Tag: Regulatory

Data from up to two years of treatment in PATHFNDR-1 and PATHFNDR-2 open-label extension studies show PALSONIFY maintained lower IGF-1 levels and stable symptoms

HAMPTON, N.J., June 14, 2026 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) announced today the presentation of long-term results from the Phase 2 study of barzolvolimab in a flash talk session at the European Academy of Allergy and Clinical Immunology (EAACI) Annual Meeting in Istanbul, Türkiye. The data presented demonstrated that barzolvolimab treatment results in rapid, significant, and durable improvements in angioedema in patients with chronic spontaneous urticaria (CSU) refractory to antihistamines. These results were sustained off-treatment, seven months after completion of barzolvolimab dosing (Week 76). The data continue to demonstrate barzolvolimab’s potential to shift the goal of CSU treatment from symptom control to disease modification and further support the ongoing Phase 3 trials of barzolvolimab in CSU.

– Lorundrostat was associated with significant reductions in heart failure risk biomarkers in a proteomic analysis of data from participants with uncontrolled hypertension –

– Verekitug, administered once every three months, led to clinically meaningful improvements in nasal polyp score (NPS) in approximately 80% of participants –

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.