Tag: Regulatory

HAMPTON, N.J., June 14, 2026 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) today presented positive results from the Phase 1 healthy participant study of CDX-622, a novel, bispecific antibody that targets soluble SCF and TSLP, at the European Academy of Allergy and Clinical Immunology (EAACI) Annual Meeting in Istanbul, Türkiye. Data demonstrated that CDX-622 induced rapid, durable, dose-dependent reductions in serum tryptase, indicative of mast cell depletion, and was well-tolerated at all dose levels. Building on Celldex’s leadership in mast cell science, the data also demonstrated that neutralizing soluble stem cell factor (SCF) enables the potential for meaningful mast cell inhibition and depletion without impacting other KIT-dependent functions. CDX-622 is currently being studied in a Phase 1b proof of mechanism study in mild to moderate asthma to assess the impact of dual neutralization of SCF and TSLP.

Vancouver, Canada, June 14, 2026 (GLOBE NEWSWIRE) --

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BRIDGEWATER, N.J., June 14, 2026 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today announced first clinical proof-of-concept data for LB2501, its investigational in vivo CD19/CD20 dual-targeting CAR-T cell therapy, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (R/R B-NHL). The results are being presented today in a late-breaking session at the European Hematology Association (EHA) 2026 Congress (Abstract #LB5006).

A former Pentagon advisor on what Washington is doing about it and where he's looking on U.S. soil.

Media Release

COPENHAGEN, Denmark; June 13, 2026

 -- Patients with PWS treated with setmelanotide therapy (N=17) achieved clinically meaningful BMI or BMI z-score reductions, reductions in fat mass with preservation of lean mass, and improvements in hyperphagia and anxiety measures --   

-- Positive results reinforce rationale for Phase 3 development of MC4R agonism in PWS --

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