BTIG downgraded Outlook Therapeutics to Neutral from Buy with no price target after the company received a Complete Response Letter from the FDA for its BLA for ONS-5010 in wet AMD. While the firm still sees “a strong and disruptive use case” for ONS-5010 in wet AMD and other degenerative retinal diseases, it recognizes this regulatory update as “a material setback” and expects that remediation would likely require “significant time and capital,” prompting a downgrade while awaiting additional clarity on next steps.
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