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ISELIN, N.J. - Outlook Therapeutics, Inc. (NASDAQ: OTLK), currently valued at $36.5 million in market capitalization, announced today that the U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025, for the review of its Biologics License Application (BLA) for ONS-5010, potentially the first FDA-approved ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD).
The FDA's acceptance of the resubmitted BLA and the setting of the PDUFA date represent critical steps for Outlook Therapeutics in its efforts to market ONS-5010, to be branded as LYTENAVA™ (bevacizumab-vikg) in the United States. While analyst price targets range from $3 to $24, suggesting significant potential upside according to InvestingPro data, the company faces near-term financial challenges with a weak overall financial health score. The company's Chief Financial Officer and Interim Chief Executive Officer, Lawrence Kenyon, expressed pride in the progress made towards offering the first on-label, ophthalmic bevacizumab for wet AMD treatment to clinicians and patients in the U.S.
The resubmission of the BLA was based on results from the NORSE EIGHT study, which demonstrated the efficacy and safety of ONS-5010 in treating wet AMD, as well as additional chemistry, manufacturing, and controls (CMC) information requested by the FDA. The FDA classified this as a Class 2 review, indicating a six-month review period from the resubmission date.
ONS-5010 has already achieved regulatory approval in the European Union and the United Kingdom under the name LYTENAVA™ (bevacizumab gamma). If approved by the FDA, LYTENAVA™ is expected to receive 12 years of regulatory exclusivity in the U.S. market. Despite recent market challenges, with the stock down nearly 88% over the past year, InvestingPro analysis suggests the company may be undervalued at current levels. For deeper insights into OTLK's valuation metrics and 10+ additional ProTips, consider exploring InvestingPro's comprehensive analysis tools.
Outlook Therapeutics has been actively preparing for the potential commercialization of LYTENAVA™ in the United States. The company is also working towards initiating its commercial launch of the drug in the EU and the UK for wet AMD treatment, anticipated in the second quarter of 2025. Investors should note that analysts currently do not expect profitability this year, with the company reporting an EBITDA of -$82.87 million in the last twelve months.
The information in this article is based on a press release statement.
In other recent news, Outlook Therapeutics has resubmitted its Biologics License Application (BLA) for ONS-5010 to the U.S. Food and Drug Administration (FDA), aiming to secure approval for this investigational drug. The company reported that ONS-5010 demonstrated non-inferiority to Lucentis in treating wet age-related macular degeneration (wet AMD) during the NORSE EIGHT clinical trial, with notable improvements in visual acuity. Meanwhile, Outlook Therapeutics has expanded its authorized common stock from 60 million to 260 million shares, a decision approved by stockholders to enhance financial flexibility. Additionally, the company terminated an agreement with Streeterville Capital, LLC, utilizing proceeds from a new $33.1 million unsecured convertible promissory note issued to Avondale Capital, LLC. In corporate governance, Faisal G. Sukhtian has been appointed as the new Chairman of the Board, with Randy Thurman continuing as Lead Independent Director. H.C. Wainwright analyst Douglas Tsao revised the price target for Outlook Therapeutics to $3.00, maintaining a Buy rating, following the clinical trial outcomes for ONS-5010. The company's ophthalmic formulation of bevacizumab, LYTENAVA™, has received marketing authorization in the EU and UK, with plans for a commercial launch in the first half of 2025. These developments reflect the company's ongoing efforts to advance its product portfolio and financial structure.
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