Financials
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
COGT Catalyst Timeline
Dated clinical, regulatory and corporate events for Cogent Biosciences, Inc.
Catalyst Timeline
Dated clinical, regulatory & corporate events for Cogent Biosciences, Inc.
Upcoming catalysts 2
Event history 50
Past FDA Catalysts and PDUFA Decisions
How COGT actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| 2026-06-30 | Bezuclastinib | NDA Submission | NDA |
Drug Pipeline Intelligence
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Bezuclastinib Small moleculeNCT05208047 | Advanced Gastrointestinal Stromal Tumors | Phase 3 | RECRUITING | 482 | Jan 1, 2030 |
Clinical Trial Results
Readouts, endpoints and source filings for every COGT program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
| bezuclastinib BreakthroughPriority | advanced systemic mastocytosis | 2026-06-12 | 65% objective response rate; 81% ORR per PPR criteria; 91% of patients achieving ≥50% reduction in variant allele frequency; 89% of patients achieving ≥50% reduction in bone marrow mast cells or clearance of aggregates; 12-month PFS rate of 79%; 12-month OS rate of 87%Read More | Cogent Biosciences Announces Detailed Data from APEX Pivotal Trial of Bezuclastinib in Patients with Advanced Systemic Mastocytosis at the 2026 European Hematology Association (EHA) CongressRead More |
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| Morris ArleneDirector | Option | 41,927 41,927 held | $5.64 | 08/27/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in COGT
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| Fairmount Funds Management LLC | 14.1 % (-7.8 %) | 212.98 M | 5.50 M |
COGT Institutional Ownership Trends
Options Data
Option Volume
Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026-10-16 | ||||||||||||
Real-Time Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last | Vol | OI | Last | Vol | OI | |
| No data available | ||||||
Calls vs Puts by Expiry
Competitive positioning
How COGT ranks across every disease it competes in
COGT News
Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) for Bezuclastinib in Patients with Advanced Systemic Mastocytosis (AdvSM)
Cogent Biosciences announced that the FDA has accepted its New Drug Application for bezuclastinib, aimed at treating Advanced Systemic Mastocytosis (AdvSM). The acceptance is backed by positive results from the APEX trial, which showed a 65% overall response rate. The PDUFA target action date is set for June 29, 2027, with no advisory committee planned.
Read more →Cogent Biosciences Reports Recent Business Highlights and Second Quarter 2026 Financial Results
Cogent Biosciences reported positive developments including the potential FDA approval of bezuclastinib for GIST and NonAdvSM patients by the end of 2026. The company has successfully onboarded a skilled customer-facing team and maintains a robust cash position to support operations. However, it also reported a significant net loss and rising R&D expenses.
Read more →Cogent Biosciences Announces Submission of New Drug Application (NDA) for Bezuclastinib in Advanced Systemic Mastocytosis (AdvSM)
Cogent Biosciences has submitted a New Drug Application for bezuclastinib to the FDA for treating Advanced Systemic Mastocytosis. The submission is based on positive results from the APEX pivotal trial, which demonstrated a 65% objective response rate and a well-tolerated safety profile. The company is optimistic about achieving FDA approval by Q4 2026.
Read more →Cogent Biosciences Announces Preclinical Data from Novel JAK2 V617F Inhibitor at the 2026 European Hematology Association (EHA) Congress
Cogent Biosciences presented promising preclinical data for its JAK2 V617F inhibitor, CGT1145, at the 2026 EHA Congress. The drug exhibits high selectivity and oral bioavailability, potentially addressing key disease drivers in myeloproliferative neoplasms. The company aims to submit an Investigational New Drug application in 2026.
Read more →Cogent Biosciences Announces Detailed Data from APEX Pivotal Trial of Bezuclastinib in Patients with Advanced Systemic Mastocytosis at the 2026 European Hematology Association (EHA) Congress
Cogent Biosciences presented updated results from the APEX trial of bezuclastinib for advanced systemic mastocytosis at the 2026 EHA Congress. The trial demonstrated a 65% objective response rate and significant reductions in mast cell burden. The drug also showed a favorable safety profile. An NDA submission is planned for June 2026.
Read more →Cogent Biosciences Announces Detailed Clinical Data from PEAK Phase 3 Trial with Bezuclastinib in Combination with Sunitinib in Gastrointestinal Stromal Tumors (GIST) at 2026 American Society of Clinical Oncology (ASCO) Annual Meeting
Cogent Biosciences announced promising results from the PEAK Phase 3 trial, demonstrating that the bezuclastinib and sunitinib combination significantly improves progression-free survival in GIST patients compared to sunitinib alone. The combination therapy was well tolerated, with no new risks identified. The FDA has granted Priority Review for this treatment, with a PDUFA date set for November 30, 2026.
Read more →Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) with Priority Review for Bezuclastinib in Combination with Sunitinib for Patients with GIST
Cogent Biosciences has announced the FDA's acceptance of its New Drug Application for bezuclastinib in combination with sunitinib for treating GIST patients. The application has been granted Priority Review, with a target action date set for November 30, 2026. The combination therapy demonstrated a significant improvement in median progression-free survival compared to sunitinib alone, marking a potential breakthrough in treatment options.
Read more →Cogent Biosciences Announces Participation in the 2026 Jefferies Global Healthcare Conference
Cogent Biosciences, Inc. will participate in the Jefferies Global Healthcare Conference on June 3, 2026. The event will feature a live webcast accessible via the company's website. Additionally, Cogent announced inducement equity awards for new employees, reflecting its commitment to growth and innovation in precision therapies for genetically defined diseases.
