Outlook Therapeutics Receives FDA Approval for Lytenava to Treat nAMD
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 4 days ago
0mins
Outlook Therapeutics announced that the U.S. Food and Drug Administration, FDA, has granted the appeal following completion of the Formal Dispute Resolution, FDR, process with the Office of New Drugs, OND. The FDA concluded that substantial evidence of effectiveness has been established for Lytenava for the treatment of neovascular age-related macular degeneration, nAMD. As a result, Outlook Therapeutics expects to resubmit the ONS-5010/Lytenava Biologics License Application, BLA, in June 2026.
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Analyst Views on OTLK
Wall Street analysts forecast OTLK stock price to rise
3 Analyst Rating
1 Buy
2 Hold
0 Sell
Moderate Buy
Current: 0.740
Low
0.50
Averages
3.83
High
10.00
Current: 0.740
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.
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- Stock Surge: Following the FDA approval announcement, Outlook Therapeutics' share price soared 140% on Thursday, on track for its best week since listing, reflecting strong investor optimism regarding the drug's potential.
- Future Plans: Outlook Therapeutics plans to resubmit its Biologics License Application (BLA) in June 2026, expecting a Class 1 review with a regulatory decision possible within 60 days post-resubmission, indicating confidence in future market opportunities.
- Insider Buying: Director Randy H. Thurman purchased 5,000 shares at $0.429 each on Wednesday, along with three other directors, demonstrating strong insider confidence in the company's prospects.
See More
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- Warrant Adjustment: The company agreed to amend previously issued warrants to GMS Ventures, reducing the exercise price from $1.78 to $0.5855, which is expected to further incentivize investor participation and boost market confidence.
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- Warrant Amendment: As part of the transaction, Outlook Therapeutics agreed to amend previously issued warrants held by GMS Ventures, reducing the exercise price to $0.5855 per share, aimed at improving shareholder returns and facilitating future financing.
- Stock Performance Review: Over the past year, Outlook Therapeutics' stock has traded between $0.16 and $3.39, closing at $0.74, up 26.39% from the previous trading day, reflecting positive market expectations for the company's future developments.
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See More
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