ISELIN, N.J., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on optimizing the standard of care for bevacizumab for the treatment of retina diseases, today announced that a Type A Meeting request has been submitted to the U.S. Food and Drug Administration (FDA) to discuss the complete response letter (CRL) dated August 27, 2025 regarding the biologics license application (BLA) resubmission for ONS-5010, an investigational ophthalmic formulat ...

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]