Recent initial public offering Amylyx Pharmaceuticals jumped Monday as the Food and Drug Administration prepares to review its controversial ALS treatment again. The IPO stock made double-digit percentage gains in morning trades.
The FDA's Peripheral and Central Nervous System Drugs Advisory Committee will meet Sept. 7 to discuss Amylyx's treatment for amyotrophic lateral sclerosis, or ALS. Also known as Lou Gehrig's disease, the neurodegenerative condition leads to progress muscle dysfunction.
In March, four members of the same 10-person committee shot down Amylyx's treatment, saying the evidence isn't compelling enough to warrant approval. Then, the FDA delayed its review date to examine new data Amylyx submitted. In September, the panel will look at the new data. The agency will make a decision on the drug, now known as AMX0035, by Sept. 29.
The IPO stock ended the regular session with a fractional gain at 19.50 on today's stock market. Earlier, shares soared as high as 19%. Amylyx shares went public in January.
IPO Stock: Two Key Studies
Amylyx's treatment was tested in a study called Centaur. In Centaur, some patients received AMX0035 and some received a placebo. Patients who received the drug showed stronger improvements in muscle function. But the benefits on survival aren't as clear.
Now, the FDA is waiting on the results of a study called Phoenix to help confirm Centaur's results.
During the meeting in March, one panelist argued the FDA should approve AMX0035. He noted the drug consists of two ingredients already on the open market. There's little to stop patients from trying to recreate the medicine on their own, he said.
The IPO stock fell nearly 14% after the advisory committee voted against recommending AMX0035.
Amylyx also acknowledges the urgent need for new ALS treatments.
"As we have heard from the ALS community, there is a crucial need for new and effective treatments in ALS, and our team will continue to work around the clock to advance treatments for ALS in the U.S.," Tammy Sarnelli, Amylyx's global head of regulatory affairs, said in a written statement.
Highly Rated Biotech Stock
The news Monday sent Amylyx shares gapping higher.
The IPO stock has a Relative Strength Rating of 97 out of a best-possible 99. This puts Amylyx stock in the leading 3% of all stocks in terms of 12-month performance, according to IBD Digital.
Bullishly, shares are also well ahead of their 50-day moving average, MarketSmith.com shows.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
