FDA sets Seres on the pri­or­i­ty re­view path for its mi­cro­bio­me C. dif­fi­cile drug, set­ting up April de­ci­sion

Though sev­er­al com­pa­nies have been look­ing at new drugs and can­di­dates to go af­ter C. dif­fi­cile, one biotech is at the FDA’s doorstep.

Seres Ther­a­peu­tics an­nounced Wednes­day morn­ing that the fed­er­al reg­u­la­to­ry agency ac­cept­ed its BLA for SER-109, the biotech’s mi­cro­bio­me can­di­date to pre­vent re­cur­rent C. dif­fi­cile in­fec­tion (rC­DI). FDA gave a PDU­FA date of April 26, and ac­cord­ing to the biotech, the agency is not plan­ning on an ad­comm.

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