Ionis Pharma Shares Drop 12% After Tofersen Study Misses Primary Endpoint
October 18 2021 - 9:55AM
Dow Jones News
By Chris Wack
Ionis Pharmaceuticals Inc. shares fell 12% to $30.90 after the
company said a study for tofersen missed its primary endpoint.
The company said its partner Biogen reported topline results
from its placebo-controlled study of tofersen, an investigational
antisense medicine being evaluated for people with superoxide
dismutase 1 amyotrophic lateral sclerosis.
Tofersen didn't meet its primary endpoint, but trends favoring
tofersen were seen across multiple secondary and exploratory
measures of disease activity and clinical function.
Biogen said a pre-specified integration of data from the study
and its ongoing open-label extension study reinforced the findings,
and showed that early tofersen initiation led to less decline
across multiple measures including motor function, respiratory
function, muscle strength, and quality of life in people with
SOD1-ALS.
Biogen, which licensed tofersen from Ionis in 2018, said it is
actively engaging with regulators, the medical community, patient
advocacy groups and other key stakeholders to determine next
steps.
Biogen said it will expand eligibility for its ongoing early
access program to all people with SOD1-ALS in countries where such
programs are permitted by local regulations and future access may
be secured. If a path forward for tofersen isn't established or if
another controlled trial is required by regulators, Biogen said it
could revise or discontinue the EAP.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
October 18, 2021 10:40 ET (14:40 GMT)
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