The European Commission approved Crinetics Pharmaceuticals’ once‑daily oral therapy, PALSONIFY (paltusotine), on April 27, 2026, granting the drug market access in all 27 EU member states and three European Economic Area countries. PALSONIFY is the first oral therapy for adult acromegaly, offering a convenient alternative to the monthly injectable somatostatin receptor ligands that have dominated the market for decades.
The approval follows positive data from Crinetics’ two pivotal Phase 3 studies, PATHFNDR‑1 and PATHFNDR‑2, which demonstrated rapid onset of action, reliable biochemical control, and sustained efficacy in both previously treated and treatment‑naïve patients. The studies showed that paltusotine, a selective somatostatin receptor 2 agonist, can achieve biochemical control in a high proportion of patients within weeks, a key driver of its clinical value.
The European acromegaly market is estimated to include roughly 49,000 patients, a figure that expands the addressable population for PALSONIFY beyond the 36,000‑patient estimate used in earlier reports. With the approval, Crinetics plans to launch the drug first in Germany and Austria, with broader European commercialization to follow. The oral formulation gives the company a clear competitive advantage over injectable therapies, potentially improving patient adherence and preference.
Crinetics’ financial performance in the fourth quarter of 2025 supports the company’s ability to capitalize on the approval. Revenue reached $6.1 million, surpassing estimates, while earnings per share were –$1.29, beating the forecast of –$1.34. The company reported $1.0 billion in cash and investment securities as of December 31, 2025, providing a strong financial foundation for the upcoming launch and continued pipeline development.
"The European Commission's decision to approve Palsonify reflects the strength of the clinical data and marks a pivotal step toward bringing this important therapy to even more people living with acromegaly," said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. "This approval represents another exciting milestone for Palsonify as it accelerates to become the new standard in acromegaly care in the U.S., and soon abroad. This is also a notable achievement for Crinetics in pursuit of our vision to become the global leader in endocrinology." "Orphan designation from the EMA further highlights the unmet need in acromegaly and the potential benefit paltusotine can bring for patients," added Dana Pizzuti, M.D., Chief Medical and Development Officer.
The approval validates Crinetics’ oral GPCR platform and positions the company to extend the technology to other endocrine indications. Paltusotine is already in Phase 3 clinical development for carcinoid syndrome, and the company has additional candidates in the pipeline, including atumelnant for congenital adrenal hyperplasia and ACTH‑dependent Cushing's syndrome. The EMA clearance marks Crinetics’ first regulatory approval outside the United States, following FDA approval in September 2025, and underscores the company’s global commercialization strategy.
The European Commission’s approval of PALSONIFY represents a significant advance for patients with acromegaly, offering a convenient once‑daily oral option that could improve adherence and outcomes. For Crinetics, the approval expands its market reach, strengthens its financial position, and reinforces its strategy to leverage a proven oral GPCR platform across multiple endocrine disorders.
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