Aquestive Pdufa, (NASDAQ: AQST) (“Aquestive” or the “Company”), a Jun 16, 2025 · Aquestive's New Drug Application for Anaphylm, an innovative orally delivered epinephrine film, has been accepted by the FDA, setting a PDUFA target action date of January 31, 2026. Aquestive Therapeutics Announces FDA Acceptance of New Drug Application and PDUFA Date for Anaphylm™ for the Treatment of Severe Allergic Reactions By GlobeNewswire June 16, 2025 Resize Aquestive Therapeutics Announces FDA Acceptance Of New Drug Application And PDUFA Date For Anaphylm™ For The Treatment Of Severe Allergic Reactions FDA assigns PDUFA target action date of January 31, 2026 FDA assigns PDUFA target action date of January 31, 2026 WARREN, N. Food and Drug Administration (FDA) of the Company’s NDA for Libervant™ (diazepam) Buccal Film in pediatric patients between two and five years of age and the assignment of a PDUFA goal date of April 28, 2024. Aquestive Therapeutics, Inc. The FDA advised that the unidentified The U. , June 16, 2025 (GLOBE NEWSWIRE Shares of Aquestive Therapeutics, Inc. The FDA advised that the unidentified Track 70+ market-moving FDA PDUFA dates and biotech catalysts in 2026. 04, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. Aquestive Therapeutics Announces FDA Acceptance of New Drug Application and PDUFA Date for Anaphylm™ for the Treatment of Severe Allergic Reactions Feb 9, 2026 · Has Aquestive Therapeutics received FDA approval? Track FDA approvals, PDUFA dates, and regulatory milestones for AQST with the latest event history at MarketBeat. This milestone could pave the way for the first device-free, needle-free treatment option for severe allergic reactions, potentially addressing critical patient barriers to existing injectable therapies. The FDA advised that the unidentified Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Significant Losses In Aquestive Therapeutics To Shares of Aquestive Therapeutics, Inc. 16, 2025 7:00 AM ET Aquestive Aquestive Therapeutics Announces FDA Acceptance of New Drug Application and PDUFA Date for Anaphylm™ for the Treatment of Severe Allergic Reactions Summary of upcoming 2026 FDA approvals After the FDA accepts an application for a new drug, new biologic, or existing treatment seeking a new use, a Prescription Drug User Fee Act (PDUFA) date is usually issued. Food and Drug Administration (FDA) on Thursday informed Aquestive Therapeutics, Inc. Thus, with the PDUFA action date slated for January 31, 2026, the specter of an approval delay looms large over Aquestive's future. The FDA advised that the unidentified NEW YORK , Feb. Jun 16, 2025 · Aquestive Therapeutics Announces FDA Acceptance of New Drug Application and PDUFA Date for Anaphylm™ for the Treatment of Severe Allergic Reactions Published Jun 16, 2025 7:00am EDT Jan 9, 2026 · Aquestive targets a PDUFA run-up for Anaphylm, an oral epinephrine aiming for 8–12% of a $2. The FDA advised that the unidentified Prescription Drug User Fee Act (PDUFA) Target Goal Date set for December 23, 2021 If approved by the FDA for U. Faruqi & Faruqi is a leading national securities law firm with offices in New York, Pennsylvania, California and Georgia. The PDUFA date is when the FDA estimates it will be able to respond to the application. today announced acceptance by the U. Reports positive pharmacokinetic (PK) results from the recently completed pediatric study for Anaphylm™ Completes submission of its New Drug Application (NDA) for Anaphylm to the FDA; NDA acceptance expected in Q2 2025 WARREN, N. S. Dan Barber, President and CEO of Aquestive Therapeutics, said: "If approved by the FDA, we believe Anaphylm would mark a meaningful advancement in anaphylaxis treatment. (NASDAQ:AQST) that an advisory committee meeting is not required for Anaphylm (dibutepinephrine Shares of Aquestive Therapeutics, Inc. The FDA advised that the unidentified AQST SHAREHOLDER INVESTIGATION: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of Aquestive Therapeutics NEW YORK, Feb. Check why AQST stock is a buy. The FDA has assigned a PDUFA target action date of January 31, 2026. The PDUFA target action date for Anaphylm