Crinetics Pharmaceuticals has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for paltusotine, an investigational drug aimed at treating acromegaly. This marks a significant milestone for the company, potentially offering a novel, once-daily oral treatment option for patients with this endocrine disorder.
The submission is based on positive Phase 3 clinical trial data demonstrating paltusotine's efficacy and safety in patients with acromegaly. Paltusotine is a selective somatostatin receptor type 2 (SST2) nonpeptide agonist. The company anticipates a response from the FDA regarding the NDA's status in December 2024, with a potential launch in 2025.
Financial Strength and Pipeline Expansion
In October 2024, Crinetics completed an upsized public offering of common stock, generating gross proceeds of $575 million. This financial boost is expected to support the anticipated launch of paltusotine, further clinical development efforts, and investment in early-stage programs. As of September 30, 2024, Crinetics reported $862.7 million in cash, cash equivalents, and investment securities, projecting sufficient funding for its operating plan into 2029.
Crinetics is also advancing its pipeline with four new internally discovered drug candidates currently in IND-enabling studies. These include the first candidate from their novel nonpeptide drug conjugate (NDC) platform, targeting SST2-expressing tumors, with preclinical data to be presented at the North American Neuroendocrine Tumor Society (NANETS) meeting. Additionally, a development candidate has been selected in the TSH antagonist program for Graves’ disease and thyroid eye disease, with an IND filing expected in 2025.
Ongoing Clinical Programs
Additional data from the Phase 2 study of atumelnant in congenital adrenal hyperplasia (CAH) is anticipated by early 2025. Crinetics also expects to finalize a Phase 3 protocol and initiate site startup activities for paltusotine in carcinoid syndrome by the end of 2024.
Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics, stated, “The submission of our first NDA was a significant milestone in the company’s history, and we remain on track for the expected launch of our investigational drug paltusotine for acromegaly in 2025, which will be a pivotal event for the company.”
