资料显示，relacorilant为一种口服选择性糖皮质激素受体拮抗剂，除用于内源性皮质醇增多症相关适应 症外，亦在卵巢癌等疾病领域开展研发。此次审批受挫意味着该药物的商业化进程将面临进一步不确定 性，市场关注后续监管沟通及补充研究方案的推进情况。 对此，Corcept首席执行官Joseph K.Belanoff表示，公司"对这一结果感到意外和失望"，并称将"尽快与 FDA会面，讨论并确定最佳的后续推进路径"。 周三，Corcep医疗(CORT.US)股价暴跌超46%，报37.33美元。消息面上，该公司表示已收到美国食品药 品监督管理局(FDA)发出的完整回应函，其新药申请未获批准。该申请旨在寻求批准口服药物 Relacorilant用于治疗因皮质醇增多症(高皮质醇血症)引发的继发性高血压。 公司称，FDA在回应函中确认，Corcept的关键性GRACE临床试验达成主要终点，且GRADIENT试验数 据具有验证性意义；但监管机构认为，现有资料仍不足以支持对该疗法作出有利的收益—风险评估，因 而要求补充更多有效性证据。 ...

Core Insights - Arcutis Biotherapeutics has seen a significant stock increase of 96% in 2025, with a recent rise of 9.3% following FDA's acceptance of a supplemental New Drug Application for Zoryve cream [1] Company Overview - Arcutis is a medical dermatology company that has commercialized Zoryve, a therapy approved for three inflammatory dermatoses: atopic dermatitis, seborrheic dermatitis, and plaque psoriasis [2] - Zoryve is available in both foam and cream formulations, with concentrations ranging from 0.3% to 0.05% [2] Recent Developments - The FDA has accepted an sNDA for Zoryve cream 0.3% specifically for children aged two to five years with plaque psoriasis, with a review completion target set for June 29, 2026 [4] - The company has previously secured approval for Zoryve cream 0.3% for children aged six years and older and Zoryve 0.05% for children aged two to five years with atopic dermatitis [4] Financial Performance - Following strong third-quarter results, Arcutis' stock experienced a surge due to management's sales outlook exceeding market expectations [5]

Core Viewpoint - Biohaven's stock plummeted by 40.22% to a 52-week low following the FDA's complete response letter (CRL) rejecting the approval of its main asset, Vyglxia (troriluzole) [1] Group 1: FDA Response and Market Reaction - The FDA issued a CRL for Biohaven's new drug application (NDA) for Vyglxia, which targets spinocerebellar ataxia, a rare neurodegenerative disease [1] - The stock downgrade by Bank of America from "Buy" to "Neutral" and the target price reduction from $49 to $10 reflects the negative market sentiment following the FDA's decision [1] - Biohaven's CEO expressed disappointment over the FDA's decision, indicating the company's commitment to continue discussions with the FDA regarding the drug's regulatory pathway [1] Group 2: Company Restructuring and Financial Implications - Biohaven announced a restructuring plan that includes pausing or delaying non-priority R&D projects, aiming for a 60% reduction in annual R&D spending [2] - Analyst Jason Gerberry expressed caution regarding the restructuring plan, suggesting it may limit resource allocation to the company's three core assets, including Kv7 ion channel activator Opakalim [2] - The valuation model has been adjusted to exclude projections related to troriluzole due to the uncertainty surrounding its approval [2]

Core Points - The Hong Kong government plans to establish the "Hong Kong Drug and Medical Device Regulatory Center" by 2026 to become an internationally recognized authority in drug and medical device regulation [1] - The government will accelerate the "1+" new drug approval mechanism, prioritizing the approval of innovative drugs that can treat serious or rare diseases as recommended by the Hospital Authority [1] - Hong Kong aims to standardize clinical data within the Greater Bay Area and build a real-world data platform to facilitate faster market access for innovative drugs to mainland China and international markets [1]