Outlook Therapeutics Faces FDA Rejection for ONS-5010 Biologics License Application
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1h ago
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Source: Yahoo Finance
- FDA Response: Outlook Therapeutics' ONS-5010 biologics license application was rejected by the FDA in a complete response letter due to insufficient confirmatory evidence, indicating that while previous studies demonstrated efficacy, the FDA requires additional supporting data, highlighting the complexities and uncertainties of regulatory approval.
- Market Impact: This decision may delay the market entry of ONS-5010, affecting the company's competitiveness in the wet age-related macular degeneration (AMD) treatment market, particularly in the U.S., potentially leading to significant revenue losses.
- Company Position: CEO Bob Jahr stated that the company remains committed to providing a safe and consistent FDA-approved alternative for wet AMD patients, expressing disappointment over the FDA's decision but affirming their intent to take necessary steps to achieve approval, demonstrating confidence in the product's potential.
- Future Outlook: Outlook Therapeutics will need to reassess its clinical data and application strategy to meet FDA requirements, which not only impacts the future of ONS-5010 but may also influence the company's overall R&D direction and resource allocation.
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 4.00 USD with a low forecast of 1.00 USD and a high forecast of 8.00 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.
4 Analyst Rating
1 Buy
3 Hold
0 Sell
Hold
Current: 1.865
Low
1.00
Averages
4.00
High
8.00
Current: 1.865
Low
1.00
Averages
4.00
High
8.00
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.
