FDA Accepts Bezuclastinib NDA with Priority Review
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 2 days ago
0mins
Source: Newsfilter
- NDA Approval: Cogent Biosciences' New Drug Application for Bezuclastinib in combination with Sunitinib has been accepted by the FDA for Priority Review, with a PDUFA date set for November 30, 2026, marking a significant advancement in GIST treatment and potentially enhancing market competitiveness.
- Clinical Trial Results: The PEAK Phase 3 trial demonstrated a median progression-free survival of 16.5 months for the Bezuclastinib combination compared to 9.2 months for Sunitinib monotherapy, indicating a 50% reduction in risk (HR=0.50), which provides a new treatment option for GIST patients and may redefine treatment standards.
- Safety Data: The safety profile of the Bezuclastinib combination was comparable to Sunitinib, with common adverse events including hypertension and neutropenia, and most adverse reactions were manageable low-grade events, ensuring patient acceptance and treatment continuity.
- ASCO Presentation: Cogent plans to present the full results of the PEAK trial at the ASCO conference on May 30, 2026, further enhancing the company's visibility in the biopharmaceutical sector and preparing for the upcoming market launch.
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Analyst Views on COGT
Wall Street analysts forecast COGT stock price to rise
12 Analyst Rating
10 Buy
2 Hold
0 Sell
Strong Buy
Current: 35.380
Low
34.00
Averages
50.36
High
67.00
Current: 35.380
Low
34.00
Averages
50.36
High
67.00
About COGT
Cogent Biosciences, Inc. is a clinical-stage biotechnology company. It is focused on developing precision therapies for genetically defined diseases. Its approach is to design rational precision therapies that treat the underlying cause of disease and improve the lives of patients. Its advanced program is bezuclastinib, also known as CGT9486, a highly selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. KIT D816V is responsible for driving systemic mastocytosis (SM), a serious and rare disease caused by unchecked proliferation of mast cells. The Company has on-going Phase I studies of its CNS-penetrant, selective mutant ErbB2 inhibitor and its potential best-in-class, wild-type-sparing, PI3Ka inhibitor. In addition, the Company’s research team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases targeting mutations in KRAS and JAK2.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Bezuclastinib Combination Shows Significant Benefit in GIST Patients
- Clinical Trial Results: The combination of Bezuclastinib and sunitinib demonstrated a significant progression-free survival (PFS) advantage in GIST patients, achieving 16.5 months compared to 9.2 months for sunitinib alone, with a hazard ratio of 0.50 (p<0.0001), marking a major breakthrough in treatment efficacy.
- Good Tolerability: The combination therapy was well tolerated, consistent with the known safety profile of sunitinib, and no unique risks were observed, indicating its potential for clinical application and the possibility of becoming a new standard of care.
- FDA Priority Review: The FDA has accepted the NDA for the Bezuclastinib combination and granted priority review, with a PDUFA date set for November 30, 2026, providing new hope for patients in need of effective treatment options.
- New Clinical Trial Initiation: Cogent announced the initiation of a new clinical trial to evaluate the safety and efficacy of the Bezuclastinib combination in first-line GIST patients, further validating its application potential across different patient populations.
See More
Cogent Biosciences Set for Dual Product Launches
- FDA Priority Review: Cogent Biosciences' lead candidate, bezuclastinib, has received FDA priority review for its New Drug Application targeting gastrointestinal stromal tumors (GIST), with a target action date set for November 30, 2026, which could provide a new treatment option for patients.
- Combination Therapy: The drug is intended for use in combination with Pfizer's GIST therapy, sunitinib, specifically for patients who have previously been treated with imatinib, aiming to enhance treatment efficacy and meet the urgent market demand for new therapies.
- Significant Market Potential: CEO Andrew Robbins expressed excitement over the acceptance of the bezuclastinib NDA for GIST, indicating that preparations for the expected launches in both GIST and systemic mastocytosis are well underway, reflecting the company's confidence in the market potential of the new drug.
- Dual Launch Strategy: In addition to GIST, the NDA for bezuclastinib targeting non-advanced systemic mastocytosis has also been accepted by the FDA, with a target action date of December 30, 2026, further enhancing Cogent Biosciences' competitive position in the market.
See More
FDA Accepts Bezuclastinib NDA with Priority Review
- NDA Approval: Cogent Biosciences' New Drug Application for Bezuclastinib in combination with Sunitinib has been accepted by the FDA for Priority Review, with a PDUFA date set for November 30, 2026, marking a significant advancement in GIST treatment and potentially enhancing market competitiveness.
- Clinical Trial Results: The PEAK Phase 3 trial demonstrated a median progression-free survival of 16.5 months for the Bezuclastinib combination compared to 9.2 months for Sunitinib monotherapy, indicating a 50% reduction in risk (HR=0.50), which provides a new treatment option for GIST patients and may redefine treatment standards.
