Regeneron Pharmaceuticals has announced that the European Commission has conditionally approved Lynozyfic (linvoseltamab) for adults with relapsed and refractory multiple myeloma.

This approval targets patients who have undergone at least three prior treatments and whose disease has progressed.

Lynozyfic is a bispecific antibody that activates T cells to eliminate cancerous plasma cells. It is the first BCMAxCD3 therapy to offer a response-adapted schedule, with dosing every four weeks after achieving a very good partial response or better following 24 weeks of therapy.

The approval is based on data from the LINKER-MM1 trial. Results showed a 71% objective response rate, with 50% achieving complete or stringent complete responses. The median duration of response was 29 months. Key findings included a minimal residual disease negativity rate of 41% in patients with complete responses.

Common adverse reactions included musculoskeletal pain, cytokine release syndrome and neutropenia. Most cytokine release syndrome cases were mild or moderate, with no Grade 4 cases reported.

Dr Paula Rodriguez-Otero from Clínica Universidad de Navarra said: “In a clinical trial, linvoseltamab demonstrated compelling and impressive efficacy with the potential for complete remission in this patient population, including those with high disease burden.”

This marks Regeneron’s second bispecific antibody approval. George Yancopoulos, President of Regeneron, noted: “We are excited by the potential of Lynozyfic and its differentiated clinical profile.”

Rein Therapeutics has begun screening and recruiting patients for its renew phase 2 trial, assessing LTI-03 as a potential treatment for idiopathic pulmonary fibrosis (IPF). The study will enrol up to 120 patients across 50 global sites, with topline results expected in the first half of 2026.

LTI-03 is a novel, multi-pathway, Caveolin-1-related peptide designed to improve alveolar epithelial cell survival and inhibit profibrotic signalling. The phase 2 study follows positive findings from a phase 1b trial, where LTI-03 demonstrated dose-dependent effects in five biomarkers, with four achieving statistical significance.

Brian Windsor, president and CEO of Rein Therapeutics, said: “The initiation of the renew trial in patients with IPF marks a significant step forward for Rein as we prepare to ultimately identify and share the potential benefits of LTI-03 on patient lung function.”

The double-blind, placebo-controlled trial will evaluate the safety, tolerability and efficacy of LTI-03 in patients diagnosed with IPF within five years of screening. Participants may continue standard antifibrotic therapy alongside treatment.

Patients will be randomised into two cohorts, receiving either 5 mg/day or 10 mg/day of LTI-03 via inhaled dry powder. The primary endpoint measures treatment-emergent adverse events over 24 weeks, while secondary endpoints assess lung function, biomarker activity and healthy tissue regeneration.

The trial is conducted in collaboration with Qureight and includes sites in the US, UK, Germany, Austria and Poland.