NDA Acceptance for Paltusotine
The FDA accepted the NDA for paltusotine for acromegaly with a PDUFA date of September 25, 2025. This is Crinetics' first NDA filing.
Positive Clinical Data for Paltusotine and Atumelnant
Paltusotine showed rapid, sustained reductions in carcinoid symptoms in Phase II, while Atumelnant demonstrated significant biomarker and symptom improvements in CAH and Cushing's disease trials.
Strong Financial Position
Crinetics ended 2024 with approximately $1.4 billion in cash and investments, expected to fund operations into 2029.
Expansion into European Market
Crinetics is preparing for EMA filing for paltusotine in acromegaly and has established a hub in Switzerland to expand into the European market.
IND Submissions for 2025
Crinetics plans to submit 4 INDs in 2025, including for the SST2-targeting NDC 9682 for tumors, PTH antagonist for hyperparathyroidism, TSH antagonist for hyperthyroidism, and SST3 agonist for ADPKD.