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Crinetics Pharmaceuticals to Report Third Quarter 2025 Financial Results on November 6, 2025
Globenewswire· 2025-10-06 20:05
SAN DIEGO, Oct. 06, 2025 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced that it will report third quarter 2025 financial results on Thursday, November 6, 2025 after the market closes. Company management will host a conference call at 4:30 p.m. ET to discuss financial results and provide a business update. Conference Call & Webcast Thursday, November 6 at 4:30 p.m. ET Domestic:1 833-470-1428International:1 646-844-6383Access Code:166837 Webcast: Participants can use the ...
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]
Crinetics to Present New Research on Paltusotine, Atumelnant and Unmet Needs in Acromegaly Treatment at the American Association of Clinical Endocrinology Annual Meeting 2025
Globenewswire· 2025-05-15 20:05
Core Insights - Crinetics Pharmaceuticals is presenting two abstracts at the AACE Annual Meeting 2025, highlighting the investigational candidate paltusotine's rapid and durable treatment effects in acromegaly patients and the significant symptom burden experienced by patients on standard treatments [1][2][3] Group 1: Paltusotine Development - Paltusotine is a once-daily oral medication that has shown promising results in controlling IGF-1 levels in surgically naïve acromegaly patients, with three out of four patients in one trial achieving IGF-1 normalization [4][10] - The company is preparing for a PDUFA action date of September 25 in the U.S., indicating potential regulatory approval for paltusotine [3][10] - Paltusotine is positioned as a viable first-line therapy for patients who cannot undergo surgery, with sustained IGF-1 control observed over 24 months in clinical trials [4][10] Group 2: Symptom Burden and Treatment Discontinuation - A study revealed that patients on long-acting injectable somatostatin analogs reported symptom exacerbations on 32% of days, leading to reduced quality of life and increased healthcare utilization [5][7] - A retrospective analysis indicated that 54% of acromegaly patients discontinued therapy, with only 20% remaining on their initial treatment, highlighting dissatisfaction with current injectable therapies [7] - The findings underscore the need for more effective treatments that provide consistent symptom control for acromegaly patients [5][7] Group 3: Atumelnant Development - Atumelnant, another investigational compound by Crinetics, is in development for ACTH-dependent Cushing's syndrome and has shown promising results in a Phase 2a study [11] - The compound is designed to selectively target the melanocortin type 2 receptor, potentially offering significant treatment benefits for patients with conditions related to excess ACTH [11]