Axsome’s long-delayed depression drug is back for label talks at the FDA, triggering a sharp rise in stock price – Endpoints News

Axsome’s on-and-off quest to gain FDA approval for its depression drug AXS-05 is back on.

After markets closed on Monday, the biotech issued a short, simple alert in an SEC filing stating that the team had “received from the United States Food and Drug Administration (the “FDA”) proposed labeling for the Company’s product candidate AXS-05 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 respond to the FDA for final labeling approval.”

The filing sparked a frenzy among investors – most of whom have had a steady diet of bad biotech news to digest this year – sending shares of Axsome $AXSM soaring 51% after the bell and pushing its market capitalization to 1, $44 billion.

It’s a polar shift from last summer, when Axsome announced that the process of labeling their potential blockbuster for the Major Depressive Order had been shelved after regulators identified “gaps” that had interrupted discussions on the label.

There’s no guarantee of success, of course, but regulators and developers typically hash out a drug label in the weeks leading up to an approval. So the long-delayed drug now has a chance for short-term success.

Axsome got the party started again for AXS-05 in April when an earlier filing with the SEC indicated that they had reached an agreement with the FDA on post-marketing terms.

Axsome’s drug offers a combination of dextromethorphan and bupropion, which some analysts enthusiastically believe can fetch more than $1 billion a year. And biotechnology has won breakthrough titles at the FDA for major depression as well as Alzheimer’s disease agitation as Lundbeck now makes strides.

Marc Goodman of SVB Securities picked up on the matter in a note, saying:

The usual process is that the FDA and a company would start labeling negotiations about a month before the PDUFA date, but since there is no action date, it’s hard to know when. in this situation, but we will assume approval in about 1 month. Given the saga of this drug approval process, we think many investors are still somewhat hesitant about full approval, and so we wouldn’t be surprised to see another significant jump in the stock on approval. complete.

Axsome has also been battling issues around its migraine drug AXS-07, which was rejected a few weeks ago over CMC issues.

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