PALSONIFY™ (paltusotine)
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Crinetics Pharmaceuticals to Participate in The 44th Annual J.P. Morgan Healthcare Conference
Globenewswire· 2025-12-18 21:05
SAN DIEGO, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), today announced that that Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics, will present at the 44th Annual J.P. Morgan Healthcare Conference being held in San Francisco, CA on Tuesday, January 13, 2026 at 9:45 a.m. Pacific Time. To access the live audio-only webcast, click here. The archived webcast will also be accessible on the Events & Presentations page in the Investors section of the Cr ...
Crinetics Announces First Patient Dosed in Pivotal Adult Trial of Atumelnant in Congenital Adrenal Hyperplasia (CAH)
Globenewswire· 2025-12-11 21:05
Core Insights - Crinetics Pharmaceuticals has initiated the CALM-CAH Phase 3 trial for atumelnant, a novel oral ACTH receptor antagonist aimed at treating classic congenital adrenal hyperplasia (CAH) [1][2] - The trial will assess atumelnant's effectiveness in normalizing adrenal androgen levels and reducing glucocorticoid levels to physiological ranges, setting a new standard for disease control assessment [2][3] - Atumelnant is the first small molecule ACTH receptor antagonist in late-stage clinical development, showing promising results in a Phase 2 study with significant reductions in key biomarkers [2][4] Company Overview - Crinetics Pharmaceuticals focuses on transforming the treatment of endocrine diseases and related tumors, emphasizing patient needs and innovative therapies [5] - The company has a robust pipeline, including its lead product PALSONIFY™ for acromegaly and atumelnant for CAH and ACTH-dependent Cushing's syndrome [6][7] - Crinetics has received Orphan Drug Designation from the FDA for atumelnant, highlighting its potential impact on rare diseases [3]
Crinetics Pharmaceuticals Announces December 2025 Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Globenewswire· 2025-12-10 21:34
Core Insights - Crinetics Pharmaceuticals granted stock options and restricted stock units (RSUs) to new non-executive employees as part of its 2021 Employment Inducement Incentive Award Plan, totaling 39,575 shares in stock options and 26,525 RSUs [1][2] Company Overview - Crinetics Pharmaceuticals is a global pharmaceutical company focused on transforming the treatment of endocrine diseases and related tumors, emphasizing patient needs and targeting G-protein coupled receptors (GPCRs) with small molecules [3] Product Pipeline - The lead product, PALSONIFY™ (paltusotine), is the first oral treatment approved by the U.S. FDA for adults with acromegaly who have not responded adequately to surgery [4] - Paltusotine is also in clinical development for carcinoid syndrome associated with neuroendocrine tumors, with a pipeline that includes over 10 disclosed programs targeting various endocrine conditions [4]
Crinetics Announces First Patient Dosed in Phase 1/2 Trial Evaluating CRN09682 for the Treatment of Neuroendocrine Tumors and Other Somatostatin Receptor 2-Expressing Tumors
Globenewswire· 2025-12-03 13:00
Core Insights - Crinetics Pharmaceuticals has initiated a Phase 1/2 clinical trial for CRN09682, targeting SST2-positive neuroendocrine tumors and other solid tumors, marking a significant milestone for the company's nonpeptide drug conjugate platform [1][2] Company Overview - Crinetics Pharmaceuticals is focused on transforming the treatment of endocrine diseases and related tumors, leveraging expertise in G-protein coupled receptors (GPCRs) and small molecule design [5] - The company has a deep pipeline of over 10 disclosed programs, including PALSONIFY™ (paltusotine), which is the first oral treatment approved by the U.S. FDA for acromegaly [6][7] Drug Development - CRN09682 is a first-in-class, non-radioactive, nonpeptide drug conjugate designed to selectively bind to SST2-expressing tumor cells, releasing a potent cytotoxic agent, monomethyl auristatin E (MMAE), directly within the tumor [4] - The Phase 1/2 BRAVESST2 trial will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of CRN09682, with up to 150 participants expected to be enrolled [3] Clinical Trial Details - The trial consists of a dose-escalation study to determine the maximum tolerated dose and a dose expansion phase to further evaluate CRN09682 in selected SST2-expressing tumor types [3] - Eligible patients must have metastatic or locally advanced disease progression following standard therapies, confirmed by somatostatin receptor imaging [3]
Crinetics Announces First Patient Randomized in Pivotal Phase 3 CAREFNDR Trial Evaluating Paltusotine in Carcinoid Syndrome
Globenewswire· 2025-11-20 21:05
