Odds are increasing that Biogen Inc.’s experimental and controversial Alzheimer’s drug Approval may be obtained after Food and Drug Administration officials say there is sufficient evidence in clinical trials to demonstrate the effectiveness of the therapy.
The FDA document release Wednesday ahead of an advisory committee meeting for aducanumab mentioned “substantial evidence of effectiveness to support approval”, a stamp in favor of holding the company’s stock. biotechnology soared 40%.
BIIB of Biogen,
shares fell 7.3% on Thursday.
On Friday, starting at 10 a.m. ET, a group of independent health experts will mostly gather to discuss and then make a recommendation to the FDA on whether to approve the aducanumab, will be called Aduhelm if it is approved. The governing body is not required to follow the committee’s recommendation during the advisory committee meeting but usually does. The FDA has until March 7 to make a final decision on whether to approve the therapy or not.
Brian Abrahams, an analyst at RBC Capital Markets who said he perceives the FDA’s documents as “surprisingly supportive”, noted that the FDA has “clear prediction of agent approval.”
See more:More clinical trials on the controversial drug Biogen are needed, says the Alzheimer’s expert
Much of the current investor interest in Biogen focuses on the revival of aducanumab and the persistent hope that FDA approval is in the tag. That said, some Wall Street analysts and health experts are still skeptical of the drug’s effectiveness.
Back in December of last year, Baird analyst Brian Skyers told investors that “there are a lot of reasons that we think aducanumab is being rejected, our word count restrictions don’t give away. let us put them all here ”. It was about time that Dr. Howard Fillet called for new trials evaluating therapy.
After reading the FDA documents this week, Raymond James analyst Steven Seedhouse told investors he was still not convinced that the drug was working. “In fact, our belief that the drug may not be as effective has increased,” he wrote in a note on Thursday. “We’re not sure how else to say: The FDA might approve a drug that might not work. They just did with remdesivir, so why not? “
(Remdesivir is the method of treatment COVID-19 by Gilead Sciences Inc.
New research published November 1 in the Journal of the Alzheimer’s Disease Association concludes that data shared by Biogen so far have not demonstrated the clinical benefits of aducanumab.
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There are currently no approved drugs to treat Alzheimer’s-related cognitive impairment, which aducanumab aims to treat patients, although there are several therapies used to treat patients. some behavioral symptoms of neuropathy. According to Goldman Sachs estimates cited this year in a pharmaceutical trade publication, aducanumab approval could mean up to $ 12 billion in top revenue for Biogen, according to Goldman Sachs’ estimates. cited this year in a pharmaceutical trade publication and it will also mark the first pharmaceutical success in the treatment of Alzheimer’s disease following a string of failed successes, such as Eli Lilly & Co.’s LLY,
solanezumab in 2016 and again earlier this year.
Biogen announced last March that it eliminated the development of aducanumab after an analysis showed that the drug would not meet the key criteria in a pair of Phase 3 trials. One day before announced Biogen’s share price of $ 320.59; the next day, the stock fell to $ 226.88.
But then in mid-October last year, Biogen surprised investors by announcing plans to revive aducanumab and filing for regulation in the near future. The stock has recovered largely since then, even reaching a two-year high of $ 355.63 on Wednesday. Mizuho Securities’s Salim Syed told investors that aducanumab approval could push the stock up to $ 400, though the failure would drop it down to $ 215.
Shares of Biogen have risen 19.8% so far this year, while the SPDR S&P Biotech ETF has risen 27% and the S&P 500 SPX,
increased by 6.6%.