With seizure drug held up at FDA again, Aquestive replaces longtime CEO
The C-suite musical chairs reverberating through biotech the last few months continued Tuesday afternoon with another small cap company announcing a transition at the top.
Longtime Aquestive Therapeutics CEO Keith Kendall will leave the company effective immediately, the biotech announced late Tuesday, bringing an end to his seven-and-a-half year tenure. Kendall will remain a consultant through the end of the year and be replaced by Daniel Barber, the company’s COO since May 2019, on a permanent basis.
Aquestive did not announce a reason for the change, only saying the move was “unrelated to the Company’s strategy, operations, financial condition, reported financial results, internal controls or disclosure controls and procedures.”
Much like the rest of the sector, Aquestive has fallen on hard times during the current bear market, as its stock $AQST is down more than 70% since the start of 2020. It’s a slide that’s continued for most of its public trading life as well, with Aquestive shares down about 90% from its IPO price back in 2018.
The biotech’s most recent struggles stem from an oft-troubled drug application for oral film to treat seizures. Originally submitted in late 2019, the drug candidate was rejected in September 2020 due to what the FDA said was lower-than-desired exposure levels in certain weight groups, per Aquestive’s recounting.
Though the company resubmitted its application in 2021 and received a PDUFA date for that December, the FDA notified Aquestive that it could not make a final decision at that time. Per an Aquestive news release, agency officials were still “considering the regulatory issues” related to the drug’s approvability, though the company did not get into more specifics.
It’s not entirely clear whether this will amount to a second CRL or when the issue would be resolved. In its first quarter earnings report earlier this month, Aquestive said further communication with the agency revealed the delay stems from “orphan-drug exclusivity issues related to” the NDA, suggesting a patent conflict.
Aquestive’s drug, branded Libervant, is an oral formulation of diazepam, self-administered as a film and placed inside the cheek.
The challenge now falls on Barber to try to resolve this issue. He joins several new chief executives in trying to right the ship at their respective companies with the bear market showing no signs of abating, including Zentalis earlier this week.