Aquestive Therapeutics, Inc. - AQST STOCK NEWS

Aquestive Therapeutics (NASDAQ: AQST) reported positive results from the Phase 1 clinical trial of AQST-109, an innovative sublingual epinephrine delivery system for anaphylaxis. The study demonstrated a median time to peak concentration (Tmax) of 15 minutes or less, comparable to traditional autoinjectors like EpiPen® and Auvi-Q®. Key clinical measures for safety and efficacy were within expected ranges, with no serious adverse events reported. AQST-109 aims to provide a needle-free alternative, enhancing patient accessibility and safety. A pivotal pharmacokinetic study is anticipated in 2022.

Aquestive Therapeutics (NASDAQ: AQST) has announced it will report its Q3 2021 results on November 2, 2021, after market close. A conference call for investors is scheduled for November 3, 2021, at 8:00 a.m. ET. The company's focus is on developing innovative pharmaceutical products, including Libervant™ (diazepam) Buccal Film. The press release highlights potential risks related to COVID-19's impact on clinical trials, regulatory timelines, and market access. Additionally, the company’s collaboration with other pharmaceutical firms aims to advance drug development.

Aquestive Therapeutics (AQST) announced a bridge waiver agreement with lenders, allowing the deferral of the first principal payment due under its 12.5% Senior Secured Notes to March 30, 2023. This amendment includes a $2.7 million payment to note holders in quarterly installments starting March 30, 2022. CEO Keith Kendall highlighted lender support and the potential for a $30 million debt access upon FDA approval of Libervant, a novel treatment for refractory epilepsy. The FDA has set a PDUFA date of December 23, 2021, for Libervant’s approval.

Aquestive Therapeutics, Inc. (NASDAQ: AQST) announced participation in three investor conferences in September 2021, aimed at showcasing its innovative pharmaceutical solutions. The events include H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, Lake Street Virtual Best Ideas Growth Conference on September 14, and the 2021 Cantor Virtual Global Healthcare Conference on September 30 at 8:00 a.m. ET. Webcast replays will be available for 90 days post-event. For further details, visit investors.aquestive.com.

Aquestive Therapeutics (AQST) announced a $30 million capital access contingent on FDA approval for Libervant, an innovative oral diazepam for managing seizure clusters. The company amended its agreement with lenders, extending the term for six months to June 30, 2022, allowing for a $10 million draw post-FDA approval and an additional $20 million upon U.S. market access. The FDA has set a PDUFA goal date of December 23, 2021, for Libervant's resubmitted NDA. Aquestive remains confident in its non-invasive product's potential, aligning with its broader strategy to address unmet patient needs.

Aquestive Therapeutics, Inc. (NASDAQ: AQST) announced its participation in the 12th Annual Wedbush PacGrow Healthcare Virtual Conference on August 11, 2021, at 11:30 am ET. The panel discussion will focus on advancing novel epilepsy targets. The company is known for its innovative pharmaceuticals, including Sympazan®, an oral film for clobazam. It is committed to addressing unmet medical needs through proprietary technologies like PharmFilm®. Forward-looking statements regarding their product Libervant™ highlight potential risks, including regulatory uncertainties and market access challenges.

Aquestive Therapeutics (AQST) announced significant developments, including the FDA's acceptance of the NDA for Libervant with a PDUFA goal date of December 23, 2021. The company is also on track to report top-line data from its Phase 1 study for AQST-109 in the second half of 2021. Full-year revenue guidance has been increased to $46-$48 million, reflecting a solid performance, especially in Sympazan. Total revenues for Q2 2021 were $15.3 million, with a net loss of $12.4 million.

Aquestive Therapeutics (NASDAQ: AQST) will announce its second-quarter results on August 3, 2021, after market close. An investor conference call is scheduled for August 4, 2021, at 8:00 a.m. ET. The company is known for its innovative pharmaceutical products, including Sympazan and the development of Libervant among other candidates. Investors can access the conference call details through the company's website. The report is expected to cover business updates and strategies, particularly regarding ongoing product developments.

Aquestive Therapeutics (AQST) announced that the FDA has accepted the resubmission of the New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film for managing seizure clusters. The PDUFA goal date is set for December 23, 2021. If approved, Libervant will be the first orally delivered diazepam product for this indication. The company is preparing for a potential commercial launch in early 2022. Libervant aims to provide a non-invasive and consistent alternative to current treatments for refractory epilepsy patients.