SEC Form EFFECT filed by Cogent Biosciences Inc.
| UNITED STATES | |
| SECURITIES AND EXCHANGE COMMISSION | |
| Washington, D.C. 20549 | |
| Notice of Effectiveness | |
| Effectiveness Date: | May 9, 2025 |
| Accession Number: | 0001193125-25-113367 | ||||||
| Submission Type: | POS AM | ||||||
| |||||||
| UNITED STATES | |
| SECURITIES AND EXCHANGE COMMISSION | |
| Washington, D.C. 20549 | |
| Notice of Effectiveness | |
| Effectiveness Date: | May 9, 2025 |
| Accession Number: | 0001193125-25-113367 | ||||||
| Submission Type: | POS AM | ||||||
| |||||||
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| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 11/10/2025 | $40.00 | Hold → Buy | Stifel |
| 11/10/2025 | $38.00 | Neutral → Outperform | Wedbush |
| 10/16/2025 | $16.00 | Hold | Stifel |
| 9/3/2025 | $30.00 | Strong Buy | Raymond James |
| 3/7/2025 | $17.00 | Sector Outperform | Scotiabank |
| 12/11/2024 | Buy → Hold | Needham | |
| 2/26/2024 | $14.00 → $8.00 | Outperform → Neutral | Robert W. Baird |
| 2/8/2024 | $11.00 | Buy | Citigroup |
WALTHAM, Mass. and BOULDER, Colo., Feb. 10, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (NASDAQ:COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced multiple upcoming posters highlighting bezuclastinib results from the SUMMIT trial in NonAdvanced Systemic Mastocytosis (NonAdvSM) patients at the 2026 American Academy of Allergy Asthma & Immunology Annual Meeting (AAAAI) being held in Philadelphia, PA, February 27-March 2, 2026. In December 2025, Cogent announced that the company submitted its New Drug Application for bezuclastinib in NonAdvSM to the U.S. Food and Drug Administration. The submission is based on posi
- Cogent will submit the PEAK New Drug Application (NDA) under previously announced RTOR designation; on track to complete NDA submission in April 2026 WALTHAM, Mass. and BOULDER, Colo., Jan. 26, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (NASDAQ:COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today 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. "We are excited to announce this Breakthrough Therapy Designat
- PEAK trial first ever study to demonstrate statistical significance over an active comparator in GIST patients, with bezuclastinib plus sunitinib combination demonstrating mPFS of 16.5 months and ORR of 46% in patients who had received prior treatment with imatinib - Cogent is expected to initiate the RTOR process immediately; completion of the PEAK NDA submission expected in April 2026 WALTHAM, Mass. and BOULDER, Colo., Jan. 20, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (NASDAQ:COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced that the U.S. Food and Drug Administration (FDA) has agreed to accept its Ne
Stifel upgraded Cogent Biosciences from Hold to Buy and set a new price target of $40.00
Wedbush upgraded Cogent Biosciences from Neutral to Outperform and set a new price target of $38.00
Stifel initiated coverage of Cogent Biosciences with a rating of Hold and set a new price target of $16.00
4 - Cogent Biosciences, Inc. (0001622229) (Issuer)
4 - Cogent Biosciences, Inc. (0001622229) (Issuer)
4 - Cogent Biosciences, Inc. (0001622229) (Issuer)
4 - Cogent Biosciences, Inc. (0001622229) (Issuer)
4 - Cogent Biosciences, Inc. (0001622229) (Issuer)
SCHEDULE 13G/A - Cogent Biosciences, Inc. (0001622229) (Subject)
8-K - Cogent Biosciences, Inc. (0001622229) (Filer)
8-K - Cogent Biosciences, Inc. (0001622229) (Filer)
SC 13G/A - Cogent Biosciences, Inc. (0001622229) (Subject)
SC 13G/A - Cogent Biosciences, Inc. (0001622229) (Subject)
SC 13G/A - Cogent Biosciences, Inc. (0001622229) (Subject)
-- Bezuclastinib demonstrated rapid and deep clinical benefit in AdvSM patients resulting in an objective response rate (CR+CRh+PR+CI) of 57% per mIWG criteria and 80% per PPR criteria -- -- Bezuclastinib demonstrated a powerful effect on mast cell burden with 89% of patients achieving ≥50% reduction in bone marrow mast cells or clearance of aggregates – -- Bezuclastinib was very well tolerated with only 14.8% of patients requiring dose reduction and no patients requiring discontinuation due to treatment related adverse events -- -- APEX NDA submission expected in 1H 2026 – -- Cogent to host investor conference call and webcast today at 8:00 a.m. ET -- WALTHAM, Mass. and BOULDER, Colo.,
-- Bezuclastinib achieves clear clinical benefit across all symptom domains including significant improvements on 11 individual symptoms plus the most severe symptom at baseline -- -- Bezuclastinib demonstrates that reducing objective measures of disease, including serum tryptase, correlates with improvement in symptom severity; the first time this has been shown in NonAdvSM patients -- -- New 48-week data demonstrate a clear, continued deepening of symptomatic improvement over time -- -- Bezuclastinib demonstrated a favorable safety and tolerability profile supporting chronic use -- -- Granted Breakthrough Therapy Designation for bezuclastinib in October 2025; New Drug Applic
-- Patients treated with bezuclastinib showed a superior mean change in total symptom score at 24 weeks (-24.3 points vs. -15.4 points, -8.91 point placebo-adjusted difference; p=0.0002), compared to patients treated with placebo, establishing new benchmarks for placebo-adjusted and absolute symptomatic improvement for this patient population -- -- Bezuclastinib demonstrated a powerful effect on mast cell burden, with 87.4% of patients treated with bezuclastinib achieving at least 50% reduction in serum tryptase compared to 0% of patients treated with placebo -- -- Bezuclastinib demonstrated a favorable safety and tolerability profile supporting chronic use in this patient population -- -
WALTHAM, Mass. and BOULDER, Colo., May 23, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (NASDAQ:COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced the appointment of Cole Pinnow as Chief Commercial Officer. Mr. Pinnow is a leader in the biopharmaceutical industry with an impressive track record in commercial strategy, including several successful product launches. At Cogent, he will be responsible for building and leading the commercial team including sales, marketing, access, and commercial operations. A key priority will be preparing the company for the potential commercial launch of bezuclastinib, for patients
WALTHAM, Mass. and BOULDER, Colo., Nov. 28, 2022 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (NASDAQ:COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced the appointment of Rachael Easton, MD, Ph.D., Vice President, Head of Clinical Development. "We are pleased to welcome Dr. Easton to Cogent as we continue to develop bezuclastinib in Systemic Mastocytosis and GIST," said Andrew Robbins, the company's President and Chief Executive Officer. "Dr. Easton is an accomplished physician-scientist who brings a wealth of experience in both early and late-stage clinical development across multiple therapeutic areas. Her backgrou
CAMBRIDGE, Mass. and BOULDER, Colo., May 3, 2021 /PRNewswire/ -- Cogent Biosciences, Inc. (NASDAQ:COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced the appointment of Evan Kearns as Chief Legal Officer. In his new role, Mr. Kearns will oversee all corporate legal operations for Cogent Biosciences. "I am excited to welcome Evan to the Cogent team as our Chief Legal Officer," said Andrew Robbins, President and Chief Executive Officer of Cogent Biosciences. "Evan's expert counsel and proven leadership in ad