Cogent Biosciences (COGT) has upcoming FDA regulatory milestones for bezuclastinib. The table below outlines estimated target dates and event types for these pending regulatory actions.
This section highlights FDA-related milestones and regulatory updates for drugs developed by Cogent Biosciences (COGT).
Over the past two years, Cogent Biosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
bezuclastinib, CGT1815, and Bezuclastinib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Bezuclastinib FDA Regulatory Timeline and Events
Bezuclastinib is a drug developed by Cogent Biosciences for the following indication: In patients with non-advanced systemic mastocytosis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- bezuclastinib
- Announced Date:
- April 21, 2026
- Indication:
- In patients with non-advanced systemic mastocytosis
Announcement
Cogent Biosciences, Inc announced that the results from the Phase 3 PEAK trial have been selected for oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago, IL, May 29-June 2, 2026.
AI Summary
Cogent Biosciences announced that results from its Phase 3 PEAK trial have been selected for an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL, May 29–June 2, 2026. Being chosen for an oral presentation at ASCO highlights the importance of the PEAK data to the oncology community and signals that the findings may influence clinical practice or ongoing research in gastrointestinal stromal tumors (GIST).
In related news, Cogent said it is on track this quarter to start a Phase 2 trial testing the combination of bezuclastinib plus sunitinib as a first-line treatment for GIST patients with exon 9 mutations who are either treatment‑naive or have recently begun imatinib. For more information, the company listed Christi Waarich, Senior Director of Investor Relations, as the contact for inquiries.
Read Announcement- Drug:
- bezuclastinib
- Announced Date:
- April 1, 2026
- Indication:
- In patients with non-advanced systemic mastocytosis
Announcement
Cogent Biosciences, Inc announced the completion of the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in patients with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment with imatinib.
AI Summary
Cogent Biosciences announced it has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration for bezuclastinib. The application seeks approval to treat patients with gastrointestinal stromal tumors (GIST) who have already received imatinib. This marks a major regulatory step for the company as it pursues approval of this investigational therapy for a specific, previously treated patient group.
The NDA package reportedly includes clinical trial data on the drug’s safety and effectiveness in the targeted GIST population. If reviewed and approved by the FDA, bezuclastinib could offer an additional treatment option for patients with limited choices after imatinib. Cogent will now await the FDA’s formal review process and any regulatory decisions or requests for more information.Read Announcement
- Drug:
- bezuclastinib
- Announced Date:
- March 16, 2026
- Target Action Date:
- December 30, 2026
- Indication:
- In patients with non-advanced systemic mastocytosis
Announcement
Cogent Biosciences, Inc announced that the Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2026.
AI Summary
Cogent Biosciences announced that the Prescription Drug User Fee Act (PDUFA) target action date for its regulatory review is December 30, 2026. The PDUFA date is the FDA’s target timing for completing its review of a drug application and issuing an approval or other decision. This date gives a clear timeline for when a final regulatory outcome is expected for Cogent’s submission.
Having a set PDUFA date helps the company, investors and patients plan. If the FDA approves the application, Cogent could move forward with manufacturing, marketing and wider patient access. If the FDA asks for more information, the company would need to respond and the timeline could change. Between now and December 30, 2026, Cogent will likely focus on preparing for either outcome, keeping stakeholders informed, and taking steps needed for commercial and operational readiness after a regulatory decision.
Read Announcement- Drug:
- bezuclastinib
- Announced Date:
- March 16, 2026
- Indication:
- In patients with non-advanced systemic mastocytosis
Announcement
Cogent Biosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for bezuclastinib in patients with NonAdvanced Systemic Mastocytosis (NonAdvSM)
AI Summary
Cogent Biosciences announced that the U.S. Food and Drug Administration has accepted its New Drug Application (NDA) for bezuclastinib to treat patients with NonAdvanced Systemic Mastocytosis (NonAdvSM). NDA acceptance means the FDA has determined the submission is complete enough to begin a formal review of the drug’s data. This step moves bezuclastinib from the submission phase into the active regulatory evaluation process.
