GAINESVILLE, Fla. – Cyclo Therapeutics, Inc. (Nasdaq: CYTH) (“Cyclo Therapeutics” or the “Company”), a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families suffering from disease, today announced a positive opinion has been adopted from the Paediatric Committee (PDCO) of the European Medicines...
treatment News
NEWARK, Calif. — CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for seladelpar, an investigational treatment for the management of primary biliary cholangitis (PBC)...
NEWARK, Calif. — CymaBay Therapeutics, Inc., a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for investigational treatment, seladelpar, for the management of primary biliary cholangitis,...
VANCOUVER, Wash. — CytoDyn Inc. (OTCQB: CYDY), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that the Company has submitted its revised HIV clinical trial protocol to the FDA. The Company believes this submission will lead to the removal of the...
Majority of Initial Patients Enrolled in COURAGE-ALS Show Intended Middle to Fast Disease Progression Phenotype at Baseline SOUTH SAN FRANCISCO – Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that new data were presented at the 32nd International Symposium on ALS/MND including an analysis of baseline characteristics from the initial patients enrolled in...
SOUTH SAN FRANCISCO, Calif. — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization in the European Union (EU) for MYQORZO® (aficamten), a cardiac myosin inhibitor, for the treatment of...
SINGAPORE — CytoMed Therapeutics Limited (NASDAQ: GDTC) (“CytoMed” or “Company”), a Singapore-based clinical stage biopharmaceutical company focused on harnessing its proprietary technologies to develop novel affordable donor-derived cell-based immunotherapies for the treatment of a broad range of cancers, including both blood and solid tumours, is pleased to announce the publication of...
LOS ANGELES – CytRx Corporation (OTCQB: CYTR) (“CytRx”), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, today noted that Orphazyme A/S (NASDAQ: ORPH) (“Orphazyme”) announced that its phase 2/3 trial evaluating arimoclomol for the treatment of inclusion body myositis (“IBM”) did not...
LOS ANGELES – CytRx Corporation (OTCQB: CYTR) (“CytRx”), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, today noted that Orphazyme A/S (NASDAQ: ORPH) (“Orphazyme”) announced it has received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) following...
LOS ANGELES – CytRx Corporation (OTCQB: CYTR) (“CytRx”), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, today noted that Orphazyme A/S (NASDAQ: ORPH) (“Orphazyme”) announced that the ORARIALS-01 pivotal trial for arimoclomol in Amyotrophic Lateral Sclerosis (“ALS”) did not meet primary and...