Core Insights - NovaBridge Biosciences announced the appointment of Dr. Cadmus C. Rich as Chief Medical Officer and Dr. Carlos Quezada-Ruiz as Chairman of the Scientific Advisory Board for its subsidiary Visara, Inc. [1][2][3] Leadership Appointments - Dr. Rich and Dr. Quezada-Ruiz are recognized leaders in ophthalmology and drug development, enhancing Visara's capabilities in clinical functions and scientific advisory [2][5] - Dr. Rich aims to accelerate the development of innovative ophthalmology treatments, particularly focusing on the VIS-101 program [2][12] - Dr. Quezada-Ruiz has extensive experience in developing retinal therapies and is committed to advancing VIS-101 into registrational development [2][10] VIS-101 Program - VIS-101 is a novel bifunctional biologic targeting VEGF-A and ANG-2, with potential applications in treating wet AMD, DME, and RVO [5][12] - The program is expected to be Phase 3-ready by 2026, following the completion of a Phase 2 study [5][12] - The dual targeting mechanism of VIS-101 is anticipated to provide more durable treatment benefits compared to current standards of care [12][18] Strategic Transformation - The appointments of Dr. Rich and Dr. Quezada-Ruiz reflect NovaBridge's strategic transformation into a global biotech platform and its commitment to delivering shareholder value [3][5] - The ability to attract distinguished leaders underscores the potential of VIS-101 and the company's innovative "hub-and-spoke" strategy [3][5] Company Overview - Visara, Inc. is focused on developing best-in-class ophthalmic therapeutics and is majority-owned by NovaBridge, which controls global rights to VIS-101 outside of Greater China [13][18] - NovaBridge is dedicated to accelerating access to innovative medicines through a combination of business development expertise and agile clinical development [15][16]

Core Viewpoint - Biogen Inc. received a Complete Response Letter (CRL) from the FDA regarding its supplemental New Drug Application (sNDA) for a high dose regimen of nusinersen for spinal muscular atrophy (SMA), requesting updates to the technical information in the Chemistry Manufacturing and Controls (CMC) module [1][2] Group 1: FDA Response and Company Actions - The FDA's letter did not indicate any deficiencies in the clinical data for the high dose regimen [2] - Biogen plans to promptly resubmit the application based on readily available information [2] - The company is collaborating with global regulatory authorities to advance the high dose regimen as an additional option for SMA patients [2] Group 2: Product Information - SPINRAZA (nusinersen) is approved in over 71 countries for treating SMA in infants, children, and adults, with more than 14,000 individuals treated worldwide [3] - The drug has demonstrated efficacy across various ages and SMA types, supported by a well-established safety profile from data in patients treated for up to 10 years [4] Group 3: Company Background - Biogen, founded in 1978, is a leading biotechnology company focused on innovative science to develop new medicines and create value for shareholders and communities [6]