On Friday, Aquestive Therapeutics (NASDAQ: NASDAQ:AQST) maintained its Buy rating and $10.00 price target from H.C. Wainwright. This affirmation follows the recent announcement that the FDA granted seven years of Orphan Drug exclusivity to Aquestive’s Libervant (diazepam) buccal film.
Libervant is designed for the acute treatment of frequent seizure activity in epileptic patients aged two to five years.
"The designation provides certain benefits, including financial incentives, to support clinical development and the potential for up to seven years of market exclusivity in the U.S. upon regulatory approval," the analysts said.
The FDA’s approval of Libervant for pediatric use was announced on April 26, 2024. The Orphan Drug exclusivity was awarded based on the determination that Libervant’s buccal route of administration is a significant improvement over the traditional rectal method, offering enhanced ease of use for patients and caregivers.
Orphan Drug designation is a status given by the FDA’s Office of Orphan Products Development to drugs and biologics meant for the safe and effective treatment of rare diseases affecting fewer than 200,000 people in the U.S.
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