SEATTLE, WA – Aptevo Therapeutics Inc. (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR™ and ADAPTIR-FLEX™ platform technologies, presented preliminary results from its ongoing Phase 1b/2 RAINIER study evaluating mipletamig, a CD123 x CD3 bispecific molecule, in combination with azacitidine and venetoclax...
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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...
AUSTIN, Texas — IntraBio Inc., a biopharmaceutical company focused on developing therapies for rare neurological diseases, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of AQNEURSA® (levacetylleucine) for the treatment of Niemann-Pick disease type C (NPC)....
SEATTLE, Wash. — Arbele, a biotechnology company focused on developing innovative targeted cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ARB1002, its investigational antibody-drug conjugate (ADC) for the treatment of pancreatic cancer. ARB1002 is composed of an anti-CDH17 monoclonal antibody chemically...
CAMBRIDGE, Mass. — Arbor Biotechnologies, Inc., a biotechnology company discovering and developing the next generation of genetic medicines, today announced the first patient was dosed at Mayo Clinic in the redePHine study evaluating ABO-101, an investigational CRISPR gene editing therapy, in people living with primary hyperoxaluria type 1 (PH1). There...
Results from all 117 patients dosed in the pivotal Phase 2 iMMagine-1 study of anito-cel demonstrated 97% ORR and 68% CR/sCR at a median follow-up of 12.6 months No delayed neurotoxicities including no Parkinsonism, no cranial nerve palsies, and no Guillain-Barré syndrome, and no immune-mediated enterocolitis have been observed to...
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 new positive data from its pivotal Phase 2 iMMagine-1 study of anitocabtagene autoleucel (anito-cel), in patients with relapsed or refractory...
REDWOOD CITY, Calif. — Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company focused on delivering a new class of innovative immunotherapies for patients with cancer and other incurable diseases, announced today that a late-breaking abstract for its novel D-Domain binder in anitocabtagene autoleucel (anito-cel) has been accepted for presentation at the...
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, the 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 advance the clinical development of ARGX-119, a first-in-class agonist antibody to muscle-specific kinase (MuSK), to a registrational study in...