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ISELIN, N.J. - Outlook Therapeutics, Inc. (NASDAQ:OTLK), a $43 million market cap biotechnology company, announced Monday it has completed a Type A Meeting with the U.S. Food and Drug Administration regarding its biologics license application for ONS-5010, an investigational ophthalmic formulation of bevacizumab for wet age-related macular degeneration (AMD) treatment. According to InvestingPro data, the company’s shares have declined nearly 49% year-to-date, reflecting investor uncertainty around regulatory approvals.
Following what the company described as a "productive discussion" with regulators, Outlook Therapeutics expects to resubmit its BLA before the end of 2025. The meeting addressed the complete response letter issued by the FDA on August 27, 2025. While the company faces near-term challenges, with InvestingPro analysis showing analyst price targets ranging from $1 to $8, two analysts have recently revised their earnings expectations upward for the upcoming period.
"Based on our meeting, and pending receipt of the agency’s written minutes, we plan to resubmit the BLA later this year," said Bob Jahr, Chief Executive Officer of Outlook Therapeutics, according to the company’s press release.
ONS-5010, also known as LYTENAVA (bevacizumab-vikg in the U.S., bevacizumab gamma in Europe), has already received marketing authorization from the European Commission and the UK’s Medicines and Healthcare products Regulatory Agency for wet AMD treatment.
The company has begun commercial launch of the product in Germany and the United Kingdom. If approved in the United States, it would be the first FDA-approved ophthalmic formulation of bevacizumab specifically for retinal indications. Investors tracking this development can access additional insights and 9 more exclusive ProTips through InvestingPro, including detailed financial health metrics and valuation analysis.
Wet AMD is a condition where abnormal blood vessels grow under the macula in the retina, potentially leading to vision loss.
The information in this article is based on a press release statement from Outlook Therapeutics.
In other recent news, Outlook Therapeutics experienced significant developments following the U.S. Food and Drug Administration’s (FDA) decision regarding its wet age-related macular degeneration (wet AMD) treatment. The FDA issued a Complete Response Letter, rejecting the company’s resubmitted Biologics License Application for ONS-5010/LYTENAVA, due to insufficient evidence of effectiveness. This decision stemmed from the treatment’s failure to meet the primary endpoint in the NORSE EIGHT clinical trial, despite achieving non-inferiority at a later stage. As a result, H.C. Wainwright downgraded Outlook Therapeutics from Buy to Neutral, adjusting the price target from $3.00 to $1.00.
In addition to regulatory challenges, Outlook Therapeutics announced the appointment of Bob Jahr as the new Chief Executive Officer. Jahr, who brings over 20 years of experience in the biopharmaceutical industry, previously served as Chief Commercial Officer for Sobi North America. His leadership is expected to guide the company through its current challenges. These recent developments highlight key changes and challenges for Outlook Therapeutics.
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