The FDA de­lays its de­ci­sion on Bio­gen's con­tro­ver­sial pitch on its Alzheimer's drug — and the biotech's shares soar

Usu­al­ly, a 3-month de­lay on a PDU­FA dead­line is un­wel­come news at a bio­phar­ma com­pa­ny. For Bio­gen $BI­IB, it’s man­na from heav­en.

The big biotech re­port­ed Fri­day morn­ing that the FDA has called for a 3-month de­lay on its March PDU­FA dead­line for the Alzheimer’s drug ad­u­canum­ab. Ac­cord­ing to the com­pa­ny, Bio­gen and its part­ners at Ei­sai have sup­plied ad­di­tion­al in­for­ma­tion to the FDA that the agency has deemed a ma­jor amend­ment that re­quires added time to study.

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