- Safety Data: The safety profile of the Bezuclastinib combination was comparable to Sunitinib, with common adverse events including hypertension and neutropenia, and most adverse reactions were manageable low-grade events, ensuring patient acceptance and treatment continuity.
- ASCO Presentation: Cogent plans to present the full results of the PEAK trial at the ASCO conference on May 30, 2026, further enhancing the company's visibility in the biopharmaceutical sector and preparing for the upcoming market launch.
See More
HighVista Strategies Cuts Stake in Viridian Therapeutics by $7 Million
- Stake Reduction Details: HighVista Strategies reported a sale of 238,243 shares of Viridian Therapeutics in its SEC filing dated May 15, 2026, representing an estimated $7.08 million trade, indicating a cautious outlook on the company's future performance.
- Impact of Stock Price Fluctuations: Despite Viridian Therapeutics' stock price rising 35% over the past year, the value of its position declined by $8.97 million at quarter-end, reflecting market concerns regarding the upcoming FDA decision.
- Company Financial Overview: Viridian's latest financial report indicates a revenue of $70.85 million and a net loss of $342.6 million over the trailing twelve months, highlighting the financial pressures faced during its development phase, which may affect investor confidence.
- Market Outlook and Challenges: With an FDA decision looming on June 30 for its lead therapy, Viridian's market performance may be impacted, especially after its Phase 3 clinical data fell short of expectations, prompting investors to carefully assess risks and opportunities.
See More
Cogent Biosciences Presents Pivotal Data at EHA Congress
- APEX Trial Oral Presentation: Cogent Biosciences will present pivotal results from the APEX trial on June 13, 2026, at the EHA Congress, with Dr. Daniel DeAngelo from Harvard Medical School discussing the efficacy and safety of bezuclastinib in patients with advanced systemic mastocytosis, which is expected to attract industry attention and drive further research.
- Poster Presentation of New Data: On the same day, Cogent will also showcase a poster detailing the effects of bezuclastinib on the pathobiology of advanced systemic mastocytosis, providing critical data to support its clinical application and further solidifying the company's leadership in this field.
- Progress on JAK2 V617F Program: Cogent's JAK2 V617F program will be highlighted in a poster presentation on June 12, 2026, introducing preclinical characteristics of CGT1145, a novel selective inhibitor, demonstrating the company's ongoing commitment to innovative drug development for genetically driven diseases.
- Strategic Positioning and Market Impact: Focused on developing precision therapies for genetically defined diseases, Cogent's bezuclastinib, as its most advanced clinical program, aims to effectively inhibit the KIT D816V mutation, which is expected to create significant market opportunities and bolster investor confidence.
See More
Major Wall Street Rating Updates
- Chipotle Upgrade: Argus upgraded Chipotle Mexican Grill from Hold to Buy, indicating a return to growth, which reflects market optimism about the company's future performance.
- Full Truck Alliance Initiation: Bank of America initiated coverage on Full Truck Alliance (FTA) with a Buy rating and a price target of $11.3, implying a 33% total return potential, showcasing confidence in its business model.
- Alto Neuroscience Promising Outlook: Bank of America initiated coverage of Alto Neuroscience (ANRO) with a Buy rating and a $35 price target, emphasizing its innovative potential in treating psychiatric disorders, which may attract more investor interest.
- Amazon Supply Chain Expansion: Bank of America reiterated its Buy rating on Amazon, highlighting the significant market potential of Amazon Supply Chain Services, which offers comprehensive logistics solutions for all businesses, further solidifying its market leadership.
See More
Bezuclastinib Combination Shows Significant Benefit in GIST Patients
- Clinical Trial Results: The combination of Bezuclastinib and sunitinib demonstrated a significant progression-free survival (PFS) advantage in GIST patients, achieving 16.5 months compared to 9.2 months for sunitinib alone, with a hazard ratio of 0.50 (p<0.0001), marking a major breakthrough in treatment efficacy.
- Good Tolerability: The combination therapy was well tolerated, consistent with the known safety profile of sunitinib, and no unique risks were observed, indicating its potential for clinical application and the possibility of becoming a new standard of care.
- FDA Priority Review: The FDA has accepted the NDA for the Bezuclastinib combination and granted priority review, with a PDUFA date set for November 30, 2026, providing new hope for patients in need of effective treatment options.
- New Clinical Trial Initiation: Cogent announced the initiation of a new clinical trial to evaluate the safety and efficacy of the Bezuclastinib combination in first-line GIST patients, further validating its application potential across different patient populations.
See More
Cogent Biosciences Set for Dual Product Launches
- FDA Priority Review: Cogent Biosciences' lead candidate, bezuclastinib, has received FDA priority review for its New Drug Application targeting gastrointestinal stromal tumors (GIST), with a target action date set for November 30, 2026, which could provide a new treatment option for patients.
