Axsome Therapeutics is bracing for another setback as the FDA is now expected to nix an application for its migraine med due to unresolved manufacturing issues.
The company has been in a state of limbo waiting for the FDA's ruling on an application for AXS-07, which was snared up in regulatory delays as the agency paused manufacturing site inspections due to a rise in COVID-19 cases. Back in February, Axsome said the FDA was going to get the inspection done prior to the April 30 deadline for a decision, but, as it turns out, there are further issues with the application.
According to a Monday Securities and Exchange Commission disclosure, the FDA relayed Friday that chemistry, manufacturing and controls issues identified in the review of the new drug application for AXS-07 are “unresolved." As a result, Axsome expects the FDA to issue a complete response letter.
Even in light of Monday’s news, analysts at Mizuho have not adjusted sales projections, estimating that the drug could bring in $11 million in 2022 and up to $375 million in 2030.
The looming rejection is a roadblock for Axsome given AXS-07 is one of two late-stage assets awaiting regulators' go-ahead. Attention now turns to major depressive disorder med AXS-05, which Mizuho analysts expect will nab approval “in the coming weeks or months.”
Last week, the company disclosed that it agreed to some postmarketing requirements requested by the FDA for AXS-05 and that a decision on a new drug application is expected in the second quarter of this year. Unlike the weaker projections for AXS-07, Mizuho has high hopes for the depression med, with an estimated $1.61 billion in sales by 2030.
Manufacturing hiccups also snarled up AXS-05 when the FDA similarly could not finish a manufacturing inspection last year by the imposed deadline. But, once the inspection was completed, the agency identified a couple deficiencies that Axsome has since addressed.
On the horizon for the company is another new drug submission, this time for the fibromyalgia med AXS-14, which is expected in 2023.
Regardless of analysts' high-hopes, the company’s shares tumbled Monday nearly $9 per share to $30.14, a 23% drop. It’s a continuation of a chaotic roller coaster ride on Wall Street since August when the shares first free-fell from more than $50 apiece to $27. Since then, Axsome has bounced up and down but has yet to once again eclipse $50 per share.
Editor's note: This story was updated with a more recent timeline for AXS-14. The company expects to apply for an NDA in 2023, not the fourth quarter of 2022.