FDA Approval Progress for Paltusotine
The NDA review for paltusotine remains on track, with anticipated FDA approval expected in September 2025. The regulatory team has maintained excellent momentum, and the launch team has been assembled in preparation for the anticipated approval.
Commercial Launch Strategy for PALSONIFY
Crinetics has made meaningful progress in interactions with healthcare professionals, patients, and payers as they approach the launch of PALSONIFY. They have built out a commercial team and are onboarding a sales force to support the launch.
Pipeline Progress and Multiple Clinical Trials
Crinetics is advancing several clinical programs, including trials for carcinoid syndrome and congenital adrenal hyperplasia. They also plan to initiate a Phase II/III study for ACTH dependent Cushing's syndrome in 2026.
Strong Financial Position
Crinetics ended the quarter with $1.2 billion in cash, cash equivalents, and investments, with sufficient funds to operate into 2029. They have lowered the high end of their guidance for net cash used in operations for 2025.