Crinetics Pharmaceuticals, Inc.

The FDA handed a CRL to the Swedish biotech Camurus for its hormone disorder therapy over “facility-related deficiencies” at a third-party manufacturer. The therapy, dubbed CAM2029, had a PDUFA date of Oct. 21 for acromegaly, but production issues were found at a third-party factory in September. There were no issues with the candidate’s efficacy or safety, Camurus said in a Tuesday release. CAM2029 does not have a new decision date, but Camurus said “timely resolution of the CRL” will depend on the unnamed third-party manufacturer’s responses. Labeling discussions for the asset were already in the final stages when the CRL was given, the company said. Acromegaly occurs when the body makes too much growth hormone, which leads to abnormally large hands and feet. Subcutaneously administered CAM2029 features a peptide inhibitor of growth hormones called octreotide. Camurus announced data from a pair of Phase 3 trials investigating CAM2029 in June and July 2023, showing acromegaly symptoms improved in patients. In May, Camurus said the EMA had received its regulatory application. Jefferies analysts said the delay could lead to Camurus launching its drug later than expected. Crinetics Pharmaceuticals has its own acromegaly candidate and announced the submission of its FDA application last month. CAM2029 is also being investigated for gastroenteropancreatic neuroendocrine tumors and polycystic liver disease.

SAN DIEGO, Oct. 16, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced that it will report third quarter 2024 financial results on Tuesday, November 12, 2024 after the market closes. Company management will host a conference call at 4:30 p.m. ET to discuss financial results and provide a business update. Conference Call & Webcast Tuesday, November 12 @ 4:30 p.m. ET Domestic: 1-800-579-2543International: 1-785-424-1789Conference ID: CRNXQ3 Participants can use the dial-in numbers above OR access the call via live webcast on the Events section of the Crinetics website. To ensure a timely connection, it is recommended that participants dial-in or register at least 15 minutes prior to the scheduled start of the call. The webcast will be archived on the Investor Relations section of www.crinetics.com. About Crinetics Pharmaceuticals Crinetics Pharmaceuticals is a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors. Crinetics’ lead development candidate, paltusotine, is the first investigational once-daily, oral, selectively-targeted somatostatin receptor type 2 (SST2) nonpeptide agonist that has completed Phase 3 clinical development for acromegaly and is in Phase 2 clinical development for carcinoid syndrome associated with neuroendocrine tumors. Crinetics is also developing atumelnant (CRN04894), an investigational, first-in-class, oral ACTH antagonist, that is currently completing Phase 2 clinical studies for the treatment of congenital adrenal hyperplasia and Cushing’s disease. All of the company’s drug candidates are orally delivered, small molecule new chemical entities resulting from in-house drug discovery efforts, including additional discovery programs addressing a variety of endocrine conditions such as hyperparathyroidism, polycystic kidney disease, Graves’ disease (including thyroid eye disease), diabetes, obesity and GPCR-targeted oncology indications. Investors:Gayathri DiwakarHead of Investor Relationsgdiwakar@crinetics.com (858) 345-6340 Media: Natalie BadilloHead of Corporate Communications nbadillo@crinetics.com (858) 345-6075

Plus, news about Inhibikase, Bio-Thera, Richter, InnoCare and Scholar Rock: Crinetics prices $500M offering: The San Diego biotech upsized the offering by $100 million from $400 million . The biotech last month asked the FDA to approve its oral acromegaly drug, called paltusotine. — Kyle LaHucik Boehringer Ingelheim teams up with Circle Pharma: The German drugmaker will pay up to $607 million in a pact with the macrocycles biotech , which unveiled a $90 million Series D last month. The duo plans to work on a cyclin inhibitor to prevent cancer cells from growing. — Kyle LaHucik Inhibikase’s $110M PIPE: The Boston and Atlanta biotech will use the money to fund a Phase 2b in pulmonary arterial hypertension, a condition that recently received a new FDA-approved treatment from Merck. — Kyle LaHucik Bio-Thera, Richter partner on a biosimilar to Stelara: As part of the commercialization and licensing agreement , Bio-Thera will develop, manufacture and supply the copycat drug, while Richter will have exclusive rights to commercialize it in Europe, the UK and Switzerland. Bio-Thera will receive an upfront payment of $8.5 million, as well as potential development and commercial milestones up to $101.5 million. — Katherine Lewin InnoCare’s Phase 2 study hits primary endpoint in psoriasis: The tyrosine kinase 2 inhibitor, dubbed ICP-488, showed “excellent” efficacy and safety, according to the company, with 78.6% of patients in China seeing at least a 75% improvement in their plaque psoriasis on the highest dose over a 12-week treatment period. InnoCare CEO Jasmine Cui said the Beijing-based company plans to “further accelerate” development of ICP-488. — Katherine Lewin Scholar Rock upsized its public offering. It now aims to raise $300 million. — Jaimy Lee