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Blueprint gets European Union nod for Ayvakyt. Aquestive receives CRL for seizure clusters treatment Libervant. PMV Pharma makes impressive IPO debut, stock soars. For further details see: Blueprint European Approval, And Other News: The Good, Bad And Ugly Of Biopharma ...
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Aquestive Therapeutics (AQST) announces that FDA has issued a complete response letter regarding the New Drug Application for Libervant Buccal Film for management of seizure clusters.FDA cited that, in a study submitted by the company with the NDA, certain weight groups showed a lo...
Complete Response Letter cites exposure levels (Cmax) in certain weight groups No additional clinical studies anticipated by Aquestive No Clinical Safety issues or Non-Clinical Chemistry, Manufacturing and Controls (CMC) issues identified Conference call and webcast today at 6...
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Aquestive Therapeutics (NASDAQ: AQST ) initiates a Phase 1 clinical trial in 28 healthy volunteers evaluating the safety and pharmacokinetics (PK) of AQST-108, an oral sublingual formulation of epinephrine, for the potential treatment of allergic reactions, including anaphylaxis (ac...
First healthy volunteer dosed in a Phase 1 study of AQST-108 for the treatment of allergic reactions including anaphylaxis Pharmacokinetic and pharmacodynamics data expected in fourth quarter 2020 WARREN, N.J., Aug. 20, 2020 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQ...
Overview Aquestive Therapeutics (NASDAQ: AQST ) has posted Q2 results beating the street by $0.36 in EPS and $12.91 million in revenues, on the back of a sturdy quarter related to sales of its licensed commercialised pharmaceutical products, including Sympazan, Suboxone, Kynmobi and Zuplenz....
Finalizing preparations for pharmacokinetic (PK) clinical trials of AQST-108 First planned PK clinical trial expected to begin during the third quarter of 2020 WARREN, N.J., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused...
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Meets primary study endpoints with pharmacokinetics (PK) comparable whether Anaphylm is administered by subjects or by healthcare providers (HCPs) Final supportive study, the Oral Allergy Syndrome (OAS) challenge study, currently enrolling Continues to anticipate requesting a pr...
WARREN, N.J., July 23, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technolog...