Crinetics Pharmaceuticals Inc. (CRNX) has sought FDA approval for its lead development candidate, PALSONIFY, and a decision is expected on September 25, 2025.PALSONIFY, formerly known as Paltusotine, is proposed for the treatment of acromegaly.Acromegaly is caused by a benign pituitary tumor that secretes excess growth hormone (GH). This overproduction of GH leads to somatic overgrowth, causing enlarged hands, feet, distinctive facial changes, multiple comorbidities, and even premature mortality.Roughly 27,000 people in the United States are affected by acromegaly.There are several treatment options for this condition, and injectable Somatostatin receptor ligands (SRLs) are considered a mainstay of treatment for acromegaly. Novartis’ Sandostatin and Signifor are examples of injectable SRLs. However, these injections come with certain drawbacks, such as injection site reactions, a return or worsening of symptoms toward the end of the dosing cycle, and the emotional burden of relying on others for administration, which some patients find upsetting. Crinetics’ PALSONIFY is designed to be a once-daily oral option for the control of acromegaly. If approved, it will be the first and only once-daily, oral, selective somatostatin receptor type 2 nonpeptide agonist available for adults living with acromegaly.CRNX closed Wednesday’s (Aug.27, 2025) trading at $30.40, down 1.71%.