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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 (CRNX) announced significant advancements in its ongoing clinical programs and financial results for Q2 2020. Paltusotine received Orphan Drug Designation for acromegaly, enhancing development incentives. Half of the Phase 2 ACROBAT Edge trial patients completed the study, with topline data expected in Q4 2020. The company raised $107.9 million in net proceeds from a public offering. Despite increased net losses of $16.5 million, Crinetics strengthened its cash position to $205.2 million as of June 30, 2020.
Crinetics Pharmaceuticals (Nasdaq: CRNX) announced that the FDA has granted Orphan Drug Designation for paltusotine to treat acromegaly, a rare endocrine disease. This designation incentivizes development, potentially exempting the company from user fees and providing seven years of market exclusivity upon approval. The designation highlights the promising Phase 2 clinical trial results for paltusotine. Crinetics plans to report topline results for the ACROBAT trials later this year and initiate a Phase 3 trial in 2021.
Crinetics Pharmaceuticals (Nasdaq: CRNX) announced that 28 of 47 patients have completed the ACROBAT Edge Phase 2 trial, evaluating the effects of oral paltusotine on IGF-1 levels in acromegaly patients switched from injectable treatments. Topline results from the Edge and Evolve trials, with 47 and 13 patients respectively, are expected in Q4 2020. Management is planning to initiate Phase 3 clinical development for paltusotine in early 2021 based on these results and regulatory feedback.
Crinetics Pharmaceuticals (Nasdaq: CRNX) announced the appointment of Adriana Cabré as Vice President of Human Resources, effective immediately. Cabré brings over 25 years of HR experience, previously serving as President of ACC People Strategies and Chief People Officer at National University. This leadership change aims to enhance Crinetics' culture as it expands its operations in the rare endocrine disease sector. The company's lead candidate, paltusotine, is undergoing Phase 2 trials for acromegaly, with plans for further trials in 2021.
Crinetics Pharmaceuticals (Nasdaq: CRNX) reported positive interim results from its ACROBAT Edge Phase 2 trial of oral paltusotine for acromegaly treatment. Patients switching to paltusotine maintained IGF-1 levels previously achieved with injectable therapies. A public offering raised net proceeds of $107.9 million, strengthening the company's financial position. However, R&D expenses increased to $13.9 million, leading to a net loss of $17.4 million for Q1 2020. The company anticipates advancing paltusotine into Phase 3 trials in 2021 and has ongoing programs targeting neuroendocrine tumors.