WALTHAM, Mass. and BOULDER, Colo., Aug. 26, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced its participation in a fireside chat at the Citi Biopharma Back to School Conference on Wednesday, September 3, 2025 at 9:00 a.m. ET. A live webcast will be available on the Investors & Media page of Cogent’s website at investors.cogentbio.com. A replay of the webcast will be available ...

Investment Rating - The report indicates a positive investment outlook for the hereditary angioedema (HAE) treatment sector, particularly following the approval of the first oral on-demand treatment, sebetralstat [14][21]. Core Insights - The report highlights the urgent need for effective HAE treatments due to the high risk of life-threatening episodes, with nearly half of HAE patients facing potential asphyxiation [10][16]. - Sebetralstat, approved by the FDA, is noted for its rapid onset of action, achieving near-complete inhibition of plasma kallikrein within 15 minutes of administration [21]. - The KONFIDENT trial results demonstrate that sebetralstat significantly reduces symptom relief time compared to placebo, with median relief times of 1.61 hours for the 300 mg dose and 1.79 hours for the 600 mg dose [20][21]. Summary by Sections Section 1: HAE Overview - HAE is characterized by recurrent episodes of angioedema without urticaria, with a prevalence of approximately 1.5 per 100,000 individuals [7]. - The disease can lead to severe complications, including laryngeal edema, which has a mortality rate of up to 40% among patients [7][10]. Section 2: Current Treatment Landscape - Existing treatments include long-term preventive therapies (LTP) and on-demand treatments for acute episodes [10][11]. - The global HAE drug market reached $2.9 billion in 2022, with $2 billion attributed to long-term prevention and $900 million to acute on-demand treatments [13]. Section 3: Sebetralstat Approval and Efficacy - Sebetralstat is the first oral on-demand treatment for HAE, approved on July 7, 2025, and is expected to address unmet needs in the treatment landscape [21]. - The KONFIDENT trial, involving 136 patients across 20 countries, confirmed the efficacy and safety of sebetralstat, showing significant improvements in symptom relief and severity reduction compared to placebo [21]. Section 4: Future Developments - Pharvaris is developing deucrictibant, a competitive oral antagonist for HAE, with promising Phase II trial results indicating effective management of HAE attacks [26]. - The report anticipates further advancements in HAE treatments, with ongoing clinical trials expected to yield additional data in the coming years [26].

Core Viewpoint - Cogent Biosciences, Inc. has successfully closed an upsized underwritten public offering of 25,555,556 shares of common stock at a price of $9.00 per share, raising approximately $230 million in gross proceeds [1][2]. Group 1: Offering Details - The offering included 3,333,333 shares from the underwriters' option to purchase additional shares [1] - The net proceeds will be utilized for the development and commercial preparation of bezuclastinib and other product candidates, as well as for working capital and general corporate purposes [2]. - J.P. Morgan, Leerink Partners, and Guggenheim Securities served as joint book-running managers for the offering [2]. Group 2: Company Overview - Cogent Biosciences focuses on developing precision therapies for genetically defined diseases, with its leading clinical program being bezuclastinib, a selective tyrosine kinase inhibitor targeting the KIT D816V mutation [6]. - The company is also conducting a Phase 1 study of a novel FGFR2 inhibitor and is developing therapies targeting mutations in ErbB2, PI3Kα, and KRAS [6].

Core Viewpoint - Cogent Biosciences, Inc. has announced a public offering of 22,222,223 shares of common stock at a price of $9.00 per share, aiming to raise approximately $200 million in gross proceeds before expenses [1][2]. Group 1: Offering Details - The offering includes a 30-day option for underwriters to purchase an additional 3,333,333 shares on the same terms [1]. - The expected closing date for the offering is around July 10, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for the development, regulatory, and commercial preparation activities related to bezuclastinib and other product candidates [2]. - Funds will also support the planned commercial launch of bezuclastinib, along with working capital and general corporate purposes [2]. Group 3: Company Overview - Cogent Biosciences focuses on developing precision therapies for genetically defined diseases, with bezuclastinib being the most advanced clinical program [5]. - Bezuclastinib is a selective tyrosine kinase inhibitor targeting the KIT D816V mutation, which is associated with systemic mastocytosis and advanced gastrointestinal stromal tumors [5]. - The company is also conducting a Phase 1 study of a novel FGFR2 inhibitor and developing therapies targeting mutations in ErbB2, PI3Kα, and KRAS [5].

