New Drug Application (NDA) for NonAdvSM submitted in December 2025, NDA submission for AdvSM on track for 1H 2026NDA submission for GIST on track for April 2026; bezuclastinib has the potential to be the first new therapy for second-line GIST in over 20 yearsClinical data presentations from all three pivotal trials, PEAK, SUMMIT and APEX, expected at major medical meetings in 1H 2026Investigational New Drug (IND) applications expected in 2026 for potentially best-in-class pan-KRAS(ON) and selective JAK2 V61 ...

New Drug Application (NDA) for NonAdvSM submitted in December 2025, NDA submission for AdvSM on track for 1H 2026NDA submission for GIST on track for April 2026; bezuclastinib has the potential to be the first new therapy for second-line GIST in over 20 yearsClinical data presentations from all three pivotal trials, PEAK, SUMMIT and APEX, expected at major medical meetings in 1H 2026Investigational New Drug (IND) applications expected in 2026 for potentially best-in-class pan-KRAS(ON) and selective JAK2 V61 ...

Company Overview - Cogent Biosciences specializes in precision therapies for genetically defined diseases, focusing on targeted kinase inhibition and rare mutations [6] - The company's lead product candidate is CGT9486, a selective tyrosine kinase inhibitor targeting KIT D816V and other KIT exon 17 mutations, aimed at treating systemic mastocytosis and advanced gastrointestinal stromal tumors [7] - Cogent operates a precision medicine model with revenue potential linked to successful drug development and commercialization, including licensing agreements [7][8] Transaction Summary - Evan Kearns, the chief legal officer, sold 65,000 shares for a transaction value of $2.52 million, reducing his direct ownership by 37.27% [1][2][10] - Post-transaction, Kearns holds 109,398 shares valued at approximately $4.25 million based on the market close price of $38.70 [2][4][10] - This sale is Kearns's only open-market transaction on record and did not involve any derivatives or indirect interests [10] Market Context - As of December 26, the stock price was $38.70, reflecting a one-year price change of 345.38% [4][9] - The stock's surge followed a public offering announcement in November, which strengthened the balance sheet and reset expectations around clinical milestones [9][11] - The company submitted its first NDA for bezuclastinib in non-advanced systemic mastocytosis, with additional filings planned for 2026 [9]

WALTHAM, Mass. and BOULDER, Colo., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced that Andrew Robbins, President and Chief Executive Officer, will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on Tuesday, January 13, 2026 at 8:15 a.m. PT/11:15 a.m. ET. A live webcast will be available on the Investors & Media page of Cogent’s website ...

WALTHAM, Mass. and BOULDER, Colo., Dec. 30, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced it has submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in NonAdvanced Systemic Mastocytosis (NonAdvSM). The submission is based on positive clinical data from the SUMMIT pivotal trial and follows the Breakthrough Therapy Designa ...

Group 1: Company Overview - Cogent Biosciences Inc. (NASDAQ:COGT) is recognized as a promising emerging technology stock, particularly in the biotechnology sector [1] - The company focuses on developing precision therapies for genetically defined diseases [4] Group 2: Recent Developments - On December 19, JPMorgan raised the price target for Cogent Biosciences to $67 from $65, maintaining an Overweight rating [1] - On December 8, Cogent Biosciences announced positive top-line results from the APEX Part 2 clinical trial for bezuclastinib, a selective KIT D816V inhibitor, showing an Objective Response Rate (ORR) of 57% based on modified IWG/mIWG criteria and 80% based on Pure Pathological Response criteria [2][3] - The APEX trial involved 81 patients with advanced systemic mastocytosis, with 68 evaluable patients contributing to the primary efficacy analysis [2] Group 3: Safety and Efficacy - Bezuclastinib was well-tolerated, with no patients discontinuing due to treatment-related adverse events; common side effects included hair color change (30.9%), neutropenia (29.6%), and altered taste (28.4%) [3] - Dose reductions were infrequent, occurring in only 14.8% of participants, highlighting the drug's favorable safety profile [3] Group 4: Future Plans - This announcement marks the third successful pivotal trial for bezuclastinib, following previous trials in 2025 [4] - Cogent Biosciences plans to submit a New Drug Application (NDA) to the FDA in the first half of 2026, with multiple commercial launches anticipated in the second half of that year [4] - Detailed data from the APEX trial is expected to be presented at a major medical conference in early 2026 [4]

Core Viewpoint - The Russell 2000 index is positioned to potentially be the second-best-performing index in the U.S. stock exchanges as 2025 approaches, driven by a significant shift towards small-cap stocks due to the Federal Reserve's easing cycle [1]. Interest Rate Impact - The Federal Reserve has reduced the benchmark federal funds rate by 25 basis points, bringing it to a range of 3.5-3.75%, down from a high of 5.25-5.5% in 2023 during a tightening cycle aimed at controlling post-pandemic inflation [2]. Small Business Financing - Lower interest rates are favorable for small businesses, particularly as the period from mid-December to early March is historically strong for the Russell 2000 due to tax-loss harvesting and increased investor risk appetite at the start of the new year [3]. Top Performers in Russell 2000 - **Celcuity (CELC)**: - Stock Price: $100 - YTD Return: +695% - Market Cap: $4.71 billion - The company focuses on cellular analysis and precision oncology, experiencing significant stock price increases due to breakthrough clinical trials [5][6]. - **Better Home & Finance (BETR)**: - Stock Price: $48 - YTD Return: +442% - Market Cap: $794.72 million - Operates as an AI-powered mortgage lender and fintech company, with projected annual sales growth of over 50% this year and 67% next year [9][12]. - **Cogent Biosciences (COGT)**: - Stock Price: $40 - YTD Return: +413% - Market Cap: $5.58 billion - Focused on precision therapies for genetically defined diseases, with strong clinical progress on its lead drug, bezuclastinib [13][14]. Earnings Projections - Celcuity is expected to report a loss of -$3.86 per share in FY25 and -$4.05 in FY26, despite positive EPS revisions [8]. - Better Home's EPS revisions for FY25 and FY26 have slightly decreased, indicating potential short-term momentum loss [12]. - Cogent is projected to have a narrower adjusted loss of -$1.77 per share in FY26, with modestly higher EPS revisions in the last 60 days [14]. Investment Considerations - The strong performance of the Russell 2000 suggests that these top-performing stocks may be worth monitoring, although better buying opportunities may arise in the future [16].

