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Aquestive Therapeutics, Inc. (AQST)
Dopo ore:
- GlobeNewswire
Aquestive Therapeutics Provides Business Update
Receives positive feedback from FDA on pivotal study protocol for Anaphylm™ (epinephrine) Sublingual FilmReaffirms fourth quarter 2023 Anaphylm pivotal Phase 3 study start and first quarter 2024 topline data readoutOutlines expected remaining activities for Anaphylm program prior to NDA submissionIndicates FDA review of Libervant™ (diazepam) Buccal Film NDA on track with no open questions Anticipates increasing 2023 revenue and decreasing non-GAAP adjusted EBITDA loss guidance in upcoming earnin
- GlobeNewswire
Aquestive Therapeutics Reaffirms Timeline and Pathway for Anaphylm™ (epinephrine) Sublingual Film
WARREN, N.J., Sept. 20, 2023 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company advancing medicines to solve patients' problems with current standards of care and provide transformative products to improve their lives, today provided an update on the development timeline and pathway for its oral epinephrine product candidate, Anaphylm™. As previously disclosed, Aquestive submitted its revised protocol for the proposed pivotal PK clinical trial to the Food an
- GlobeNewswire
Aquestive Therapeutics Receives FDA Acceptance of New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film in Pediatric Patients and Assignment of Prescription Drug User Fee Act (PDUFA) Date
FDA Acceptance of Libervant™ (diazepam) Buccal Film NDA for treatment of seizure clusters in patients between two and five years of agePrescription Drug User Fee Act (PDUFA) target goal date set for April 28, 2024 WARREN, N.J., Sept. 11, 2023 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (the “Company” or “Aquestive”), a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their live
