Aquestive Therapeutics, Inc. develops and manufactures specialty pharmaceutical products using proprietary oral-film and drug-delivery technologies. News about AQST centers on the company’s proprietary pipeline, including Anaphylm™ (dibutepinephrine) sublingual film for Type I allergic reactions, including anaphylaxis, and AQST-108, an epinephrine prodrug topical gel being explored for dermatological conditions such as alopecia areata.
Recurring updates also cover FDA interactions and NDA communications for Anaphylm, pharmacokinetic and human-factor study topics, quarterly financial results, licensee and CDMO manufacturing activity, investor presentations, equity inducement grants, and legal, compliance, and board-governance changes.
Aquestive Therapeutics (AQST) announced it will report Q4 and full-year 2020 results on March 9, 2021, after market close. Management will host a conference call for investors on March 10, 2021, at 8:00 a.m. ET. The call can be accessed via phone or live webcast on the company’s investor website. The company focuses on developing differentiated pharmaceutical products addressing unmet patient needs, with its main product being Sympazan, an oral film for treating epilepsy. A forward-looking statement outlines potential risks related to clinical trials and regulatory approvals.
Aquestive Therapeutics (NASDAQ: AQST) announced the appointments of Julie Krop, M.D., and Marco Taglietti, M.D., as new Board members, effective February 10, 2021. Krop is the Chief Medical Officer at Freeline Therapeutics and Taglietti serves as CEO of SCYNEXIS. They join the Board during a pivotal phase for the company, which continues to develop products targeting CNS and allergy markets. The company also noted the resignation of Douglas K. Bratton after 17 years of service. The new directors are expected to enhance strategic direction and clinical development efforts.
Aquestive Therapeutics (NASDAQ: AQST) announced the appointment of Mark Lepore, MD, as Chief Medical Officer for Allergy, emphasizing its focus on the epinephrine delivery program. Dr. Lepore brings over 14 years of drug development experience, previously holding leadership roles at Lupin Pharmaceuticals and Teva Pharmaceuticals. The company is also advancing the resubmission of its Libervant™ (diazepam) Buccal Film application, with expected FDA feedback soon. This strategic leadership addition may strengthen the company’s position in addressing anaphylaxis treatment needs.
Mitsubishi Tanabe Pharma America (MTPA) and Aquestive Therapeutics (AQST) announced a licensing and supply agreement for EXSERVAN™ (riluzole), an oral film for treating ALS. MTPA will commercialize the product in the U.S., with Aquestive as the sole manufacturer. EXSERVAN aims to aid patients with swallowing difficulties. The rollout is planned for mid-2021, with Aquestive receiving upfront fees, milestone payments, and royalties on sales. The oral film utilizes Aquestive's PharmFilm® technology, offering a dissolvable alternative to traditional riluzole tablets.
On January 7, 2021, Aquestive Therapeutics (NASDAQ: AQST) provided updates on its drug candidates Libervant™ and AQST-108. The company resubmitted a revised dosing regimen for Libervant to the FDA, with feedback expected by late January 2021. The NDA resubmission is anticipated in the first half of 2021. AQST-108, an innovative sublingual film delivering epinephrine for anaphylaxis, completed a Phase 1 trial demonstrating consistent delivery and safety. The company plans further clinical studies for AQST-108 in 2021, aiming to enhance its market presence and regulatory approvals.
Aquestive Therapeutics (NASDAQ: AQST) announced management's participation in two upcoming virtual conferences: H.C. Wainwright BioConnect 2021 (January 11-14) and Westwicke Healthcare Day at ICR Conference 2021 (January 14 at 2:30 PM ET). The company will also host one-on-one investor meetings during this week. Webcasts of the discussions will be available on the company's Investor website for 30 days post-event. Aquestive focuses on innovative pharmaceutical solutions, including their proprietary product, Sympazan®, and aims to address unmet medical needs with new drug technologies.
Aquestive Therapeutics (NASDAQ: AQST) announced the resignation of CFO John Maxwell, effective year-end 2020, to pursue other interests. Maxwell joined the company in January 2017 and was instrumental in its evolution into a public pharmaceutical entity. Ernie Toth will succeed him as interim CFO. The company confirmed no operational issues are linked to Maxwell's departure and maintained its 2020 financial outlook. The company specializes in developing innovative therapies, including the commercial product Sympazan and a pipeline targeting central nervous system diseases.
Aquestive Therapeutics, Inc. (NASDAQ: AQST) announced participation in the Piper Sandler Virtual 32nd Annual Healthcare Conference from December 1-3, 2020. The management team will engage in a fireside chat and hold one-on-one investor meetings on December 2, 2020. A webcast of the chat will be available on the Company's website, with a replay accessible for 30 days post-event. Aquestive focuses on developing differentiated pharmaceutical products addressing unmet patient needs, with a pipeline targeting CNS diseases and innovative drug delivery technologies like PharmFilm®.
Aquestive Therapeutics (NASDAQ: AQST) announced receiving a $10 million milestone payment as part of a royalty monetization agreement with Marathon Asset Management, bringing total proceeds for Q4 to $50 million. The funds will aid in repaying senior notes and support the development of key products, including Libervant™ for managing seizure clusters. The company anticipates up to $75 million in additional milestone payments through mid-2022, contingent upon meeting specific royalty targets.
The FDA confirmed that issues identified in its Complete Response Letter (CRL) dated September 25, 2020, can potentially be addressed through modeling and simulations for Aquestive's drug candidate, Libervant™. Following a Type A meeting on November 12, 2020, the agency recommended a follow-up meeting before resubmission of the New Drug Application (NDA). Aquestive believes no additional clinical studies will be required and is preparing the requested analysis for resubmission as soon as the follow-up meeting is scheduled.