Needham analyst Ami Fadia has reiterated their neutral stance on BIIB stock, giving a Hold rating on September 16.
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Ami Fadia has given his Hold rating due to a combination of factors surrounding Biogen’s recent developments. The FDA issued a Complete Response Letter (CRL) for Biogen’s supplemental New Drug Application (sNDA) for a high dose regimen of nusinersen, which has introduced some uncertainty. The CRL requests updates to the technical information in the Chemistry, Manufacturing, and Controls (CMC) module, though specifics and timelines for these updates remain unclear.
Despite this, the CRL did not highlight any issues with the clinical data, which is a positive aspect. However, the lack of clarity and potential delays could exert pressure on the stock. Consequently, the high dose regimen of nusinersen is not currently factored into the valuation model, leading to the decision to maintain a Hold rating.
Fadia covers the Healthcare sector, focusing on stocks such as Biogen, Jazz Pharmaceuticals, and Axsome Therapeutics. According to TipRanks, Fadia has an average return of 13.2% and a 49.89% success rate on recommended stocks.
In another report released on September 16, J.P. Morgan also maintained a Hold rating on the stock with a $175.00 price target.