Outlook Therapeutics Stock Faces Steep Decline Following FDA's Second Rejection of Wet AMD Treatment Candidate

quiet_lurker · 2026-01-04T15:59:37+00:00

Outlook Therapeutics faced a sharp stock decline after the FDA rejected its AMD therapy for lacking confirmatory efficacy evidence. Despite this setback, the company gained international approval, prompting a strategy to navigate U.S. regulations while expanding abroad.

quiet_lurker

2026-01-04 15:59:37

Abstract generation in progress

Outlook Therapeutics (OTLK) experienced a dramatic share collapse after the FDA delivered another regulatory setback for its lead wet age-related macular degeneration (wet AMD) therapy. The agency rejected the company’s biologics license application for ONS-5010/LYTENAVA (bevacizumab-vikg), citing insufficient confirmatory efficacy evidence despite acknowledging that one well-controlled trial demonstrated therapeutic benefit.

The Regulatory Roadblock

The FDA’s response letter underscored a persistent challenge facing Outlook: while the agency recognized the resubmission included fresh mechanistic and natural history data, these additions failed to alter its fundamental position. The critical gap remains the lack of confirmatory evidence—yet notably, regulators offered no guidance on what would satisfy this requirement, leaving the company without a clear pathway forward for U.S. approval.

Market Impact and After-Hours Freefall

The rejection triggered a sharp market reaction. OTLK closed regular trading at $1.58, reflecting a 15.51% decline, but the real damage emerged in post-market sessions where shares collapsed to $0.58—a devastating $1.00 drop representing a 63.29% loss. The severity of the move reflected investor disappointment over the repeated regulatory hurdle.

International Progress Offers Strategic Counterweight

While the U.S. approval quest stalls, Outlook has secured meaningful international traction. LYTENAVA (bevacizumab gamma) achieved marketing authorization from the European Commission and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). Commercial availability in Germany and the UK commenced in June 2025, establishing the therapy as the first and only approved ophthalmic bevacizumab formulation for wet AMD in adults across those markets.

Company’s Path Forward

Management emphasized it is evaluating multiple routes toward potential U.S. clearance while simultaneously accelerating its international expansion strategy. The divergence between domestic regulatory challenges and international success highlights how therapy approval timelines and thresholds vary significantly across jurisdictions, with European authorities embracing the candidate while FDA demanded additional proof.

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