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Cogent Biosciences Highlights Additional Data with Six Bezuclastinib Posters from SUMMIT Trial at 2026 AAAAI Annual Meeting Cogent Biosciences (Nasdaq: COGT) reported additional SUMMIT trial data for bezuclastinib in NonAdvanced systemic mastocytosis showing durable, deepening benefit through 48 weeks. Key results: mean Total Symptom Score (TSS) change of -32.0 (56% improvement), 99% achieved ≥50% serum tryptase reduction and 83.3% normalization, and clinically meaningful BMD gains at week 24.The company also disclosed inducement equity grants totaling 24,000 stock options and 21,000 RSUs dated Feb 25, 2026.

#COGT Cogent Biosciences Highlights Additional Data with Six Bezuclastinib Posters from SUMMIT Trial at 2026 AAAAI Annual Meeting

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Cogent Biosciences Announces Breakthrough Therapy Designation for Bezuclastinib in Combination with Sunitinib for Patients with Gastrointestinal Stromal Tumors (GIST) 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.

#COGT Cogent Biosciences Announces Breakthrough Therapy Designation for Bezuclastinib in Combination with Sunitinib for Patients with Gastrointestinal Stromal Tumors (GIST)

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Cogent Biosciences to Initiate New Drug Application (NDA) Submission for Bezuclastinib Under Real-Time Oncology Review (RTOR)  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.

#COGT Cogent Biosciences to Initiate New Drug Application (NDA) Submission for Bezuclastinib Under Real-Time Oncology Review (RTOR) 

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Cogent Biosciences Announces Anticipated 2026 Commercial and Clinical Milestones for Bezuclastinib and Precision Therapies Portfolio 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.

#COGT Cogent Biosciences Announces Anticipated 2026 Commercial and Clinical Milestones for Bezuclastinib and Precision Therapies Portfolio

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Cogent Biosciences Submits New Drug Application for Bezuclastinib in NonAdvanced Systemic Mastocytosis Cogent Biosciences, Inc. (Nasdaq: COGT) announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclas

Cogent Biosciences #COGT Submits New Drug Application for Bezuclastinib in NonAdvanced Systemic Mastocytosis
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Cogent Biosciences Announces Submission of New Drug Application for Bezuclastinib in NonAdvanced Systemic Mastocytosis 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.

#COGT Cogent Biosciences Announces Submission of New Drug Application for Bezuclastinib in NonAdvanced Systemic Mastocytosis

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Cogent Biosciences Announces Positive Top-line Results of APEX Trial of Bezuclastinib in Patients with Advanced Systemic Mastocytosis (AdvSM) 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.

#COGT Cogent Biosciences Announces Positive Top-line Results of APEX Trial of Bezuclastinib in Patients with Advanced Systemic Mastocytosis (AdvSM)

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Cogent Biosciences Announces Pricing of Concurrent Public Offerings of Common Stock and 1.625% Convertible Senior Notes Due 2031 Cogent Biosciences, Inc. (“Cogent”) (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced the pricing of its previously announced underwritten public

#COGT Cogent Biosciences Announces Pricing of Concurrent Public Offerings of Common Stock and 1.625% Convertible Senior Notes Due 2031

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Cogent Biosciences Announces Proposed Concurrent Public Offerings of Convertible Senior Notes Due 2031 and Common Stock 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.

#COGT Cogent Biosciences Announces Proposed Concurrent Public Offerings of Convertible Senior Notes Due 2031 and Common Stock

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Cogent Biosciences Reports Positive Results from Bezuclastinib PEAK Phase 3 Trial in Gastrointestinal Stromal Tumors (GIST) 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.

#COGT Cogent Biosciences Reports Positive Results from Bezuclastinib PEAK Phase 3 Trial in Gastrointestinal Stromal Tumors (GIST)

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Cogent Biosciences Reports Recent Business Highlights and Third Quarter 2025 Financial Results  Phase 3 PEAK results in 2 nd -line GIST patients expected in November; pivotal APEX results in AdvSM patients expected in December Breakthrough Therapy Designation granted for bezuclastinib; New Drug Application (NDA) filing for NonAdvSM remains on track for year-end 2025 Multiple bezuclastinib

#COGT Cogent Biosciences Reports Recent Business Highlights and Third Quarter 2025 Financial Results 

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Cogent Biosciences Announces Multiple Presentations at the 67th Annual American Society of Hematology (ASH) Meeting 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.

