Regeneron's Lynozyfic Shows 100% Complete Response And Rapid Biomarker Normalization In Phase 1/2 AL Amyloidosis Trial With Organ Function Improvement Signals; First Results From The Phase 1/2 LINKER-AL2 Trial To Be Detailed In An Asco Oral Presentation; The Phase 2 Portion Of The Trial With Registrational Intent Is Ongoing

Normalization of free light chains occurred by day 15 across all doses

100% of patients achieved a hematologic complete response (CR) at the highest tested dose

Majority of patients with renal or cardiac involvement demonstrated improvement in organ function, despite short follow-up

First results from the Phase 1/2 LINKER-AL2 trial to be detailed in an ASCO oral presentation; the Phase 2 portion of the trial with registrational intent is ongoing

TARRYTOWN, N.Y., May 21, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) today announced positive results from the Phase 1/2 LINKER-AL2 trial evaluating Lynozyfic® (linvoseltamab) in adults with second-line-plus systemic amyloid light chain (AL) amyloidosis, which will be featured in an oral presentation at the American Society of Clinical Oncology (ASCO) 2026 Annual Meeting on Friday, May 29 at 2:45 p.m. CDT. The Phase 2 portion of the trial with registrational intent is underway, part of a broad clinical development program investigating Lynozyfic. Lynozyfic is a BCMAxCD3 bispecific antibody that is already approved to treat certain adults with relapsed or refractory (R/R) multiple myeloma (MM).

Systemic AL amyloidosis is a rare and potentially fatal hematologic disorder for which there are currently no approved therapies after initial treatment fails. The disorder is characterized by plasma cells that produce abnormal light chain proteins, which clump together to form amyloid deposits in tissues and vital organs (e.g., heart, kidneys, etc.), resulting in life-threatening organ dysfunction. The current standard-of-care for initial treatment is a four-drug combination that includes daratumumab, bortezomib, cyclophosphamide and dexamethasone. In first-line treatment, this daratumumab-and-chemotherapy-containing quadruple combination showed a 53% hematologic complete response (CR), with a median time to response of 59 days per historical clinical data. In LINKER-AL2, the safety and efficacy of Lynozyfic as a monotherapy was evaluated in patients who received at least one prior therapy, and were either relapsed, refractory or had a suboptimal response ("second-line-plus").