First product candidate to demonstrate significant MASH effects and weight loss at 24 weeks Trial met its primary endpoint with statistically significant MASH resolution without worsening of fibrosis in up to 59.1% of participants in an ITT analysis Fibrosis improvement without worsening of MASH in up to 34.5% of participants...
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GAITHERSBURG, Md. — Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company focused on serious liver diseases, today announced that the company has begun enrolling patients in the PERFORMA Phase 3 trial evaluating the efficacy and safety of pemvidutide in patients with metabolic dysfunction-associated steatohepatitis (MASH). Pemvidutide is an investigational...
GAITHERSBURG, Maryland — Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing pemvidutide to address serious liver diseases, today announced that analyses of data from its IMPACT Phase 2b clinical trial in metabolic dysfunction-associated steatohepatitis (MASH) will be presented at the European Association for the Study of the Liver (EASL) Congress...
SAN FRANCISCO, Calif. — Alumis Inc. (Nasdaq: ALMS), a late-stage biopharmaceutical company developing next-generation targeted therapies for patients with immune-mediated diseases, today announced that its Phase 2b LUMUS trial of envudeucitinib for the treatment of moderate-to-severe systemic lupus erythematosus (SLE) did not meet its primary and secondary endpoints in the overall...
REYKJAVIK, Iceland — Alvotech, a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced positive top-line results from a confirmatory clinical study for AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept). “The progress of our product pipeline clearly illustrates the advantage of our...
Positive high-level results from the FoCus Phase III trial in Wilson disease showed ALXN1840 met the primary endpoint with a statistically significant improvement in daily mean copper mobilisation from tissues, demonstrating superiority compared with standard-of-care (SoC) treatments. The primary endpoint gauged the daily mean Area Under the Effect Curve (AUEC)...
Atlanta, Georgia – Treatment with Alyftrek (vanzacaftor/tezacaftor/deutivacaftor) may help reverse pancreatic dysfunction in young children with cystic fibrosis (CF), challenging the long-held belief that this complication is irreversible. New findings presented by Vertex Pharmaceuticals, the therapy’s developer, at the North American Cystic Fibrosis Conference (NACFC) showed improvements in pancreatic function...
Indianapolis, Indiana – The next-generation triple-combination CFTR modulator Alyftrek has demonstrated a favorable safety profile and improved CFTR function in children with cystic fibrosis (CF) as young as 2, according to findings from a Phase 3 clinical trial. The study, known as TIMBERLINE (NCT05422222), also found that children who switched...
STOCKHOLM, Sweden – AlzeCure Pharma (STO:ALZCUR)(FRA:AC6) – AlzeCure Pharma AB (publ) (FN STO:ALZCUR), a pharmaceutical company that develops candidate drugs for diseases affecting the nervous system, focusing on Alzheimer’s disease and pain, today announced it has received a positive response from the U.S. Food and Drug Administration (FDA) regarding the...
STOCKHOLM, SWEDEN –AlzeCure Pharma (STO:ALZCUR)(FRA:AC6) AlzeCure Pharma AB (publ) (FN STO:ALZCUR), a pharmaceutical company that develops small molecule drug candidates for CNS diseases, focusing on Alzheimer’s disease and pain, today announced that another scientific article has been published on the phase I clinical results supporting the continued development of the...