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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 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 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]
Crinetics (CRNX) Q2 Revenue Jumps 150%
The Motley Fool· 2025-08-08 02:57
Core Insights - Crinetics Pharmaceuticals reported a GAAP revenue of $1.0 million for Q2 2025, exceeding the consensus estimate of $0.61 million, but the GAAP net loss per share widened to $(1.23), larger than the anticipated $(1.08) per share, due to increased R&D and administrative expenses [1][5][6] Financial Performance - GAAP revenue for Q2 2025 was $1.0 million, a 150% increase from $0.4 million in Q2 2024 [2] - GAAP net loss per share was $(1.23), a 30.9% increase from $(0.94) in Q2 2024 [2] - Research and Development expenses rose to $80.3 million, up 37.8% from $58.3 million in Q2 2024 [2] - Selling, General & Administrative expenses doubled to $49.8 million from $24.8 million in Q2 2024 [2] - The company reported a net loss of $(115.6) million for the quarter, compared to $(74.1) million in Q2 2024 [1][6] Product Pipeline and Development - The company focuses on developing oral therapies for rare endocrine diseases, with lead products including paltusotine for acromegaly and carcinoid syndrome, and atumelnant for congenital adrenal hyperplasia and Cushing's disease [3][11] - Paltusotine's New Drug Application (NDA) review is on track, with a target FDA decision date of September 25, 2025 [7] - Atumelnant is in Phase 2 trials for CAH, with Phase 3 studies planned for both adult and pediatric populations [8] Strategic Initiatives - The company is preparing for its first commercial drug launch, focusing on regulatory approvals, clinical trial effectiveness, and building relationships with healthcare professionals [4][10] - The CrinetiCare platform is being established to support patient outreach and education ahead of the potential launch of paltusotine [10] Cash Position and Future Outlook - As of June 30, 2025, the company had $1.2 billion in cash, cash equivalents, and investments, expected to fund operations into 2029 [15] - Full-year cash use for 2025 is estimated between $340 to $370 million, reflecting readiness for commercial launch and ongoing late-stage trials [15] - Management did not provide formal guidance for future revenue or earnings, focusing instead on the upcoming FDA decision for paltusotine [14]
Crinetics Pharmaceuticals Announces July 2025 Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Globenewswire· 2025-07-10 20:28
Core Points - Crinetics Pharmaceuticals granted non-qualified stock option awards for 102,350 shares and restricted stock unit (RSU) awards for 77,875 shares to 46 new non-executive employees as part of the 2021 Employment Inducement Incentive Award Plan [1][2] - The stock options have an exercise price of $31.99 per share, equal to the closing price on July 10, 2025, and will vest over four years [2] - Crinetics Pharmaceuticals is focused on developing novel therapeutics for endocrine diseases and related tumors, with lead candidate paltusotine in clinical development for acromegaly and carcinoid syndrome [3] Summary by Category Stock Options and RSUs - The stock options and RSUs were granted as inducements for new employees under the 2021 Inducement Plan, in compliance with Nasdaq Listing Rule 5635(c)(4) [1][2] - Stock options will vest 25% after one year, with the remainder vesting in 36 equal monthly installments, contingent on continued employment [2] - RSUs will vest in equal annual installments over four years, also dependent on continued employment [2] Company Overview - Crinetics Pharmaceuticals is a clinical stage pharmaceutical company specializing in endocrine diseases and tumors [3] - The company’s lead candidate, paltusotine, is the first investigational oral selective somatostatin receptor type 2 nonpeptide agonist [3] - Other drug candidates in development include treatments for congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome, with a focus on orally delivered small molecules [3]
Crinetics to Showcase the Next Generation of Endocrinology Innovation at ENDO 2025 with Eight Presentations From its Deep Pipeline
Globenewswire· 2025-06-30 20:05
Core Insights - Crinetics Pharmaceuticals is set to present long-term efficacy and safety data for its investigational drug PALSONIFY (paltusotine) in acromegaly, demonstrating both biochemical and symptom control with a well-tolerated safety profile [1][2] - The company will also showcase Phase 2 trial results for atumelnant in congenital adrenal hyperplasia (CAH) and data from early-stage development programs in Graves' hyperthyroidism and orbitopathy at the Endocrine Society's Annual Meeting, ENDO 2025 [1][3] PALSONIFY Presentations - Four abstracts will report results from the PALSONIFY development program, including an oral presentation on long-term efficacy, safety, and symptom control in acromegaly patients switching from injectable somatostatin receptor ligands to once-daily oral PALSONIFY [2][4] - Three poster presentations will cover symptom stability in acromegaly, patient-reported outcomes from PATHFNDR-1 and PATHFNDR-2, and open-label extension data from PATHFNDR-2 [2] Atumelnant Presentations - Three abstracts will focus on atumelnant, including an oral presentation of Phase 2 trial results in CAH, highlighting reductions in adrenal volume and significant decreases in potent 11-oxygenated androgens [3][7] Early-Stage Pipeline - Crinetics will present new data from its early-stage pipeline, including findings related to CRN12755 for Graves' hyperthyroidism and orbitopathy [4][8] Company Overview - Crinetics Pharmaceuticals is a clinical-stage pharmaceutical company focused on developing novel therapeutics for endocrine diseases and related tumors, with PALSONIFY and atumelnant as its lead candidates [11]
