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...
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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...
LOS ANGELES — CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical research and development company engaged in the development of high-value human therapeutics, today announced that tamibarotene, currently under evaluation in a U.S. registration trial as a third-line treatment for acute promyelocytic leukemia (APL), showed statistically significant anti-tumor activity in human myeloma cells...
GYEONGGI-DO, South Korea & GAITHERSBURG, Md. — D&D Pharmatech, Inc. (D&D), a clinical-stage biotechnology company focused on the development of disease-modifying drugs, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of DD01 for the treatment of adults with non-alcoholic steatohepatitis...
SEOUL, South Korea — Daewoong Pharmaceutical Co., Ltd.’s Bersiporocin (DWN12088) has been recognized as a significant advancement in treating idiopathic pulmonary fibrosis (IPF), a rare and debilitating disease. This first-in-class PRS inhibitor has recently received Orphan Drug Designation (ODD) from the European Medicines Agency (EMA), adding to its earlier designation...
SEOUL, South Korea – Daewoong Pharmaceutical of South Korea has announced the promising clinical results of DWN12088, which is being developed as a first-in-class Prolyl-tRNA Synthetase(PRS) inhibitor for idiopathic pulmonary fibrosis (IPF) . Daewoong Pharmaceutical (CEO Sengho Jeon) presented the results of Phase I clinical trial of DWN12088 at Amerian Thoracic Society(ATS2021) which...
TOKYO & BASKING RIDGE, N.J. & MUNICH & LYON, France – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and LYSA-LYSARC-CALYM today announced that they have entered a strategic research collaboration to study valemetostat (DS-3201), Daiichi Sankyo’s potential first-in-class EZH1/2 dual inhibitor, in B-cell malignancies starting with a phase 2 study...
BASKING RIDGE, N.J. & RAHWAY, N.J. — Daiichi Sankyo (TSE: 4568) and Merck & Co. (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the first patient has been dosed in the REJOICE-Ovarian01 phase 2/3 trial evaluating the efficacy and safety of investigational raludotatug deruxtecan...
SANTA MONICA, Calif. & TOKYO -Kite, a Gilead Company, and Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that YESCARTA® (axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T-cell therapy, will be available to patients with relapsed or refractory large B-cell lymphomas in Japan through the first treatment center now authorized...
TOKYO, Japan & BASKING RIDGE, N.J. — Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the U.S. for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have received prior...