Leerink analyst Roanna Ruiz was not surprised that Aquestive Therapeutics (AQST) received a Complete Response Letter for Anaphylm given the FDA’s prior deficiency letter. 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.
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