By Davit Kirakosyan
FDA posted documents yesterday ahead of the advisory panel for Biogen's (NASDAQ:BIIB) Tofersen for ALS.
Needham believes these documents strike a favorable tone and the FDA appears to be leaning towards approving Tofersen for SOD1-ALS.
“What we did not expect, but we believe indicates the FDA is positively inclined on approval is that while Tofersen was submitted under the accelerated approval pathway, it appears the FDA is seeking the AdCom's input on whether to grant Tofersen either accelerated or traditional approval,” said the firm.
Regardless of the outcome of the March 22 meeting, Needham believes Tofersen is not expected to significantly affect the stock price. However, they noted that these developments are an overall positive for the CNS space, which has seen recent approvals granted under a more flexible purview.
Meanwhile, BofA Securities reiterated its Neutral rating and $295 price target on the stock, noting that the FDA briefing document suggests Tofersen approval is likely given the unmet needs and there's a suggestive treatment effect.
Overall, while it remains to be seen how the AdCom will vote and the eventual FDA decision, the firm said it wouldn’t be surprised to see a positive vote for Tofersen.