It’s a gray morning for Axsome Therapeutics. Shares in the biopharmaceutical company have fallen by -36.94%, bringing the last price to 3.50 as of 2:38 PM EST. The sink comes amid reports that their trial into a complex regional pain syndrome (CRPS) treatment has been halted.
The trial, named CREATE-1, has been stopped following a recommendation by the independent data monitoring committee (IDMC) due to ‘futility’. But if you are looking to invest, or are doing so already, don’t be too disheartened by today’s numbers.
Today’s slump follows a positive end to last week, which saw shares rise and level out to a high of 5.650 on Friday 5th.
Is it as bad as it seems?
Despite the bad news, Axsome is eager to continue development of the more successful COAST-1 trial, which the IDMC recommended be continued, and will likely see share value increase as progress is made. COAST-1 is investigating knee osteoarthritis (OA) associated with bone marrow lesions (BMLs), clinically manifested by knee pain, significant physical disability, and reduced quality of life.
In addition, the drug being trialed – AXS-02 – is set to join a pipeline of three others being developed by Axsome which are aiming to target various afflictions from smoking cessation to Alzheimer’s disease.
What happens next?
Cedric O’Gorman, M.D., Senior Vice President of Clinical Development and Medical Affairs of Axsome, said that despite ‘confirmation of pharmacologic activity’ in the trial, the outcome of the IDMC’s analysis was ‘disappointing’. He also noted that the discontinuation could be concerning for those who suffer from CRPS, a condition which is characterized by severe burning or throbbing limb pain. The randomised placebo-controlled phase-3 trial compared the effects of the drug AXS-02 to a placebo. AXS-02, which the IDMC confirmed as safe, is an oral, potentially first-in-class therapeutic for chronic pain. Further data analysis of CREATE-1 will continue.
In the meantime, expect a corporate update from Axsome soon following the conclusion a conference call which is being held to discuss the trial results. If you can’t wait for that, the live webcast can be accessed on the “Webcasts & Presentations” page of the “Investors” section of the Company’s website at axsome.com.
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