SHERIDAN, WYOMING – July 8, 2025 – Regeneron has received accelerated approval from the U.S. Food and Drug Administration (FDA) for its bispecific antibody linvoseltamab, now branded as Lynozyfic, for the treatment of patients with relapsed or refractory multiple myeloma—unlocking a market potential estimated at $600 million.
While the therapy enters a space already led by Johnson & Johnson’s Tecvayli, approved in 2022, Regeneron is seeking to distinguish Lynozyfic through its efficacy profile and flexible dosing advantages. According to analysts at BMO Capital Markets, the approval is a “small win” for Regeneron, noting that Lynozyfic will be a “minor contributor to the company’s broader product portfolio.” The firm estimates around $600 million in potential revenues from the drug.
Data-Driven Approval Backed by Strong Response Rates
The FDA’s green light was based on data from the Phase I/II LINKER-MM1 study, which showed a 70% objective response rate, including a 45% complete response rate or better. Regeneron’s strategy centers on this clinical performance as a key differentiator.
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 is a bispecific antibody that binds both the BCMA and CD3 proteins to redirect T cells toward multiple myeloma cells. This mechanism of action is shared with other therapies in the space, but Regeneron’s candidate offers a unique treatment cadence.
Flexible, Patient-Centric Dosing Regimen
According to Regeneron’s announcement, “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.” This flexibility aims to improve quality of life for patients by reducing treatment frequency without sacrificing effectiveness.
“Lynozyfic has a convenient response-adapted dosing regimen,” said Sundar Jagannath, network director of the Center of Excellence for Multiple Myeloma at Mount Sinai, in a statement alongside Regeneron’s release. “This is a significant patient-centric advancement that could help reduce treatment burden.” Jagannath was also an investigator on the LINKER-MM1 trial.
Regulatory Hurdles Overcome After Initial Rejection
Lynozyfic's path to market was initially delayed. The FDA rejected the application in August 2024 due to manufacturing concerns at a third-party fill/finish site. With those issues resolved, Regeneron is now back on track in its oncology pipeline expansion. The drug will carry a boxed warning for cytokine release syndrome and neurotoxicity, in line with other T-cell engaging bispecifics.
Strategic Timing After Setback in COPD Program
The approval arrives at a pivotal time for Regeneron following setbacks with another investigational drug, itepekimab, in COPD. In May, shares declined after the drug produced mixed results in the late-stage AERIFY program. While AERIFY-1 delivered a “significant 27% reduction in moderate to severe exacerbations in former smokers with inadequately controlled COPD,” AERIFY-2 showed “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, adding that while Lynozyfic’s approval is “an incremental positive for the pharma,” “steps are still needed” to restore investor confidence.
Still, the firm concluded on a cautiously optimistic note: “But we are encouraged to see a quick win here heading into earnings.”
Lynozyfic may only represent a modest financial win, but its approval reinforces Regeneron’s position in hematologic oncology and sets the stage for further advancements in immune-engaging therapeutics.
Learn more at www.regeneron.com