Biogen Inc (NASDAQ: BIIB ) stock was up on Monday following positive results from its Phase 3 trial of nusinersen.
Nusinersen is a collaborative effort between Biogen and Ionis Pharmaceuticals Inc (NASDAQ: IONS ) to develop a treatment for spinal muscular atrophy (SMA). The treatment met its Phase 3 endpoints when used to treat infantile-onset spinal muscular atrophy.
The positive results from the Phase 3 trail of nusinersen included "statistically significant improvement in the achievement of motor milestones" in infants receiving the treatment when compared to those that didn't. This change means that the study is being stopped and all patients of the ENDEAR study will be moved into the SHINE study to receive treatment.
Biogen has paid Ionis a $75 million license fee so that it can globally commercialize nusinersen. This means it's now responsible for all development, regulatory and commercialization activities and costs connected to nusinersen. It will start submitting regulatory filings for the drug in the next few months.
"We share the community's sense of urgency as we strive to bring the first treatment for SMA, the leading genetic cause of infant mortality, to families facing this devastating disease," said Biogen's executive vice president and chief medical officer Alfred Sandrock. "We remain committed to understanding the potential of nusinersen in the broader SMA population and will continue to focus on the rapid completion of our ongoing studies."
Biogen studies that will still continue include different populations than the ones that are being stopped due to the recent results. This includes the CHERISH study for later-onset spinal muscular atrophy and the NURTURE study for pre-symptomatic infants.
BIIB stock was up 5% and IONS stock was up 35% as of Monday morning.
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