AbbVie M&A, FDA reversals, a CAR T first — a BioCentury podcast

AbbVie’s $10.9B Apogee takeout, FDA’s post-Makary course corrections, and CARsgen’s solid tumor CAR T approval

AbbVie Inc.’s $10.9 billion deal to acquire Apogee Therapeutics Inc. will expand its immunology pipeline by delivering long-acting assets for atopic dermatitis and asthma. On the latest BioCentury This Week podcast, BioCentury’s analysts break down the takeout and the assets AbbVie gains.

The team then turns to FDA’s reversal of controversial setbacks that occurred under the agency’s former leadership, including decisions on an mRNA flu vaccine from Moderna Inc., a gene therapy from Regenxbio Inc. for mucopolysaccharidosis II (MPS II), and a UniQure N.V. gene therapy, in a change that puts natural-history controls back in play for rare neurology programs.

Staying with Washington, they assess Acting CDER Director Michael Davis’ memo outlining how his predecessor, Tracy Beth Høeg, repeatedly overruled career staff to quash a drug approval. The analysts also discuss continuing signs of political involvement at FDA, namely political appointees continuing to meet with Republican lawmakers and with companies pressing to reverse or soften regulatory decisions.

Finally, they cover the first-ever approval of a CAR T for solid tumors: satricabtagene autoleucel (satri-cel) from CARsgen Therapeutics Holdings Ltd., which China’s NMPA cleared as third-line treatment for gastric and gastroesophageal junction adenocarcinoma. The approval creates the first commercial test of whether meaningful disease control can justify CAR T’s cost, complexity, and safety burden in solid tumors.