Crinetics Pharma Surges 24% on FDA Nod for Acromegaly Pill
The biotech's lead drug, Palsonify, is the first once-daily oral therapy for the rare growth disorder, prompting swift analyst upgrades.
Shares of Crinetics Pharmaceuticals (NASDAQ: CRNX) soared nearly 24% on Wednesday after the company announced it had received , the first once-daily oral treatment for the rare hormonal disorder. The stock jumped to $44.41 as investors and analysts cheered the regulatory milestone, which positions the company to challenge the long-standing injectable therapies that have dominated the market.
Acromegaly, a condition caused by excess growth hormone, has traditionally been managed with frequent and often burdensome injections. Palsonify (paltusotine) offers a significant shift in the treatment paradigm as a novel, nonpeptide somatostatin receptor agonist in pill form. The approval marks a pivotal moment for Crinetics, validating its small-molecule drug pipeline and transitioning it into a commercial-stage entity.
The FDA's decision was , PATHFNDR-1 and PATHFNDR-2, which demonstrated the drug's ability to provide reliable biochemical control and reduce symptoms in both previously treated and untreated adult patients.
Wall Street reacted swiftly to the news, with analysts at JMP Securities significantly raising their outlook on the company. The firm , signaling strong confidence in the drug's commercial potential, particularly given its reported annual price point of around $290,000.
"This is a transformative moment for our company and, more importantly, for patients with acromegaly," said Scott Struthers, Ph.D., Founder and CEO of Crinetics, in a statement. The approval of Palsonify is the first from the company's pipeline of first-in-class drugs, setting the stage for its future growth and its mission to improve the lives of those with rare endocrine diseases.