Ionis stock jumped Thursday after a Food and Drug Administration panel offered a mixed view of its Biogen (BIIB)-partnered treatment for a deadly neurodegenerative condition.
The companies are hoping to win approval for tofersen, a potential treatment for a rare form of ALS, or amyotrophic lateral sclerosis. Also known as Lou Gehrig’s disease, the condition leads to worsening muscle weakness and eventually death.
Biogen and Ionis Pharmaceuticals (IONS) tested tofersen in patients with a genetic mutation known as SOD1. There are about 330 patients in the U.S. with this form of ALS.
Late Wednesday, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted unanimously, saying the presence of a biomarker known as neurofilament in patients’ blood suggests the treatment is working. But only three panelists said the evidence is strong enough for a traditional approval. Five panelists said no and one abstained.
SVB Securities analyst Marc Goodman expects tofersen to win accelerated approval late next month.
In premarket trades on today’s stock market, Ionis stock surged 7.7% near 38. Biogen stock lifted a fraction near 262.
More to follow.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
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