The FDA will in fact be able to inspect Axsome’s manufacturing facility for its migraine drug by the decision date as the agency gets these crucial inspections back on track following COVID disruptions.
The regulatory update for the migraine treatment, called AXS-07, was welcome news for investors, according to a note from Mizuho Securities. But what investors had really been hoping for was an update on a key depression drug, which has been delayed as the agency identified deficiencies in the application.
Axsome disclosed the news in a Securities and Exchange Commission filing after market close on Monday. The FDA paused domestic surveillance inspections in late December amid a nationwide rise in COVID infections, but they resumed on Monday with cases now declining.
It’s a welcome update for the New York City-based biopharma, which has been in a state of limbo as it awaits regulatory actions from the FDA on AXS-07. The agency is expected to rule on the med by April 30.
Migraine is a packed field and has seen a rush of Big Pharma entrants in recent years, including Eli Lilly’s Reyvow and Amgen’s Aimovig, which target receptors in the brain associated with migraines. Axsome touts its drug as being “multi-mechanistic” to work beyond just targeting receptors.
Mizuho warned that Axsome may struggle to find a foothold in the market should AXS-07 be granted approval. The biotech's competitors "have greater financial resources and expertise in manufacturing, preclinical testing and marketing approved products than Axsome currently does." While Axsome currently has a cash runway up to at least 2024, risks to additional financing remain, according to Mizuho.
While the progression of AXS-07 through the regulatory process is a positive step, Mizuho said investors are likely more focused on AXS-05, the treatment for major depressive disorder. The company announced last August that the FDA would not complete a review of that drug by the PDUFA date, which was originally Aug. 22, 2021.
Since the delay, the company has responded to two deficiencies in its new drug application that were highlighted by the regulatory agency. The company said in January the deficiencies stem from the "analytical methods in the chemistry, manufacturing and controls section" of the new drug application. Mizuho said even amid the delay, it still expects AXS-05 to be approved as early as late 2022.
Prior to the FDA’s delay, Axsome reported that the drug met both the primary and key secondary endpoints in a phase 2 trial, significantly delaying the time to relapse of depressive symptoms. The company said that no relapses were observed with the drug over six months of double-blind treatment.