REGENXBIO has reached an agreement with the FDA to pursue accelerated approval for NAVSUNLI, a one-time gene therapy for Hunter syndrome (MPS II). The FDA confirmed no new patient studies are needed and will review existing long-term data quickly. REGENXBIO plans a Type A meeting in July 2026 and aims to resubmit its Biologics License Application in Q3 2026. This marks a significant step toward bringing a potential transformative treatment to patients with this rare neurodegenerative disease.
Leading Japanese companies, startups, and research institutions are developing specialized AI models using NVIDIA Nemotron open models to address Japan's unique language, industrial, and workforce challenges. These AI applications range from enterpri...
ARCpoint Inc. announced it will likely miss the July 29, 2026 deadline to file its annual financial statements and related reports due to a lack of funds to pay auditors. The company has applied for a Management Cease Trade Order (MCTO) and awaits ap...
The Rosen Law Firm is investigating potential securities claims against Putnam Investment Management, LLC, alleging that the company may have provided misleading business information to investors. Investors who purchased Putnam stock-based mutual fun...
Several stocks experienced significant declines today driven by company-specific events. SANUWAVE Health's shares dropped 39.21% despite strong revenue guidance, Twin Vee Powercats fell 30.95% amid a legal investigation, and Gorilla Technology declin...
The phase III ENDURANCE trial showed that two years of lenalidomide maintenance therapy offers the same long-term survival benefit as indefinite treatment for patients with standard-risk multiple myeloma who are not transplant candidates. After nearl...
