Crinetics Soars 28% on FDA Approval for Acromegaly Drug
PALSONIFY becomes the first once-daily oral treatment for the rare hormonal disorder, transforming the company into a commercial-stage entity.
Shares of Crinetics Pharmaceuticals (NASDAQ: CRNX) surged nearly 28% after the company announced it received U.S. Food and Drug Administration (FDA) approval for its once-daily oral medication, PALSONIFY. The drug is a new treatment for acromegaly, a rare and debilitating hormonal disorder, marking a significant milestone for patients who previously relied on injectable therapies.
The approval transforms Crinetics from a clinical-stage biotech into a commercial company. The stock reacted immediately to the news, climbing 27.9% to close at $45.91 on exceptionally high trading volume, which was nearly seven times the daily average. The decision from the FDA establishes PALSONIFY as the first once-daily, oral treatment for adults with acromegaly, a market that analysts believe has significant growth potential.
The FDA's green light was supported by positive data from two pivotal Phase 3 trials, PATHFNDR-1 and PATHFNDR-2. Across these studies, PALSONIFY demonstrated strong and sustained efficacy in controlling the disease, along with a favorable safety profile. According to the , the broad label will allow the drug to be used as a first-line treatment for a wide range of eligible patients.
Wall Street has responded with strong bullish sentiment following the approval. Multiple investment banks have raised their price targets on CRNX shares. For instance, with a $97 price target, while Leerink Partners and Morgan Stanley also increased their targets to $88 and $77, respectively. Analysts project that , driven by patient demand for a more convenient oral alternative to injections.
Crinetics plans a U.S. launch for PALSONIFY in early October, with an annual list price set at $290,000. While the approval is a major victory, the company now faces the challenges of commercial execution and potential pushback from payers on the drug's price point, factors that will be critical to its long-term success.