Shares of Axsome Therapeutics have fallen more than 20% in trading this morning after the company announced the FDA is unlikely to approve its acute migraine treatment AXS-07 due to unresolved quality control issues.
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Shares of Axsome Therapeutics fell more than 20% in trading Monday morning after the company announced the U.S. Food and Drug Administration is unlikely to approve its acute migraine treatment AXS-07 due to unresolved quality control issues.
In a filing with the U.S. Securities and Exchange Commission, New York-based Axsome said the FDA informed the company that chemistry, manufacturing and controls previously identified by the regulatory agency in its review of the New Drug Application for AXS-07 remain unresolved. Based on the communication from the FDA, the company said it expects to receive a Complete Response Letter. A PDUFA date of April 30 was set for Axsome’s migraine drug.
As a result of the announcement, shareholders are expressing their disappointment by shedding shares. The negative reaction comes a little more than six weeks after the company said it had answered all CMC questions raised by the regulatory agency. In the latest filing, Axsome did not provide specifics as to what issues the FDA was continuing to pinpoint.
The NDA for AXS-07 is supported by positive data from two Phase III studies, MOMENTUM and INTERCEPT. AXS-07 is comprised of MoSEIC meloxicam and rizatriptan. The investigational medication is a novel, oral, rapidly absorbed, multi-mechanistic entity designed for the acute treatment of migraine.
This isn’t the first time CMC issues have been raised by the FDA regarding Axsome. Last year, the regulatory agency also flagged CMC issues related to the company’s investigational major depressive disorder treatment AXS-05, which the company expected to win approval last year under Priority Review. However, in August 2021, the company reported that the FDA identified deficiencies that would prevent the agency from reviewing the NDA for AXS-05. The company said earlier this year that it addressed the issues raised by the FDA, Reuters reported.
The setback for the migraine drug comes weeks after Axsome acquired Jazz Pharmaceuticals’ narcolepsy drug Sunosi in a $53 million deal. Sunosi, a dual-acting dopamine and norepinephrine reuptake inhibitor, was approved by the FDA in 2019 to “improve wakefulness in adults living with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea.” As BioSpace reported at the time the deal was struck, Sunosi generated $57.9 million in revenue for Ireland’s Jazz Pharmaceuticals last year. The deal for Sunosi provided Axsome with a revenue-generating asset while it awaits potential approval of AXS-05 and AXS-07.
As of Dec. 31, 2021, Axsome reported it had $86.5 million in available cash. In February, the company accessed its at-the-market equity facility for an additional $20 million.
