Outlook Therapeutics, Inc. (NASDAQ:OTLK) stock plunged on Thursday after the U.S. Food and Drug Administration (FDA) update.
Outlook Therapeutics traded lower, with a session volume of 26.41 million compared to the average volume of 1.51 million as per data from Benzinga Pro.
FDA Update
The agency issued a complete response letter (CRL) to its biologics license application (BLA) resubmission, indicating that the FDA cannot approve the application in its present form for the treatment of wet age-related macular degeneration (wet AMD).
The CRL included only one deficiency for a lack of substantial evidence of effectiveness.
In the CRL, the FDA advised that, because ONS-5010 did not meet the primary efficacy endpoint in NORSE EIGHT, it is recommended that confirmatory evidence of efficacy be submitted to support the application for ONS-5010.
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Additionally, the FDA reiterated that NORSE TWO met its primary endpoint for effectiveness.
What Happens Next?
“While we are very disappointed with this outcome, we intend to meet with the FDA to receive additional clarity on their requirements to potentially approve the first on-label bevacizumab product specifically formulated, manufactured, and packaged for intravitreal use in the United States. We remain committed to providing patients with a safe and effective alternative to compounded Avastin manufactured in the United States,” commented Bob Jahr, Chief Executive Officer of Outlook Therapeutics.
In addition to requesting a meeting with the FDA to explore pathways for potential approval in the U.S., Outlook Therapeutics intends to continue its efforts to expand into additional markets in Europe.
As previously announced, Lytenava (bevacizumab gamma) received approval from the European Commission and the Medicines and Healthcare Products Regulatory Agency (MHRA) for wet AMD.
In June 2025, Lytenava (bevacizumab gamma) became commercially available in Germany and the U.K. for wet AMD.
Lytenava is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in adults in the European Union and the U.K.
In August 2023, Outlook Therapeutics received an FDA complete response letter regarding ONS-5010.
While the FDA acknowledged that the NORSE TWO pivotal trial met its safety and efficacy endpoints, the agency concluded it could not approve the application during this review cycle due to several CMC issues, open observations from pre-approval manufacturing inspections, and a lack of substantial evidence.
The ONS-5010 BLA resubmission was based on the efficacy and safety demonstrated in NORSE EIGHT and additional chemistry, manufacturing, and controls (CMC) information requested by the FDA.
As previously announced, the FDA informed Outlook Therapeutics that, in order to meet the FDA’s requirement for a second adequate and well-controlled clinical trial of ONS-5010, it could conduct a non-inferiority study evaluating ONS-5010 versus ranibizumab in a 12-week study of treatment-naïve patients with a primary efficacy endpoint at 8 weeks (NORSE EIGHT).
Price Action: OTLK stock is down 57.47% at $1.01 at the last check on Thursday.
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