As Seized Drug Stuck Again at FDA, Aquestive Replaces Longtime CEO – Endpoints News

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The C-suite musical chairs that have plagued biotech over the past few months continued Tuesday afternoon with another small-cap company announcing a transition to the top.

Longtime Aquestive Therapeutics CEO Keith Kendall will leave the company effective immediately, the biotech company announced on Tuesday, ending his seven-and-a-half-year tenure. Kendall will remain a consultant until the end of the year and will be replaced by Daniel Barber, COO of the company since May 2019, on a permanent basis.

Aquestive did not announce the reason for the change, saying only that the change was “not related to Aquestive’s strategy, operations, financial condition, reported financial results, internal controls or disclosure controls and procedures. the society”.

Much like the rest of the industry, Aquestive has had a tough time during the current bear market as its $AQST stock is down more than 70% since the start of 2020. It’s a slide that has continued through the major part of its public trading life as Well, with Aquestive shares down about 90% from its 2018 IPO price.

Biotech’s most recent struggles stem from an oft-troubled drug demand for an oral film to treat seizures. Originally submitted in late 2019, the drug candidate was rejected in September 2020 due to what the FDA said were lower than desired exposure levels in certain weight groups, according to Aquestive’s account.

Although the company resubmitted its application in 2021 and received a PDUFA date for that December, the FDA informed Aquestive that it could not make a final decision at that time. According to a press release from Aquestive, agency officials were “still reviewing regulatory issues” related to the drug’s approval, although the company did not provide further details.

It’s not entirely clear if this will amount to a second CRL or when the issue will be fixed. In its first-quarter earnings report earlier this month, Aquestive said further communication with the agency revealed the delay stemmed from “orphan drug exclusivity issues related” to the NDA, suggesting a patent conflict.

Aquestive’s medication, brand name Libervant, is an oral formulation of diazepam, self-administered as a film and placed inside the cheek.

The challenge now falls to Barber to try to solve this problem. He joins several new CEOs in trying to right the ship at their respective companies with the bear market showing no signs of abating, including Zentalis earlier this week.

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