Crinetics Pharmaceuticals shares soar after FDA clears Palsonify, the first oral acromegaly treatment

How does the FDA approval of Palsonify mark a turning point in the treatment of acromegaly for adult patients in the United States?

Crinetics Pharmaceuticals, Inc. (NASDAQ: CRNX) secured a major regulatory milestone on September 25, 2025, with the U.S. Food and Drug Administration granting approval for Palsonify (paltusotine), a first-in-class oral therapy designed to treat adults with acromegaly who either do not respond to surgery or are unable to undergo surgical procedures. The news triggered an immediate and sharp rally in Crinetics shares, which closed at USD 45.91, up nearly 28 percent on September 26. In after-hours trading, the stock held steady at USD 45.90, reflecting institutional enthusiasm tempered by some profit-taking.

The approval is notable because Palsonify is the first once-daily oral nonpeptide somatostatin receptor type 2 agonist available to patients. This represents a radical shift in acromegaly care, where injectable therapies such as octreotide and lanreotide have long dominated the treatment landscape. For patients living with this rare endocrine disorder, the transition from monthly injections to an oral option offers a meaningful quality-of-life improvement.

What did the pivotal Phase 3 PATHFNDR trials demonstrate about Palsonify’s safety and efficacy profile in acromegaly patients?

The FDA’s green light came on the back of robust data from two pivotal Phase 3 trials known as PATHFNDR-1 and PATHFNDR-2. The first trial evaluated patients who were already receiving injectable somatostatin analogues and were switched to Palsonify. Results demonstrated sustained biochemical control, measured primarily through levels of insulin-like growth factor 1 (IGF-1), the key biomarker used to monitor disease progression. Patients experienced consistent maintenance of IGF-1 levels without the dips and spikes that can occur between injection cycles.

PATHFNDR-2 focused on medically untreated patients. These participants achieved rapid declines in IGF-1, along with significant improvements in symptoms such as headaches, sweating, joint pain, and fatigue. Together, the trials demonstrated not only biochemical efficacy but also patient-reported benefits that align with the needs of individuals living with acromegaly.

Data presented at ENDO 2025, the annual meeting of the Endocrine Society, confirmed the durability of the response in open-label extensions. More than 90 percent of trial participants continued therapy, highlighting both tolerability and adherence advantages. Importantly, no serious adverse events were reported during the randomized controlled portions, cementing Palsonify’s safety credentials.

How are patients, physicians, and advocacy groups responding to the approval of an oral treatment alternative for acromegaly?

The impact of the FDA approval extends beyond the clinical data. For years, patient communities have voiced frustration over the burden of long-acting injectable therapies. Monthly injections often require clinical visits, generate breakthrough symptoms, and disrupt lifestyle routines. With Palsonify, patients now have the option of taking a once-daily oral pill that provides consistent control without the physical and logistical drawbacks of injectables.

Leaders from advocacy groups such as the Acromegaly Community stressed that this decision reflects a rare example of patient voices directly shaping regulatory outcomes. By working with the FDA through Externally Led Patient-Focused Drug Development meetings, the community underscored that symptom control and lifestyle convenience are equally important as biochemical endpoints. Physicians echoed this sentiment, with endocrinologists noting that Palsonify’s oral route addresses long-standing barriers to adherence and overall disease management.

How did investors and institutional analysts interpret Crinetics’ FDA approval and what does the stock market reaction reveal?

From a market perspective, the FDA approval delivered immediate value for Crinetics. On September 26, the American biotech company’s stock surged to USD 45.91, gaining more than 27 percent in a single session. That jump positioned Crinetics among the day’s strongest biotech performers on Nasdaq.

Institutional investors framed the decision as transformative for Crinetics, which until now had been a development-stage biotech with no commercial revenue stream. By securing its first FDA approval, the company transitions into a fully commercial entity, strengthening both its credibility and its financial outlook. Analysts described the stock rally as a reflection of pent-up confidence, suggesting that the commercial potential of Palsonify is now largely de-risked.

The broader sentiment is that Crinetics has entered a new growth phase, with investors anticipating early uptake in the United States supported by payer negotiations and strong advocacy alignment. Some observers expect the approval to serve as a catalyst for new partnerships, licensing deals, or even strategic interest from larger pharmaceutical players seeking to expand into rare endocrine disease markets.

What commercial strategies and patient access programs has Crinetics put in place to support Palsonify’s U.S. launch?

Crinetics expects Palsonify to become available in the U.S. market in early October 2025. To support adoption, the company has launched CrinetiCARE, a patient services program that includes financial assistance, benefit verification, educational resources, and direct support from nurse educators. This comprehensive framework is designed to ensure that patients can navigate reimbursement, manage treatment onboarding, and maintain adherence.

By prioritizing payer engagement and access, Crinetics is signaling its commitment to rapid market penetration. Industry experts highlight that rare disease therapies often face high costs, but programs like CrinetiCARE can mitigate barriers, ultimately driving broader adoption. Advocacy organizations have welcomed these initiatives, calling them critical in ensuring equity and affordability in acromegaly treatment.

How will global regulatory pathways and new indications shape the growth potential of Palsonify in the next two years?

While U.S. commercialization is the immediate priority, Crinetics is pursuing international expansion. A Marketing Authorization Application for paltusotine is currently under review with the European Medicines Agency, with a regulatory opinion expected in the first half of 2026. In Japan, Crinetics is collaborating with Sanwa Kagaku Kenkyuso (SKK) to develop and commercialize the drug locally.

Beyond acromegaly, Crinetics is exploring Palsonify’s potential in carcinoid syndrome, a debilitating condition associated with neuroendocrine tumors. The Phase 3 CAREFNDR trial is underway with global enrollment expected through 2025. If successful, this second indication could further expand Palsonify’s revenue base and solidify Crinetics’ position in endocrine-related oncology.

How does the approval of Palsonify validate Crinetics’ broader research pipeline and long-term business model?

The FDA decision also strengthens confidence in Crinetics’ broader research pipeline. The San Diego-based drugmaker specializes in developing small-molecule therapies targeting G-protein coupled receptors, with multiple candidates in late-stage development. Chief among these is atumelnant, which is being studied for congenital adrenal hyperplasia and ACTH-dependent Cushing’s syndrome.

Institutional sentiment suggests that success with Palsonify reduces perceived risk across the pipeline, as it validates the company’s discovery approach and regulatory capabilities. Analysts believe that Crinetics is now better positioned to attract capital, secure partnerships, and negotiate favorable licensing terms. For investors, the stock’s momentum underscores a shift in perception from high-risk development stage biotech to a maturing commercial company with a robust future.

What does the FDA approval of Palsonify mean for Crinetics’ ambition to emerge as a global leader in endocrine therapeutics over the next decade?

The FDA approval of Palsonify represents more than just a milestone for Crinetics. It marks the first true innovation in acromegaly treatment in decades and directly addresses patient frustrations with injectable therapies. For those living with the disease, it offers new hope for consistent control and improved quality of life. For Crinetics, it is the start of a commercial era that could redefine its role in global endocrine medicine.

Investor sentiment, reflected in a 28 percent share price surge, highlights the degree of market confidence in both the drug’s potential and the company’s execution capabilities. With additional regulatory filings in Europe and Japan and ongoing development for carcinoid syndrome, Palsonify could become the foundation of a multi-indication franchise. Crinetics’ broader pipeline further reinforces the outlook that the company is positioned not just as a niche biotech, but as a rising leader in endocrine therapeutics worldwide.