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Crinetics Announces Strong PALSONIFY Launch Execution and Positive Results for Concurrent Androstenedione Lowering and Glucocorticoid Dose Reduction in Phase 2 Trial of Atumelnant for Congenital Adrenal Hyperplasia
Globenewswire· 2026-01-05 13:00
Core Insights - Crinetics Pharmaceuticals reported unaudited and preliminary net product revenue of over $5 million for PALSONIFY in the fourth quarter of 2025, with over 200 enrollment forms submitted by the end of December [2][4][5] - Positive topline results from the fourth cohort of the Phase 2 congenital adrenal hyperplasia (CAH) study of atumelnant were announced, showing a 67% mean reduction in androstenedione levels and enabling 88% of participants to successfully reduce glucocorticoid doses to physiological levels [1][8][9] Company Performance - The launch of PALSONIFY, approved by the FDA on September 25, 2025, has been characterized by strong execution, with over 200 enrollment forms and a broad prescriber base [3][4][7] - Feedback from patients, physicians, and payers has been positive, leading to early formulary inclusions by payers [4][5] Clinical Study Results - The fourth cohort of the Phase 2 TouCAHn trial involved 10 patients with classic CAH, with treatment resulting in significant reductions in androstenedione levels [5][8] - Atumelnant was well-tolerated, with no serious adverse events reported, and a favorable benefit/risk profile maintained throughout the study [11][14] Future Outlook - Crinetics plans to host an investor conference call to discuss the topline results from the study, indicating ongoing engagement with investors and stakeholders [15][16] - Atumelnant is positioned as a potential transformational treatment for congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome, with ongoing Phase 3 clinical development [17][20]
Crinetics to Showcase the Next Generation of Endocrinology Innovation at ENDO 2025 with Eight Presentations From its Deep Pipeline
Globenewswire· 2025-06-30 20:05
Core Insights - Crinetics Pharmaceuticals is set to present long-term efficacy and safety data for its investigational drug PALSONIFY (paltusotine) in acromegaly, demonstrating both biochemical and symptom control with a well-tolerated safety profile [1][2] - The company will also showcase Phase 2 trial results for atumelnant in congenital adrenal hyperplasia (CAH) and data from early-stage development programs in Graves' hyperthyroidism and orbitopathy at the Endocrine Society's Annual Meeting, ENDO 2025 [1][3] PALSONIFY Presentations - Four abstracts will report results from the PALSONIFY development program, including an oral presentation on long-term efficacy, safety, and symptom control in acromegaly patients switching from injectable somatostatin receptor ligands to once-daily oral PALSONIFY [2][4] - Three poster presentations will cover symptom stability in acromegaly, patient-reported outcomes from PATHFNDR-1 and PATHFNDR-2, and open-label extension data from PATHFNDR-2 [2] Atumelnant Presentations - Three abstracts will focus on atumelnant, including an oral presentation of Phase 2 trial results in CAH, highlighting reductions in adrenal volume and significant decreases in potent 11-oxygenated androgens [3][7] Early-Stage Pipeline - Crinetics will present new data from its early-stage pipeline, including findings related to CRN12755 for Graves' hyperthyroidism and orbitopathy [4][8] Company Overview - Crinetics Pharmaceuticals is a clinical-stage pharmaceutical company focused on developing novel therapeutics for endocrine diseases and related tumors, with PALSONIFY and atumelnant as its lead candidates [11]