Tag: development

BEERSE, BELGIUM, June 13, 2026 (GLOBE NEWSWIRE) -- Johnson & Johnson today announced results from the investigational Phase 3 MonumenTAL-3 study.¹ The results showed that TALVEY^® (talquetamab), a GPRC5D bispecific antibody, in combination with daratumumab with or without pomalidomide demonstrated significant reduction in the risk of disease progression or death of up to 72.0%, and clinically meaningful reduction of up to 53.0% in the risk of death, compared to the standard regimen of daratumumab, pomalidomide, and dexamethasone (DPd) in patients with relapsed or refractory multiple myeloma (RRMM).¹ Results showed a progression-free survival (PFS) rate of up to 81.3% versus standard of care (51.2%) and an overall survival (OS) rate of up to 89.2% versus standard of care (79.1%) at 24 months.¹  

SAN DIEGO, June 12, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio^®” or the “Company”), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced the completion of its rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tinlarebant. Tinlarebant is an investigational, once-daily oral therapy for the treatment of Stargardt disease type 1 (STGD1), a rare, inherited retinal disease caused by mutations in the ABCA4 gene that leads to progressive and irreversible vision loss. STGD1 affects an estimated 53,000 people in the U.S. alone, and there are currently no approved treatment options for the disease.