Crinetics Pharmaceuticals, Inc. (CRNX) announced that the European Commission or EC has approved PALSONIFY or Paltusotine for the treatment of adult patients with acromegaly, a rare endocrine condition.
PALSONIFY or Paltusotine is an oral, selectively-targeted somatostatin receptor type 2 nonpeptide agonist.
Notably, on September 25, 2025, PALSONIFY was approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of adults with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option.
PALSONIFY is the first once-daily, oral therapy approved to treat acromegaly in the European Union, and the EC approval is valid in all 27 member states of the EU and in three European Economic Area (EEA) countries.
The EC approval was based on the strength of data from two pivotal Phase 3 studies, PATHFNDR-1 and PATHFNDR-2, evaluating PALSONIFY in both medical-naive and previously treated patients with acromegaly.
Across both trials, PALSONIFY consistently demonstrated rapid onset, reliable biochemical control, and sustained efficacy.
In Phase 3 studies, once-daily, oral PALSONIFY maintained IGF-1 levels and symptom control in patients with acromegaly who were switched from monthly injectable medications (PATHFNDR-1) and rapidly decreased IGF-1 levels and symptom burden in medically untreated acromegaly patients.
In addition, participants reported significant reductions in signs and symptoms associated with acromegaly, as measured by the Acromegaly Symptom Diary (ASD), a validated patient-reported outcome tool designed to capture the symptoms that matter to people living with acromegaly.
Following FDA approval in the fourth quarter of 2025, PALSONIFY's net product revenue was $5.4 million.
As of December 31, 2025, Crinetics' cash, cash equivalents, and investment securities totalled $1.0 billion.
CRNX has traded between $25.83 and $57.99 over the last year. The stock closed Monday's trade at $38.62, up 0.76%.
In the overnight market, CRNX is down 1.61% at $38.00.
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