Stock of Aquestive Therapeutics, Inc. (AQST) is soaring about 43 percent on Monday morning trading following its announcement about a Complete Response Letter received from the FDA for the New Drug Application seeking approval of Anaphylm Sublingual Film for the treatment of Type I allergic reactions.
Currently, AQST is trading at $4.22, up 42.98 percent, over the previous close of $2.95. The stock opened at $3.79 and has climbed as high as $4.39 so far in today's session. Over the past year, it has traded in a range of $2.12 to $7.55.
Aquestive Therapeutics said it will request a Type A meeting with the FDA to discuss the most efficient path forward for resubmission. Based on initial review of the CRL, the company estimates resubmission in third quarter of 2026. The company plans to request rapid review by the FDA.
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