Overview

• The FDA cleared Palsonify for adults with acromegaly based on PATHFNDR‑1 and PATHFNDR‑2 Phase 3 data, with the oral SST2 agonist positioned for patients not suited for surgery or with inadequate surgical response.
• Crinetics shares rose about 35% week over week following the approval, reflecting investor optimism about the launch.
• JMP Securities reaffirmed a Market Outperform rating and raised its price target to $143 from $86, citing a broad label, no new safety concerns, rapid responses, symptom improvement, and a $290,000 annual list price versus its prior $125,000 model.
• JPMorgan’s Jessica Fye maintained an Overweight rating but nudged the price target to $52 from $53 on September 24 ahead of the decision, underscoring differing valuation approaches.
• Crinetics is pursuing an EU marketing authorization with a decision expected next year, has a Japan partnership with SKK for paltusotine, and is advancing a Phase 3 in carcinoid syndrome plus two Phase 3 trials of atumelnant in congenital adrenal hyperplasia planned by year‑end.