NEW YORK & LONDON & PARIS – Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) (“Aptorum Group” or “Aptorum”), a clinical stage biopharmaceutical company focused on novel technologies including the targeting of oncological diseases, announced that the group has received clearance from the US FDA regarding the IND application to initiate...
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Aqilion has strengthened its pipeline with an innovative development program in the field of chronic inflammation. With this acquisition, Aqilion is taking over all rights to the program, now under the name Regulus, from LEO Pharma. The project is ready for clinical trials and Aqilion plans to begin clinical development in...
REDWOOD CITY, Calif. — Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, today announced that new clinical data from its Phase 1 study of CART-ddBCMA in patients with relapsed or refractory multiple myeloma will...
SAN DIEGO, Calif. — Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and medicines to treat unmet medical needs within liver and respiratory rare diseases, today announced that the European Commission (EC), based on a positive...
Amsterdam, Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced its plan to continue the development of efgartigimod to Phase 3 in adults with primary Sjögren’s disease (SjD), following the analysis of topline...
Amsterdam, Netherlands – Argenx SE, a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) approved VYVDURA® (efgartigimod alfa and hyaluronidase-qvfc) injection for subcutaneous (SC) use for the treatment of adult patients with...
Amsterdam, Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) approved VYVGART (efgartigimod alfa) for intravenous (IV) use in adults with primary immune thrombocytopenia...
Amsterdam, Netherlands – Argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental Biologics License Application (sBLA) for VYVGART Hytrulo (efgartigimod...
AMSTERDAM, THE NETHERLANDS — Argenx SE, a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced topline results from the ADDRESS study evaluating efgartigimod subcutaneous (SC) (efgartigimod alfa and hyaluronidase-qvfc) in adults with pemphigus vulgaris (PV) and pemphigus foliaceus (PF). The ADDRESS...
Amsterdam, Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that data from its Phase 3 ADHERE trial evaluating VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in patients with chronic inflammatory demyelinating polyneuropathy (CIDP)...