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FDA briefing docs suggest FDA in favor of Biogen’s tofersen, says BofA
The Fly

FDA briefing docs suggest FDA in favor of Biogen’s tofersen, says BofA

After the FDA posted briefing documents ahead of an Advisory Committee meeting to be held on March 22, BofA said the firm’s review of the document suggests that the FDA is "likely in favor" of tofersen approval for SOD1-ALS given the significant unmet need. In addition, the firm’s key opinion leader contact believes tofersen will be approved given his own and his colleagues’ clinical experience, where some patients got better overtime, notes BofA. The firm has a Neutral rating and $295 price target on Biogen shares.

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