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Crinetics Pharmaceuticals Reports First Quarter 2025 Financial Results and Provides Business Update
CRNXCrinetics Pharmaceuticals(CRNX) GlobeNewswire·2025-05-08 20:05

Core Insights - Crinetics Pharmaceuticals is on track for the FDA review of paltusotine, with a PDUFA date set for September 25, 2025, for the treatment of acromegaly [5][6] - The company is initiating a Phase 3 study for atumelnant aimed at normalizing androstenedione levels in adults with congenital adrenal hyperplasia (CAH) [3][6] - Crinetics has a strong financial position with 1.3billionincashandequivalentsasofMarch31,2025,expectedtofundoperationsinto2029[10][14]RegulatoryandClinicalDevelopments−TheFDAreviewprocessforpaltusotine′sNewDrugApplication(NDA)isprogressingpositively,withconsistentengagementfromtheFDA[6]−TheEuropeanMedicinesAgency(EMA)hasvalidatedthemarketingauthorizationapplication(MAA)forpaltusotine,withapotentialdecisionexpectedinthefirsthalfof2026[6]−ThePhase2TouCAHnstudyofatumelnantinCAHhasshownpositiveresults,leadingtotheinitiationofaPhase3CALM−CAHstudy[6][10]FinancialPerformance−Revenuesforthefirstquarterof2025were1.3 billion in cash and equivalents as of March 31, 2025, expected to fund operations into 2029 [10][14] Regulatory and Clinical Developments - The FDA review process for paltusotine's New Drug Application (NDA) is progressing positively, with consistent engagement from the FDA [6] - The European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for paltusotine, with a potential decision expected in the first half of 2026 [6] - The Phase 2 TouCAHn study of atumelnant in CAH has shown positive results, leading to the initiation of a Phase 3 CALM-CAH study [6][10] Financial Performance - Revenues for the first quarter of 2025 were 0.4 million, down from 0.6millioninthesameperiodof2024,primarilyfromalicensingagreementforpaltusotine[10][14]−Researchanddevelopmentexpensesincreasedto0.6 million in the same period of 2024, primarily from a licensing agreement for paltusotine [10][14] - Research and development expenses increased to 76.2 million in Q1 2025 from 53.3millioninQ12024,drivenbyclinicalprogramadvancements[10][14]−ThenetlossforQ12025was53.3 million in Q1 2024, driven by clinical program advancements [10][14] - The net loss for Q1 2025 was 96.8 million, compared to a net loss of $66.9 million in Q1 2024 [10][14] Upcoming Milestones - R&D Day is scheduled for June 26, 2025, to discuss early-stage pipeline strategies and data [3][10] - The company plans to initiate the CAREFNDR Phase 3 trial of paltusotine in carcinoid syndrome in the second half of 2025 [10] - Initiation of the CALM-CAH Phase 3 study in adults and a Phase 2/3 study in pediatrics is expected in the second half of 2025 [10]