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Crinetics Pharmaceuticals, Inc. (NASDAQ: CRNX) is a clinical-stage pharmaceutical company dedicated to the discovery, development, and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors. Founded with a mission to create impactful treatments, Crinetics focuses on advancing its innovative pipeline of orally delivered small molecule drugs.
The company's leading product candidate, paltusotine, is an investigational somatostatin receptor type 2 (SST2) agonist, currently in Phase 3 development for acromegaly and Phase 2 for carcinoid syndrome associated with neuroendocrine tumors. Paltusotine promises a convenient, once-daily oral treatment alternative to monthly injections, simplifying patient care and improving quality of life.
Moreover, Crinetics is advancing CRN04894 (atumelnant), a first-in-class oral ACTH antagonist in Phase 2 trials for congenital adrenal hyperplasia and ACTH-dependent Cushing's disease. This promising candidate aims to address significant unmet needs in these patient populations by reducing disease drivers and normalizing hormone levels.
Crinetics' in-house drug discovery efforts have resulted in several ongoing programs targeting conditions such as hyperparathyroidism, polycystic kidney disease, Graves' disease, thyroid eye disease, diabetes, and obesity. The company's robust pipeline highlights its commitment to developing transformative therapies for patients with rare endocrine disorders.
Recent achievements include a successful private placement of $350 million, strengthening their financial position to support ongoing research and development. The company also reported positive topline results from its Phase 2 study of paltusotine for carcinoid syndrome, as well as from its Phase 3 PATHFNDR-2 study for acromegaly, reinforcing the potential of paltusotine in providing both symptom and biochemical control.
With strategic partnerships, including collaborations with top institutional investors and the National Institutes of Health, Crinetics is well-positioned for future growth. The company remains committed to bringing innovative treatments to market and improving the lives of patients worldwide.
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.
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.
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