Crinetics Stock Soars 28% on FDA Approval of Acromegaly Drug
The biotech firm's PALSONIFY is the first once-daily oral treatment for the rare growth disorder, marking a significant commercial milestone.
Shares of Crinetics Pharmaceuticals (CRNX) surged nearly 28% after the U.S. Food and Drug Administration (FDA) approved its groundbreaking acromegaly treatment, PALSONIFY. The stock saw a massive influx of trading activity, with volume swelling to six times its daily average as investors reacted to the news.
The drug, known chemically as paltusotine, is the , a rare and chronic condition caused by excess growth hormone production. Historically, patients have had to rely on burdensome and often painful injections. PALSONIFY's approval as a convenient oral alternative represents a significant advancement in patient care and a major commercial opportunity for the San Diego-based company.
Wall Street has responded with bullish enthusiasm. Analysts at Leerink Partners lauded the drug's "compelling" clinical data, while Oppenheimer highlighted its , which allows for its use in adults who have not responded adequately to surgery or for whom surgery is not an option. This favorable labeling is expected to support a strong commercial launch.
The approval was based on robust results from two Phase 3 trials, PATHFNDR-1 and PATHFNDR-2, which demonstrated that PALSONIFY provided durable biochemical control and reduced symptom burden. The company has announced an annual wholesale price of $290,000, a figure that substantially exceeded analyst expectations and led several firms, including Baird and JMP Securities, to raise their price targets on the stock.
Crinetics is preparing for a U.S. market launch in early October and has established a patient support program called CrinetiCARE to facilitate access. The company's strong financial position, with a reported $1.2 billion in cash at the end of the second quarter, provides a solid runway for the commercialization of PALSONIFY and the continued development of its pipeline. The approval is seen by many as a that could position PALSONIFY as the new standard of care for thousands of patients living with acromegaly.