Mechelen, Belgium – Galapagos NV (Euronext & NASDAQ: GLPG) announced new and updated Phase 2 data from the ongoing ATALANTA-1 study with its CD19 CAR T-cell therapy candidate, GLPG5101, during an oral presentation (#662) at the 67th American Society of Hematology (ASH) Annual Meeting. “The new and updated results from the...
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ZUG, Switzerland — Galderma today announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Applications for nemolizumab for the treatment of prurigo nodularis and for adolescents and adults with moderate to severe atopic dermatitis. Nemolizumab is a first-in-class investigational monoclonal antibody specifically designed to inhibit...
BOSTON, Mass. — Galibra Neuroscience announced a significant regulatory milestone with the receipt of both Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) from the U.S. Food and Drug Administration (FDA) for the company’s investigational gene therapy for succinic semialdehyde dehydrogenase (SSADH) deficiency. SSADH deficiency is a rare inherited disorder...
KENSINGTON, Md. — Galimedix Therapeutics, Inc. (“Galimedix”), a Phase 2 clinical-stage biotechnology company developing novel oral and topical neuroprotective therapies with the potential to revolutionize the treatment of serious eye and brain diseases, announces encouraging data with orally available small molecule GAL-201, showing its neuroprotective and symptomatic alleviation potential in...
– AM-001 Study represents a pivotal milestone in Galmed’s transition to Aramchol Meglumine, an improved formulation of its lead compound in advanced clinical development – Aramchol Meglumine, a New Chemical Entity (NCE) protected by patents until 2035, is being developed both as a standalone agent and in novel drug combinations...
RAMAT-GAN, Israel — Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) (“Galmed” or the “Company”), a clinical-stage biopharmaceutical company for liver disease and GI oncological therapeutics, announced today a research collaboration agreement with Ramot at Tel Aviv University – Tel Aviv University’s technology transfer company – to evaluate Galmed’s brain-penetrating SCD1 inhibitor, Aramchol, as...
Aramchol, an SCD1 inhibitor, significantly attenuates and prevents biliary fibrosis in mouse models of primary sclerosing cholangitis (PSC) Aramchol treatment leads to significant inhibition (2-fold, p<0.05) of TGFβ-induced hepatic fibrosis pathways while upregulating peroxisome proliferator activated receptor (PPAR) signaling Aramchol’s effect in the prevention and treatment of biliary and hepatic...
LONDON, UK — Ayrmid Ltd. (“Ayrmid” or the “Company”), the parent company of Gamida Cell Inc., a cell therapy pioneer working to turn cells into powerful therapeutics, announced positive interim study results for omidubicel, a stem cell transplant therapy, in treating Severe Aplastic Anemia (SAA). The findings were shared by...
LONDON – GammaDelta Therapeutics Ltd. (GDT), a biotechnology company pioneering the discovery and development of allogeneic gamma delta T cell therapies for cancer, today announced that it has initiated a first-in-human Phase I clinical trial evaluating GDX012 for the treatment of acute myeloid leukaemia (AML). GDX012 is an allogeneic, non-engineered,...
TEMPE, Ariz. — GT Medical Technologies, Inc. (GT MedTech), a medical device company with the mission of improving the lives of patients with brain tumors, today announced it has enrolled the 100th patient in its ROADS clinical study. ROADS, or Radiation One and Done Study, is the randomized control trial...