Cogent Secures Priority Review as Launch Spending Rises
Cash and marketable securities declined to $792.3 million as the drug developer prepared for potential launches.
Cogent Biosciences (COGT), a clinical-stage biotechnology company, secured FDA priority review for its gastrointestinal stromal tumor treatment while widening its quarterly loss as launch preparations accelerated.
The GIST application marked the clearest advance in a quarter that moved Cogent closer to potential commercialization. The FDA set a Nov. 30, 2026, decision date for bezuclastinib after the company initiated the application under Real-Time Oncology Review in the fourth quarter and completed the submission in the first quarter.
Cogent's net loss widened 31% from a year earlier to $96.4 million. Operating expenses rose 36% to $102.6 million, producing an operating loss of the same amount.
The increase reflected a shift toward commercial readiness. General and administrative expense more than doubled to $31.8 million as Cogent invested in launch personnel and infrastructure, while research and development expense rose 14% to $70.8 million. R&D spending nevertheless declined $4.6 million from the first quarter.
Cogent completed onboarding its field-based commercial and medical customer-facing organization during the quarter, fulfilling an earlier plan to build the operation ahead of potential second-half launches. The hiring also resulted in inducement awards for 59 employees covering options on 226,700 shares and 189,700 restricted stock units.
The company also submitted its advanced systemic mastocytosis application on June 30, completing all three planned bezuclastinib submissions. Updated APEX results showed a 65% objective response rate among 68 evaluable patients, compared with 57% in the December topline disclosure; 57% achieved a complete response, complete response with partial hematologic recovery or partial response.
Cogent added a 40-patient first-line GIST extension cohort for patients with KIT exon 9 mutations after observing median progression-free survival of 25.1 months in a 32-patient subgroup. Enrollment was also completed in the SUMMIT avapritinib-switch extension trial, with preliminary results expected by year-end 2026.
Cash declined $74.1 million during the quarter, though $73.6 million raised through subsequent at-the-market sales lifted the pro forma balance to $865.9 million. Capital is expected to fund operations into late 2028, including potential approvals in GIST and systemic mastocytosis and early launch activities.