Here is STAT’s Biotech Scorecard, our regular ledger of stock-moving biotech events, for the fourth quarter:
Before Covid-19 came along, there was nothing that loomed larger in biotech than aducanumab, Biogen’s (BIIB) controversial treatment for Alzheimer’s disease. On Nov. 6, the FDA is convening a meeting of outside experts to review the data from two Phase 3 clinical trials of aducanumab. At the end of the meeting, this panel of experts is expected to vote on whether the drug should be approved, or not. The FDA isn’t required to follow the panel’s recommendation, but it will surely factor heavily into whatever decision the FDA ultimately makes. Apart from the possible approval of Covid-19 vaccines later this fall, there won’t be a bigger binary event in biotech this year than the FDA’s aducanumab advisory panel. Bonus drama points for the meeting being scheduled just three days after the presidential election.
Amgen (AMGN) will announce results from a Phase 2 (but pivotal) clinical trial of its KRAS-targeted lung cancer drug sotorasib before the end of the year. If the sotorasib data — tumor response rates and durability of response — are strong enough, Amgen intends to submit the drug for marketing approval.
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