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Cogent Biosciences, Inc. - COGT STOCK NEWS

Welcome to our dedicated page for Cogent Biosciences news (Ticker: COGT), a resource for investors and traders seeking the latest updates and insights on Cogent Biosciences stock.

Cogent Biosciences, Inc. (NASDAQ: COGT) is a pioneering biotechnology company focused on developing precision therapies for genetically defined diseases. Headquartered in Waltham, MA, and Boulder, CO, Cogent's mission is to design rational, targeted therapies that treat the underlying causes of disease, thereby improving the lives of patients. The company's lead program, bezuclastinib, is a selective tyrosine kinase inhibitor designed to potently inhibit the KIT D816V mutation and other mutations in KIT exon 17. This mutation is a key driver of Systemic Mastocytosis (SM) and Advanced Gastrointestinal Stromal Tumors (GIST), both serious diseases dependent on oncogenic KIT signaling.

Bezuclastinib is undergoing rigorous clinical trials, with the PEAK, SUMMIT, and APEX trials all targeted toward specific genetic mutations associated with these diseases. The company has made significant strides in 2024, including the initiation of a new Phase 2 clinical trial of bezuclastinib in later line GIST patients in collaboration with the Sarcoma Alliance for Research through Collaboration (SARC), The Life Raft Group, and Dana-Farber Cancer Institute.

In addition to bezuclastinib, the Cogent Research Team is developing a portfolio of novel targeted therapies focused on mutations in FGFR2, ErbB2, and PI3Kα. These programs aim to create therapies with potential best-in-class properties, targeting rare and genetically driven diseases.

The company recently secured $225 million in a private investment led by prominent investors, ensuring a robust financial position that supports its ambitious research and development goals. Cogent's financial stability is further reinforced by a strong cash runway projected to extend into 2027, allowing the company to complete its ongoing and planned clinical trials.

Latest News:

  • February 26, 2024: Cogent announces a successful $225 million funding round, enhancing its financial stability.
  • February 22, 2024: Positive Part 1b data from the ongoing SUMMIT trial evaluating bezuclastinib in NonAdvSM patients.
  • February 14, 2024: New Phase 2 clinical trial of bezuclastinib in later line GIST patients announced in collaboration with SARC.
  • January 9, 2024: Key milestones for 2024 highlighted at J.P. Morgan’s 42nd Annual Healthcare Conference.

For more detailed and updated information, visit Cogent Biosciences' official website and follow them on social media platforms like X (formerly known as Twitter) and LinkedIn.

Rhea-AI Summary

Cogent Biosciences announced a positive alignment with the FDA on their novel patient-reported outcome measure, MS2D2, for the SUMMIT trial targeting Nonadvanced Systemic Mastocytosis (NonAdvSM). The MS2D2 questionnaire will be used to assess symptom severity and changes in NonAdvSM patients throughout the trial, focusing on the eleven most frequent and severe symptoms. The enrollment for SUMMIT Part 2 is expected to complete by Q2 2025, with top-line results due by the end of 2025.

Additionally, Cogent aims to complete enrollment in the APEX study for Advanced Systemic Mastocytosis (AdvSM) by the end of 2024, with results expected by mid-2025. The PEAK study focusing on second-line Gastrointestinal Stromal Tumors (GIST) patients is also progressing well, with enrollment expected to finish by Q3 2024 and results anticipated by late 2025.

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Cogent Biosciences announced new data from Part 1 of its SUMMIT trial evaluating bezuclastinib in patients with nonadvanced systemic mastocytosis (NonAdvSM).

The data, presented at the 2024 European Hematology Association Congress, showcased significant reductions in severe symptoms and mast cell reactions for patients treated with 100 mg of bezuclastinib.

Key findings included >90% reductions in mast cell burden, >50% reductions in mast cell reactions, and improvements in skin lesions. The drug demonstrated a favorable safety profile with no serious adverse events.

Enrollment for SUMMIT Part 2 and other key studies is ongoing, with results expected between mid-2024 and year-end 2025.

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Cogent Biosciences has named Cole Pinnow as Chief Commercial Officer, effective May 23, 2024. Pinnow brings 25 years of biopharmaceutical industry experience, including roles at Pfizer where he led a $5B cancer portfolio. At Cogent, Pinnow will oversee the commercial strategy for the anticipated launch of bezuclastinib, aimed at treating systemic mastocytosis (SM) and Gastrointestinal Stromal Tumors (GIST).

His appointment includes inducement equity awards of 525,000 stock options and up to 214,000 performance-based restricted stock units, encouraging long-term company growth. CEO Andrew Robbins highlighted Pinnow's expertise as important for transitioning Cogent into a fully integrated commercial organization.

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Cogent Biosciences has announced positive updated lead-in data from its ongoing Phase 3 PEAK trial evaluating bezuclastinib in combination with sunitinib for treating gastrointestinal stromal tumors (GIST). The combination achieved a median progression-free survival (mPFS) of 19.4 months and a 33% objective response rate (ORR) in a subset of patients. The data will be presented at the ASCO Annual Meeting on June 1, 2024.