During the review, the FDA will examine safety, effectiveness, manufacturing quality, and proposed labeling. Acceptance does not guarantee approval, but it is a key milestone that allows the agency and company to exchange questions and data. If approved, bezuclastinib could become an additional treatment option for people with NonAdvSM who experience symptoms from excess mast cells.
Cogent is expected to provide updates as the FDA review progresses and as any regulatory milestones are reached.
Read Announcement- Drug:
- bezuclastinib
- Announced Date:
- January 26, 2026
- Indication:
- In patients with non-advanced systemic mastocytosis
Announcement
Cogent Biosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for bezuclastinib in combination with sunitinib for patients with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment with imatinib.
AI Summary
The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation (BTD) to Cogent Biosciences for bezuclastinib given together with sunitinib to treat patients with gastrointestinal stromal tumors (GIST) who previously received imatinib. BTD is meant to speed review of therapies for serious conditions when early clinical evidence suggests a substantial improvement over current options. Cogent said the designation recognizes the combination’s potential to help patients with imatinib-resistant GIST.
The decision was based on PEAK trial results showing a highly significant benefit in progression-free survival: a 50% lower risk of disease progression or death versus sunitinib alone (hazard ratio 0.50, 95% CI 0.39–0.65). Median PFS was 16.5 months with the combination versus 9.2 months with sunitinib monotherapy. The combo was well tolerated with no new safety signals versus known sunitinib effects. Cogent plans to present full PEAK results at a major medical meeting in the first half of 2026.
Read Announcement- Drug:
- bezuclastinib
- Announced Date:
- January 20, 2026
- Indication:
- In patients with non-advanced systemic mastocytosis
Announcement
Cogent Biosciences, Inc announced that the U.S. Food and Drug Administration (FDA) has agreed to accept its New Drug Application (NDA) for bezuclastinib in combination with sunitinib for patients with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment with imatinib under the Real-Time Oncology Review (RTOR) program.
AI Summary
Cogent Biosciences announced the U.S. Food and Drug Administration has agreed to accept its New Drug Application for bezuclastinib combined with sunitinib to treat Gastrointestinal Stromal Tumors (GIST) in patients previously treated with imatinib, under the FDA’s Real‑Time Oncology Review (RTOR) program. RTOR lets the agency review parts of an application before the full filing to speed assessment of promising cancer treatments. Cogent said it will begin the RTOR process immediately and expects to complete the NDA submission in April 2026.
The NDA is based on the PEAK trial, where the bezuclastinib plus sunitinib combo showed a median progression‑free survival of 16.5 months versus 9.2 months with sunitinib alone (hazard ratio 0.50) and an overall response rate of 46% versus 26%. The combination was generally well tolerated. Full PEAK results are planned for presentation in the first half of 2026.
Read Announcement- Drug:
- bezuclastinib
- Announced Date:
- December 30, 2025
- Indication:
- In patients with non-advanced systemic mastocytosis
Announcement
Cogent Biosciences, Inc. 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).
AI Summary
Cogent Biosciences announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for bezuclastinib to treat NonAdvanced Systemic Mastocytosis (NonAdvSM). The filing is based on positive, pivotal results from the SUMMIT trial and represents the company’s first of three planned submissions for bezuclastinib. Cogent said the submission moves the therapy closer to patients who need new treatment options.
SUMMIT showed statistically significant benefit across primary and key secondary endpoints, with clear improvement in symptoms across 11 patient‑reported measures and the most severe symptom at baseline. Reductions in serum tryptase, an objective disease marker, correlated with symptom improvements — a first in NonAdvSM. Updated 48‑week data showed continued deepening of symptom relief, and bezuclastinib demonstrated a favorable safety and tolerability profile that may support chronic use. Cogent highlighted the potential for a disease‑modifying treatment for patients with NonAdvSM.
Read Announcement- Drug:
- bezuclastinib
- Announced Date:
- December 8, 2025
- Indication:
- In patients with non-advanced systemic mastocytosis
Announcement
Cogent Biosciences, Inc. announced positive top-line results from the registration-directed APEX Part 2 clinical trial of bezuclastinib in patients with advanced systemic mastocytosis (AdvSM) demonstrating clinically meaningful results as measured by consensus criteria used to assess patient response.
