RESEARCH TRIANGLE PARK –  Biogen Inc. says it will seek federal approval for a medicine to treat early Alzheimer’s disease, a landmark step toward finding a treatment that can alter the course of the most common form of dementia.

The news sent Biogen (Nasdaq: BIIB) stock soaring. Shareas traded at nearly $300, up some 34 percent or $74.

Biogen has a major and growing presence in RTP.

The announcement Tuesday is a surprise because the company earlier this year stopped two studies of the drug when partial results suggested it was not working. The company now says a new analysis of more results suggest that the drug helped reduce a decline of thinking skills at the highest dose.

“With such a devastating disease that affects tens of millions worldwide, today’s announcement is truly heartening in the fight against Alzheimer’s. This is the result of groundbreaking research and is a testament to Biogen’s steadfast determination to follow the science and do the right thing for patients,” said Michel Vounatsos, Chief Executive Officer of Biogen, in the announcement.

“We are hopeful about the prospect of offering patients the first therapy to reduce the clinical decline of Alzheimer’s disease and the potential implication of these results for similar approaches targeting amyloid beta.”

The drug, called aducanumab, aims to help the body clear harmful plaques from the brain. Cambridge, Massachusetts-based Biogen is developing it with a Japanese company, Eisai Co. Ltd.

“The decision to file is based on a new analysis, conducted by Biogen in consultation with the FDA, of a larger dataset from the Phase 3 clinical studies that were discontinued in March 2019 following a futility analysis,” Biogen explained.

“This new analysis of a larger dataset that includes additional data that became available after the pre-specified futility analysis shows that aducanumab is pharmacologically and clinically active as determined by dose-dependent effects in reducing brain amyloid and in reducing clinical decline as assessed by the pre-specified primary endpoint Clinical Dementia Rating-Sum of Boxes (CDR-SB). In both studies, the safety and tolerability profile of aducanumab was consistent with prior studies of aducanumab.”

Read the full announcement online.