- Biogen plummeted 32% on Monday after the FDA Advisory Committee signaled that it is unconvinced Biogen’s Alzheimer’s therapy is effective in combating the disease.
- On Friday, the FDA AdCom voted 8-1 that data from the phase 3 EMERGE study evaluating Biogen’s aducanumab in patients with mild Alzheimer’s disease was not enough to show efficacy.
- The negative AdCom vote came two days after FDA scientists said in a document release that aducanumab data was “exceptionally persuasive.”
- Watch Biogen trade live here.
Biogen experienced a quick reversal in fortunes on Monday, with its stock plummeting after an FDA Advisory Committee said it was unconvinced that data from its Alzheimer’s therapy was enough to demonstrate efficacy.
Friday’s FDA AdCom votes came two days after Biogen soared 47% after FDA scientists said data from its aducanumab trials was “exceptionally persuasive.”
Biogen cratered as much as 32% in premarket trading on Monday, on pace to erase all of the gains it made over the prior week.
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 8-1 that data from Biogen’s Phase 3 EMERGE study evaluating aducanumab in patients with mild Alzheimer’s disease was not enough to show efficacy.
The AdCom also voted 7-0 that Biogen's Phase 1 PRIME study failed to show supporting evidence of efficacy. It also voted 5-0 that Biogen presented strong evidence of aducanumab's pharmacodynamic effect on Alzheimer's disease.
The voting results from Friday's AdCom meeting doesn't mean that aducanumab won't be approved by the FDA, but it significantly reduces its chances of approval.
A final approval decision from the FDA is due by March 2021.
Biogen's aducanumab was jointly developed with Japan's Eisai Co.