AI Summary
Cogent Biosciences announced positive top-line results from the registration-directed APEX Part 2 clinical trial of bezuclastinib in patients with advanced systemic mastocytosis (AdvSM). The trial showed clinically meaningful patient responses as measured by established consensus criteria used to assess treatment effect in this disease. Results indicated the drug produced improvements on key measures of disease activity and patient symptoms in the studied population.
Because APEX Part 2 was registration-directed, these findings strengthen the clinical case for bezuclastinib as a targeted therapy for AdvSM. The data suggest the drug can reduce objective markers of mast cell burden while delivering symptom relief, and the safety profile supports continued development. Cogent plans to disclose more detailed analyses and next steps as additional data are prepared for presentation and review.
Read Announcement- Drug:
- bezuclastinib
- Announced Date:
- December 6, 2025
- Indication:
- In patients with non-advanced systemic mastocytosis
Announcement
Cogent Biosciences, Inc. announced complete results from the registration-directed Part 2 of the SUMMIT clinical trial of bezuclastinib in patients with nonadvanced systemic mastocytosis (NonAdvSM).
AI Summary
Cogent Biosciences announced complete results from the registration-directed Part 2 of the SUMMIT trial evaluating bezuclastinib in nonadvanced systemic mastocytosis (NonAdvSM). In 118 patients treated with bezuclastinib versus 60 on placebo, the drug produced clinically meaningful, highly significant symptom improvements at 24 weeks (mean total symptom score change –43% vs –29%, p<0.001). More patients reached ≥50% and ≥30% symptom reduction versus placebo. Bezuclastinib also improved 11 individual symptoms including the patient’s most severe baseline symptom, and 48-week data show continued deepening of benefit over time.
Objective disease markers fell sharply: 87.4% achieved ≥50% reduction in serum tryptase, 75.6% had ≥50% reduction in bone marrow mast cells or cleared aggregates, and 85.7% had ≥50% reduction or undetectable KIT D816V VAF. For the first time in NonAdvSM, reductions in objective measures correlated with symptom improvement. Safety was generally favorable with mostly low-grade adverse events; common events included hair color change, altered taste, nausea and reversible liver enzyme elevations.
Read Announcement- Drug:
- bezuclastinib
- Announced Date:
- November 10, 2025
- Indication:
- In patients with non-advanced systemic mastocytosis
Announcement
Cogent Biosciences, Inc. today reported positive data from its Phase 3 PEAK trial of bezuclastinib plus sunitinib in patients with imatinib-resistant or intolerant Gastrointestinal Stromal Tumors (GIST).
AI Summary
Cogent Biosciences reported positive Phase 3 PEAK results for bezuclastinib combined with sunitinib in patients with imatinib‑resistant or intolerant gastrointestinal stromal tumors (GIST). The combination achieved a median progression‑free survival (mPFS) of 16.5 months versus 9.2 months for sunitinib alone (hazard ratio 0.50, 95% CI 0.39–0.65; p<0.0001), cutting the risk of progression or death by half.
Objective response rate (ORR) was 46% with the combination versus 26% with sunitinib alone (p<0.0001). Overall survival data are still immature, but the combination showed a clear, statistically significant benefit on the trial’s primary endpoint.
The safety profile was generally well tolerated with no new safety signals compared to known sunitinib effects; liver enzyme increases were mostly transient and manageable. Cogent plans to submit a new drug application in the first half of 2026 and to present full PEAK results at a scientific conference then. A company webcast was held to discuss the data.
Read Announcement- Drug:
- bezuclastinib
- Announced Date:
- October 20, 2025
- Indication:
- In patients with non-advanced systemic mastocytosis
Announcement
Cogent Biosciences, Inc announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for bezuclastinib in NonAdvanced Systemic Mastocytosis (NonAdvSM) patients previously treated with avapritinib as well as in patients with Smoldering Systemic Mastocytosis; populations with no currently approved standard of care.
