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) is a clinical-stage biotechnology company pioneering precision therapies for patients with genetically defined diseases. This dedicated news hub provides investors and researchers with essential updates on the company's innovative programs targeting systemic mastocytosis, GIST, and other mutation-driven conditions.
Access real-time information about bezuclastinib clinical trials, including the SUMMIT (NonAdvSM), APEX (AdvSM), and PEAK (GIST) studies. Stay informed on pipeline developments across Cogent's portfolio of selective kinase inhibitors, from FGFR2-targeted therapies to novel KRAS(ON) inhibitors in preclinical testing.
Our curated news collection features official press releases, regulatory filings, and scientific presentation updates. Key content categories include clinical trial milestones, research collaborations, and therapeutic development progress – all critical for understanding Cogent's position in the precision medicine landscape.
Bookmark this page for streamlined access to verified COGT updates. Investors can monitor the company's advancement of potentially transformative therapies while researchers track developments in mutation-specific treatment approaches.
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.
Cogent Biosciences (Nasdaq: COGT) presented updated preclinical data for its pan KRAS(ON) program at the 2025 AACR-NCI-EORTC conference on Oct 24, 2025. The poster describes CGT1263, a KRAS inhibitor with reported picomolar activity across KRAS mutant cell lines and selectivity over HRAS and NRAS. The company also detailed CGT1815, a prodrug designed to optimize human pharmacokinetics with supporting multi‑species PK data. Cogent says CGT1815 showed superior tumor growth inhibition versus RMC-6236 in KRASG12D and KRASG12V preclinical models, and the company aims to file an IND in 2026.
Cogent Biosciences (Nasdaq: COGT) announced the FDA granted Breakthrough Therapy Designation for bezuclastinib in NonAdvanced Systemic Mastocytosis (NonAdvSM) previously treated with avapritinib and in Smoldering Systemic Mastocytosis.
The designation is based on positive SUMMIT results showing statistical significance across all primary and key secondary endpoints; top-line SUMMIT data were reported in July 2025 and additional data will be presented at a scientific conference. Cogent completed a pre-NDA meeting and plans an NDA submission by year-end 2025, with Breakthrough benefits including Priority Review eligibility and rolling submissions.
Cogent also plans top-line reads for the Phase 3 PEAK trial in GIST in November 2025 and for the APEX trial in AdvSM in December 2025.
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