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Stock impact report

Ocular Therapeutix Says FDA Talks Progressing as It Eyes AXPAXLI NDA for Wet AMD on SOL-1 Data [Yahoo! Finance]

Ocular Therapeutix, Inc. (OCUL) 
Last ocular therapeutix, inc. earnings: 3/12 04:01 pm Check Earnings Report
US:NASDAQ Investor Relations: ocutx.com
Company Research Source: Yahoo! Finance
pursuing an NDA for AXPAXLI in wet AMD based on a single, well-powered pivotal study — the company says regulators have signaled openness to single-trial approvals when trials are rigorously designed. SOL-1 reportedly met its primary endpoint with robust statistical significance and a favorable safety profile (company reports no cases of endophthalmitis or vasculitis and disclosed all IOI events); Ocular also highlights OCT stability and potential single-injection disease control at nine months, plus promising HELIOS data in NPDR. Ocular plans to commercialize AXPAXLI independently, touts IP protection “ironclad till 2044,” believes its hydrogel manufacturing can scale, and argues a superiority label could support premium pricing and payer uptake. Interested in Ocular Therapeutix, Inc.? Here are five stocks we like better. Ocular Therapeutix (NASDAQ:OCUL) Executive Chairman, President, and CEO Dr. Pravin Dugel said the company is engaged in formal discussions with the U.S. Foo Show less Read more
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