- Biogen soared as much as 47% on Wednesday after an FDA panel said on Wednesday that efficacy data for its Alzheimer’s drug was “exceptionally persuasive.”
- The comments from the FDA panel have given investors confidence that a swift approval of the drug is likely, based on Wednesday trades.
- Biogen’s drug will be reviewed by independent experts at the FDA on Friday, who will then make recommendations to the agency.
- Watch Biogen trade live here.
Biogen soared as much as 47% on Wednesday after a FDA review panel found the efficacy of its Alzheimer’s drug, aducanumab, was “exceptionally persuasive.”
The FDA’s staff said data from a large trial of the experimental drug supports its eventual approval, boosting chances that Biogen’s drug could the market for Alzheimer’s patients in the future. The next step for the drug to be approved is Friday’s review of aducanumab by FDA’s independent experts, who will then make a recommendation to the agency.
The agency also that a second phase 3 trial of aducanumab that was terminated in 2019 because it didn’t meet its primary endpoints was not evidence that the drug was not effective.
Biogen’s aducanumab was jointly developed with Japan’s Eisai Co. A final decision is due by March 2021.
Biogen was already higher before the FDA advisory panel released documents related to aducanumab on Wednesday. Healthcare stocks have powered higher on the prospects of a divided government outcome of Tuesday's election.