While it trails Johnson & Johnson’s Tecvayli, Regeneron still hopes Lynozyfic can differentiate in terms of dosing convenience and efficacy.
The FDA on Wednesday granted accelerated approval to Regeneron’s bispecific antibody linvoseltamab for the treatment of patients with relapsed or refractory multiple myeloma. The pharma will market the drug under the brand name Lynozyfic.
Analysts at BMO Capital Markets called the approval a “small win” for Regeneron, with Lynozyfic being a “minor contributor to the company’s broader product portfolio.” BMO models around $600 million in potential revenues for Lynozyfic. Regeneron’s bispecific trails other multiple myeloma bispecifics, chief of which is Johnson & Johnson’s Tecvayli, which was approved in 2022, giving it a three-year head start.
Regeneron appears to be looking to differentiate in terms of efficacy. Data from the Phase I/II LINKER-MM1 study supported Lynozyfic’s approval, demonstrating a 70% objective response rate, including a 45% complete response rate or better. In a prepared statement on Wednesday, CEO George Yancopoulos said that with this efficacy profile, “Lynozyfic is poised to potentially become a new standard of care for multiple myeloma.”
Lynozyfic, a bispecific antibody, works by binding both the BCMA and CD3 proteins, thus directing T cells to destroy multiple myeloma cells. The FDA initially rejected the drug in August 2024, citing manufacturing problems at a third-party fill/finish site. Lynozyfic carries a boxed warning for cytokine release syndrome and neurotoxicity.
Uniquely, according to Regeneron’s Wednesday release, Lynozyfic is the first and so far only bispecific with this mode of action that can be dosed every two weeks, with the possibility of extending to every four weeks if a patient achieves very good partial response or better.
“Lynozyfic has a convenient response-adapted dosing regimen,” Sundar Jagannath, network director of the Center of Excellence for Multiple Myeloma at Mount Sinai, said in a statement alongside Regeneron’s release. “This is a significant patient-centric advancement that could help reduce treatment burden.” Jagannath served as an investigator on LINKER-MM1.
Lynozyfic’s approval on Wednesday is a “step in the right direction” for Regeneron, according to the BMO analysts, who noted that 2025 has so far been a “difficult year” for the pharma. In late May, the company’s shares took a beating after its Dupixent successor itepekimab delivered underwhelming results in the late-stage AERIFY program in chronic obstructive pulmonary disease (COPD).
The investigational antibody cleared AERIFY-1, demonstrating a significant 27% reduction in moderate to severe exacerbations in former smokers with inadequately controlled COPD. In AERIFY-2, however, itepekimab failed to hit this same threshold, showing only a 2% reduction in exacerbations at 52 weeks.
“Sentiment has undoubtedly been poor for REGN shares of late following the recent itepekimab miss in COPD,” BMO analysts wrote, noting that while Lynozyfic’s approval is an incremental positive for the pharma, “steps are still needed” to restore investor confidence in the company.
“But we are encouraged to see a quick win here heading into earnings,” the analysts said.