- Combination Therapy: The drug is intended for use in combination with Pfizer's GIST therapy, sunitinib, specifically for patients who have previously been treated with imatinib, aiming to enhance treatment efficacy and meet the urgent market demand for new therapies.
- Significant Market Potential: CEO Andrew Robbins expressed excitement over the acceptance of the bezuclastinib NDA for GIST, indicating that preparations for the expected launches in both GIST and systemic mastocytosis are well underway, reflecting the company's confidence in the market potential of the new drug.
- Dual Launch Strategy: In addition to GIST, the NDA for bezuclastinib targeting non-advanced systemic mastocytosis has also been accepted by the FDA, with a target action date of December 30, 2026, further enhancing Cogent Biosciences' competitive position in the market.
See More
FDA Accepts Bezuclastinib NDA with Priority Review
- NDA Approval: Cogent Biosciences' New Drug Application for Bezuclastinib in combination with Sunitinib has been accepted by the FDA for Priority Review, with a PDUFA date set for November 30, 2026, marking a significant advancement in GIST treatment and potentially enhancing market competitiveness.
- Clinical Trial Results: The PEAK Phase 3 trial demonstrated a median progression-free survival of 16.5 months for the Bezuclastinib combination compared to 9.2 months for Sunitinib monotherapy, indicating a 50% reduction in risk (HR=0.50), which provides a new treatment option for GIST patients and may redefine treatment standards.
- Safety Data: The safety profile of the Bezuclastinib combination was comparable to Sunitinib, with common adverse events including hypertension and neutropenia, and most adverse reactions were manageable low-grade events, ensuring patient acceptance and treatment continuity.
- ASCO Presentation: Cogent plans to present the full results of the PEAK trial at the ASCO conference on May 30, 2026, further enhancing the company's visibility in the biopharmaceutical sector and preparing for the upcoming market launch.
See More
HighVista Strategies Cuts Stake in Viridian Therapeutics by $7 Million
- Stake Reduction Details: HighVista Strategies reported a sale of 238,243 shares of Viridian Therapeutics in its SEC filing dated May 15, 2026, representing an estimated $7.08 million trade, indicating a cautious outlook on the company's future performance.
- Impact of Stock Price Fluctuations: Despite Viridian Therapeutics' stock price rising 35% over the past year, the value of its position declined by $8.97 million at quarter-end, reflecting market concerns regarding the upcoming FDA decision.
- Company Financial Overview: Viridian's latest financial report indicates a revenue of $70.85 million and a net loss of $342.6 million over the trailing twelve months, highlighting the financial pressures faced during its development phase, which may affect investor confidence.
- Market Outlook and Challenges: With an FDA decision looming on June 30 for its lead therapy, Viridian's market performance may be impacted, especially after its Phase 3 clinical data fell short of expectations, prompting investors to carefully assess risks and opportunities.
See More
Cogent Biosciences Presents Pivotal Data at EHA Congress
- APEX Trial Oral Presentation: Cogent Biosciences will present pivotal results from the APEX trial on June 13, 2026, at the EHA Congress, with Dr. Daniel DeAngelo from Harvard Medical School discussing the efficacy and safety of bezuclastinib in patients with advanced systemic mastocytosis, which is expected to attract industry attention and drive further research.
- Poster Presentation of New Data: On the same day, Cogent will also showcase a poster detailing the effects of bezuclastinib on the pathobiology of advanced systemic mastocytosis, providing critical data to support its clinical application and further solidifying the company's leadership in this field.
- Progress on JAK2 V617F Program: Cogent's JAK2 V617F program will be highlighted in a poster presentation on June 12, 2026, introducing preclinical characteristics of CGT1145, a novel selective inhibitor, demonstrating the company's ongoing commitment to innovative drug development for genetically driven diseases.
- Strategic Positioning and Market Impact: Focused on developing precision therapies for genetically defined diseases, Cogent's bezuclastinib, as its most advanced clinical program, aims to effectively inhibit the KIT D816V mutation, which is expected to create significant market opportunities and bolster investor confidence.
See More
Major Wall Street Rating Updates
- Chipotle Upgrade: Argus upgraded Chipotle Mexican Grill from Hold to Buy, indicating a return to growth, which reflects market optimism about the company's future performance.
- Full Truck Alliance Initiation: Bank of America initiated coverage on Full Truck Alliance (FTA) with a Buy rating and a price target of $11.3, implying a 33% total return potential, showcasing confidence in its business model.
- Alto Neuroscience Promising Outlook: Bank of America initiated coverage of Alto Neuroscience (ANRO) with a Buy rating and a $35 price target, emphasizing its innovative potential in treating psychiatric disorders, which may attract more investor interest.
- Amazon Supply Chain Expansion: Bank of America reiterated its Buy rating on Amazon, highlighting the significant market potential of Amazon Supply Chain Services, which offers comprehensive logistics solutions for all businesses, further solidifying its market leadership.
See More
