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H.C. Wainwright Gives Cogent Buy Rating
Cogent's Q2 results were broadly in line with expectations, with higher-than-expected operating expenses driving a lower FY26 EPS forecast, but $866M of cash provides runway into late 2028 while two possible upcoming bezuclastinib approvals and a potentially attractive M&A profile support a Buy rating, H.C. Wainwright tells investors in a research note.
Cogent Biosciences Submits NDA for Bezuclastinib
Cogent Biosciences announced it has submitted its new drug application, or NDA, to the FDA for bezuclastinib in Advanced Systemic Mastocytosis. The submission is based on clinical data from the APEX pivotal trial.
Cogent Biosciences Announces GIST Clinical Trial Data
Cogent Biosciences announced detailed clinical data from the primary analysis of the PEAK Phase 3 trial of bezuclastinib in combination with sunitinib in patients with Gastrointestinal Stromal Tumors, GIST, who have received prior treatment with imatinib. The presentation titled Primary Results of the Phase 3 Peak Study of Bezuclastinib + Sunitinib vs Sunitinib Monotherapy in Advanced Gastrointestinal Stromal Tumors will be presented. Key highlights: Bezuclastinib combination is first treatment ever to demonstrate statistically significant advantage against active comparator in GIST patients; median PFS of 16.5 months versus 9.2 months for bezuclastinib combination compared to sunitinib alone; Bezuclastinib combination provides clear PFS benefit regardless of primary or secondary KIT mutations; Mean duration of treatment estimated at 21.4 months for patients receiving bezuclastinib combination; Bezuclastinib combination well tolerated with no unique risks observed with the combination when compared to the known safety profile of sunitinib; Priority Review granted following FDA acceptance of NDA for bezuclastinib combination in GIST patients who previously received imatinib; PDUFA date scheduled for November 30, 2026
Cogent Biosciences' NDA for Bezuclastinib Accepted by FDA for Priority Review
Cogent Biosciences announced that the FDA has accepted its new drug application, or NDA, for bezuclastinib in combination with sunitinib for patients with Gastrointestinal Stromal Tumors, or GIST, who have received prior treatment with imatinib. The FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act target action date of November 30. In addition, the FDA communicated that at this time, there is no plan to hold an advisory committee, nor have they identified any potential review issues.
Cogent Biosciences to Present KRAS and ErbB2 Research Data at AACR Meeting
Cogent Biosciences announced that preclinical data from the Company's KRAS and ErbB2 pipeline programs will be presented during poster sessions at the American Association for Cancer Research, AACR, Annual Meeting 2026 taking place in April 17-22 in San Diego, CA. Title: Characterization of CGT1263, a KRAS inhibitor clinical candidate with selectivity for mutant KRAS over HRAS and NRAS. preclinical poster highlights Cogent's internally developed pan-KRAS(ON) inhibitor with greater than500x selectivity for KRAS over HRAS and NRAS. Overall, these findings suggest CGT1263 could provide an advantage for patients, enabling higher dosing designed to elicit a more profound molecular response. Investigational New Drug enabling studies are ongoing with an IND submission expected later this year. Title: Preclinical characterization of CGT4255, an EGFR sparing, pan-mutant HER2 clinical development candidate with potential best-in-class brain penetration. Cogent's EGFR-sparing, brain-penetrant ErbB2 inhibitor includes potent coverage of key mutations inadequately addressed by currently approved therapies. Activating mutations in the ErbB2 gene have been identified in multiple cancers and demonstrate a tumorigenic role similar to that of ErbB2 amplification.
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