Business
Aquestive Therapeutics Negotiates Six Month Extension to June 30, 2022 for Additional Libervant™ Related Capital Under Current Debt Agreement
Provides access to $30 million in capital contingent on FDA approval and U.S. market access for Libervant WARREN, N.J., Aug. 09, 2021 (GLOBE NEWSWIRE) --
About this update from Aquestive Therapeutics, Inc.
[{"type":"text","content":"Provides access to $30 million in capital contingent on FDA approval and U.S. market access for Libervant WARREN, N.J., Aug. 09, 2021 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today that it has reached an agreement with its lenders to amend the base indenture providing an extension of the term by six months to June 30, 2022 to provide additional debt in the aggregate of up to $30.0 million. In line with the extension to June 30, 2022, Aquestive is entitled, at its option, to draw up to $10 million following FDA approval for Libervant, the first orally delivered diazepam product for the management of seizure clusters, and up to an additional $20 million following the FDA grant of U.S. market access for Libervant. “We continue to believe that our non-invasive and innovative product for refractory epilepsy represents a meaningful improvement in the treatment options available to this patient population and a significant commercial opportunity. We appreciate the continued support from our lenders and their flexibility given the current PDUFA date for Libervant. With this six month extension, we maintain the capital optionality and may access to up to $30 million under our existing debt facility that we can potentially utilize to fund the launch of Libervant, if approved for market access,” said Keith Kendall, Chief Executive Officer of Aquestive. The FDA has accepted for filing the resubmission of the New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film for the management of seizure clusters. The FDA has assigned a Prescription Drug User Fee Act (“PDUFA”) target goal date of December 23, 2021. Aquestive received a Complete Response Letter (CRL) from the FDA in September 2020, completed a Type A meeting with the FDA in November 2020 and received further guidance from the FDA in February 2021. Based upon the Agency’s guidance, the submission included additional statistical modeling and supporting analyses of the existing clinical data. The Company continues to believe that no additional clinical studies will be required for FDA approval of Libervant for U.S. market access. About Aquestive TherapeuticsAquestive Therapeutics is a pharmac...