AI Summary
Cogent Biosciences announced that the U.S. Food and Drug Administration granted Breakthrough Therapy Designation for bezuclastinib in two groups of systemic mastocytosis patients: those with NonAdvanced Systemic Mastocytosis who previously received avapritinib and patients with Smoldering Systemic Mastocytosis. Neither group has an approved standard treatment today.
This designation reflects strong results from the SUMMIT trial, where bezuclastinib met key goals and showed consistent benefits in patients with high unmet need. Breakthrough status helps speed up development by allowing rolling submission of data, priority review, and closer collaboration with the FDA to find the fastest path to approval.
Cogent plans to present detailed SUMMIT findings at a scientific conference this year and aims to submit its New Drug Application for NonAdvanced Systemic Mastocytosis by the end of 2025. The company sees this step as critical toward offering a new treatment option for these patients.
Read Announcement- Drug:
- bezuclastinib
- Announced Date:
- July 7, 2025
- Indication:
- In patients with non-advanced systemic mastocytosis
Announcement
Cogent Biosciences, Inc. announced positive top-line results from the registration-directed Part 2 of the SUMMIT clinical trial of bezuclastinib in patients with non-advanced systemic mastocytosis (NonAdvSM) demonstrating clinically meaningful and highly statistically significant improvements across the primary and all key secondary endpoints, including patient-reported symptoms and objective measures of mast cell burden.
AI Summary
Cogent Biosciences announced positive top-line results from Part 2 of its SUMMIT clinical trial for bezuclastinib in patients with non-advanced systemic mastocytosis (NonAdvSM). The trial showed that bezuclastinib led to a clinically meaningful improvement in patient-reported symptoms and a significant reduction in mast cell burden. Specifically, patients on bezuclastinib experienced a 24.3-point decrease in total symptom score compared to a 15.4-point decrease in the placebo group, with a statistically significant p-value of 0.0002.
Moreover, 87.4% of patients in the treatment group achieved at least a 50% reduction in serum tryptase levels—a key objective measure—while no patients in the placebo group reached this milestone. These strong and statistically significant outcomes, along with a favorable safety profile, support bezuclastinib as a promising new treatment option as Cogent moves toward its FDA New Drug Application submission by the end of 2025.
Read Announcement
CGT1815 FDA Regulatory Events
CGT1815 is a drug developed by Cogent Biosciences for the following indication: In KRASG12D And KRASG12V Tumor Growth Inhibition.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CGT1815
- Announced Date:
- October 24, 2025
- Indication:
- In KRASG12D And KRASG12V Tumor Growth Inhibition
Announcement
Cogent Biosciences, Inc. announced updated preclinical data from the company's potent and selective pan KRAS(ON) inhibitor in a poster presentation at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics taking place in Boston, MA, October 22-26, 2025.
AI Summary
Cogent Biosciences announced updated preclinical data for its potent, selective pan KRAS(ON) inhibitor in a poster at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston. CEO Andrew Robbins highlighted a potential best-in-class profile for the lead molecule and said the company aims to file an Investigational New Drug application with the FDA in 2026.
The poster details identification of CGT1263, which shows picomolar activity across multiple KRAS mutant cell lines and clear selectivity over HRAS and NRAS. It also describes CGT1815, a prodrug engineered to optimize human pharmacokinetics, with supporting multi-species PK data. In head-to-head studies, CGT1815 demonstrated superior tumor growth inhibition in KRASG12D and KRASG12V models compared to RMC-6236.
Read Announcement
Bezuclastinib FDA Regulatory Timeline and Events
Bezuclastinib is a drug developed by Cogent Biosciences for the following indication: Advanced Systemic Mastocytosis (AdvSM).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Bezuclastinib
- Announced Date:
- February 10, 2025
- Indication:
- Advanced Systemic Mastocytosis (AdvSM)
Announcement
Cogent Biosciences, Inc announced an upcoming poster for bezuclastinib at the 2025 American Academy of Allergy Asthma & Immunology Annual Meeting (AAAAI) being held in San Diego, CA, February 28-March 3, 2025.
