Amylyx stock crashed Friday, losing almost all of its value, after the company said its approved ALS treatment, Relyvrio, failed in a pivotal study.
Patients who received Amylyx Pharmaceuticals' Relyvrio showed no significant difference across multiple markers measuring the severity of amyotrophic lateral sclerosis, the longhand name for ALS. In this disease, nerve cells break down, reducing muscle function.
The Food and Drug Administration approved Relyvrio based on a single study in September 2022. But Amylyx continued on with a Phase 3 study. Now, Amylyx is deciding whether to voluntarily pull the drug from the market in the U.S. and Canada. In Canada, it sells under the brand name Albrioza.
"We thought they had a real shot heading into this study, not just based on prior randomized, Phase 2 (study), but perhaps because of the recently completed Italian study where a recent press report used phrases like 'step forward for medicine,'" Evercore ISI analyst Umer Raffat said in a report.
He downgraded Amylyx stock to an in-line rating from outperform.
On today's stock market, Amylyx stock plummeted 82.3% to 3.36. Shares undercut their 50-day and 200-day moving averages, MarketSurge.com shows. That put shares at a record low.
What's Next For Amylyx Stock?
It's important to note that Relyvrio failed to make a difference across multiple measures, including the key goal of the study: improvement on the revised Amyotrophic Lateral Sclerosis Functional Rating Scale. The company tested Relyvrio over 48 weeks. Secondary measures of the study also flopped.
Raffat, the Evercore analyst, says the Italian study could still pan out for Relyvrio.
"From Amylyx's perspective, they have two trials: a positive and a negative (but that's the larger one)," he said.
Mizuho Securities analyst Graig Suvannavejh kept his buy rating on Amylyx stock.
He noted the firm is still testing Relyvrio — under the test name AMX0035 — in patients with Wolfram syndrome and progressive supranuclear palsy. Wolfram syndrome is a genetic condition associated with childhood-onset insulin-resistant diabetes and hearing loss. Progressive supranuclear palsy is a rare condition that affects walking, balance and eye function.
Amylyx says it now expects to have the results of its study in Wolfram syndrome patients in the second quarter.
Follow Allison Gatlin on X, the platform formerly known as Twitter, at @IBD_AGatlin.
