Aquestive Therapeutics, Inc. - AQST STOCK NEWS

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.

Aquestive Therapeutics (AQST) reported a net loss of $16.6 million for Q3 2020, a slight improvement from $18.4 million in Q3 2019. Total revenues fell to $8.3 million, down from $12.4 million year-over-year, due to reduced Suboxone manufacturing and supply revenue. However, Sympazan® revenues increased significantly, showing 102% growth year-over-year. The company has scheduled an FDA Type A meeting for Libervant™ on November 12, 2020, to discuss the approval pathway. Additionally, a $125 million monetization agreement for KYNMOBI™ is expected to provide capital for clinical initiatives and debt reduction.

Aquestive Therapeutics (NASDAQ: AQST) has entered a royalty monetization agreement with Marathon Asset Management, potentially providing up to $125 million in proceeds. The company will receive $40 million upon closing and could earn an additional $85 million through royalty targets. Proceeds are aimed at reducing debt, which will drop to $51.5 million, and funding development initiatives, such as Libervant and AQST-108. The agreement reflects confidence in KYNMOBI, recently approved by the FDA for treating Parkinson's disease.