The company continues to receive good news from the Food and Drug Administration.Shares in Arcutis Biotherapeutics (ARQT 2.01%) continued their excellent run in 2025 (up 96%) with another 9.3% rise in the week to Friday morning. This week's move comes as the Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for Arcutis' Zoryve (roflumilast) cream. The development raises confidence that the company will be able to extract full value from Zoryve across various indications. ...

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]