文章核心观点 - 公司开发的新药物atumelnant(CRN04894)是一种首次在人体中研究的ACTH受体拮抗剂,可以快速有效地降低患有先天性肾上腺增生症(CAH)和ACTH依赖性库欣综合征(ADCS)患者体内的关键激素水平,达到临床正常范围 [1][2][3] - 在CAH患者中,atumelnant可以使100%的患者在2周内将雄激素前体androstenedione(A4)降至正常上限以下,并在12周内维持,同时也可以大幅降低17-羟基孕酮(17-OHP)水平 [5][6][7][8] - 在ADCS患者中,atumelnant可以在10天内使100%的患者血清皮质醇降至5 mcg/dL以下,并使所有患者的24小时尿游离皮质醇正常化 [11][12] 公司和产品信息 - 公司正在开发的第二个临床产品候选药物atumelnant是一种首创的每日一次口服ACTH受体拮抗剂,可以选择性地作用于肾上腺皮质的MC2受体,从而抑制由ACTH调控的糖皮质激素和雄激素的产生 [17][18] - atumelnant目前正在进行CAH和ADCS的II期临床试验,试验结果显示该药物具有快速和持久的降低关键激素水平的作用,为这些难以控制的内分泌疾病带来新的治疗希望 [19][20] - 公司还有其他内分泌领域的新药物候选,如用于治疗肢端肥大症和神经内分泌瘤相关症状的paltusotine,以及针对甲状腺眼病、糖尿病和肥胖等的其他发现项目 [22]

First Scientific Presentation of PATHFNDR-2 Acromegaly Safety and Efficacy Data Following Positive Topline Announcement, Showing Rapid and Sustained IGF-1 Responses in People Treated with Paltusotine New PATHFNDR-1 Patient-Reported Outcomes Analysis Showed Paltusotine Lessened Day-to-Day Breakthrough Symptom Exacerbations versus Prior Treatment with Standard of Care Injections, as Assessed by Acromegaly Symptom Diary Long-Term Data from Open-Label ACROBAT Advance Extension Study Demonstrated Durable Safety ...

SAN DIEGO, May 30, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), today announced the appointment of Robert M. Cuddihy, M.D., as senior vice president of Medical Affairs. Dr. Cuddihy is a board-certified physician in endocrinology, diabetes and metabolism with more than 30 years of experience spanning clinical practice and pharmaceutical industry medical affairs. "Dr. Cuddihy's wealth of knowledge and experience both as a practicing physician in endocrinology and working within the ...

SAN DIEGO, May 30, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX), today announced the appointment of Robert M. Cuddihy, M.D., as senior vice president of Medical Affairs. Dr. Cuddihy is a board-certified physician in endocrinology, diabetes and metabolism with more than 30 years of experience spanning clinical practice and pharmaceutical industry medical affairs. "Dr. Cuddihy's wealth of knowledge and experience both as a practicing physician in endocrinology and working within the ...

SAN DIEGO, May 22, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX) a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors, today announced that the late-breaking abstracts accepted for presentation at the Endocrine Society's annual meeting (ENDO 2024) were released earlier than the previously announced embargoed date. The abstract for the Phase 2, open-label study of ...