Read more →Cogent Biosciences Announces Multiple Presentations at the European Hematology Association (EHA) 2026 Congress
Cogent Biosciences has announced two key presentations at the upcoming European Hematology Association Congress 2026. The company will present pivotal data from its APEX trial on bezuclastinib, a therapy for Advanced Systemic Mastocytosis, showcasing its findings in two oral sessions. Additionally, preclinical data from their selective JAK2 V617F program will be highlighted in a poster presentation. These presentations represent a significant platform for Cogent to share its advancements in targeted therapies at an esteemed international venue.
Read more →Cogent Biosciences Reports Recent Business Highlights and First Quarter 2026 Financial Results
Cogent Biosciences has reported significant business highlights and financial results for Q1 2026, including plans for dual launches of their drug bezuclastinib in Systemic Mastocytosis and Gastrointestinal Stromal Tumors. The company has a strong financial position, ending the quarter with $866.4 million in cash, which is expected to fund operations into 2028. The upcoming ASCO annual meeting will feature pivotal data from the Phase 3 PEAK trial, potentially setting the stage for multiple drug launches. However, the company recorded a larger net loss this quarter compared to the previous year, alongside increased R&D expenses.
Read more →Cogent Biosciences Announces Oral Presentation of Positive Phase 3 PEAK Trial in Gastrointestinal Stromal Tumors (GIST) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting
Cogent Biosciences announced that results from its Phase 3 PEAK trial will be presented at the 2026 ASCO Annual Meeting. The trial demonstrated positive outcomes for bezuclastinib combined with sunitinib in GIST patients previously treated with imatinib. The company is also set to initiate a Phase 2 trial for first-line GIST patients with exon 9 mutations.
Read more →Cogent Biosciences Announces Poster Presentations at the American Association for Cancer Research (AACR) Annual Meeting 2026
Cogent Biosciences announced the presentation of preclinical data on its KRAS and ErbB2 pipeline programs at the AACR Annual Meeting 2026. The data highlights CGT1263's selectivity and potential to reduce skin toxicity, while CGT4255 shows promise in combination with HER2 ADCs for resistant patients. The company is preparing for the potential launch of bezuclastinib later this year.
Read more →Cogent Biosciences Announces Submission of New Drug Application for Bezuclastinib in Gastrointestinal Stromal Tumors (GIST)
Cogent Biosciences has submitted a New Drug Application for bezuclastinib to the FDA for treating gastrointestinal stromal tumors (GIST) in patients previously treated with imatinib. The submission is based on positive results from the Phase 3 PEAK trial, which showed a significant increase in progression-free survival and response rates compared to existing treatments. The company aims to present full trial results at a major medical meeting in 2026.
Read more →Cogent Biosciences Announces FDA Acceptance of New Drug Application for Bezuclastinib in Patients with NonAdvanced Systemic Mastocytosis (NonAdvSM)
Cogent Biosciences has announced the FDA's acceptance of its New Drug Application for bezuclastinib, targeting patients with NonAdvanced Systemic Mastocytosis. The FDA set a target action date of December 30, 2026, and plans to avoid an advisory committee meeting. Clinical trial results indicated significant improvements across primary and secondary endpoints, showcasing bezuclastinib's efficacy and safety profile. The company is also on track to submit additional NDA applications for bezuclastinib in related indications in the near future.
Read more →Cogent Biosciences Highlights Additional Data with Six Bezuclastinib Posters from SUMMIT Trial at 2026 AAAAI Annual Meeting
Cogent Biosciences presented additional data from the SUMMIT trial at the AAAAI Annual Meeting, highlighting the efficacy of bezuclastinib in treating NonAdvanced Systemic Mastocytosis. The results showed significant improvements across primary and secondary endpoints, reinforcing the drug's potential as a preferred treatment option. The findings also indicated benefits in bone mineral density, suggesting disease modification.
Read more →Cogent Biosciences Reports Recent Business Highlights and Fourth Quarter and Full Year 2025 Financial Results
Cogent Biosciences reported strong business highlights and financial results for 2025, showcasing momentum with three successful pivotal trials. The company is advancing its lead product, bezuclastinib, with multiple NDA submissions planned for 2026. Despite a net loss of $102.5 million in Q4 2025, Cogent maintains a robust cash position of $900.8 million.
Read more →Cogent Biosciences Announces Multiple SUMMIT Posters at the 2026 AAAAI Annual Meeting
Cogent Biosciences announced that it will present multiple posters at the 2026 AAAAI Annual Meeting, focusing on bezuclastinib results from the SUMMIT trial in patients with NonAdvanced Systemic Mastocytosis. The company has submitted a New Drug Application for bezuclastinib based on positive clinical data and previously received Breakthrough Therapy Designation. The presentations will take place on February 28, 2026.
Read more →Cogent Biosciences Announces Breakthrough Therapy Designation for Bezuclastinib in Combination with Sunitinib for Patients with Gastrointestinal Stromal Tumors (GIST)
Cogent Biosciences has received Breakthrough Therapy Designation from the FDA for bezuclastinib combined with sunitinib for treating imatinib-resistant GIST. The designation is based on promising results from the PEAK trial, showing a 50% reduction in disease progression risk. Cogent plans to submit its NDA by April 2026 and present full trial results at a major medical meeting.
Read more →Cogent Biosciences Announces Breakthrough Therapy Designation for Bezuclastinib in Combination with Sunitinib for Patients with Gastrointestinal Stromal Tumors (GIST)
Cogent Biosciences has received Breakthrough Therapy Designation from the FDA for its drug bezuclastinib in combination with sunitinib for treating gastrointestinal stromal tumors (GIST) in patients resistant to imatinib. The designation is based on promising results from the PEAK trial, showing a 50% reduction in disease progression risk. The company plans to submit its New Drug Application by April 2026 and present full trial results at a major medical meeting.
Read more →