Crinetics Pharmaceuticals, Inc. (CRNX) Tuesday announced positive results from Phase 3 PATHFNDR-2 studies evaluating the efficacy and safety of oral, once-daily investigational paltusotine for the treatment of acromegaly.
PATHFNDR-2 was a randomized, double-blind, placebo-controlled 24-week treatment and the study met statistical significance on the primary endpoint. The company said all secondary endpoints also met statistical significance.
Paltusotine was generally well-tolerated and no serious adverse events were reported.
Acromegaly is a disorder in adults due to malfunctioning of the pituitary gland.
Crinetics intends to submit a New Drug Application to the U.S. Food and Drug Administration in the second half of 2024.
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