财务数据和关键指标变化 - 公司2024年第一季度净亏损为6690万美元,而2023年同期为4600万美元,主要由于研发和管理费用的增加 [46][49] - 公司2024年第一季度收入为60万美元,而2023年同期为270万美元,主要来自公司与日本合作伙伴SKK的Paltusotine授权安排 [50] - 公司预计2024年剩余时间每季度现金消耗将在5000万至6000万美元之间 [51] - 公司2024年3月31日现金和投资约为9亿美元,预计可为公司运营提供资金支持至2028年 [46] 各条业务线数据和关键指标变化 - Paltusotine在治疗肢端肥大症的PATHFNDR-2期3项目中达到主要和次要终点,为NDA申报提供支持 [14][15] - Paltusotine在治疗类癌综合征的开放标签2期试验中显示症状明显改善,公司计划与FDA讨论3期试验设计 [19] - Atumelnant在治疗先天性肾上腺增生症(CAH)和库欣病的2期试验正在进行,公司将在6月内发布初步数据 [35][36][37][38][39][40][41][42][43] 各个市场数据和关键指标变化 - 公司正在与医疗专家和主要支付方就Paltusotine的上市做准备,反馈积极 [18] - 公司计划在2024年下半年针对医疗服务提供者推出Paltusotine的宣传活动,2025年初针对患者推出 [16][17] 公司战略和发展方向及行业竞争 - 公司正在加快推进管线中其他早期项目的临床前研究,包括用于治疗甲状腺功能亢进症和糖尿病肥胖的候选药物 [103][104][105][106][107][108][109][110][111][112][113][114][115][116] - 公司的内部发现和开发能力为长期成功奠定基础 [21] 管理层对经营环境和未来前景的评论 - 公司对Paltusotine和Atumelnant的临床进展以及管线其他早期项目的发展前景表示乐观 [9][21][53] - 公司认为Paltusotine和Atumelnant有望为相关适应症患者带来新的治疗选择 [30][31][35][36][37][38][39][40][41][42][43] 问答环节重要的提问和回答 问题1 **Yasmeen Rahimi 提问** 对Atumelnant在库欣病试验的初步数据有何期望 [55][56][57][58][59][60] **Alan Krasner 回答** 公司希望从10天给药期间观察到皮质醇水平的变化,这将为后续Atumelnant在库欣病的开发提供指导性信息 [58][59][60] 问题2 **Cory Jubinville 提问** 对Atumelnant在CAH试验中观察到的"显著"降低A4和17OHP的描述有何含义,以及公司对这一结果的满意程度 [68][69][70][71] **Scott Struthers 回答** 公司将在6月3日的会议上公布更多细节,目前不方便过多评论,但总的来说公司对结果感到满意 [70][71] 问题3 **Douglas Tsao 提问** 公司如何看待早期管线项目的优先次序和临床进展计划 [102][103][104][105][106][107] **Scott Struthers 回答** 公司正在尽快推进所有早期项目,包括PTH受体拮抗剂、TSH拮抗剂以及糖尿病和肥胖项目,未来12-24个月内将有更多临床数据陆续公布 [104][105][106][107]

SAN DIEGO, May 10, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX) today announced that on May 10, 2024, the Compensation Committee of Crinetics' Board of Directors granted non-qualified stock option awards to purchase an aggregate of 176,000 shares of its common stock to fifteen new non-executive employees under the Crinetics Pharmaceuticals, Inc. 2021 Employment Inducement Incentive Award Plan (the "2021 Inducement Plan"). The stock options were granted as inducements material to th ...

Crinetics Pharmaceuticals, Inc. (CRNX) came out with a quarterly loss of $0.93 per share versus the Zacks Consensus Estimate of a loss of $0.84. This compares to loss of $0.85 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -10.71%. A quarter ago, it was expected that this company would post a loss of $0.89 per share when it actually produced a loss of $0.90, delivering a surprise of -1.12%.Over the last four quarters, the com ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38583 Crinetics Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 26-3744114 (State or other j ...

公司业绩 - CRNX股价在3月19日上涨了19.1%[1] - 公司报告了两项晚期研究中领先候选药物paltusotine的积极数据[1] - PATHFNDR-2研究达到了主要终点，显示出paltusotine治疗的患者中有56%达到了IGF-1水平≤正常上限的1.0倍[4] 产品研发 - PATHFNDR-2研究评估了paltusotine在患有肢端肥大症的参与者中的疗效和安全性[3] - CRNX表示paltusotine在PATHFNDR-2研究中整体耐受性良好，没有严重不良事件[5] - 公司管理层相信来自PATHFNDR-2研究的数据证实了paltusotine在未接受药物治疗的肢端肥大症患者中提供症状控制和生化控制的潜力[6] 未来计划 - CRNX目前正在对paltusotine进行另一项中期研究，用于治疗类癌综合征[12] - 公司计划在2024年下半年向FDA提交paltusotine用于肢端肥大症适应症的审批申请，预计在2025年在美国市场推出该产品[11]