PALSONIFY (paltusotine)
Search documents
Crinetics Pharmaceuticals (NasdaqGS:CRNX) Earnings Call Presentation
2025-09-25 22:00
PALSONIFY FDA Approval and Clinical Data - PALSONIFY (paltusotine) has received FDA approval for acromegaly treatment[1] - In Phase 3 studies, 83% of patients switching from standard-of-care maintained IGF-1 control with PALSONIFY compared to 4% on placebo (p<00001)[24] - In Phase 3 studies with non-pharmacologically-treated patients, 56% achieved IGF-1 ≤ 10xULN with PALSONIFY versus 5% with placebo (p<0001)[26] - Symptom exacerbation rate declined from prior SRL screening to 0-3 months, 3-6 months, and 6-9 months of PALSONIFY treatment[35] - Less than 4% of patients taking PALSONIFY discontinued due to adverse events (AEs)[37] Commercial Launch Strategy - The company has four pillars to optimize the launch of PALSONIFY: ACTIVATE, ADOPT, ACCESS, and ADHERE[42] - The company has an experienced team in place, including 36 sales team members, 14 Medical Science Liaisons, 5 Nurse Educators, 6 CrinetiCARE Specialists, 4 Field Reimbursement Liaisons, and 4 Payer National Account Directors[44] - The company is targeting approximately 3,600 community HCPs and 45 core pituitary treatment centers (PTCs), totaling around 1,800 PTC + Academic HCP targets[44] - In the US, there are an estimated 36,000 people living with acromegaly, with 11,500 actively managed and addressable in the short term[45] Pipeline and Future Development - The company is building a foundation for its pipeline beyond Palsonify, with programs in various stages of development for indications such as hyperparathyroidism, ADPKD, ACTH-dependent Cushing's syndrome, and congenital adrenal hyperplasia[58, 59]
Crinetics Pharmaceuticals Announces August 2025 Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Globenewswire· 2025-08-11 20:05
Core Points - Crinetics Pharmaceuticals granted stock options and restricted stock units (RSUs) to new non-executive employees as part of its 2021 Employment Inducement Incentive Award Plan [1][2] - A total of 75,850 stock options and 53,400 RSUs were awarded, aimed at attracting talent to the company [1] - The stock options have an exercise price of $26.85 per share, equal to the closing price on August 8, 2025, and will vest over four years [2] Company Overview - Crinetics Pharmaceuticals is a clinical-stage pharmaceutical company focused on developing therapeutics for endocrine diseases and related tumors [3] - The lead candidate, PALSONIFY (paltusotine), is in clinical development for acromegaly and carcinoid syndrome associated with neuroendocrine tumors [3] - Other drug candidates include Atumelnant, targeting congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome, with a focus on orally delivered small molecules [3]
Crinetics Pharmaceuticals to Report Second Quarter 2025 Financial Results on August 7, 2025
Globenewswire· 2025-07-11 12:00
Group 1 - Crinetics Pharmaceuticals, Inc. will report its second quarter 2025 financial results on August 7, 2025, after market close [1] - A conference call will be held at 4:30 p.m. ET on the same day to discuss the financial results and provide a business update [1][2] - The conference call can be accessed via dial-in numbers or a live webcast, with a recommendation to connect 15 minutes prior to the start [2] Group 2 - Crinetics Pharmaceuticals is a clinical stage pharmaceutical company focused on developing novel therapeutics for endocrine diseases and related tumors [4] - The lead development candidate, PALSONIFY (paltusotine), is in clinical development for acromegaly and carcinoid syndrome associated with neuroendocrine tumors [4] - Other drug candidates include Atumelnant, which is in development for congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome, with all candidates being orally delivered small molecules [4]
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]