In addition, Cogent announced a new Phase 2 trial of bezuclastinib plus sunitinib, sponsored by the Sarcoma Alliance for Research through Collaboration (SARC), targeting later-line GIST patients. Enrollment in the PEAK trial is ahead of schedule, now expected to be completed in Q3 2024. The treatment continues to show a favorable safety profile.

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Cogent Biosciences, Inc. (Nasdaq: COGT) reported on track clinical trial enrollment for three studies with topline results expected in 2025. The company ended the first quarter of 2024 with $435.7 million in cash, sufficient to fund operations until 2027. Recent business highlights include positive clinical data from SUMMIT trial and oversubscribed private placement.

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Cogent Biosciences, Inc. (Nasdaq: COGT) announces new preclinical data on its ErbB2 inhibitor program at AACR 2024, expecting to start IND-enabling studies in mid-2024. The data highlights the potential of a brain-penetrant ErbB2 inhibitor with promising characteristics for rare disease populations.
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Cogent Biosciences, Inc. provides a business update and financial results for Q4 and full year 2023. The company is actively enrolling three registration-directed clinical trials for bezuclastinib, with promising results. The pro-forma cash of $487 million ensures funding until 2027. Key milestones include topline results expected by YE 2025 for various studies.
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Cogent Biosciences reports positive data from SUMMIT trial on bezuclastinib for NonAdvSM patients at AAAAI meeting. Part 2 initiated with encouraging results. Safety and tolerability profile reported. Investor webcast scheduled.
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Cogent Biosciences, Inc. announces a private investment in public equity financing expected to raise approximately $225 million, positioning the company well financially through 2027. The financing, led by Commodore Capital and a large investment management firm, includes both new and existing investors. The company plans to use the funds to advance bezuclastinib through ongoing clinical trials and aims to establish it as a leading KIT mutant inhibitor for systemic mastocytosis and gastrointestinal stromal tumors.
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Cogent Biosciences, Inc. (Nasdaq: COGT) will present posters for bezuclastinib at the 2024 American Academy of Allergy Asthma & Immunology Annual Meeting and host a virtual investor webcast on February 23 at 8:00 a.m. ET. The posters will feature initial results from the SUMMIT Phase 2 clinical study of Bezuclastinib and perspectives on relevant symptoms of Non-Advanced Systemic Mastocytosis. The webcast will discuss the SUMMIT Part 1b data led by Andrew Robbins, Cogent’s President and CEO, and include a presentation by PD Dr. Frank Siebenhaar, M.D., Head University Outpatient Clinic, Institute of Allergology, Charité - Universitätsmedizin Berlin.
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FAQ

What does Cogent Biosciences, Inc. specialize in?

Cogent Biosciences specializes in developing precision therapies for genetically defined diseases, focusing on targeted treatments that address the underlying causes of these conditions.

What is the main clinical program of Cogent Biosciences?

The main clinical program of Cogent Biosciences is bezuclastinib, a selective tyrosine kinase inhibitor designed to inhibit KIT D816V and other mutations in KIT exon 17, crucial for treating Systemic Mastocytosis (SM) and Advanced Gastrointestinal Stromal Tumors (GIST).

Where is Cogent Biosciences headquartered?

Cogent Biosciences is headquartered in Waltham, Massachusetts, and Boulder, Colorado.

What recent achievements has Cogent Biosciences accomplished?

Recent achievements include securing $225 million in funding, announcing positive Part 1b data from the SUMMIT trial, and initiating a new Phase 2 clinical trial for bezuclastinib in collaboration with SARC.

What are the financial prospects of Cogent Biosciences?

Cogent Biosciences is financially stable, with a strong cash runway extending into 2027, supported by recent funding and strategic financial management.

What other programs is Cogent developing besides bezuclastinib?

Besides bezuclastinib, Cogent is developing novel targeted therapies focused on mutations in FGFR2, ErbB2, and PI3Kα, aiming to create best-in-class treatments for genetically driven diseases.

How can I stay updated with Cogent Biosciences' latest news?

You can stay updated by visiting Cogent Biosciences' official website and following their social media pages on X (formerly known as Twitter) and LinkedIn for the latest news and updates.

What are Cogent Biosciences' key clinical trials?

Key clinical trials include the PEAK, SUMMIT, and APEX trials, all focused on evaluating the efficacy of bezuclastinib in treating diseases driven by KIT mutations.

Who are Cogent Biosciences' key collaborators?

Key collaborators include the Sarcoma Alliance for Research through Collaboration (SARC), The Life Raft Group, and Dana-Farber Cancer Institute.

How does bezuclastinib work?

Bezuclastinib is designed to potently inhibit the KIT D816V mutation and other mutations in KIT exon 17, which are responsible for driving diseases like Systemic Mastocytosis and Advanced Gastrointestinal Stromal Tumors.

Cogent Biosciences, Inc.

Nasdaq:COGT

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