Odds are growing that Food and Drug Administration officials said Biogen Inc.’s experimental and somewhat controversial Alzheimer’s disease drug could be approved because there was enough evidence in clinical trials to prove the effectiveness of the therapy.
The publication of the FDA document on Wednesday in advance of an advisory committee meeting for educanumab noted “substantial evidence of effectiveness to support approval”, a seal of support that sent shares of the biotech company up to 40%.
The stock was down 7.3% on Thursday.
On Friday, starting at 10 am ET, a group of independent medical experts will gather to discuss virtually and then make a recommendation to the FDA on whether Educanumab is approved, which will be called Adhelm if approved. Regulators are not required to follow the committee’s recommendation but often occur during the advisory committee meeting. The FDA has until March 7 to make a final decision about approving the therapy.
Brian Abraham, an analyst at RBC Capital Markets, said he found the FDA documents “surprisingly helpful”, noting that the FDA has a “clear prediction for approving the agent.”
See it all:Alzheimer’s experts say more clinical trials are needed for the controversial biogen drug
Most of the current investor interest in Biogen is focused on the resurgence of educanumab and the continued expectation that the card has FDA approval. That said, some Wall Street analysts and medical experts are skeptical about the drug’s effectiveness.
Back in December of last year, Baird analyst Brian Skicourt told investors that “there are so many reasons why we think educanumab is being dismissed, our word count restrictions don’t allow us to keep them all here.” It was around the same time that Drs. Howard Fillett called for new tests evaluating therapy.
After reading the FDA document this week, Raymond James analyst Steven Seedhouse told investors that he is still not convinced that the drug works. “In fact, we believe the drug probably doesn’t work,” he wrote in a note on Thursday. “We’re not sure how else to put it: FDA can approve a drug that may not work. They just did it with Remedisvir, so why not again?”
(Remedisvir is Gilead Sciences Inc. covid-19 treatment. It received full FDA approval last month, although some experts have questioned how well the drug works.)
New research 1, published in The Journal of the Alzheimer’s Association, has concluded that data shared by Biogen to date have failed to demonstrate the clinical benefits of educanumab.
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There are currently no approved drugs that treat cognitive decline associated with Alzheimer’s disease, which is intended to treat in patients with educanum, although there are some treatments used to treat some behavioral symptoms of neurological disease. Huh. According to an estimate cited in a pharmaceutical trade publication this year, according to Goldman Sachs, Educonum’s approval could mean up to $ 12 billion in peak sales for Biogen, and this could be followed by a string of high-profile Alzheimer’s treatments. The first drug for will also mark success. Only failures like Eli Lilly & Co.,
Solanezumab in 2016 and again earlier this year.
Biogen announced in March of last year that it had stopped the development of educanumab because an analysis showed the drug would not meet the primary endpoints in a pair of Phase 3 trials. The day before the announcement Biogen’s stock price was $ 320.59; The next day, the stock tumbled to $ 226.88.
But then in mid-October of last year, Biogen announced new plans to revive aducanumab and submit a regulatory application in the near future, surprising investors. The stock has since recovered substantially, even to a two-year high of $ 355.63 on Wednesday. Salim Syed of Mizuho Securities told investors that an educanumab approval could push the stock up to $ 400, although a failure would send it to $ 215.
So far this year, Biogen’s stock is 19.8%, while SPDR S&P Biotech ETF has gained 27% and S&P 500 SPX.
An increase of 6.6%.