After some apparent hesitation, the Food and Drug Administration (FDA) has agreed to consider — or more accurately, reconsider — Amylyx Pharmaceuticals’ (NASDAQ:AMLX) application for an amyotrophic lateral sclerosis (ALS) treatment. The story clearly isn’t finished yet, but at least the AMLX stock have something to celebrate today.
Amylyx Pharmaceuticals is relentless in its pursuit of treatment options for patients living with neurodegenerative diseases. To this end, the company is advancing AMX0035, a drug for ALS, Alzheimer’s disease and other neurodegenerative conditions.
It’s understandable if ALS patients and Amylyx’s stakeholders are hoping for quick, full approval of AMX0035. Unfortunately, regulatory approval can be a slow process, and obstacles often get in the way. For example, a panel of advisers to the FDA reportedly voted against approving AMX0035 in March. Apparently, the panel determined at that time that Amylyx’s clinical study data hadn’t established that the drug was effective against ALS.
That may have been frustrating, no doubt, but it wasn’t the end of the road for AMX0035. Today, Amylyx Pharmaceuticals disclosed that the FDA will reconvene a meeting of experts to review Amylyx’s application for AMX0035.
New Hope for AMLX Stock Holders
Plus, there’s more potentially positive news. Reportedly, the FDA has requested more information from Amylyx Pharmaceuticals, and has delayed its deadline for making a determination on AMX0035 by three months, to Sept. 29. In other words, now there’s more time for the FDA to say “yay” or “nay” on AMX0035 — and perhaps, more time for Amylyx to state its case.
This could be a win for the company, of course, but also for ALS sufferers in the U.S. Notably, AMX0035 has already been approved in Canada with certain conditions.
Meanwhile, AMLX stock tested the key $22 midday today, and for at least one trading session, the buyers were clearly in control. The next step could be $25 or even higher — and for Amylyx Pharmaceuticals, the next step just might be a regulatory green light for AMX0035.
On the date of publication, David Moadel did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.