Crinetics Pharmaceuticals to Host R&D Day on June 26, 2025
Globenewswire· 2025-06-16 12:00
Company Overview - Crinetics Pharmaceuticals is a clinical stage pharmaceutical company focused on discovering, developing, and commercializing novel therapeutics for endocrine diseases and endocrine-related tumors [2] - The lead development candidate, paltusotine, is the first investigational once-daily, oral, selective somatostatin receptor type 2 (SST2) nonpeptide agonist in clinical development for acromegaly and carcinoid syndrome associated with neuroendocrine tumors [2] - Other candidates in development include Atumelnant for congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome, with a focus on orally delivered, small molecule, new chemical entities [2] Upcoming Event - Crinetics Pharmaceuticals will host an in-person and virtual R&D Day in New York on June 26, 2025, from 9:00 AM to 12:00 PM ET [1] - The event will provide updates on early-stage pipeline assets, next steps, and portfolio strategy aimed at driving long-term value [1] - A live question-and-answer session will follow the formal presentations during the event [1]
Crinetics Pharmaceuticals Announces June 2025 Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Globenewswire· 2025-06-10 20:29
Core Viewpoint - Crinetics Pharmaceuticals has granted stock options and restricted stock units to new non-executive employees as part of its 2021 Employment Inducement Incentive Award Plan to attract talent [1][2]. Group 1: Stock Options and RSUs - The Compensation Committee granted a total of 74,000 stock options and 48,850 RSUs to 20 new employees [1]. - The stock options have an exercise price of $33.08 per share, equal to the closing price on June 10, 2025 [2]. - Stock options will vest over four years, with 25% vesting after one year and the remainder vesting in 36 equal monthly installments [2]. Group 2: Company Overview - Crinetics Pharmaceuticals is a clinical stage pharmaceutical company focused on developing therapeutics for endocrine diseases and related tumors [3]. - The lead candidate, paltusotine, is in clinical development for acromegaly and carcinoid syndrome [3]. - Other drug candidates are being developed for conditions such as congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome, with a focus on orally delivered small molecules [3].
Crinetics Pharmaceuticals Announces June 2025 Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
GlobeNewswire News Room· 2025-06-10 20:29
Core Points - 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 [1][2] - The stock options total 74,000 shares with an exercise price of $33.08, equal to the closing price on June 10, 2025, and will vest over four years [2] - The RSUs total 48,850 shares and will also vest over four years in equal annual installments [2] Company Overview - Crinetics Pharmaceuticals is a clinical stage pharmaceutical company focused on developing novel therapeutics for endocrine diseases and related tumors [3] - The lead candidate, paltusotine, is in clinical development for acromegaly and carcinoid syndrome associated with neuroendocrine tumors [3] - Other drug candidates include Atumelnant, targeting congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome, with a focus on orally delivered small molecules for various endocrine conditions [3]
Crinetics Pharmaceuticals to Participate in the Jefferies Global Healthcare Conference 2025
Globenewswire· 2025-05-23 12:00
Company Participation - Crinetics Pharmaceuticals will participate in the Jefferies Global Healthcare Conference from June 3-5, 2025 in New York, NY [1][2] Company Presentation Details - The company presentation is scheduled for Thursday, June 5, 2025, at 12:50 p.m. Eastern Time [2] Company Overview - Crinetics Pharmaceuticals is a clinical stage pharmaceutical company focused on developing novel therapeutics for endocrine diseases and related tumors [3] - The lead candidate, paltusotine, is an investigational once-daily, oral, selective somatostatin receptor type 2 (SST2) nonpeptide agonist, currently in clinical development for acromegaly and carcinoid syndrome associated with neuroendocrine tumors [3] - Atumelnant is in development for congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome [3] - All drug candidates are orally delivered, small molecule, new chemical entities resulting from in-house drug discovery efforts, targeting various endocrine conditions [3]