The pace of new modality approvals is picking up

Last week’s FDA approval of Sarepta’s Amondys 45 marks the ninth new modality drug to be approved in the last year, a sign that the pace of new therapeutic formats making it to market is reaching a trot, if not yet a gallop. Despite the hurdles, the regulatory breakthroughs and deep late-stage pipeline indicate that new modality therapies are finally creating a heavy footprint in drug development.

Six major classes of drugs outside small molecules and standard mAbs have products on the market, with all but one seeing an approval in the last year. The outlier, bispecific antibodies, could see an approval in the next few months — mivantamab from Johnson & Johnson (NYSE:JNJ) and Genmab A/S (NASDAQ:GMAB; CSE:GMAB) is under review at FDA...