#COGT Cogent Biosciences Announces Multiple Presentations at the 67th Annual American Society of Hematology (ASH) Meeting

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Cogent Biosciences Announces KRAS Poster Presentation at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics 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.

#COGT Cogent Biosciences Announces KRAS Poster Presentation at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

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Cogent Biosciences Announces FDA Breakthrough Therapy Designation for Bezuclastinib 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.

#COGT Cogent Biosciences Announces FDA Breakthrough Therapy Designation for Bezuclastinib

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Precision Medicine Biotech Cogent Biosciences to Present Latest Developments at Major Biopharma Conference Cogent Biosciences to participate in Citi Biopharma Conference on Sept 3. Company also grants 54.5K stock options to new employees under inducement plan with 4-year vesting schedule.

#COGT Cogent Biosciences Announces Participation in the Citi Biopharma Conference

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Cogent Biosciences Reports Recent Business Highlights and Second Quarter 2025 Financial Results Cogent Biosciences (NASDAQ: COGT) reported significant achievements in Q2 2025, highlighted by positive top-line results from the SUMMIT trial evaluating bezuclastinib in NonAdvanced Systemic Mastocytosis. The trial met its primary endpoint with a statistically significant improvement in Total Symptom Score (24.3-point reduction vs. 15.4 points for placebo, p=0.0002).The company strengthened its financial position through two major transactions: a $400 million debt facility with SLR Capital Partners and an upsized $230 million public offering. With $453 million in pro-forma cash, Cogent is funded through anticipated launch and into 2027. Q2 2025 resulted in a net loss of $73.5 million, with R&D expenses of $62.2 million.Key upcoming catalysts include pivotal trial results from PEAK (GIST) and APEX (AdvSM) trials in 2H 2025, followed by the company's first NDA submission by year-end.

#COGT Cogent Biosciences Reports Recent Business Highlights and Second Quarter 2025 Financial Results

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Cogent Biosciences Announces Pricing of Upsized Public Offering of Shares of Common Stock Cogent Biosciences (NASDAQ: COGT) has announced the pricing of its upsized public offering of 22,222,223 shares of common stock at $9.00 per share, expecting to raise approximately $200 million in gross proceeds.The offering includes a 30-day option for underwriters to purchase up to an additional 3,333,333 shares under the same terms. The company plans to use the proceeds for bezuclastinib development, regulatory and commercial preparation activities, and general corporate purposes. The offering is expected to close around July 10, 2025.J.P. Morgan, Leerink Partners, and Guggenheim Securities are serving as joint book-running managers, with LifeSci Capital acting as lead manager for the offering.

#COGT Cogent Biosciences Announces Pricing of Upsized Public Offering of Shares of Common Stock

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Cogent Biosciences Announces Proposed $150 Million Public Offering of Common Stock Cogent Biosciences (NASDAQ: COGT), a biotechnology company specializing in precision therapies, has announced a proposed $150 million public offering of common stock. The company will also grant underwriters a 30-day option to purchase up to an additional $22.5 million of shares.The proceeds will fund the development and commercial preparation of bezuclastinib and other product candidates, support bezuclastinib's planned commercial launch, and provide working capital. J.P. Morgan, Leerink Partners, and Guggenheim Securities are serving as joint book-running managers, with LifeSci Capital as lead manager.

#COGT Cogent Biosciences Announces Proposed $150 Million Public Offering of Common Stock

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Cogent Biosciences Lands Massive $400M Financing Deal as 3 Pivotal Trial Results Loom in 2025 Major financing backs bezuclastinib launch plans while three pivotal trial readouts approach. Initial $50M drawn with $350M available upon milestones. See growth strategy.

#COGT Cogent Biosciences Secures up to $400 Million in Non-Dilutive Financing

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