Luck turned on Wednesday. Prior to Friday’s meeting at the company’s request for treatment for Alzheimer’s disease, the US Food and Drug Administration published reports that suggested it favored approval.
The company’s stock (ticker: BIIB) was $ 353, up 42% on Wednesday afternoon, nine times its recent average daily volume. The lost ground was sent to Biogen stock in about 2018, after initial excitement about the investigational drug aducanumab. Since then, the pharmaceutical approach collapsed and the company and scientists evaluated data from conflicting clinical trials.
On Wednesday, Wall Street scrambled to upgrade its forecasts, after FDA filings showed the agency’s willingness to give skeptical test data the benefit of the doubt – perhaps from a lack of options for Alzheimer’s patients.
At Friday’s meeting, the FDA will convene outside advisors to consider Biogen’s approval request. The agency usually follows the recommendations of these advisory committees, but not always. One of the FDA’s briefing documents for the meeting noted: “A novel drug for the treatment of Alzheimer’s disease has not been approved since 2004.”
Aducanumab targets plaque produced in the brain cells of Alzheimer’s patients. After initially concluding that its drug had failed its Phase 3 trial, Biogen re-examined the data and found that what it says is evidence that the treatment works.
In their briefing documents, FDA employees agreed. It stated that the reanalyzed Phase 3 trial “provides primary evidence of effectiveness,” which is further supported by the chemical changes found in patients, as well as evidence obtained from earlier Phase I studies.
In a note following Wednesday’s FDA filing, Wells Fargo Securities analyst Jim Birchenf said he expects Friday’s advisory committee to recommend approval. “The outcome of any FDA panel is hard to predict,” he wrote, “We believe the risk-reward is favorable and look at the positive recommendation as compared to the negative vote.”
Birchenough raised their rating on Biogen stock from Hold to Buy and raised their price target to $ 390. He said that this earnings is 15 times more for 2021. Investors enjoy negative security with the company’s cash flow from many of its sclerosis treatments.
Alzheimer’s scientists continue to argue about biogen data. Mayo Clinic neurologist David Knopman, a long-time member of the FDA advisory committee, recused himself from Friday’s meeting and published an editorial in the Alzheimer’s Association’s scientific journal on Sunday that highlighted Biogen’s claims for its conflicting data Challenged. Nopman and his co-authors called for another Phase 3 trial.
Two other researchers, who consult for Biogen, defended educanumab in a rebuttal section. “We believe the data are sufficient for warrant approval,” he wrote. “Lack of approval will be disastrous not only for patients who will lose hope, but advocates and the community at large.”
A brief document by the FDA’s statistical expert seems to align with Biogen’s critics, stating that Biogen’s analysis is flawed and fails to show that educanumab works. But other filth by agency reviewers concludes that the drug is effective and safe.
Amidst all this, Biogen said it would conduct an uncontrolled study of the long-term safety and effectiveness of aducanumab.
Biogen approval prospects were best viewed by many Wall Street analysts as a 50/50. Raymond James analyst Steven Seedhouse gave an underperform rating on the stock. In a Wednesday note, he acknowledged that the FDA documents were “a resounding victory” for Biogen and that his thesis was “flying.”
Write Bill Alpert at [email protected]