Outlook Therapeutics Faces 60.82% Drop After FDA Rejects Lytenava Application
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 02 2026
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Source: Benzinga
- FDA Rejection: The U.S. FDA has once again rejected Outlook Therapeutics' ONS-5010/Lytenava biologics license application, citing insufficient evidence of effectiveness, which led to a staggering 60.82% drop in premarket trading, marking a new 52-week low and reflecting market pessimism regarding the product's prospects.
- Regulatory History: Since August 2023, the FDA has issued multiple complete response letters regarding ONS-5010, emphasizing the need for additional confirmatory evidence of efficacy, indicating significant challenges for the company in obtaining approval and potentially impacting its future market expansion plans.
- Industry Context: Similar to Outlook, Opthea Limited's global Phase 3 COAST trial failed to meet its primary endpoint in March 2025, highlighting widespread difficulties in the wet age-related macular degeneration treatment space, further exacerbating investor concerns in this sector.
- Market Reaction: Outlook Therapeutics' stock price fell to $0.61 in premarket trading on Friday, reflecting investor uncertainty about the company's future development pathways, which may hinder its expansion plans in the U.S. and other markets.
Analyst Views on OTLK
Wall Street analysts forecast OTLK stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for OTLK is 3.83 USD with a low forecast of 0.50 USD and a high forecast of 10.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
3 Analyst Rating
1 Buy
2 Hold
0 Sell
Moderate Buy
Current: 0.508
Low
0.50
Averages
3.83
High
10.00
Current: 0.508
Low
0.50
Averages
3.83
High
10.00
About OTLK
Outlook Therapeutics, Inc. is a biopharmaceutical company. The Company is focused on developing and commercializing ONS-5010/LYTENAVA (bevacizumab-gamma), an ophthalmic formulation of bevacizumab for use in retinal indications. It is advancing ONS-5010 / LYTENAVA (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), and branch retinal vein occlusion (BRVO). Bevacizumab-vikg is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. ONS-5010/LYTENAVA, consisted of three clinical trials which it refers to as NORSE ONE, NORSE TWO and NORSE THREE.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
