CompetitionPaltusotine's lead indication is acromegaly where SRLs are SOC, but fail to provide durable disease control and require painful injections.
Regulatory ApprovalCrinetics is approaching its September 25 PDUFA for Palsonify (paltusone) in acromegaly, following NDA acceptance in December of last year on the back of positive Phase 3 PATHFNDR-1 and PATHFNDR-2 results.
Safety ConcernsManagement reiterated comfort in atumelnant’s safety profile, despite a single case of AST/ALT elevations in the 120mg cohort, citing the growing body of clinical experience.