AXSM Stock Up Big After FDA Proposes New Label for their AXS-05 Drug

Axsome Therapeutics (NASDAQ: AXSM) is currently soraing in premarket trading, as it is already up over 50% and climbing (As of 8:00am EST on June 27 2022). However, when searching for what caused this jump, I was not able to find anything, as a result I will be making this post to inform interested investors as to why the AXSM stock is actually up today.

AXSM 8-K Report

The only piece of information that I was able to find about the AXSM stock today was their 8-K form that they released earlier this morning. This is a very short 8-K report and thus I will post the whole thing to save you time.

"On June 24, 2022, Axsome Therapeutics, Inc. (the “Company”) received from the U.S. Food and Drug Administration (the “FDA”) proposed labeling for the Company's AXS-05 product candidate with respect to its New Drug Application (the “NDA”) for AXS-05 for the treatment of major depressive disorder. The Company is reviewing the proposed labeling and will reply to the FDA to secure final labeling agreement."

What Does All of this Mean?

A "current label" refers to the product label that Axsome submitted their AXS-05 drug to the FDA with. However, in this article it mentions a "proposed label", which is essentially the same label as the "current label" with some minor/moderate changes that have been proposed by the FDA for their AXS-05 in order to comply with FDA labelling rules. If Axsome is content with these changes, they will enter into a "final labelling agreement" with the FDA, and I believe will be done with the "NDA" stage of an FDA Approval.

After this "final labelling agreement" is signed, the FDA will inspect Axsome's manufacturing facilites to make sure that they are up to their standard. If AXSM passes this inspection, I believe that they will then present their drug to an "FDA Advisory Board" (including physicians, pharmacists, chemists and more). This will likely take 1-2 days, and then the board will make a decision via a vote. This decision gets sent to the FDA, which can either accept or reject it, however, if it accepted this is the point where AXSM will receive "FDA Approval".

My source for this process can be found here