Major October Catalyst for Outlook? Chardan

 Chardan initiated coverage on Outlook Therapeutics Inc 

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 with a Buy rating and a price target of $10 based on the company's commercial potential with its lead ophthalmic formulation of ONS-5010 (bevacizumab, Avastin), an anti-VEGF antibody in development for wet age-related macular degeneration (wet AMD). 

The company recently re-submitted the marketing application with the FDA for ONS-5010. It expects to learn of a potential PDUFA date by the end of October, with the potential FDA approval in late August 2023.

Chardan notes that ONS-5010 is being developed as an ophthalmic formulation of Roche Holdings AG's 

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 Avastin (bevacizumab) that was initially approved in 2004 for metastatic colorectal cancer.

But it has been widely adopted for off-label use by eyecare practitioners as an effective treatment for several retinal diseases.

Despite several approved anti-VEGF treatments available for wet AMD, off-label Avastin remains the treatment of choice, accounting for ~50% share of the anti-VEGF market, primarily driven by comparable efficacy and safety at a much lower cost ($50-$100 for Avastin injection compared to ~$2k for treatments from Regeneron Pharmaceuticals Inc 

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 and Novartis AG 

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.

We believe it is unlikely that practitioners will move away from bevacizumab, so providing an option for an FDA-approved ophthalmic formulation of the drug at a reasonable price point would likely be met with enthusiasm. 

https://www.benzinga.com/general/biotech/22/09/28853135/chardan-initiates-coverage-on-this-eye-stock-with-bullish-stance-on-its-lead-candidate