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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 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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