Core Insights - Crinetics Pharmaceuticals has initiated the pivotal Phase 3 CAREFNDR trial to evaluate the efficacy and safety of paltusotine for treating carcinoid syndrome associated with neuroendocrine tumors, building on positive Phase 2 results [1][2][3] Company Overview - Crinetics Pharmaceuticals is focused on developing transformative therapies for endocrine diseases and related tumors, with a core expertise in targeting G-protein coupled receptors [7][8] - The company’s lead product, paltusotine, is the first once-daily oral treatment approved for adults with acromegaly who have had an inadequate response to surgery [8] Clinical Trial Details - The CAREFNDR trial will enroll 141 adults with carcinoid syndrome, randomizing participants in a 2:1 ratio to receive either paltusotine 80 mg or a matching placebo [2] - The primary endpoint of the trial is to measure the change in flushing episodes per day from baseline to Week 12, with bowel movement frequency as a key secondary endpoint [2] - Following the 16-week randomized period, the trial includes a 104-week open-label extension to evaluate long-term efficacy and safety [2] Product Information - Paltusotine is a selectively-targeted somatostatin receptor type 2 (SST2) nonpeptide currently in Phase 3 development for carcinoid syndrome, showing rapid and sustained reductions in symptoms during Phase 2 trials [5][6] - Approximately 20% of patients with neuroendocrine tumors experience carcinoid syndrome, characterized by symptoms such as diarrhea and flushing [6] Future Development - Crinetics is also exploring additional treatment options for neuroendocrine tumors through CRN09682, an investigational anti-tumor candidate that has received Investigational New Drug clearance [3]
Crinetics Pharmaceuticals Announces November 2025 Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Globenewswire· 2025-11-10 21:28
Core Insights - Crinetics Pharmaceuticals granted stock options and restricted stock units (RSUs) to new non-executive employees as part of its 2021 Employment Inducement Incentive Award Plan, totaling 37,675 shares in stock options and 25,300 RSUs [1][2] Group 1: Stock Options and RSUs - The stock options have an exercise price of $41.45 per share, equal to the closing price on November 10, 2025 [2] - Stock options will vest over four years, with 25% vesting on the one-year anniversary and the remainder in 36 equal monthly installments, contingent on continued employment [2] - RSUs will also vest over four years in equal annual installments starting on the one-year anniversary, subject to continued employment [2] Group 2: Company Overview - Crinetics Pharmaceuticals is focused on transforming the treatment of endocrine diseases and related tumors, emphasizing patient needs [3] - The company specializes in discovering and developing therapies targeting G-protein coupled receptors (GPCRs) with tailored pharmacology [3] - Crinetics' lead product, PALSONIFY™ (paltusotine), is the first oral treatment approved by the U.S. FDA for adults with acromegaly who have inadequate surgical responses [4] Group 3: Pipeline and Development - The company has a deep pipeline with over 10 disclosed programs, including atumelnant, which is in late-stage development for congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome [4] - Additional discovery programs target various endocrine conditions, including neuroendocrine tumors, Graves' disease, polycystic kidney disease, hyperparathyroidism, diabetes, obesity, and GPCR-targeted oncology indications [4]
Crinetics Pharmaceuticals Announces October 2025 Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Globenewswire· 2025-10-10 20:41
Core Insights - Crinetics Pharmaceuticals granted stock options and restricted stock units (RSUs) to 20 new non-executive employees as part of its 2021 Employment Inducement Incentive Award Plan, totaling 78,975 shares in stock options and 54,475 shares in RSUs [1][2] Company Overview - Crinetics Pharmaceuticals is a global pharmaceutical company focused on transforming the treatment of endocrine diseases and related tumors, emphasizing patient needs and targeting G-protein coupled receptors (GPCRs) with small molecules [3] Product Pipeline - The lead product, PALSONIFY™ (paltusotine), is the first oral treatment approved by the U.S. FDA for adults with acromegaly who have had inadequate surgical responses or for whom surgery is not an option. Paltusotine is also in clinical development for carcinoid syndrome associated with neuroendocrine tumors [4] - Crinetics has a deep pipeline with over 10 disclosed programs, including atumelnant, which is in late-stage development for congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome. Other discovery programs target various endocrine conditions such as Graves' disease, polycystic kidney disease, and GPCR-targeted oncology indications [4]
