Outlook Therapeutics Receives CRL for Lytenava, Chardan Calls it a "Significant Setback"

Outlook Therapeutics received a complete response letter from the FDA for Lytenava in wet age-related macular degeneration, which Chardan calls a "significant setback." However, the CRL doesn't mean the end for Lytenava, which has already been approved and launched in Germany and the UK. The firm has a Neutral rating and $3 price target on Outlook shares, with US approval seen as unlikely without additional studies.

Outlook Therapeutics, Inc. (OTLK) has received a significant setback from the U.S. Food and Drug Administration (FDA) regarding its investigational drug Lytenava for the treatment of wet age-related macular degeneration (wet AMD). The FDA declined to approve Lytenava, citing a lack of substantial evidence of effectiveness [1].

The pre-market session saw Outlook Therapeutics' shares plummet by over 66%, indicating the market's immediate reaction to the news [1]. Wet AMD is a leading cause of vision loss among people aged 50 and older, and the condition is characterized by abnormal blood vessels growing under the retina, leading to rapid vision loss [2].

Despite the FDA's decision, Outlook Therapeutics remains committed to addressing the deficiency and potentially securing FDA approval. The company plans to meet with the FDA to clarify its requirements and intends to continue expanding its commercial availability of Lytenava in other markets, including Europe [2].

Chardan Capital Research has given Outlook Therapeutics a Neutral rating and a $3 price target on its shares, with the firm indicating that U.S. approval is unlikely without additional studies [3]. The company's stock price has been volatile in response to the FDA's decision, reflecting investor concerns over the drug's future prospects.

References:
[1] https://stocktwits.com/news-articles/markets/equity/outlook-therapeutics-stock-nose-dives-66-in-pre-market-here-s-why/chs6EjSRdmQ
[2] https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-provides-regulatory-update-us-food-and-drug
[3] https://www.chardan.com/research/outlook-therapeutics-inc-otlk