Cogent Biosciences sets key 2025 milestones for drug trials

This news is based on a press release statement from Cogent Biosciences, Inc. and contains forward-looking statements that involve risks and uncertainties. The actual future results of the company may differ from those projected. For deeper insights into Cogent's financial health (currently rated as FAIR by InvestingPro) and access to additional ProTips, consider exploring InvestingPro's comprehensive analysis tools. For deeper insights into Cogent's financial health (currently rated as FAIR by InvestingPro) and access to additional ProTips, consider exploring InvestingPro's comprehensive analysis tools.

The company aims to present findings from the SUMMIT trial for Non-Advanced Systemic Mastocytosis (NonAdvSM) in July 2025, and from the APEX trial for Advanced Systemic Mastocytosis (AdvSM) in the second half of the year. Additionally, results from the PEAK Phase 3 trial for second-line Gastrointestinal Stromal Tumors (GIST) patients are expected by the end of 2025.

Cogent's President and CEO, Andrew Robbins, expressed confidence in the enrollment progress and the anticipation surrounding bezuclastinib, which may become the first selective KIT mutant inhibitor sparing the central nervous system. The company also plans to initiate Expanded Access Programs (EAP) in the U.S. for SM and GIST patients in the first quarter of 2025.

Moreover, Cogent is advancing its pipeline with an ongoing Phase 1 study of CGT4859, a novel FGFR2 inhibitor, and intends to submit Investigational New Drug (IND) applications for its ErbB2 and PI3Kα programs during the year.

The company's strong financial position is expected to support its transition to a commercial-stage entity. Cogent will also participate in a presentation and Q&A session at the J.P. Morgan Healthcare Conference on Tuesday, January 14.

In a related announcement, Cogent granted inducement equity awards to nine new employees as part of their compensation package, in accordance with Nasdaq Listing Rule 5635(c)(4).

This news is based on a press release statement from Cogent Biosciences, Inc. and contains forward-looking statements that involve risks and uncertainties. The actual future results of the company may differ from those projected.

In other recent news, Cogent Biosciences has reported promising trial results for its drug bezuclastinib, aimed at treating systemic mastocytosis. The SUMMIT trial showed a 56% average improvement in Total (EPA:TTEF) Symptom Score at 24 weeks. The safety profile of bezuclastinib was also highlighted, with most treatment-emergent adverse events being low-grade and reversible. Furthermore, Cogent completed enrollment for SUMMIT Part 2 ahead of schedule, with top-line results expected in July 2025.

In the realm of financial analysis, Piper Sandler and Citi have maintained an Overweight and Buy rating respectively, with price targets of $23.00 and $15.00. Needham revised its stock price target for Cogent from $16.00 to $15.00, maintaining a Buy rating, while H.C. Wainwright maintained its Buy rating and a $17.00 price target for Cogent.

Finally, Cogent has added two new inhibitors, CGT6737 and CGT6297, to its developmental pipeline. The company has completed patient enrollment for its Phase 3 PEAK trial, which is evaluating bezuclastinib for the treatment of gastrointestinal stromal tumors. Results are expected by the end of 2025. Cogent's SUMMIT trial for nonadvanced systemic mastocytosis is set to complete enrollment in early 2025, with results anticipated later that year. These are recent developments in the company's endeavors.

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