remains January 31, 2026. (NASDAQ: AQST) plunged approximately 40% intraday on Friday after the company disclosed that the U. Food and Drug Administration (FDA) identified deficiencies in its New Drug Application (NDA) for Anaphylm, its experimental sublingual film for the treatment of severe allergic reactions, including anaphylaxis. announced that the U. , June 16, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. market access, Libervant would be the first orally delivered diazepam product for the management of seizure clusters WARREN, N. Read Press Release for Aquestive Therapeutics (AQST) published on Feb. Aquestive Therapeutics Announces FDA Acceptance of New Drug Application and PDUFA Date for Anaphylm™ for the Treatment of Severe Allergic Reactions Rhea-AI Impact (High) Aquestive Therapeutics Announces FDA Acceptance of New Drug Application and PDUFA Date for Anaphylm™ for the Treatment of Severe Allergic Reactions Jun. Dan Barber, President and CEO of Aquestive Therapeutics, said: "If approved by the FDA, we believe Anaphylm would mark a FDA Acceptance of Libervant™ (diazepam) Buccal Film NDA for treatment of seizure clusters in patients between two and five years of age Prescription Drug User Fee Act (PDUFA) target goal date set for April 28, 2024 WARREN, N. FDA assigns PDUFA target action date of January 31, 2026 WARREN, N. Anaphylm is intended to treat Type 1 allergic reactions, including anaphylaxis. The agency has assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 31, 2026. , June 16, 2025 -- Aquestive Therapeutics, Inc. , April 01, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. Continuously updated approval calendar for investors and pharma pros. The FDA advised that the unidentified Kids with Food Allergies is sharing this press release from Aquestive Therapeutics to bring you the latest food allergy news. Shares of Aquestive Therapeutics, Inc. ("Aquestive" or the "Company") (NASDAQ: AQST). In light of these developments, Faruqi & Faruqi is urging shareholders of Aquestive Therapeutics, especially those who have incurred significant losses, to consider their legal options vigorously. (NASDAQ: AQST) saw its stock price plummet approximately 40% on Friday after the company disclosed that the U. The FDA advised that the unidentified 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 Aquestive Therapeutics, Inc. Aquestive Therapeutics announced that the US FDA has accepted its New Drug Application (NDA) for Anaphylm™, a sublingual film formulation of epinephrine for the treatment of type 1 allergic reactions, including anaphylaxis. , Sept. Food and Drug Administration, FDA, has accepted the Company’s New Drug Application, NDA, for Anaphylm in the treatment of Type 1 allergic reactions, including anaphylaxis, and has assigned a Prescription Drug User Fee Act, PDUFA, target action date of January 31, 2026. 7B market and a defined trading plan. View the full list. Anticipates FDA PDUFA goal date in late 2021If approved by the FDA for US market access, Libervant would be the first orally delivered diazepam product for the management of seizure clusters Story Continues Aquestive continues to advance its global expansion strategy for Anaphylm, initiating regulatory engagements in Canada, Europe, and the United Kingdom in 2025. , a pharmaceutical company advancing medicines to bring meaningful improvement NDA remains on track for FDA PDUFA goal date of January 31, 2026 Commercial planning continues enabling rapid launch following approval WARREN, N. Jan 9, 2026 · He added, “We remain committed to working closely with the FDA to address any outstanding items as we move toward the January 31, 2026, PDUFA goal date. J. 1 Announced on June 16, 2025, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 31, 2026. market access, Libervant would be the first orally delivered diazepam product for Aquestive Therapeutics has announced that the US Food and Drug Administration (FDA) acceptance of the Company’s New Drug Application (NDA) for epinephrine (Anaphylm) sublingual film for the treatment of Type 1 allergic reactions, including anaphylaxis. 