FDA Rejects Regeneron’s Blood Cancer Bispecific, Delaying Competition with J&J and Pfizer

FDA Rejection:
The FDA has rejected Regeneron's application for linvoseltamab, a bispecific antibody for multiple myeloma, due to issues with the third-party manufacturer, not related to the drug's safety or efficacy.

Competition Delayed:
This rejection delays Regeneron's entry into the market, allowing competitors like Johnson & Johnson and Pfizer to maintain their lead in the multiple myeloma treatment space.

Manufacturing Issues:
The rejection was due to unresolved findings at the contract manufacturer's site, which requires a re-inspection before approval can be granted.

Pipeline Concerns:
Regeneron faces challenges with other bispecific hopefuls in its pipeline, including nezastomig and dalmitamig, which have shown mixed results in clinical trials.

Market Impact:
The delay in approval for linvoseltamab further complicates Regeneron's position in the oncology market, where it faces stiff competition from established players.