Crinetics Pharmaceuticals(CRNX)
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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 (CRNX) Poised for Transformational Growth in 2026: Piper Sandler
Yahoo Finance· 2025-12-11 16:17
Core Viewpoint - Crinetics Pharmaceuticals Inc. (NASDAQ:CRNX) is recognized by Wall Street analysts as a promising biotech stock, with expectations for significant growth in 2026 due to the launch of key drugs [1][2]. Group 1: Company Overview - Crinetics Pharmaceuticals is a clinical-stage drug company focused on developing oral treatments for rare endocrine diseases and tumors, including acromegaly, Cushing's disease, carcinoid syndrome, and congenital adrenal hyperplasia (CAH) [5]. - The company utilizes small molecules and peptide agonists that target hormone receptors in its drug development efforts [5]. Group 2: Pipeline and Research - The company is currently conducting the BRAVESST2 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of CRN09682, a drug developed from its nonpeptide drug conjugate (NDC) platform [3]. - The first patient has been dosed in Phase ½ of the study evaluating CRN09682 in patients with metastatic or locally advanced somatostatin receptor type 2 (SST2)-positive neuroendocrine tumors [2]. Group 3: Financial Position - Crinetics is in a strong financial position, with more cash than debt on its balance sheet, which allows the company to accelerate its pipeline development [3]. Group 4: Leadership Insight - Stephen Betz, Chief Scientific Officer and Co-Founder of Crinetics, emphasized that CRN09682 was developed to meet the need for a more efficacious, safer, and convenient targeted therapy for patients with SST2-expressing tumors [4].
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]
Biotech Fund Dumps $12.3 Million in Crinetics Stock as Shares Remain 19% Lower on the Year
The Motley Fool· 2025-11-27 18:23
Core Insights - MPM BioImpact fully exited its position in Crinetics Pharmaceuticals, selling 428,975 shares for approximately $12.3 million, which represented 2.1% of its assets under management in the previous quarter [1][2][7] - Crinetics Pharmaceuticals has experienced a significant decline in stock price, down 19% over the past year, while the S&P 500 has increased by 13% during the same period [3] - The company reported a net loss of $130.1 million for the third quarter, despite generating $143,000 in revenue from a licensing agreement for its lead candidate, Paltusotine [9] Company Overview - Crinetics Pharmaceuticals is a clinical-stage biotechnology company focused on developing oral therapies for rare endocrine diseases and related tumors, with Paltusotine targeting acromegaly and neuroendocrine tumors [5] - The company's market capitalization is $4.4 billion, with a trailing twelve-month (TTM) revenue of $1.5 million and a TTM net income loss of $423.1 million [4] Recent Developments - The FDA approved Palsonify on September 25, 2025, marking a significant transition for Crinetics from a clinical-stage to a commercial-stage company [6][9] - The company has a cash reserve of $1.1 billion as of September 30, 2023, which supports its operations into 2029 [9] - The exit by MPM BioImpact may indicate a shift in risk tolerance or a search for better investment opportunities, particularly as Crinetics navigates its commercial launch [6]
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]
Berkshire warns of AI deepfakes impersonating Warren Buffett
Reuters· 2025-11-07 17:38
Core Message - Warren Buffett emphasizes the uniqueness of his persona, stating that there is only one "Oracle of Omaha" and addressing concerns regarding AI-generated impersonations of him [1] Summary by Categories - **AI Impersonation Concerns** - The rise of AI technology has led to the creation of impersonations of notable figures, including Warren Buffett [1] - Buffett's statement serves as a warning to those who generate or view such AI-created content [1]
Crinetics Pharmaceuticals, Inc. (CRNX) Reports Q3 Loss, Lags Revenue Estimates
ZACKS· 2025-11-06 23:21
Core Insights - Crinetics Pharmaceuticals, Inc. (CRNX) reported a quarterly loss of $1.38 per share, which was worse than the Zacks Consensus Estimate of a loss of $1.27, and compared to a loss of $0.96 per share a year ago, indicating a significant decline in performance [1] - The company posted revenues of $0.14 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 94.7%, while revenues were zero a year ago [2] - The stock has underperformed, losing about 16.8% since the beginning of the year, contrasting with the S&P 500's gain of 15.6% [3] Financial Performance - The earnings surprise for the recent quarter was -8.66%, and the company has only surpassed consensus EPS estimates once in the last four quarters [2][3] - The current consensus EPS estimate for the upcoming quarter is -$1.30 on revenues of $3.25 million, and for the current fiscal year, it is -$4.85 on revenues of $4.98 million [7] Market Outlook - The company's stock is currently rated Zacks Rank 3 (Hold), indicating expected performance in line with the market in the near future [6] - The outlook for the Medical - Drugs industry, where Crinetics operates, is relatively strong, ranking in the top 39% of over 250 Zacks industries, suggesting potential for better performance compared to lower-ranked industries [8]
Crinetics Pharmaceuticals, Inc. 2025 Q3 - Results - Earnings Call Presentation (NASDAQ:CRNX) 2025-11-06
Seeking Alpha· 2025-11-06 22:31
Core Insights - The article emphasizes the importance of enabling Javascript and cookies in browsers to prevent access issues [1] Group 1 - The article suggests that users may face blocks if ad-blockers are enabled, indicating a need to disable them for proper access [1]