Crinetics Wins FDA Approval for Oral Acromegaly Drug PALSONIFY
The nod for the first-in-class daily pill marks a pivotal shift to commercial-stage, though investors appear to have already priced in the milestone.
Crinetics Pharmaceuticals (NASDAQ: CRNX) has secured a landmark U.S. Food and Drug Administration (FDA) approval for its acromegaly treatment, PALSONIFY™ (paltusotine), making it the first once-daily oral therapy for a condition dominated by injectable drugs. The decision marks a significant turning point for the company, transitioning it from a clinical-stage to a commercial enterprise.
The approval specifically covers the treatment of adults with acromegaly, a rare hormonal disorder, who have had an inadequate response to or cannot undergo surgery. after the drug demonstrated strong efficacy and safety in two pivotal Phase 3 trials, PATHFNDR-1 and PATHFNDR-2. For patients, the introduction of a daily pill offers a much-anticipated alternative to the burdensome injections that have long been the standard of care.
Despite the milestone achievement, the market's reaction was subdued, with Crinetics' share price seeing little immediate movement. This suggests that investors had largely anticipated the positive outcome. One report from July noted that a "," a sentiment that appears to have carried through to the final decision.
Wall Street analysts remain broadly optimistic about the company's trajectory, viewing the approval as a transformative event. While firms like JPMorgan and Stifel recently made minor downward adjustments to their price targets, the consensus remains positive. Cantor Fitzgerald, for example, reiterated its 'Overweight' rating with a $90 price target. The approval, as one analyst noted, "transforms Crinetics from a clinical-stage biotech into a commercial-stage pharmaceutical company with revenue-generating potential." This new chapter is supported by a strong balance sheet, with company filings showing more cash than debt.
PALSONIFY is expected to be commercially available in the U.S. in early October 2025. The company's ability to successfully launch and market the drug will be a key focus for investors moving forward, as they weigh the drug's first-in-class potential against the inherent risks of commercial execution in the competitive pharmaceutical landscape. With , the focus now shifts from regulatory hurdles to market adoption.