Core Viewpoint - Cogent Biosciences, Inc. has initiated an underwritten public offering of $150 million in common stock, with an additional option for underwriters to purchase up to $22.5 million more [1][2] Group 1: Offering Details - The offering is subject to market conditions and there is no assurance regarding its completion or the final terms [1] - The net proceeds will be used for the development and commercial preparation of bezuclastinib and other product candidates, as well as for working capital and general corporate purposes [2] - J.P. Morgan, Leerink Partners, and Guggenheim Securities are acting as joint book-running managers for the offering [2] Group 2: Regulatory Information - The securities will be offered under an automatic shelf registration statement filed with the SEC on February 10, 2023 [3] - A preliminary prospectus supplement will be filed with the SEC detailing the terms of the offering [4] Group 3: Company Overview - Cogent Biosciences focuses on developing precision therapies for genetically defined diseases, with bezuclastinib being the most advanced clinical program [5] - Bezuclastinib is designed to inhibit the KIT D816V mutation, which is linked to systemic mastocytosis and advanced gastrointestinal stromal tumors [5] - The company is also developing a portfolio of targeted therapies for mutations in ErbB2, PI3Kα, and KRAS [5]

Core Insights - Shares of Cogent Biosciences (COGT) increased by 23.4% following the positive results from a late-stage study of bezuclastinib for treating non-advanced systemic mastocytosis (SM) patients [1][7]. Study Results - The phase III SUMMIT study met all primary and key secondary endpoints, showing significant improvements in the treatment of SM patients with bezuclastinib compared to placebo [2][9]. - Bezuclastinib treatment resulted in a mean total symptom score (TSS) reduction of 24.3 points at 24 weeks, compared to a 15.4-point reduction in the placebo group, leading to a placebo-adjusted improvement of 8.91 points [8]. - 87.4% of patients treated with bezuclastinib experienced a ≥50% reduction in serum tryptase levels, a key biomarker, while no patients in the placebo group achieved this [9]. Safety and Tolerability - Bezuclastinib was reported to be well-tolerated with a favorable safety profile, indicating its potential for chronic use in this patient population [10]. Future Plans - Cogent Biosciences plans to submit a new drug application to the FDA for bezuclastinib by the end of 2025, aiming to establish it as a new standard of care for non-advanced SM [11]. - The company is also evaluating bezuclastinib for advanced SM and gastrointestinal stromal tumors in separate pivotal studies, with top-line data expected in the second half of 2025 [12]. Market Performance - Year-to-date, Cogent Biosciences shares have increased by 19.9%, outperforming the industry, which saw a decline of 1.9% [4].

Market Overview - U.S. stocks experienced a decline, with the Dow Jones index falling over 400 points, down 1% to 44,379.69, NASDAQ down 0.85% to 20,426.99, and S&P 500 down 0.39% to 6,255.16 [1] - In commodities, oil increased by 0.7% to $67.44, while gold decreased by 0.5% to $3,325.80, silver fell 0.8% to $36.795, and copper dropped 2.7% to $5.0025 [5] Company News - Cogent Biosciences, Inc. announced positive topline results from Part 2 of the SUMMIT trial for bezuclastinib, showing significant improvements across primary and key secondary endpoints [2] - Mustang Bio, Inc. shares surged 319% to $4.99 after receiving FDA Orphan Drug Designation for MB-101 in astrocytomas and glioblastoma [9] - Artelo Biosciences, Inc. saw a 79% increase in shares to $17.98 following preclinical efficacy results with ART12.11 in a stress-induced depression model [9] - LogProstyle Inc. shares rose 155% to $2.08 after reporting year-over-year financial growth for FY25 [9] - Core Scientific, Inc. shares dropped 21% to $14.21 after CoreWeave announced plans to acquire the company in an all-stock deal [9] - Jasper Therapeutics, Inc. shares fell 51% to $3.2964 after reporting an 89% response rate in its Urticaria study and the decision to halt the program [9] - Apogee Therapeutics, Inc. shares decreased by 16% to $40.03 following the release of 16-week data from Part A of the Phase 2 APEX clinical trial for APG777 [9] Regional Market Performance - European shares showed positive movement, with the eurozone's STOXX 600 rising 0.43%, Spain's IBEX 35 Index up 0.43%, London's FTSE 100 gaining 0.01%, Germany's DAX 40 increasing by 1%, and France's CAC 40 up 0.39% [6] - Asian markets closed mixed, with Japan's Nikkei down 0.56%, Hong Kong's Hang Seng down 0.12%, while China's Shanghai Composite gained 0.02% and India's BSE Sensex increased by 0.01% [7]

Core Insights - Cogent Biosciences, Inc.'s bezuclastinib demonstrated significant clinical benefits for patients with non-advanced systemic mastocytosis, supporting plans for FDA approval by the end of 2025 [1][4] Group 1: Clinical Trial Results - The SUMMIT trial achieved its primary endpoint with a statistically significant mean change in total symptom score (TSS) at 24 weeks, showing a mean reduction of 24.3 points in the bezuclastinib arm compared to 15.4 points in the placebo arm, resulting in a placebo-adjusted improvement of 8.91 points [5] - Statistically significant benefits were observed across all key secondary endpoints, including a reduction in serum tryptase, where 87.4% of bezuclastinib-treated patients had a ≥50% reduction compared to none in the control arm [6] Group 2: Future Plans and Financials - Cogent plans to submit its first new drug application (NDA) for bezuclastinib in NonAdvSM by the end of 2025 and will present detailed results from the SUMMIT trial at a medical meeting later this year [4][6] - The company is also on track to provide topline results from the PEAK and APEX trials in the second half of 2025, with a cash balance of $237 million and access to an additional $350 million through a debt facility [7] Group 3: Market Reaction - Following the positive trial results, COGT stock rose by 15.7% to $8.77 during the premarket session [8]

