IPO stock Amylyx Pharmaceuticals surged Friday ahead of an important Food and Drug Administration meeting to discuss its ALS treatment.
On Wednesday, a panel of experts will weigh the benefits and risks of Amylyx's drug, known by the test name AMX0035, in patients with amyotrophic lateral sclerosis. ALS is a progressive nerve and muscle disease often referred to as Lou Gehrig's disease. After his diagnosis, former New Orleans Saints player Steve Gleason founded Team Gleason, a nonprofit organization to support people living with ALS.
But the IPO stock has yo-yoed on its efforts. SVB Leerink analyst Marc Goodman says AMX0035 is the first experimental ALS drug to significantly improve muscle function and survival in patients. The FDA panel will review Amylyx's drug ahead of a potential approval on June 29.
Amylyx management "remains confident that the strong clinical data for both function and survival benefits (vs. biomarker data) should support a regular approval," Goodman said in a note to clients. The alternative would be an accelerated approval, which would require additional testing.
On today's stock market, the IPO stock jumped 15.2% to 25.
IPO Stock: A Short-Lived Breakdown?
The biotech company is also experimenting with AMX0035 in patients with Alzheimer's disease and an inherited disorder called Wolfram syndrome. Wolfram syndrome is characterized by diabetes, gradual vision loss and deafness.
Amylyx went public in January and showed all the signs of being a hot IPO stock. From its IPO price at 19, shares soared more than 76% to a high point at 33.41 in late February. But they've fallen this month. The FDA accepted AMX0035 for review last year, but then delayed the review while seeking more data.
On Tuesday, the IPO stock showed signed of breaking down, barely closing above their IPO price. Early this year, Amylyx stock had surged 36% from an IPO base buy point at 24.60, MarketSmith.com shows.
According to Leerink's Goodman, however, Amylyx management isn't concerned the drug will pass FDA muster. The FDA likely scheduled the advisory committee meeting "due to increased interest and awareness around ALS," Goodman said in his report, citing commentary from Amylyx executives.
He kept his outperform rating on the IPO stock.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
