Regeneron reported renewed regulatory and manufacturing challenges for odronextamab, its anti‑CD20×CD3 bispecific for lymphoma, complicating the company’s efforts to secure U.S. approval. The program has faced a series of setbacks this year, and the latest issues add uncertainty to filing timelines and supply plans. Company briefings signaled the firm is addressing manufacturing shortfalls while engaging regulators on resolution paths; the developments underscore the operational demands of scaling complex biologics amid an accelerating bispecific competitive landscape.