AI Summary
Cogent Biosciences, Inc. announced that it will present a research poster on its drug bezuclastinib at the 2025 American Academy of Allergy Asthma & Immunology Annual Meeting. The poster will focus on patients with non-advanced systemic mastocytosis who received 100 mg of bezuclastinib for at least 48 weeks, highlighting the long-term benefits of the treatment. The presentation is part of a Phase 2 clinical trial known as the Summit Trial.
The session, titled "Novel Mechanisms of Mast Cells, Basophils and IgE," is scheduled for March 1, 2025, from 9:45 am to 10:45 am PT at the San Diego Convention Center. The poster, labeled as number 520, will provide important insights into the efficacy and safety of the treatment.
Read Announcement- Drug:
- Bezuclastinib
- Announced Date:
- December 9, 2024
- Indication:
- Advanced Systemic Mastocytosis (AdvSM)
Announcement
Cogent Biosciences, Inc. announced updated clinical results from the Open Label Extension (OLE) portion of SUMMIT, a clinical trial evaluating bezuclastinib in patients with nonadvanced systemic mastocytosis (NonAdvSM).
AI Summary
Cogent Biosciences recently shared updated clinical results from the Open Label Extension (OLE) of the SUMMIT trial, which is testing bezuclastinib in patients with nonadvanced systemic mastocytosis (NonAdvSM). The trial data revealed a 56% average improvement in the Total Symptom Score (TSS) at 24 weeks, with 76% of patients experiencing at least a 50% reduction in their symptoms. Moreover, 89% of patients saw more than a 50% decrease in serum tryptase levels by four weeks, and 95% of those with elevated baseline tryptase reached levels below 20 ng/ml by week 24.
The strong symptomatic and pharmacodynamic improvements indicate that bezuclastinib could offer rapid and sustained benefits for NonAdvSM patients. In addition to these promising results, enrollment in the SUMMIT Part 2 trial was completed ahead of schedule with 179 patients, and top-line results from this study are expected in July 2025.
Read Announcement- Drug:
- Bezuclastinib
- Announced Date:
- December 8, 2024
- Indication:
- Advanced Systemic Mastocytosis (AdvSM)
Announcement
Cogent Biosciences, Inc reported positive updated data from Part 1 of the Company's ongoing Phase 2 APEX clinical trial evaluating bezuclastinib in patients with advanced systemic mastocytosis (AdvSM) at the 66th American Society of Hematology (ASH 2024) Annual Meeting & Exposition taking place December 7-10, 2024 in San Diego, CA.
AI Summary
Cogent Biosciences, Inc. presented encouraging updated data from Part 1 of its ongoing Phase 2 APEX trial at the 66th American Society of Hematology (ASH) 2024 Annual Meeting in San Diego. The study is evaluating the safety, efficacy, and pharmacological profile of bezuclastinib in patients with advanced systemic mastocytosis (AdvSM). Results showed high overall response rates, especially in the 100 mg BID dosing group, where patients achieved an 83% response rate per mIWG criteria and an 88% response rate per pure pathological response criteria. The median time to response was 2.2 months, and many patients experienced significant improvements in key disease biomarkers. These early findings support bezuclastinib's potential to provide rapid and deep clinical responses with a manageable safety profile, offering a promising new treatment approach for AdvSM patients. Part 2 of the trial is on track with top-line data expected in mid-2025.
Read Announcement- Drug:
- Bezuclastinib
- Announced Date:
- September 3, 2024
- Target Action Date:
- Q1 2025
- Estimated Target Date Range:
- January 1, 2025 - March 31, 2025
- Indication:
- Advanced Systemic Mastocytosis (AdvSM)
Announcement
Cogent Biosciences, Inc announced that Registration-directed SUMMIT trial in NonAdvanced Systemic Mastocytosis (NonAdvSM) now on track to complete enrollment in Q1 2025
AI Summary
Cogent Biosciences, Inc. announced that its registration-directed SUMMIT trial for NonAdvanced Systemic Mastocytosis (NonAdvSM) is progressing well. The company now expects to complete patient enrollment in this global trial during the first quarter of 2025, which is roughly three months ahead of the original schedule. Top-line results from the study are anticipated in the second half of 2025. This update highlights the strong global interest and rapid enrollment driven by the need for new, precision therapies. The SUMMIT trial is designed to evaluate bezuclastinib’s potential as a best-in-class KIT mutant inhibitor, reinforcing Cogent’s commitment to advancing treatments for genetically defined diseases. Overall, the accelerated timeline for this trial represents a significant milestone in their efforts to provide effective therapies for patients with NonAdvSM.
