Biogen’s big unanswered question
The world has had plenty of time to chew over Biogen’s promise to submit a once-waylaid Alzheimer’s disease treatment for FDA approval. The question now is simply when.
And we might get an answer tomorrow, when Biogen reports its quarterly earnings. To date, executives have promised only that they’d submit the drug, aducanumab, as soon as possible, which analysts have taken to mean the first quarter. Any detail Biogen provides will be key to setting expectations for what could be a superlatively lucrative product.
As Baird analyst Brian Skorney pointed out this week, timing could be key. Biogen would have to submit aducanumab no later than May to ensure that the FDA’s final decision would come ahead of the 2020 presidential election, according to Skorney. The company hasn’t been a campaign topic thus far, but there’s a mounting concern among investors that aducanumab’s debatable efficacy — and undoubtedly controversial price — could become a political issue that sways the FDA.
Speaking of earnings, STAT’s Adam Feuerstein rounded up the major quarterly themes for companies including Alexion Pharmaceuticals, Amgen, and Vertex Pharmaceuticals. Read more.
And we might get an answer tomorrow, when Biogen reports its quarterly earnings. To date, executives have promised only that they’d submit the drug, aducanumab, as soon as possible, which analysts have taken to mean the first quarter. Any detail Biogen provides will be key to setting expectations for what could be a superlatively lucrative product.
As Baird analyst Brian Skorney pointed out this week, timing could be key. Biogen would have to submit aducanumab no later than May to ensure that the FDA’s final decision would come ahead of the 2020 presidential election, according to Skorney. The company hasn’t been a campaign topic thus far, but there’s a mounting concern among investors that aducanumab’s debatable efficacy — and undoubtedly controversial price — could become a political issue that sways the FDA.
Speaking of earnings, STAT’s Adam Feuerstein rounded up the major quarterly themes for companies including Alexion Pharmaceuticals, Amgen, and Vertex Pharmaceuticals. Read more.
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