Crinetics Q1 2024 Earnings Report
Key Takeaways
Crinetics Pharmaceuticals reported Q1 2024 financial results, highlighting positive data from Phase 3 trials of paltusotine in acromegaly and Phase 2 study in carcinoid syndrome. The company is preparing for an NDA submission for paltusotine in the second half of 2024 and plans to initiate a Phase 3 study in carcinoid syndrome by the end of the year. They strengthened their balance sheet with a $350 million private placement.
Phase 3 PATHFNDR-2 study of paltusotine achieved primary and all secondary endpoints.
Phase 2 study of paltusotine in carcinoid syndrome reported positive results.
Strengthened balance sheet with $350 million private placement financing.
Initial results from Phase 2 studies of atumelnant in CAH and ACTH-dependent Cushing’s syndrome will be presented at ENDO in June 2024.
Crinetics
Crinetics
Forward Guidance
Crinetics anticipates several key milestones including presenting initial results from Phase 2 studies of atumelnant at ENDO 2024, submitting an NDA for paltusotine for acromegaly in the second half of 2024, and initiating a Phase 3 program of paltusotine for carcinoid syndrome by the end of 2024.
Positive Outlook
- Initial results from the ongoing Phase 2 studies of atumelnant in congenital adrenal hyperplasia (CAH) and ACTH-dependent Cushing’s syndrome will be presented at the Endocrine Society’s annual meeting, ENDO 2024, being held June 1-4, 2024 in Boston.
- Submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking regulatory approval of paltusotine for the treatment of acromegaly is anticipated in the second half of 2024.
- Initiation of a Phase 3 program of paltusotine for carcinoid syndrome by the end of 2024, pending discussions with the FDA.