Read Announcement- Drug:
- Bezuclastinib
- Announced Date:
- September 3, 2024
- Target Action Date:
- H2 2025
- Estimated Target Date Range:
- July 1, 2025 - December 31, 2025
- Indication:
- Advanced Systemic Mastocytosis (AdvSM)
Announcement
Cogent Biosciences, Inc announced that top-line results expected 2H 2025
AI Summary
Cogent Biosciences, Inc. provided key updates on their clinical trial progress for bezuclastinib, a promising KIT mutant inhibitor. The Phase 3 PEAK trial for gastrointestinal stromal tumors (GIST) enrolled 413 patients and recently passed an interim futility analysis, keeping the study on track. Top-line results for the PEAK trial are expected by the end of 2025, supporting plans for a New Drug Application in this patient group.
Additionally, the registration-directed SUMMIT trial for nonadvanced systemic mastocytosis has seen accelerated enrollment, with completion expected in the first quarter of 2025. Top-line results for the SUMMIT trial are projected to be available in the second half of 2025, reflecting strong global interest and commitment to advancing precision therapies for genetically defined diseases.
Read Announcement- Drug:
- Bezuclastinib
- Announced Date:
- September 3, 2024
- Indication:
- Advanced Systemic Mastocytosis (AdvSM)
Announcement
Cogent Biosciences, Inc today provided several updates from the company's ongoing registration-directed clinical trials of its potential best-in-class KIT mutant inhibitor, bezuclastinib.
AI Summary
Cogent Biosciences, Inc. shared important updates on its registration-directed clinical trials for its promising KIT mutant inhibitor, bezuclastinib. The company confirmed that its Phase 3 PEAK trial for patients with gastrointestinal stromal tumors (GIST) has completed enrollment with 413 patients, surpassing its target. An interim futility analysis was conducted based on progression-free survival, with the Independent Data Monitoring Committee recommending that the study continue without changes. Additionally, the SUMMIT trial, which evaluates bezuclastinib in nonadvanced systemic mastocytosis (NonAdvSM), is progressing well, with patient enrollment expected to finish by the first quarter of 2025 and results anticipated in the second half of the year. These advancements underscore strong patient interest and the potential of bezuclastinib as a best-in-class therapy targeting KIT mutations.
Read Announcement - Drug:
- Bezuclastinib
- Announced Date:
- June 27, 2024
- Indication:
- Advanced Systemic Mastocytosis (AdvSM)
Announcement
Cogent Biosciences, Inc. announced it has reached alignment with the U.S. Food and Drug Administration (FDA) on the Company's novel patient reported outcome measure, Mastocytosis Symptom Severity Daily Diary (MS2D2), for use in Part 2 of the registration-directed SUMMIT trial evaluating bezuclastinib in Nonadvanced Systemic Mastocytosis (NonAdvSM) patients.
AI Summary
Cogent Biosciences, Inc. announced that it has reached alignment with the U.S. Food and Drug Administration (FDA) on its new patient-reported outcome measure, the Mastocytosis Symptom Severity Daily Diary (MS2D2). The MS2D2 is designed to track patient symptoms from the beginning of treatment and throughout the trial, helping to capture changes in the severity of key symptoms over time. This FDA agreement allows the diary to be used in Part 2 of the registration-directed SUMMIT trial, which evaluates bezuclastinib in patients with Nonadvanced Systemic Mastocytosis (NonAdvSM). In the trial, data gathered by the MS2D2 will contribute to a Total Symptom Score used as the primary endpoint for measuring treatment effectiveness. Cogent Biosciences plans to complete enrollment in SUMMIT Part 2 by the second quarter of 2025 and to report top-line results by the end of 2025.
Read Announcement