PresentationGood morning, and welcome to the Cogent Biosciences webcast. I will now turn the call over to Christi Waarich, Senior Director of Investor Relations.Christi WaarichSenior Director of Investor Relations Thank you, operator. Today's call will cover our SM updates announced over the weekend and this morning. You can find the press releases in the Investors and Media section of our website at cogentbio.com. Before we get started, please be reminded that remarks made during this webcast may be forwa ...

Cogent Biosciences (NasdaqGS:COGT) Update Summary Company Overview - **Company**: Cogent Biosciences - **Product**: Bezuclastinib - **Focus**: Treatment of systemic mastocytosis (SM) and gastrointestinal stromal tumors (GIST) Key Industry Insights - **Market Potential**: Bezuclastinib has a global annual market potential exceeding $7.5 billion across three patient populations [4] - **Regulatory Submissions**: Plans to submit three New Drug Applications (NDAs) within the next several months, aiming for product launches by the end of 2026 [5][31] Core Findings from Clinical Trials SUMMIT Trial - **Patient Population**: Included non-advanced systemic mastocytosis patients, specifically those with indolent smoldering and bone marrow mastocytosis subtypes [5] - **Primary Endpoint**: Achieved a statistically significant mean change in total symptom score at week 24, with a reduction of approximately nine points in the bezuclastinib group compared to placebo (p-value < 0.001) [9] - **Secondary Endpoints**: Significant reductions in various markers of mast cell disease, with 95.4% of patients showing at least a 50% reduction in serum tryptase [12] - **Symptom Improvement**: 86% of patients reported clinically meaningful symptom improvement by week 48, with 56% achieving over a 50% improvement [23] APEX Trial - **Patient Demographics**: Enrolled patients with advanced systemic mastocytosis, including a higher proportion of aggressive cases and those with prior avapritinib treatment [25] - **Response Rates**: Achieved a 57% overall response rate (ORR) on the primary endpoint and an 80% ORR on the key secondary endpoint of pure pathological response [26][29] - **Safety Profile**: No patients discontinued treatment due to adverse events, with only 14.8% requiring dose reductions [28] Comparative Analysis with Competitors - **Differentiation from Avapritinib**: Bezuclastinib demonstrated broader and deeper symptom improvement across multiple domains compared to avapritinib, which showed a plateau in efficacy after 28 weeks [22][56] - **Patient Selection**: Bezuclastinib is considered suitable for a wider range of patients, including those with prior avapritinib exposure, showing consistent response rates [84] Additional Insights - **Correlation of Biomarkers and Symptoms**: The study found a significant correlation between reductions in mast cell disease markers and symptom severity, suggesting that monitoring these biomarkers could guide therapy decisions [16][64] - **Quality of Life Impact**: Improvements in symptom scores are expected to enhance patients' quality of life, as evidenced by the broad symptom relief reported [36] Future Directions - **NDA Submissions**: Anticipated submission of NDAs for both non-advanced and advanced systemic mastocytosis in December 2025 [50] - **Long-term Follow-up**: Ongoing studies will provide further insights into the long-term efficacy and safety of bezuclastinib, with data expected to support its position as a preferred treatment option [21][29] This summary encapsulates the key points from the Cogent Biosciences update, highlighting the promising results of bezuclastinib in treating systemic mastocytosis and its potential market impact.

Core Insights - Cogent Biosciences announced positive top-line results from the APEX Part 2 clinical trial of bezuclastinib for advanced systemic mastocytosis (AdvSM), marking the third positive pivotal trial result for the drug in 2025 [1][2] - The company plans to submit a new drug application (NDA) to the FDA for bezuclastinib in AdvSM in the first half of 2026 and will present detailed data from the APEX trial at a scientific meeting during the same period [1][7] Clinical Trial Results - In the APEX Part 2 trial, 81 AdvSM patients were treated with 150 mg of bezuclastinib, with 68 patients evaluable for the primary endpoint [2][5] - The trial showed a 57% objective response rate (ORR) per mIWG criteria and an 80% ORR per pure pathological response (PPR) criteria [4][5] - Significant clinical activity was observed, with 89% of patients achieving a ≥50% reduction in serum tryptase and bone marrow mast cells, and 91% showing a ≥50% reduction in KIT D816V variant allele frequency [3][4] Safety and Tolerability - Bezuclastinib demonstrated a favorable safety profile, with only 14.8% of patients requiring dose reduction and no discontinuations due to treatment-related adverse events [6][4] - The most common treatment-related adverse events included hair color change (30.9%), neutropenia (29.6%), and altered taste (28.4%) [6] Future Plans - Cogent is preparing for multiple commercial launches in the second half of 2026 based on the positive results from the APEX trial and previous trials [2][11] - The company will host a live webcast to discuss the full data from the SUMMIT trial and the APEX results [8]