Crinetics Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted its new drug application (NDA) for investigational candidate paltusotine for the treatment and long-term maintenance therapy of acromegaly in adults. If approved, paltusotine will be the first and only once-daily, oral, selective somatostatin receptor type 2 nonpeptide agonist available for adults living with acromegaly.
The FDA has set a prescription drug user fee target action date of September 25, 2025, for completing the review of the NDA, with no advisory committee meeting anticipated as part of the application's review.
Paltusotine was granted orphan drug designation for the treatment of acromegaly by the FDA in July 2020. Orphan drug designation is provided to drugs intended for the safe and effective treatment, diagnosis, or prevention of rare diseases that affect fewer than 200,000 people in the United States.
Crinetics' lead development candidate, paltusotine, has completed phase 3 clinical development for acromegaly and is initiating phase 3 clinical development for carcinoid syndrome associated with neuroendocrine tumors. In phase 3 studies, once-daily, oral paltusotine maintained IGF-1 levels and symptom control in patients with acromegaly who were switched from monthly injectable medications (Pathfndr-1) and rapidly decreased IGF-1 levels and symptom burden in medically untreated acromegaly patients (Pathfndr-2).
Acromegaly is a serious rare disease generally caused by a benign pituitary adenoma (tumor) that secretes excess growth hormone (GH). Excess GH secretion causes excess secretion of insulin-like growth factor-1 (IGF-1) from the liver, leading to progressive and serious systemic complications. Acromegaly symptoms include headache, joint aches, fatigue, and sleep apnea, among others.
Crinetics Pharmaceuticals is a clinical-stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors. Their lead development candidate, paltusotine, is the first investigational once-daily, oral, selective somatostatin receptor type 2 (SST2) nonpeptide agonist that is in clinical development for acromegaly and carcinoid syndrome associated with neuroendocrine tumors. Today the company's shares have moved -2.4% to a price of $57.43. If you want to know more, read the company's complete 8-K report here.
