Biogen Inc.'s (BIIB, Financial) management and shareholders are keeping their fingers crossed that the Food and Drug Administration rules favorably on the company's controversial Alzheimer's drug. The decision on what BioPharma Dive called "the most closely watched drug in all biotech" is expected by the first week in June.
A thumb's down by the agency is likely to send shockwaves throughout the industry and Biogen stock. An OK would make aducanumab the first marketed drug meant to slow the progression of Alzheimer's and, according to analysts, generate billions in annual sales for the company.
Naysayers note that the FDA's statisticians and an outside bevy of experts didn't like the aducanumab data and how Biogen analyzed it. In a November meeting, nearly everyone in the group voted against the drug. While the FDA doesn't have to follow the recommendation, it usually does.
On the other side of the ledger, the FDA stands to be criticized if the drug isn't approved because the need for an Alzheimer's treatment is monumental. Also, the FDA's clinicians have backed Biogen's application.
Analysts seem to like—but not love—aducanumab's chances for approval. Evercore's Umer Raffat had told BioPharma Dive that an extended review would increase the odds for approval to 70%. Investment bank Stifel was a bit less bullish, forecasting the drug has a 60% of being green-lighted.
The Biogen drug is one of five key decisions the FDA is expected to make over the next several months. Another that is likely to have a major impact on the company's shares is ACADIA Pharmaceuticals Inc.'s (ACAD, Financial) Nuplazid for the treatment of Parkinson's disease psychosis. In 2020, sales of the medication climbed 30%.
Nuplazid is important to ACADIA because it's the company's only drug. ACADIA is trying to get it approved for additional uses, one being dementia-related psychosis; a decision is expected within days. However, things are not looking promising. The FDA found some shortcomings in the drug's application that caused Vamil Divan, an analyst at Mizuho Securities, to lower the odds for approval by 10% to 60%. Investors also seem to be concerned. At just more than $25, ACADIA's share price has been chopped in half this year.
Decisions affecting other companies on the list are likely to have less of an impact because they have much larger market caps and diverse product lines. AstraZeneca (AZN, Financial) falls into that category. The company is trying to be the fourth to get a Covid shot approved for use in the U.S., but the vaccine has been steeped in controversy. A clearer picture should emerge next month when AstraZeneca executives meet with an FDA advisory group to address concerns about their shot.
Another key verdict is expected on Sanofi's (SNY, Financial) new treatment for people with Pompe disease, a genetic mutation that stops their bodies from producing a key enzyme that breaks down a complex sugar called glycogen. The resulting buildup of glycogen causes progressive tissue damage and other health problems.
Meanwhile, pharma giants Merck & Co. Inc. (MRK, Financial) and Pfizer Inc. (PFE, Financial) are locked in a race to be the first to get approval of a vaccine against key emerging strains of pneumococcal disease. Pfizer is expected to hear first, in June, with Merck learning the fate of its treatment the following month.
Disclosure: The author has positions in AstraZeneca and Sanofi.
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