A court cleared the path for a suit accusing Bristol Myers Squibb of delaying FDA approval of Breyanzi, a gene therapy for non-Hodgkin lymphoma. The claim ties the alleged slow-walk to milestone-payment dynamics stemming from BMS’s 2019 Celgene acquisition. The procedural development means BMS could face a trustee suit over whether it handled the approval timeline in a way that affected contractual payments tied to regulatory milestones. The filing could also add reputational risk as well as potential legal costs for the company. Gene-therapy developers—and the broader biotech sector—will be watching how courts weigh alleged incentives against the practical realities of regulatory review and post-submission decision-making.
Get the Daily Brief