% required dose reductions. Cogent expects an NDA submission in 1H 2026 and will present detailed data in 1H 2026.
Cogent Biosciences (NASDAQ: COGT) reported full Part 2 SUMMIT results for bezuclastinib in nonadvanced systemic mastocytosis (NonAdvSM) presented at ASH on December 6, 2025. Data show clinically meaningful, statistically significant symptomatic and objective improvements at 24 weeks with continued deepening at 48 weeks.
Key facts: 65.4% achieved ≥30% TSS reduction at 24 weeks, 87.4% had ≥50% serum tryptase reduction at week 24, and 48-week follow-up showed 56.4% achieving ≥50% TSS reduction. Breakthrough Therapy designation was granted in October 2025 and an NDA is on track for December 2025 submission.
Cogent Biosciences (Nasdaq: COGT) will participate in the Jefferies Global Healthcare Conference in London on Wednesday, November 19, 2025 at 11:30 a.m. GMT (6:30 a.m. ET).
A live webcast will be available on Cogent’s Investors & Media page at investors.cogentbio.com, with a replay posted approximately two hours after the event and archived for up to 30 days.
Cogent Biosciences (Nasdaq: COGT) priced concurrent offerings: an Equity Offering of 9,677,420 shares at $31.00 per share (upsized from $200.0M) and a $200.0 million aggregate principal amount of 1.625% convertible senior notes due 2031. Cogent estimates combined net proceeds of approximately $475.3 million. The Equity Offering is expected to close on November 13, 2025 and the Convertible Notes Offering on November 18, 2025, each subject to customary closing conditions.
The convertible notes carry an initial conversion rate of 22.2469 shares per $1,000 principal (approx. $44.95 conversion price, ~45.0% premium to the offering price). Cogent intends to use proceeds to repay $50 million of term loans and fund development, anticipated commercial launch of bezuclastinib, working capital and general corporate purposes.
Cogent Biosciences (Nasdaq: COGT) announced concurrent underwritten public offerings: $200 million aggregate principal amount of convertible senior notes due 2031 and $200 million of common stock, each with a 30‑day option to purchase up to an additional $30 million.
Proceeds are intended to repay $50 million of term loans and fund development, regulatory activities, the anticipated commercial launch of bezuclastinib, working capital and general corporate purposes. Offerings are subject to market conditions and final terms will be set at pricing.
Cogent Biosciences (Nasdaq: COGT) reported positive Phase 3 PEAK results for bezuclastinib + sunitinib in imatinib-resistant or intolerant GIST on Nov 10, 2025. The combination achieved mPFS 16.5 months vs 9.2 months for sunitinib (HR=0.50; 95% CI: 0.39–0.65; p<0.0001) and ORR 46% vs 26% (p<0.0001). Safety was generally tolerable; no new combination-specific risks identified. Cogent plans an NDA submission in 1H 2026, will present full PEAK data at a scientific conference in 1H 2026, and is hosting an investor webcast Nov 10, 2025 at 8:00 a.m. ET.
Cogent Biosciences (Nasdaq: COGT) reported Q3 2025 business highlights and financials ahead of near-term pivotal readouts and regulatory milestones. Key items include Breakthrough Therapy Designation for bezuclastinib, positive SUMMIT top-line results in NonAdvSM with statistical significance on primary and key secondary endpoints, and an NDA filing for NonAdvSM on track for year-end 2025. The company expects top-line PEAK results in November 2025 and APEX results in December 2025, and will present multiple abstracts at ASH 2025.
Financials: cash, cash equivalents and marketable securities were $390.9M as of September 30, 2025; pro forma cash position of $430M is expected to fund operations into 2027. Q3 R&D was $69.0M; net loss was $80.9M. Recent financing included a $215.8M upsized offering and $39M via ATM.
Cogent Biosciences (Nasdaq: COGT) announced three ASH 2025 presentations highlighting bezuclastinib and a preclinical JAK2 V617F mutant-selective inhibitor.
Key items: two oral presentations from the pivotal SUMMIT trial in Non-Advanced Systemic Mastocytosis (Dec 6 and Dec 8, 2025), a poster on bezuclastinib disease-burden effects (Dec 8, 2025), and a poster describing a novel JAK2 V617F mutant-selective inhibitor with the program stated to be on-track for an IND in 2026.