Wedbush remains bullish on Cogent, says APEX Part 2 likely to succeed

Wedbush notes that Cogent Biosciences provided a program update for its Phase 2 APEX study of bezuclastinib in advSM, which has begun and will enroll about 65 patients at the optimized 150 mg QD dose. COGT expects to complete enrollment by year-end 2024 and anticipates that a successful study would support a regulatory submission in advSM. Cogent expects to present updated data from 30 patients from Part 1 of the study at a medical conference in the second half of 2023. The company stated that the efficacy and safety profile in these patients remain consistent with what was reported at ASH, Wedbush adds. Given the data and the higher predicted clinical exposure of bezuclastinib’s optimized formulation, the firm believes that APEX Part 2 is likely to succeed. In the nearer-term, Wedbush looks forward the lead-in data from the Phase 3 PEAK study of bezuclastinib + sutent in GIST in the first half of 2023 and expects a positive initial readout. The firm has an Outperform rating on the shares with a price target of $20.