Crinetics Pharmaceuticals, Inc. operates as a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors. Its product candidate, CRN00808, is an oral nonpeptide somatostatin agonist for the treatment of acromegaly. The firm is also developing other oral nonpeptide somatostatin agonists for neuroendocrine tumors and hyperinsulinism, as well as an oral nonpeptide ACTH antagonist for the treatment of Cushing's disease. The company was founded by R. Scott Struthers, Yun-Fei Zhu and Stephen F. Betz in 2008 and is headquartered in San Diego, CA.
相关临床试验
61
32 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2008
进行中（未招募）
29
47.5%
已完成
10
16.4%
尚未招募
3
4.9%
招募中
16
26.2%
终止
3
4.9%
暂无批准数据
- Crinetics Pharmaceuticals will present six datasets at ENDO 2026, including long-term safety and efficacy from the PATHFNDR open-label extension studies for paltusotine. - Three presentations will focus on the atumelnant clinical program, featuring Phase 2 data in congenital adrenal hyperplasia and Phase 1b/2a results in ACTH-dependent Cushing's syndrome. - All eight covering analysts maintain Buy ratings on CRNX with a consensus 1-year target price of $88.14, representing over 167% upside potential. - The company's pipeline targets rare endocrine diseases with candidates including paltusotine, atumelnant, CRN09682, and oral GLP-1/GIP nonpeptide programs.
- ADAR1 Capital Management disclosed a $37 million investment in Crinetics Pharmaceuticals during Q1 2026, purchasing 829,963 shares and bringing their stake to 2.44% of the fund's assets under management. - Crinetics recently launched Palsonify, its first commercial oral treatment for acromegaly, a rare hormonal disorder, with Q1 revenue significantly beating expectations despite subsequent stock price decline. - The company maintains $1.3 billion in cash reserves while burning approximately $150 million quarterly on R&D and commercialization efforts for its rare endocrine disease pipeline.
- Paltusotine (PALSONIFY) received FDA approval in September 2025 as the first once-daily oral therapy for acromegaly, marking a historic milestone in treatment paradigm shift from injectable therapies. - The oral somatostatin receptor type 2 agonist demonstrated rapid and durable IGF-1 normalization with meaningful symptom improvement in Phase III PATHFNDR trials, positioning it as a cornerstone therapy. - DelveInsight forecasts significant market expansion driven by strong physician adoption, patient preference for oral alternatives, and lifecycle expansion opportunities including potential use in carcinoid syndrome. - The acromegaly pipeline shows robust activity with 10+ companies developing 12+ therapies, including promising candidates like Atesidorsen and TE 8214 in various clinical stages.
- Crinetics Pharmaceuticals enrolled its first patient in the Phase 3 CALM-CAH trial for atumelnant, targeting congenital adrenal hyperplasia treatment. - The company received FDA Orphan Drug Designation for atumelnant, providing regulatory advantages and potential tax incentives. - Chief Medical and Development Officer Dr. Dana Pizzuti will step down on December 31, 2025, creating leadership uncertainty. - Despite the executive departure, analysts maintain a "Moderate Buy" consensus rating with substantial upside potential projected.
- Crinetics Pharmaceuticals has dosed the first patient in the CALM-CAH Phase 3 trial evaluating atumelnant, a novel once-daily oral ACTH receptor antagonist for classic congenital adrenal hyperplasia. - The Phase 3 study builds on positive Phase 2 results that demonstrated rapid and sustained reductions in key disease biomarkers including androstenedione and 17-hydroxyprogesterone. - Atumelnant is the first-and-only small molecule ACTH receptor antagonist in late-stage clinical development, designed to block excess androgen production in the adrenal gland. - The FDA has granted Orphan Drug Designation for atumelnant in the treatment of classic CAH, highlighting the significant unmet medical need in this rare endocrine disorder.
- The FDA has granted orphan drug designation to atumelnant, Crinetics Pharmaceuticals' novel oral ACTH receptor antagonist for treating classic congenital adrenal hyperplasia. - Phase 2 TouCAHn trial results showed up to 80% mean reduction in androstenedione levels and meaningful improvements in clinical symptoms including resumption of menses. - The company plans to initiate Phase 3 CALM-CAH study in adults and Phase 2/3 BALANCE-CAH study in pediatrics in the second half of 2025. - Orphan drug status provides seven years of market exclusivity, FDA fee exemptions, and financial incentives for clinical development if approved.
- Industry experts at the 2025 Clinical Trial Supply West Coast conference identified risk management as critical for pharmaceutical supply chains amid rising tariffs and AI disruption. - President Trump's tariffs on pharmaceutical imports, including a 15% rate on EU products with potential increases to 250%, are forcing companies to develop backup sourcing strategies. - Artificial intelligence is accelerating the shift from site-centric to patient-centric clinical trials, though human input remains essential for interventional trials with scarce data. - Regulatory changes including FDA guidance on decentralized trials and diversity requirements are reshaping clinical trial operations and supply chain planning.
- The FDA approved osilodrostat (Isturisa) as a second-line treatment for adults with endogenous Cushing syndrome in April 2025, expanding treatment options for patients unable to undergo surgery. - Relacorilant demonstrated significant cardiometabolic benefits in Phase III trials, showing notable blood pressure reductions of -10.1 mm Hg systolic and -6.3 mm Hg diastolic compared to placebo increases. - Multiple companies including Corcept Therapeutics, Crinetics Pharmaceuticals, and AstraZeneca are developing novel therapies with over 4 investigational treatments in various clinical phases. - The Cushing syndrome pipeline includes diverse therapeutic approaches targeting cortisol synthesis inhibition and glucocorticoid receptor modulation across oral and parenteral administration routes.
- DelveInsight's analysis reveals 4+ key companies are developing 6+ therapies for congenital hyperinsulinism, with emerging treatments including CRN-04777, HM 15136, RZ358, and dasiglucagon expected to significantly impact the market. - Recent regulatory developments include FDA's Breakthrough Therapy Designation for RZ358 in January 2025 and removal of clinical holds in September 2024, while Zealand Pharma received a Complete Response Letter for dasiglucagon in October 2024. - The congenital hyperinsulinism market is anticipated to grow with significant CAGR during 2020-2034, driven by increasing disease awareness and research activities, though challenges remain with high treatment costs and diagnostic complexities.
- The FDA has established PDUFA target action dates for three promising therapies in Q3 2025: sepiapterin for phenylketonuria (July 29), apitegromab for spinal muscular atrophy (September 22), and paltusotine for acromegaly (September 25). - PTC Therapeutics' sepiapterin demonstrated a 63% reduction in blood phenylalanine levels in PKU patients, with 84% achieving therapeutic control and over 97% able to liberalize their protein-restricted diets. - Scholar Rock's apitegromab showed statistically significant motor function improvements in SMA patients already receiving standard care, while Crinetics' paltusotine achieved IGF-1 normalization in 83% of acromegaly patients switching from injectable treatments. - These approvals could provide significant therapeutic advances for patients with rare genetic disorders who currently have limited treatment options or face challenges with existing therapies.