Crinetics Pharmaceuticals to Report Third Quarter 2025 Financial Results on November 6, 2025
Globenewswire· 2025-10-06 20:05
Core Insights - Crinetics Pharmaceuticals, Inc. will report its third quarter 2025 financial results on November 6, 2025, after market close, followed by a conference call at 4:30 p.m. ET to discuss the results and provide a business update [1] Company Overview - Crinetics Pharmaceuticals is a global pharmaceutical company focused on transforming the treatment of endocrine diseases and related tumors, emphasizing patient needs [4] - The company specializes in discovering, developing, and commercializing novel therapies, particularly targeting G-protein coupled receptors (GPCRs) with small molecules [4] Product Pipeline - Crinetics' lead product, PALSONIFY™ (paltusotine), is the first once-daily oral treatment approved by the U.S. FDA for adults with acromegaly who have had an inadequate response to surgery or for whom surgery is not an option [5] - Paltusotine is also in clinical development for carcinoid syndrome associated with neuroendocrine tumors [5] - The company has a deep pipeline of over 10 disclosed programs, including the late-stage investigational candidate atumelnant for congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome [5] - Additional discovery programs target various endocrine conditions such as neuroendocrine tumors, Graves' disease, polycystic kidney disease, hyperparathyroidism, diabetes, obesity, and GPCR-targeted oncology indications [5]
Crinetics Pharmaceuticals Announces September 2025 Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Globenewswire· 2025-09-10 20:30
Core Points - Crinetics Pharmaceuticals granted stock options and RSUs to 20 new non-executive employees as part of its 2021 Inducement Plan to attract talent [1][2] - The stock options have an exercise price of $35.00 per share, equal to the closing price on September 10, 2025, and will vest over four years [2] - Crinetics is a clinical-stage pharmaceutical company focused on developing therapeutics for endocrine diseases and related tumors, with its lead candidate being PALSONIFY™ for acromegaly [3] Summary by Category Stock Options and RSUs - The Compensation Committee granted a total of 62,475 stock options and 43,800 RSUs under the 2021 Inducement Plan [1] - Stock options will vest over four years, with 25% vesting after one year and the remainder in 36 equal monthly installments [2] - RSUs will also vest over four years in equal annual installments starting from the one-year anniversary of the vesting commencement date [2] Company Overview - Crinetics Pharmaceuticals specializes in discovering and developing novel therapeutics for endocrine diseases and tumors [3] - The company’s lead candidate, PALSONIFY™, is in clinical development for acromegaly and carcinoid syndrome associated with neuroendocrine tumors [3] - Other development programs include treatments for congenital adrenal hyperplasia, Cushing's syndrome, and various endocrine conditions [3]
Crinetics Receives FDA Orphan Drug Designation for Atumelnant in the Treatment of Congenital Adrenal Hyperplasia (CAH)
Globenewswire· 2025-08-21 12:45
Core Insights - Crinetics Pharmaceuticals received Orphan Drug Designation from the FDA for atumelnant, a novel oral ACTH receptor antagonist aimed at treating classic congenital adrenal hyperplasia (CAH) [1][4] - Atumelnant is the first and only small molecule ACTH receptor antagonist in clinical development, highlighting its potential significance in addressing unmet medical needs in CAH [1][5] Company Overview - Crinetics Pharmaceuticals is a clinical-stage pharmaceutical company focused on developing novel therapeutics for endocrine diseases and related tumors, with all drug candidates being small molecules from in-house discovery efforts [6] - The company's lead candidate, PALSONIFY™ (paltusotine), is in clinical development for acromegaly and carcinoid syndrome associated with neuroendocrine tumors, while atumelnant targets congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome [6] Clinical Development - The Phase 2 TouCAHn trial of atumelnant showed robust positive topline results, including up to an 80% mean reduction in androstenedione and significant improvements in clinical signs and symptoms of CAH [2][3] - Crinetics plans to initiate the CALM-CAH Phase 3 study in adults and the BALANCE-CAH Phase 2/3 study in pediatrics in the second half of 2025 [2] Mechanism of Action - Atumelnant acts selectively at the melanocortin type 2 receptor (MC2R) on the adrenal gland, demonstrating strong binding affinity and suppression of glucocorticoids and androgens controlled by ACTH [5] - The innovative mechanism aims to restore normal levels of adrenal androgens and reduce glucocorticoid supplementation to physiological levels, improving the quality of life for patients [2][3]