AQST - Aquestive Therapeutics gets pathway for Libervant FDA resubmission

Aquestive Therapeutics (AQST) +11.6% after-hours as it completed its Type A meeting with the Food and Drug Administration confirming a pathway for resubmission for approval of the company's Libervant (diazepam) Buccal Film drug candidate for management of seizure clusters.Based on the FDA's preliminary comments and the discussion with the FDA during the Type A meeting, Aquestive continues to believe that no additional clinical studies will be required for the resubmission of the NDA for Libervant.The FDA's rejection of Aquestive's application for Libervant Buccal Film in September sent shares plunging more than 40%.

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Aquestive Therapeutics gets pathway for Libervant FDA resubmission