Core Viewpoint - Outlook Therapeutics has submitted a Type A Meeting request to the FDA to discuss the complete response letter (CRL) regarding the biologics license application (BLA) resubmission for ONS-5010, an investigational treatment for wet AMD [1][2]. Company Overview - Outlook Therapeutics is focused on developing and commercializing ONS-5010/LYTENAVA™ (bevacizumab-vikg), an ophthalmic formulation of bevacizumab aimed at optimizing the standard of care for retinal diseases [7]. - The company has commenced the commercial launch of LYTENAVA™ in Germany and the UK for the treatment of wet AMD [7]. Product Details - ONS-5010/LYTENAVA™ is an investigational product in the U.S. and has received centralized Marketing Authorization in the EU and the UK for treating wet AMD [4][5]. - Bevacizumab-vikg is a recombinant humanized monoclonal antibody that targets human vascular endothelial growth factor (VEGF) to reduce endothelial cell proliferation and vascular leakage in the retina [6]. Regulatory Context - The FDA's CRL acknowledged that the NORSE TWO pivotal trial met safety and efficacy endpoints but requested additional confirmatory evidence of efficacy for ONS-5010 [2]. - The Type A meeting aims to clarify the specific confirmatory evidence required by the FDA to address the deficiencies noted in the CRL [2][3].

Core Viewpoint - Capricor Therapeutics' shares fell 33% following the FDA's issuance of a complete response letter (CRL) regarding the biologics license application (BLA) for deramiocel, intended to treat cardiomyopathy associated with Duchenne muscular dystrophy (DMD) [1][6] Regulatory Update - The FDA concluded its review of the BLA but could not approve it in its current form, citing a lack of substantial evidence of effectiveness and the need for additional clinical data [2][6] - The CRL also pointed out unresolved issues in the Chemistry, Manufacturing and Controls (CMC) section of the application, although management believes these concerns have been addressed in prior communications with the FDA [3][6] Market Reaction - The investor community was surprised by the CRL, especially since the FDA had previously accepted the BLA and granted it priority review in March, with a decision expected by August 31, 2025 [4][6] - Year-to-date, Capricor's shares have declined 44.7%, contrasting with a 0.9% decline in the industry [3] Future Plans - Capricor plans to engage in discussions with the FDA to clarify the issues raised in the CRL and to outline a regulatory path for deramiocel [6][7] - The BLA was based on data from the phase II HOPE-2 study and an open-label extension study, and a potential approval could have made deramiocel the first therapy for DMD cardiomyopathy [7]