Shares of Axsome Therapeutics (NASDAQ: AXSM) rose nearly 23% today for no apparent reason, but that doesn't mean the leap in the stock price is coming out of the blue. The pharma stock has now gained 91% since the beginning of March after several positive updates have stoked excitement among investors hoping the small-cap company can bring new treatments for depression to the market.
The pharma company emerged on the investing scene only months ago after reporting surprisingly solid results from a mid-stage study in major depressive disorder (MDD). Axsome Therapeutics reported in early January that its lead drug candidate, AXS-05, met the trial's primary endpoint and resulted in 47% of patients achieving remission by the six-week mark. That has drawn several comparisons with the portfolio and trial results of Sage Therapeutics, which received marketing approval from the Food and Drug Administration for its postpartum-depression drug -- the first to ever hit the market -- earlier this month.
As of 1:25 p.m. EDT on Monday, the stock had settled to a 18.8% gain.
Already in March, Axsome Therapeutics has initiated a phase 3 trial for AXS-07 in migraine, secured $24 million in debt financing, and reported full-year 2018 operating results. That gives the pharma company three ongoing phase 3 trials across its pipeline and an end-of-2018 pro forma cash balance of $52.6 million. For context on just how quickly its fortunes have changed, the business had a market cap of just $60 million in late December 2018.
Investors shouldn't expect the pace of updates to subside anytime soon. Axsome will have topline data for its lead program, AXS-05 in treatment of resistant depression, in the second quarter of 2019. Mid-stage results from AXS-05 in smoking cessation and from AXS-12 in narcolepsy are also expected to be reported before July.
The recently initiated phase 3 trial of AXS-07 in migraine should have results in the first quarter of 2020, while phase 2/3 data from AXS-05 in Alzheimer's disease agitation should be reported in the first half of next year.
There are a lot of moving parts at Axsome right now, but investors sure aren't complaining given the stock's epic rise in recent months. Even still, the business boasts a market cap of only $500 million at the moment, which would likely increase significantly should it find success in its pipeline programs. Can a pharma company with no experience or track record successfully navigate the hurdles of clinical trials and regulatory paperwork? Investors will soon find out.
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