The year is almost over! Here is STAT’s biotech scorecard, our regular ledger of stock-moving biotech events, for the fourth quarter:
Biogen has maintained a constant presence in STAT’s quarterly scorecards and this one is no different. Of course, all eyes are on Aduhelm and the thus-far poor U.S. commercial launch. What will CEO Michel Vounatsos say about the embattled Alzheimer’s treatment when the company reports third-quarter earnings? Will Biogen announce cost-cutting measures, including layoffs? And what will be Aduhelm’s fate in Europe, where regulators there are expected to render an approval decision in October or November? Looking beyond Alzheimer’s, Biogen is expected to have a readout on a drug called tofersen, which is being investigated in a Phase 3 clinical trial for patients with SOD1 ALS, a rapidly progressing form of the fatal neurodegenerative disease.
When the Food and Drug Administration granted accelerated approval to Aduhelm, the agency set a controversial — and looser — regulatory standard for neurodegenerative disease drugs that other companies are seeking to leverage. Watch for Eli Lilly to make good on a promise to file its Alzheimer’s drug, called donanemab. Biogen and its partner Eisai are also taking another bite at Alzheimer’s with the filing of lecanemab. Sometimes, the FDA says, “Do not file your drug with us” — and then changes its mind. That’s reportedly what happened to privately held Amylyx Pharma, so it’s now reading an application for its ALS treatment.
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