Overview

• The FDA approved Palsonify for adults with acromegaly who had an inadequate response to surgery or are not candidates for surgery.
• The decision drew on PATHFNDR-1 and PATHFNDR-2 Phase 3 data in which the drug showed rapid onset, reliable biochemical control, and sustained efficacy.
• Crinetics plans to introduce Palsonify in the United States in early October.
• Beyond the U.S., a marketing authorization application is under review in the European Union with the company guiding to a potential decision next year, and Sanwa Kagaku Kenkyusho is partnered for development and commercialization in Japan.
• On September 24, JPMorgan trimmed its price target to $52 from $53 but kept an Overweight rating, citing slightly higher spending assumptions.