Cogent Biosciences (COGT) Conference Call Summary Company Overview - **Company**: Cogent Biosciences - **Focus**: Development of bezuclastinib for the treatment of non-advanced systemic mastocytosis (SM) Key Industry Insights - **Industry**: Rare disease treatment, specifically systemic mastocytosis - **Current Treatment Landscape**: Limited options for patients with non-advanced SM, highlighting the unmet medical need for effective therapies Core Findings from the SUMMIT Trial - **Trial Results**: The SUMMIT trial demonstrated positive top-line results, meeting all primary and key secondary endpoints with statistically significant benefits compared to placebo [5][24][54] - **Patient Population**: The trial included 179 patients with moderate to severe symptoms of non-advanced SM, with a significant percentage being female [20][22] - **Primary Endpoint**: The mean change in total symptom score at week 24 was significantly better in the bezuclastinib group (24.32) compared to placebo (15.41), with a placebo-adjusted effect size of 8.91 [25] - **Secondary Endpoints**: Significant reductions in serum tryptase levels and other markers of mast cell burden were observed, with 87.4% of patients achieving at least a 50% reduction in serum tryptase [26][54] Safety Profile - **Adverse Events**: Bezuclastinib showed a favorable safety profile, with 98% of patients experiencing treatment-emergent adverse events (TEAEs) compared to 88% in the placebo group [29] - **Serious Adverse Events**: Serious AEs were low, with 5% in placebo versus 4.2% in the bezuclastinib cohort [29] - **Common AEs**: Hair color changes (69%), altered taste (23.7%), and nausea (22%) were among the most common TEAEs [30] Future Outlook - **Regulatory Submissions**: Cogent plans to submit a New Drug Application (NDA) for bezuclastinib later in 2025, aiming for commercial approval [6][54] - **Upcoming Trials**: Results from two additional pivotal trials (APeX and PEAK) are expected later in 2025, which could further establish bezuclastinib's role in treating advanced SM and gastrointestinal stromal tumors (GIST) [9][51] - **Market Potential**: The company is positioned to become a leader in the treatment of non-advanced SM, with a strong financial position to support its initiatives [54] Competitive Landscape - **Comparison with Avapritinib**: The conference highlighted the potential for bezuclastinib to outperform avapritinib in terms of efficacy and safety, with physicians expressing interest in switching patients who are not well-controlled on avapritinib [60][88] - **Patient Preferences**: Patients currently on avapritinib expressed satisfaction but showed a strong interest in switching to bezuclastinib based on the promising SUMMIT trial results [93] Additional Considerations - **Patient Quality of Life**: The trial results indicate not only symptomatic relief but also potential disease modification, which is crucial for improving patients' overall quality of life [96][98] - **Ongoing Research**: Further analysis of the SUMMIT trial data is anticipated, which may provide deeper insights into specific symptom domains and long-term outcomes [87][90] This summary encapsulates the key points from the Cogent Biosciences conference call, focusing on the promising results of the SUMMIT trial and the potential impact of bezuclastinib in the treatment landscape for systemic mastocytosis.

Core Insights - Bezuclastinib has shown significant clinical benefits in treating patients with non-advanced systemic mastocytosis (NonAdvSM), achieving a statistically significant mean change in total symptom score (TSS) at 24 weeks compared to placebo [1][2][3] - The drug demonstrated a substantial reduction in serum tryptase levels, with 87.4% of patients experiencing at least a 50% reduction, contrasting with 0% in the placebo group [1][2] - Bezuclastinib is expected to submit a New Drug Application (NDA) to the FDA by the end of 2025, supported by a strong financial position with $237 million in cash and access to an additional $350 million [1][2][6] Clinical Trial Results - The SUMMIT trial achieved its primary endpoint with a mean reduction of 24.3 points in TSS for the bezuclastinib group versus 15.4 points for placebo, resulting in a placebo-adjusted improvement of 8.91 points (p=0.0002) [2][3] - All key secondary endpoints also showed statistically significant improvements, including a ≥50% reduction in serum tryptase (p<0.0001) and other measures of mast cell burden [3][4] Safety and Tolerability - Bezuclastinib exhibited a favorable safety profile, with the majority of treatment-emergent adverse events (TEAEs) being low grade; 98.3% in the bezuclastinib arm compared to 88.3% in the placebo arm [4][5] - Common TEAEs included hair color change (69.5% vs. 5.0% placebo), altered taste (23.7% vs. 0%), and nausea (22.0% vs. 13.3%) [4][5] Future Plans - Cogent plans to present detailed results from the SUMMIT trial at an upcoming medical meeting later this year and is on track to share pivotal trial results from the PEAK and APEX trials in the second half of 2025 [1][6][5]