Outlook Therapeutics Faces Setback as FDA Rejects ONS-5010 Treatment

Shares of Outlook Therapeutics (OTLK) took a nosedive in premarket trading today, plummeting over 60%. This significant drop comes in the wake of the U.S. Food and Drug Administration (FDA) rejecting the company’s proposed ONS-5010 treatment for wet age-related macular degeneration (AMD). The FDA has requested further confirmatory clinical evidence before granting approval.

Outlook, a biopharmaceutical company headquartered in Iselin, N.J., had sought approval for ONS-5010 as the first ophthalmic formulation of bevacizumab specific to retinal indications. Unfortunately, the FDA issued a complete response letter, indicating that the application could not be approved in its current form.

The FDA highlighted several concerns, including chemistry, manufacturing, and control issues found during pre-approval manufacturing inspections. Additionally, the agency noted a lack of substantial evidence supporting the treatment’s efficacy.

Outlook expressed its intent to promptly request a formal meeting with the FDA to gain a clearer understanding of the deficiencies outlined in the response letter. The company aims to collaborate with the agency to determine the best course of action for resolving these concerns. Following the meeting, Outlook intends to outline its next steps and provide an estimated timeline for resolution.

In response to the FDA’s decision, Outlook Therapeutics’ shares tumbled drastically from their previous close at $1.41 to a mere 51.4 cents during premarket trading.

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