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Crinetics Pharmaceuticals, Inc. reports news on the commercialization of PALSONIFY and the development of therapies for endocrine diseases and endocrine-related tumors. The company’s lead product, PALSONIFY (paltusotine), is a once-daily oral treatment approved for adults with acromegaly who had an inadequate response to surgery or for whom surgery is not an option. Recurring updates include product revenue, commercial launch activity, regulatory approvals and submissions, and financial results.
Crinetics’ pipeline news also covers paltusotine in carcinoid syndrome associated with neuroendocrine tumors, atumelnant in congenital adrenal hyperplasia and ACTH-dependent Cushing’s syndrome, and CRN09682 for SST2-expressing neuroendocrine tumors and other solid tumors. The company also reports discovery work involving GPCR-targeted small molecules and other endocrine targets.
Crinetics Pharmaceuticals (Nasdaq: CRNX) has initiated a Phase 1 study for CRN04777, an oral SST5 agonist aimed at treating congenital hyperinsulinism (HI). This rare disease causes excessive insulin production leading to life-threatening hypoglycemia. The study will assess safety and tolerability in healthy adults and evaluate CRN04777's capacity to suppress insulin secretion upon glucose or sulfonylurea stimulation. The FDA has granted this investigational drug a rare pediatric disease designation, highlighting its potential significance in addressing an under-served medical need.
Crinetics Pharmaceuticals (Nasdaq: CRNX) aims to advance its drug paltusotine to a Phase 3 trial for acromegaly in H1 2021. Additionally, two Phase 1 studies are set to commence in January and February 2021 for CRN04894 and CRN04777, targeting congenital adrenal hyperplasia and congenital hyperinsulinism, respectively. The company plans to highlight key priorities at the virtual J.P. Morgan Healthcare Conference on January 13, 2021. Crinetics continues to enhance its clinical teams, expanding to 90 employees, to support its growing pipeline of endocrine therapies, including new formulations of paltusotine.
Crinetics Pharmaceuticals (Nasdaq: CRNX) announced its participation in key conferences in December 2020. Management will present at the Evercore ISI 3rd Annual HealthCONx Conference on December 3rd, showcasing their innovations in oral drugs. Additionally, they will also feature in the Piper Sandler's 32nd Annual Healthcare Conference from December 1st to 3rd, with on-demand presentations available. The company focuses on developing novel therapeutics for rare endocrine diseases, with its lead candidate, paltusotine, targeting acromegaly and other conditions.
Crinetics Pharmaceuticals (Nasdaq: CRNX) appointed Dr. Peter Trainer as Vice President of Clinical Endocrinology. Dr. Trainer, a distinguished endocrine expert, will lead the Phase 3 development of paltusotine, a nonpeptide somatostatin receptor agonist aimed at treating acromegaly. His prior roles include significant positions in academia and healthcare organizations in the UK. Crinetics is also preparing to start clinical trials for a new nonpeptide ACTH antagonist for conditions like Cushing’s disease. The company focuses on innovative therapeutics for rare endocrine diseases.
Crinetics Pharmaceuticals (Nasdaq: CRNX) announced a webinar on November 20, 2020, at 11:00 AM ET, focusing on the oral therapy paltusotine for acromegaly. Key Opinion Leaders Dr. Peter Trainer and Dr. Monica Roberto Gadelha will discussing treatment landscapes and clinical insights following Phase 2 ACROBAT studies results. Crinetics plans to advance its Phase 3 program for paltusotine in the first half of 2021. The webinar will also include updates on other pipeline assets, including two anticipated Phase 1 trials.
Crinetics Pharmaceuticals (Nasdaq: CRNX) reported positive topline results for its ACROBAT Edge and Evolve Phase 2 trials of oral paltusotine for acromegaly. The drug maintained insulin-like growth factor-1 (IGF-1) levels in patients switching from injected therapies. The company also received Rare Pediatric Disease Designation for CRN04777, a treatment for congenital hyperinsulinism. Financially, R&D expenses rose to $13.7 million, with a net loss of $18.3 million. Cash reserves increased to $186.8 million, bolstered by an equity offering.
Crinetics Pharmaceuticals has announced positive topline results from its Phase 2 ACROBAT Edge and Evolve studies of paltusotine, targeting acromegaly. The drug maintained IGF-1 levels after transitioning from injected somatostatin receptor ligands. In the primary analysis, no significant difference in IGF-1 control was noted after switching treatments. Paltusotine was well tolerated among 60 participants, with no drug-related discontinuations or adverse events leading to serious side effects. The company aims to initiate a Phase 3 program in the first half of 2021.
Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) announced that the FDA has granted rare pediatric disease designation for CRN04777, an investigational SST5 agonist aimed at treating congenital hyperinsulinism (HI). This serious condition causes life-threatening hypoglycemia in infants. The RPD designation may provide a priority review voucher upon approval. Dr. Christine Ferrara-Cook emphasized the critical nature of this condition, while CEO Scott Struthers highlighted the urgent need for new treatments. Crinetics plans a Phase 1 clinical study for CRN04777 in early 2021.
Crinetics Pharmaceuticals (Nasdaq: CRNX) announced that its ACTH antagonist presentation will take place at the virtual European Congress of Endocrinology on September 8, 2020. Newly presented data shows that the lead ACTH antagonist reduced corticosterone levels and positively affected adrenal gland function in a rat model. Crinetics aims to initiate Phase 1 trials in late 2020 or early 2021. Additionally, results from a Phase 1 study of paltusotine will be available, showing a favorable 70% oral bioavailability and mild side effects, indicating its potential for chronic treatment of acromegaly.
Crinetics Pharmaceuticals (Nasdaq: CRNX) announced participation in key healthcare conferences this September, inviting investors to join via webcast. Key events include the Baird Global Healthcare Conference on September 9 at 12:50 PM ET, H.C. Wainwright's 22nd Annual Global Investment Conference on September 14 at 10:30 AM ET, and the Cantor Fitzgerald Global Healthcare Conference on September 15 at 2:00 PM ET. All sessions will feature Scott Struthers, CEO. Recordings will be available on the company's website.