San Diego, CA based Crinetics Pharmaceuticals (CRNX) delivered a watershed moment on Friday as the FDA granted approval of Palsonify (paltusotine), the first once-daily, oral therapy for acromegaly—a rare hormonal disorder—propelling shares to their strongest session of the year. On Friday, Crinetics stock leapt ~+24% to $46.11 after trading near $35 prior to the announcement, making it the top gainer among U.S. biotech stocks for the day., but it is still down approx. 11% YTD.
Analyst Commentary and Forecasts
Sell-side analysts responded decisively. JMP Securities lifted its price target from $86 to $143, citing Palsonify’s clean label and transformative potential as a standard of care therapy for acromegaly. Oppenheimer reiterated its Outperform rating, pointing out that while the annual wholesale acquisition cost of $290,000 exceeded consensus expectations, the absence of major label restrictions and strong clinical data augur well for rapid uptake. Eight analysts currently rate Crinetics as a Buy or Outperform, with consensus estimates for 12-month price targets ranging from $35 to $143. Technical signals are reportedly bullish, but neutral sentiment is observed based on longer-term profitability concerns.
Commercial Rollout and Market Dynamics
Palsonify is expected to be available in early October, supported by CrinetiCARE services to enhance patient access and adherence. Entering a market dominated by injectable therapies, the company is betting its oral formulation will drive adherence and market share capture. The FDA approval, clean labeling, and indication for adults across a wide patient spectrum validate Crinetics’ small molecule platform and elevate its profile among endocrine-focused peers.
Pipeline Prospects and Industry Response
Crinetics’ pipeline, including treatments for congenital adrenal hyperplasia and carcinoid syndrome, now carry less regulatory risk with Palsonify’s nod. Analysts expect this momentum and the strong cash position to fuel future expansions and acquisitions in fragmented endocrine therapy markets.
The Sum…
Crinetics Pharmaceuticals (CRNX), with its landmark Palsonify approval, has turned a corner from underperformance to leadership, buoyed by bullish analyst sentiment and game-changing clinical data, poised to redefine care standards for rare endocrine diseases.
Sources
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