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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.
On November 10, 2022, Crinetics Pharmaceuticals (Nasdaq: CRNX) announced the grant of non-qualified stock option awards totaling 200,000 shares under its 2021 Employment Inducement Incentive Award Plan to four new non-executive employees. This grant, effective immediately, aligns with Nasdaq Listing Rule 5635(c)(4). The options have an exercise price of $18.59 per share, equivalent to the fair market value on the grant date, and will vest over four years, contingent on continued employment.
Crinetics Pharmaceuticals (Nasdaq: CRNX) announced the completion of enrollment for its Phase 3 PATHFNDR-1 study evaluating paltusotine in acromegaly patients. A total of 58 participants, exceeding the planned 52, were enrolled. Topline results are anticipated in Q3 2023. The study aims to assess the safety and efficacy of once-daily oral paltusotine compared to placebo. If successful, data will be submitted to regulatory authorities for approval for all acromegaly patients requiring treatment. The PATHFNDR-2 study remains ongoing, with results expected in Q4 2023.
Crinetics Pharmaceuticals (Nasdaq: CRNX) announced on October 10, 2022, that it granted stock options for 237,600 shares to eleven new non-executive employees under its 2021 Employment Inducement Incentive Award Plan. The options, exercisable at $16.89 per share, vest over four years, beginning with 25% on the one-year anniversary and the remainder monthly thereafter, contingent on continued employment. This plan adheres to Nasdaq Listing Rule 5635(c)(4) and aims to attract talent to drive the company's focus on developing therapeutics for rare endocrine diseases.
Crinetics Pharmaceuticals (Nasdaq: CRNX) announced that the UK MHRA granted CRN04777 an 'Innovation Passport' for treating congenital hyperinsulinism. This designation allows access to the Innovative Licensing and Access Pathway (ILAP), aimed at expediting market entry for critical therapies. Congenital hyperinsulinism is a serious condition affecting infants, necessitating continuous glucose management. The ILAP enhances coordination with the MHRA and allows for quicker Marketing Authorization Application reviews. CRN04777, an oral SST5 selective agonist, demonstrated promising results in preclinical studies.
Crinetics Pharmaceuticals (CRNX) appointed Dr. Dana Pizzuti as chief development officer, bringing over 30 years of pharmaceutical experience in clinical development and regulatory affairs. Dr. Pizzuti previously held key roles at companies like Ascendis Pharma, where she led successful regulatory applications. She will oversee the advancement of Crinetics’ drug pipeline, including Phase 3 studies for paltusotine targeting acromegaly. This management change aims to strengthen Crinetics’ capacity to navigate regulatory processes and enhance its multi-asset pipeline.
Radionetics Oncology announced the appointment of Umesh Gangadharmath, Ph.D., as Senior Vice President, Technical Operations. With over 16 years of radiopharmaceutical expertise, he is expected to lead the company in filing three INDs over the next two years. The company also doubled its workforce to 20 employees in a year, aiming to advance its radiotherapeutics pipeline. Radionetics focuses on peptide-targeted radiotherapeutics, projected to thrive in a market expected to reach $12.6 billion by 2027.
Crinetics Pharmaceuticals (Nasdaq: CRNX) granted non-qualified stock options for 246,600 shares to 13 new employees on September 10, 2022, under the 2021 Inducement Plan. This plan incentivizes new hires and complies with Nasdaq's Listing Rule 5635(c)(4). The options have an exercise price of $21.03 per share, reflecting the common stock's fair market value on the grant date. Shares will vest over four years, with 25% vesting annually. Crinetics focuses on developing therapeutics for rare endocrine diseases and has ongoing clinical trials for multiple drug candidates.
Crinetics Pharmaceuticals (Nasdaq: CRNX) announced its participation in the H.C. Wainwright 24th Annual Global Investment Conference from September 12-14, 2022. The company will provide a corporate overview starting at 7:00 a.m. Eastern Time on September 12, 2022. Interested parties can access a webcast available on-demand.
Crinetics is focused on developing therapeutics for rare endocrine diseases, with its lead candidate Paltusotine in advanced clinical stages.
Crinetics Pharmaceuticals (CRNX) presented new data on their investigational compound, paltusotine, at the 35th Brazilian Congress of Endocrinology and Metabolism. The results show that paltusotine effectively lowers and maintains insulin-like growth factor-1 (IGF-1) levels comparable to injected somatostatin receptor ligands (SRLs) for up to 103 weeks. An impressive 88% of trial participants opted to continue treatment, with 89% preferring the oral paltusotine to injected SRLs. The drug demonstrated a safety profile similar to that of injected SRLs, indicating its potential as a long-term therapy for acromegaly.
Crinetics Pharmaceuticals (CRNX) announces that Dr. Monica R. Gadelha will present interim data from the ACROBAT Advance open label extension study at the 35th Brazilian Congress of Endocrinology and Metabolism (CBEM) on September 4, 2022. The presentation highlights paltusotine's long-term safety and maintenance of IGF-1 levels in acromegaly patients transitioning from injectable therapies. Paltusotine is an investigational oral treatment designed to selectively target somatostatin receptor type 2, aiming to improve patient compliance and outcomes.
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