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-0.00119904076738607 -0.00239808153477213 -0.0035971223021582 -0.00479616306954426 -0.0299760191846523 -0.0179856115107912 -0.0263788968824939 -0.0300959232613908
Stock impact report

Leerink sees ‘silver lining' in Aquestive CRL given defined path to approval [Yahoo! Finance]

Aquestive Therapeutics, Inc. (AQST) 
Last aquestive therapeutics, inc. earnings: 3/11 04:30 pm Check Earnings Report
US:NASDAQ Investor Relations: investors.aquestive.com/investor-relations
Company Research Source: Yahoo! Finance
That said, the “silver lining” is that this outcome appears recoverable with a relatively defined path to approval, the firm adds. The good news is that no additional studies beyond these seem to have been requested by the FDA, the CRL does not appear to raise any concerns about comparability data or CMC, and Leerink sees these studies are manageable and able to execute. The potential incremental risks are that this will delay Anaphylm's U.S. launch, and it introduces some clinical and commercial risk as resubmission depends on favorable HF testing & PK study results. The firm has an Outperform rating on the name. Shares jumped over 45% to $4.29 in morning trading. Unlock hedge fund-level data and powerful investing tools for smarter, sharper decisions Stay ahead of the market with the latest news and analysis and maximize your portfolio's potential Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now See Insiders' Hot S Show less Read more
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