Regeneron Initial Data on Multiple Myeloma Drug Encouraging

Regeneron (REGN) announced encouraging initial results from its Phase Ib trial, LINKER-MM2, evaluating linvoseltamab in combination with carfilzomib or bortezomib for relapsed/refractory multiple myeloma, demonstrating high objective response rates of 90% and 85%, respectively. The FDA has accepted for review the resubmitted BLA for linvoseltamab with a target action date of July 10, 2025, while the European Commission granted conditional marketing approval for the drug under the brand name Lynozyfic. These developments are crucial as Regeneron seeks to bolster its oncology portfolio amid declining sales of its lead drug, Eylea, due to competition.

Analysis

Regeneron Pharmaceuticals (REGN) has reported encouraging initial data from its LINKER-MM2 Phase Ib study for linvoseltamab in relapsed/refractory multiple myeloma (MM). When combined with carfilzomib, linvoseltamab demonstrated a 90% objective response rate (ORR) and a 76% complete response (CR) rate at a median follow-up of 15 months. In combination with bortezomib, it showed an 85% ORR and 50% CR with a median follow-up of nine months. These positive results are significant as Regeneron aims to strengthen its oncology franchise, which recently saw European Commission conditional marketing approval for linvoseltamab (brand name Lynozyfic) for heavily pretreated R/R MM patients. The FDA has also accepted the resubmitted Biologics License Application (BLA) for linvoseltamab, with a target action date of July 10, 2025, after a previous Complete Response Letter (CRL) related to third-party fill/finish manufacturing issues. Similar FDA resubmission for another oncology candidate, odronextamab, has a target date of July 30, 2025. This pipeline progression is crucial for Regeneron, particularly as sales of its lead drug, Eylea, are under pressure from competition, notably Roche's Vabysmo. Despite these positive developments in oncology, REGN shares have underperformed, declining 17.3% year-to-date compared to the industry's 4.9% fall.

Key Decisions for Investors

• Investors should closely monitor the upcoming FDA target action dates for linvoseltamab (July 10, 2025) and odronextamab (July 30, 2025), as successful approvals are critical catalysts for Regeneron's oncology growth narrative and could help offset Eylea's revenue challenges.
• The strong early-stage clinical data for linvoseltamab combinations in multiple myeloma is a positive indicator for Regeneron's pipeline, but the company's ability to overcome previous manufacturing-related regulatory hurdles will be key to realizing its commercial potential.
• Given the significant year-to-date stock underperformance against the industry, investors should weigh the long-term potential of the oncology pipeline against ongoing competitive pressures on Eylea and the execution risks associated with new drug launches and regulatory approvals.