Go or no go? J&J’s bispecific FDA first

Next month is expected to be relatively quiet on the US regulatory front. Nevertheless, Amicus’s Pompe disease candidate AT-GAA will come under scrutiny after a three-month delay, while Johnson & Johnson’s teclistamab could become the first FDA-approved BCMA-targeting bispecific.

As summer gets into full swing no FDA adcoms are scheduled, but both Acadia and Bluebird will get final decisions for projects that have previously gone through panels.