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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 (CRNX) has announced new stock option grants under its 2021 Employment Inducement Incentive Award Plan. The company granted options to purchase 96,100 shares to sixteen new non-executive employees and 100,000 shares to one new executive employee on January 10, 2025.
The options were granted at an exercise price of $40.59 per share, matching Crinetics' closing price on The Nasdaq Global Select Market. The vesting schedule spans four years, with 25% vesting after one year and the remaining shares vesting in 36 equal monthly installments, contingent on continued employment. These grants were made in accordance with Nasdaq Listing Rule 5635(c)(4) as inducement awards for new employees.
Crinetics Pharmaceuticals (CRNX) announced positive topline results from its Phase 2 trial of atumelnant for Congenital Adrenal Hyperplasia (CAH). The study, involving 28 patients across 3 dose cohorts, demonstrated substantial and statistically significant reductions in key biomarkers, including up to 80% mean reduction of androstenedione.
The trial showed meaningful improvements in CAH symptoms, with notable results including: testosterone normalization in majority of female participants, consistent reduction in total adrenal volume, and resolution of androgen mediated polycythemia in most affected participants. Atumelnant was generally well-tolerated, with no treatment-related severe adverse events or discontinuations.
Based on these positive results, Crinetics plans to proceed with a global Phase 3 pivotal trial for adults and prepare for a Phase 2b/3 trial in pediatric patients this year.
Crinetics Pharmaceuticals (Nasdaq: CRNX) has announced that its Founder and CEO, Scott Struthers, Ph.D., will present at the 43rd Annual J.P. Morgan Healthcare Conference. The event will take place in San Francisco, CA on Tuesday, January 14, 2025, at 4:30 p.m. Pacific Time.
To access the live webcast of the presentation, interested parties can click a provided link. Additionally, the archived webcast will be available on the Events & Presentations page in the Investors section of Crinetics' website at www.crinetics.com/events.
For those who wish to arrange a 1x1 meeting with the management, it is advised to contact their conference representative.
Crinetics Pharmaceuticals (Nasdaq: CRNX) announced the appointment of Isabel Kalofonos as Chief Commercial Officer. Ms. Kalofonos will oversee the commercial strategy and operations for the potential launch of paltusotine and pre-commercialization activities for the company's pipeline.
Scott Struthers, CEO, praised her vast expertise in launching therapies and leading commercial strategies. Ms. Kalofonos expressed enthusiasm for joining Crinetics, emphasizing her commitment to building a top-tier commercial team and advancing treatments for acromegaly and other endocrine disorders.
Ms. Kalofonos brings over 20 years of experience in the pharmaceutical and biotech industry, having held senior roles at ImmunoGen, Galderma, and Takeda Pharmaceuticals. She has a proven track record in launching breakthrough therapies, including ELAHERE and TAKHZYRO.
On January 10, 2025, Crinetics will grant Ms. Kalofonos a stock option to purchase 100,000 shares, with specific vesting conditions under the 2021 Employment Inducement Incentive Award Plan.
Crinetics Pharmaceuticals (CRNX) has granted non-qualified stock options to sixteen new non-executive employees under its 2021 Employment Inducement Incentive Award Plan. The options allow purchase of 146,400 shares at an exercise price of $57.17 per share, matching CRNX's closing price on Nasdaq Global Select Market on December 10, 2024. The stock options will vest over four years, with 25% vesting after one year and the remainder vesting in 36 monthly installments, contingent on continued employment. These grants comply with Nasdaq Listing Rule 5635(c)(4) as inducement awards for new employees.
Crinetics Pharmaceuticals (Nasdaq: CRNX) announced FDA acceptance of its New Drug Application (NDA) for paltusotine, a treatment for adult acromegaly patients. The FDA set a target action date of September 25, 2025. If approved, paltusotine will become the first once-daily, oral, selective somatostatin receptor type 2 nonpeptide agonist for acromegaly.
The NDA submission included data from two Phase 3 clinical trials: PATHFNDR-1 and PATHFNDR-2, which evaluated the drug's safety and efficacy in previously treated and untreated adults. The FDA indicated no advisory committee meeting is anticipated during review. Paltusotine received Orphan Drug Designation in July 2020 for treating acromegaly, a rare disease affecting fewer than 200,000 people in the US.
Crinetics Pharmaceuticals (Nasdaq: CRNX), a clinical stage pharmaceutical company specializing in endocrine diseases and tumors, has announced its participation in three major investor conferences this December. The company will present at the Piper Sandler 36th Annual Healthcare Conference in New York, and both the Citi Global Healthcare Conference and Evercore 7th Annual HealthCONx Conference in Miami. Management will conduct fireside chats on December 3rd at 7:30 AM ET (Evercore), December 4th at 9:30 AM ET (Citi), and December 5th at 1:00 PM ET (Piper Sandler). Live and archived webcasts will be available on the company's website.
Crinetics Pharmaceuticals (NASDAQ: CRNX) will present two abstracts at NANETS 2024, showcasing advancements in neuroendocrine tumor treatments. The company will debut its nonpeptide drug conjugate platform, featuring CRN09682, a lead candidate targeting SST2-expressing tumors, with IND submission planned for early 2025. The presentation includes preclinical data demonstrating CRN09682's potent and selective anti-tumor activity. Additionally, Phase 2 trial data for paltusotine, an oral SST2 agonist for carcinoid syndrome treatment, will be presented, showing reduced symptom frequency and severity across 36 trial participants.
Crinetics Pharmaceuticals (NASDAQ: CRNX) announced two key presentations at NANETS 2024, showcasing advancements in their neuroendocrine tumor pipeline. The company will present preclinical data for CRN09682, a first-in-class nonpeptide drug conjugate targeting SST2-expressing tumors, planned for IND submission in early 2025. Additionally, they will share Phase 2 trial results for paltusotine, demonstrating reduced frequency and severity of carcinoid syndrome symptoms in patients with functional NETs. The presentations include data from all 36 trial participants, supporting further clinical development. A company-sponsored symposium will feature both drug candidates and their novel nonpeptide approaches to treating carcinoid syndrome and neuroendocrine tumors.
Crinetics Pharmaceuticals (CRNX) reported Q3 2024 financial results, highlighting the submission of its New Drug Application for paltusotine for acromegaly treatment. The company completed an upsized public offering raising $575M and advanced four drug candidates to IND-enabling studies. Q3 financial results showed R&D expenses of $61.9M and G&A expenses of $25.9M, with a net loss of $76.8M. Cash position strengthened to $862.7M as of September 30, 2024, with additional $575M raised in October, extending runway into 2029.
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