As previously reported, Wedbush analyst David Nierengarten downgraded Cogent Biosciences to Neutral from Outperform with a price target of $5, down from $20, after the company presented initial results from the Phase 2 SUMMIT Part 1a study of bezuclastinib in patients with indolent systemic mastocytosis, as well as updated data from the Phase 2 APEX study of bezuclastinib in advanced systemic mastocytosis. While results from the studies showed that bezuclastinib is an active agent, with rapid and sustained improvements in disease symptoms and reductions across disease biomarkers, Wedbush does not think the data presented established a differentiated efficacy profile. The firm is also mindful that Cogent’s decision to forego the validated ISM-SAF TSS measures and implement novel PRO tools for its ISM program May delay regulatory decisions. In addition, the emergence of concerning safety signals lowers Wedbush’s confidence that bezuclastinib can overcome significant first mover advantages for competitor Ayvakit in both aSM and ISM, and therefore it is moving to the sidelines.
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