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, Inc. (Nasdaq: COGT) generates frequent news flow as a biotechnology company developing precision therapies for genetically defined diseases. Its updates often center on the clinical and regulatory progress of bezuclastinib, a selective tyrosine kinase inhibitor designed to inhibit KIT D816V and other KIT exon 17 mutations associated with systemic mastocytosis and advanced gastrointestinal stromal tumors (GIST).
News for COGT commonly includes clinical trial milestones from the pivotal SUMMIT, APEX and PEAK studies. SUMMIT evaluates bezuclastinib in NonAdvanced Systemic Mastocytosis (NonAdvSM), APEX in Advanced Systemic Mastocytosis (AdvSM), and PEAK in imatinib-resistant or intolerant GIST in combination with sunitinib. Press releases have highlighted positive top-line results, detailed efficacy and safety data, and plans for New Drug Application (NDA) submissions to the U.S. Food and Drug Administration.
Investors and followers of COGT can also expect regulatory and designation announcements, such as Breakthrough Therapy Designation for bezuclastinib in specific NonAdvSM populations, as well as updates on Expanded Access Programs for eligible GIST and SM patients. Financial and corporate news appears regularly, including equity and convertible note offerings, cash runway commentary, and participation in major healthcare investor conferences like the J.P. Morgan Healthcare Conference and the Jefferies Global Healthcare Conference.
In addition, Cogent issues news on its early-stage pipeline, including a selective and potent FGFR2/3 inhibitor in Phase 1/2 and discovery programs targeting ErbB2, PI3Kα, KRAS and JAK2. For readers tracking COGT, this news page provides an organized view of trial readouts, regulatory plans, financing events and scientific presentations that shape the company’s development trajectory. Bookmark this feed to monitor Cogent’s ongoing disclosures about its precision oncology and hematology programs.
Cogent Biosciences (Nasdaq: COGT) announced that the FDA granted Breakthrough Therapy Designation for bezuclastinib combined with sunitinib for patients with GIST after prior imatinib. The designation is based on PEAK trial results showing a 50% reduction in risk of progression or death (HR 0.50, 95% CI 0.39–0.65) and mPFS of 16.5 months vs. 9.2 months for sunitinib alone. The combination showed no new safety risks versus known sunitinib profile. Cogent is on track to complete its PEAK NDA submission under RTOR in April 2026, plans a PEAK full-data presentation in H1 2026, and expects a mid-2026 Phase 2 trial for first-line exon 9 GIST patients.
Cogent Biosciences (Nasdaq: COGT) announced FDA agreement to accept its NDA for bezuclastinib + sunitinib for imatinib‑resistant GIST under the Real‑Time Oncology Review (RTOR) program. The Phase 3 PEAK trial showed a 50% reduction in risk of progression or death (HR 0.50, 95% CI 0.39–0.65), mPFS 16.5 months vs 9.2 months, and ORR 46% vs 26% versus sunitinib. Cogent will initiate RTOR immediately and expects to complete the NDA submission in April 2026. Full PEAK results will be presented in H1 2026 and a Phase 2 first‑line exon 9 trial is planned for mid‑2026.
Cogent Biosciences (NASDAQ: COGT) outlined key 2026 commercial and clinical milestones for bezuclastinib and its precision therapies pipeline.
Planned regulatory and clinical milestones include NDA acceptance for NonAdvSM by end-February 2026, an NDA submission for GIST in April 2026, an NDA submission for AdvSM in 1H 2026, and presentations of pivotal trial data (SUMMIT, PEAK, APEX) at major medical meetings in 1H 2026. The company targets a commercial launch of bezuclastinib in 2H 2026 if approved. Pipeline actions include IND submissions in 2026 for a pan-KRAS(ON) inhibitor and a selective JAK2 V617F inhibitor. Cogent reported a cash balance of ~ $900 million entering 2026 and noted active expanded access programs and a new SVP, Sales hire.
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.
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