Biogen's (BIIB) Zuranolone is Likely to be Approved Says Former FDA Officer - Truist

Truist Securities analyst Robyn Karnauskas reiterated a Buy rating and $647.00 price target on Biogen (NASDAQ: BIIB) after speaking with an FDA KOL who thinks zuranolone will be approved.

The analyst stated "We spoke to Dr. Paul Andreason, the former Medical Officer for the FDA Division of Psychiatry Products, regarding his view on how the FDA perceives the bar for approving Sage's SAGE Therapeutics (NASDAQ: SAGE) zuranolone in collaboration with Biogen, as well as other new depression therapeutics. Bottom line, based on his view of what the FDA is looking for, approval on the basis of WATERFALL and SHORELINE (even if the other trials disappoint) is likely. He sees the drug’s application analogous to eketamine. This could quickly get a patient out of a depression episode and could also be a drug that would be ideal for primary care physicians who won’t run the risk of giving the wrong drug if they don’t have the precise depression diagnosis. We model ~$1.6B peak sales WW and believe the drug could add up to ~$72/share in NPV if approved. We currently assign zero credit in our model."

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Shares of Biogen closed at $388.44 yesterday.

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