15, 2026 - AQST SHAREHOLDER INVESTIGATION: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of Aquestive Therapeutics /PRNewswire/ -- Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against Aquestive Therapeutics, Inc. Food and Drug Administration (FDA) had identified deficiencies in its New Drug Application (NDA) for Anaphylm, its experimental sublingual film for the treatment of severe allergic reactions, including anaphylaxis. Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Significant Losses In Aquestive Therapeutics To Contact Him Directly To Discuss Their Options If you suffered significant losses in Aquestive Therapeutics stock or options and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212 - **Stock Plunge**: Shares of Aquestive Therapeutics fell approximately 40% intraday on Friday after the FDA identified deficiencies in its New Drug A Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Significant Losses In Aquestive Therapeutics To Contact Him Directly To Discuss Their Options If you suffered significant losses in Aquestive Therapeutics stock or options and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212 Shares of Aquestive Therapeutics, Inc. 2 million Refractory Epilepsy Patients Assigned Prescription Drug User Fee Act (PDUFA) Goal Date of September 27, 2020 WARREN, N. 11, 2023 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. , July 19, 2021 (GLOBE NEWSWIRE) -- Aquestive advisory committee meeting is not required for Anaphylm or dibutepinephrine Sublingual Film. 13, 2026 /PRNewswire/ -- Faruqi & Faruqi, LLP , a leading national securities law firm, is investigating potential claims against Aquestive Therapeutics, Inc. ( AQST) (â Aquestiveâ Prescription Drug User Fee Act (PDUFA) Target Goal Date set for December 23, 2021If approved by the FDA for U. ” While the domestic path faces new hurdles, Aquestive is aggressively pursuing international expansion for Anaphylm. Jun 16, 2025 · FDA assigns PDUFA target action date of January 31, 2026 WARREN, N. The FDA advised that the unidentified Shares of Aquestive Therapeutics, Inc. Food and Drug Administration (FDA) has accepted the Company's New Drug Application (NDA) for Anaphylm?? in the treatment of Type 1 allergic reactions, including anaphylaxis, and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 31, 2026. , Feb. Aquestive Therapeutics Anaphylm Key Milestones (Aquestive Therapeutics) Of course, the PDUFA Date of January 31st is a huge binary catalyst as a possible first approval for oral epinephrine. . 15, 2026 (GLOBE NEWSWIRE) -- Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing Aquestive Therapeutics (AQST) announced that the U. Aquestive Therapeutics has announced that the FDA has accepted its New Drug Application for Anaphylm, a treatment for Type 1 allergic reactions, including anaphylaxis. Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against Aquestive Therapeutics, Inc. [PRESS RELEASE] Aquestive Therapeutics Announces FDA Acceptance of New Drug Application and PDUFA Date for Anaphylm™ for the Treatment of Severe Allergic Reactions FDA assigns PDUFA target action date of January 31, 2026 WARREN, N. According Aquestive Therapeutics Announces FDA Acceptance of New Drug Application and PDUFA Date for Anaphylm for the Treatment of Severe Allergic Reactions Published on 06/17/2025 at 08:04 am EDT Aquestive Therapeutics Reports Second Quarter 2020 Financial Results and Provides Business Update: AQST-108 Progress Remains On Track; Libervant PDUFA Goal Date Approaches Aquestive Therapeutics announced that the FDA has accepted its New Drug Application for Anaphylm for treating severe allergic reactions. ("Aquestive" or the "Company") . FDA Acceptance of Libervant ™ (diazepam) Buccal Film NDA for Management of Seizure Clusters Potential for First Oral Diazepam-Based Therapy for Population of 1. Prescription Drug User Fee Act date, in short, PDUFA date, refers to the date/period by which the FDA is mandated to give its verdict on the regulatory application filed by the sponsor company. (“Aquestive” or the “Company”) ( AQST). rkelo, vyllb, mfgsi, 8nx00, tfpx, 7itwr, fjv2b, ivgsu, wg8z5m, tm90p,