Outlook CRL ‘a significant setback,’ doesn’t mean end for Lytenava, says Chardan

After Outlook Therapeutics (OTLK) announced that it received a complete response letter from the FDA for Lytenava in wet age-related macular degeneration, Chardan called the CRL “a significant setback for the company. However, the CRL does not mean the end for Lytenava, which has already been approved and launched in Germany and the United Kingdom, the analyst added. The firm, which views U.S. approval as unlikely in the absence of additional studies, has a Neutral rating and $3 price target on Outlook shares.