On 31 Jan 2020, Aquestive Therapeutics, Inc. (NASDAQ: AQST) spotted trading -59.50% off 52-week high price. On the other end, the stock has been noted 37.29% away from the low price over the last 52-weeks. The stock changed 1.00% to recent value of $4.05. The stock transacted 409546 shares during most recent day however it has an average volume of 1094.19K shares. The company has 34.86M of outstanding shares and 29.22M shares were floated in the market.
Aquestive Therapeutics, Inc. (AQST) recently stated that the U.S. Food and Drug Administration (FDA) issued a response letter (Response) dated January 10, 2020 denying Aquestive’s Citizen’s Petition received by the FDA on November 1, 2019, including the supplement to the Citizen’s Petition received by the FDA on December 4, 2019 (Docket No. FDA-2019-P-5121) (Petition). The Petition requested, among other things, that the FDA stay authorization of a New Drug Application for Valtoco® (diazepam nasal spray) submitted by Neurelis, Inc. until additional clinical studies were conducted. In the Response, the FDA indicated that it had accepted Neurelis’s NDA for Valtoco on January 10, 2020. Valtoco has received orphan drug exclusivity from the FDA’s Center for Drug Evaluation and Research commencing as of January 10, 2020 for the labeled indication of acute treatment of intermittent stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy six years of age and older.
“This patient population has been underserved for some time with little choice beyond the rectally administered gel and choice is important. We believe that our candidate drug Libervant™ (diazepam) Buccal Film will, if accepted by the FDA, further expand patient choice as the first orally administered dosage form for this patient population,” stated Keith J. Kendall, Chief Executive Officer of Aquestive.
“We appreciate that the FDA has confirmed in the Response its guidance that 505(b)(2) drugs can be accepted without proving bioequivalence if they demonstrate “relative bioavailability” to the reference drug. The FDA stated in the Response, when granting exclusivity based upon “major contribution to patient care” over and above already accepted products for the indication, it may consider such factors as convenience of treatment location, duration of treatment, patient comfort, reduced treatment burden, advances in ease and comfort of drug administration, longer periods between doses, and potential for self-administration. In making this determination for Valtoco, the FDA indicated in the Response that the intranasal route of administration provides a major contribution to patient care over the rectal route of administration by providing a importantly improved ease of use.”
According to the most recent quarter its current ratio was 1.9 that represents company’s ability to meet its current financial obligations. The price moved ahead of -16.36% from the mean of 20 days, -31.19% from mean of 50 days SMA and performed -12.03% from mean of 200 days price. Company’s performance for the week was 4.38%, -30.41% for month and YTD performance remained -30.41%.