Crinetics Pharma Stock Soars 24% on FDA Approval for Acromegaly Drug
The once-daily oral treatment, PALSONIFY, is the first of its kind for the rare endocrine disorder, prompting a wave of analyst upgrades.
Crinetics Pharmaceuticals (NASDAQ: CRNX) saw its shares surge nearly 24% after the company announced it had received for PALSONIFY (paltusotine). The drug is the first once-daily oral treatment for acromegaly, a rare and chronic hormonal disorder, marking a significant milestone for both the company and patients seeking more convenient treatment options.
The approval immediately catalyzed investor enthusiasm, with the stock climbing to a new 20-day high of $44.41 in the session following the announcement. This regulatory win addresses a major unmet need for individuals with acromegaly who have had an inadequate response to surgery or for whom surgery is not a viable option. Previously, many patients relied on burdensome injectable treatments.
The FDA's decision was underpinned by positive data from two pivotal Phase 3 clinical trials, PATHFNDR-1 and PATHFNDR-2. These studies demonstrated that PALSONIFY was not only effective in providing reliable biochemical control but was also well-tolerated, with patients reporting significant improvement in their symptoms and overall quality of life.
Wall Street analysts reacted decisively to the news, with several firms upgrading their price targets for CRNX stock. Piper Sandler maintained an "Overweight" rating, calling the drug a potential and setting a price target of $97. JMP Securities was even more bullish, raising its target to $143 from $86, citing the drug's "clean label" and rapid efficacy. Oppenheimer also reiterated its "Outperform" rating, noting the drug's higher-than-expected list price as a key factor in its commercial potential.
With a broad label and a thoughtful pricing strategy, Crinetics is poised for significant revenue growth as PALSONIFY prepares for its U.S. launch in early October 2025. The company has established a patient support program, CrinetiCARE®, to facilitate access and adoption. This approval solidifies Crinetics' position as a leader in developing novel therapeutics for rare endocrine diseases and offers a promising new outlook for the acromegaly community.