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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 announced on June 10, 2024, that its Compensation Committee granted non-qualified stock options to purchase a total of 158,000 shares to nine new non-executive employees. This is part of the company's 2021 Employment Inducement Incentive Award Plan, designed to attract new talent. The stock options, priced at $45.01 per share, will vest over four years. The plan follows Nasdaq Listing Rule 5635(c)(4), offering equity awards to new employees as a material inducement for joining Crinetics.
Crinetics has announced positive initial findings from two ongoing open-label studies of its drug candidate atumelnant (CRN04894) for treating congenital adrenal hyperplasia (CAH) and ACTH-dependent Cushing's syndrome (ADCS). In the CAH study, all participants (n=6) maintained androstenedione (A4) below normal levels, with more than 90% reduction in A4 and 97% reduction in 17-OHP sustained through 12 weeks. In the ADCS trial, atumelnant normalized 24-hour urinary free cortisol levels for all participants (n=5) within the treatment period. The studies reported no severe or serious adverse events. A conference call for investors is scheduled for June 3, 2024, highlighting these initial results and further developments.
Crinetics presented new data at ENDO 2024, showcasing once-daily oral paltusotine as a potential first-choice treatment for acromegaly.
Results from Phase 3 PATHFNDR-2 trial indicated significant efficacy, with 56% of participants achieving normal IGF-1 levels versus 5% on placebo. Paltusotine showed rapid and sustained IGF-1 reduction, with 92.6% of patients responding by end of treatment. The drug was well tolerated with no serious adverse events.
PATHFNDR-1 trial data revealed paltusotine reduced daily breakthrough symptom exacerbations compared to standard injections. Long-term data from the ACROBAT Advance study showed durable safety and efficacy over 42 months.
Crinetics plans to submit a New Drug Application in the second half of 2024.
Crinetics Pharmaceuticals (Nasdaq: CRNX) announced the appointment of Dr. Robert M. Cuddihy as Senior Vice President of Medical Affairs. Dr. Cuddihy brings over 30 years of experience in endocrinology, diabetes, and metabolism, with expertise in both clinical practice and the pharmaceutical industry. He previously served in key roles at Dartmouth Hitchcock Medical Center and Clinics, Amgen, Janssen, Sanofi, and Capsida Biotherapeutics. CEO Scott Struthers emphasized Dr. Cuddihy's ability to enhance the company's development and commercialization efforts for its investigational products, paltusotine and atumelnant, and its discovery pipeline. Dr. Cuddihy expressed enthusiasm for advancing therapies targeting endocrine diseases.
Crinetics Pharmaceuticals (Nasdaq: CRNX) announced the early release of late-breaking abstracts for ENDO 2024, focusing on a Phase 2 study of atumelnant (CRN04894) for Congenital Adrenal Hyperplasia (CAH). Initial data from four subjects were submitted, with plans to present extended results from six subjects in cohort 1 and more in cohort 2 at ENDO 2024. Detailed findings will be shared on June 3, 2024, during the Late-Breaking Poster Presentation session.
Crinetics Pharmaceuticals announced on May 10, 2024, the granting of non-qualified stock options to fifteen new non-executive employees under the 2021 Employment Inducement Incentive Award Plan. The options have an exercise price of $48.00 per share and will vest over four years. This inducement is pursuant to Nasdaq Listing Rule 5635(c)(4).
Crinetics Pharmaceuticals reported strong financial results for Q1 2024, highlighted by positive data from Phase 2 studies of Atumelnant (CRN04894) in congenital adrenal hyperplasia and ACTH-dependent Cushing’s Syndrome. The company is set to present late-breaking results at ENDO in June. Additionally, a Phase 3 study for paltusotine in carcinoid syndrome is expected to start by year-end. Crinetics also secured $350 million in financing to support commercial readiness and pipeline development, totaling $901.0 million in cash and equivalents as of March 31, 2024.
Crinetics Pharmaceuticals will present advancements from their Atumelnant (CRN04894) and Paltusotine development programs at ENDO 2024. Initial data from the Phase 2 trial of Atumelnant in Congenital Adrenal Hyperplasia and findings from the Phase 1b/2a ACTH-Dependent Cushing’s Syndrome trial will be showcased. Data from Phase 3 PATHFNDR 1 and 2 trials of Paltusotine in Acromegaly, along with new long-term safety and efficacy findings, will also be presented. Crinetics aims to build the premier endocrine-focused pharmaceutical company with these developments.
Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) will report its first quarter 2024 financial results on May 9, 2024. The company will host a conference call to discuss financial results and provide a business update. Investors can participate via phone or webcast.
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