Nijmegen, Netherlands – The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Pleco Therapeutics BV’s lead compound, PTX-252 for the treatment of Acute Myeloid Leukemia (AML). PTX-252 is a novel molecular entity developed to increase the sensitivity of cancer cells to chemotherapy. The FDA’s designation acknowledges...
treatment News
SOUTH SAN FRANCISCO, Calif. — Pliant Therapeutics, Inc. (Nasdaq: PLRX) announced 12-week interim data from the 320 mg dose group of INTEGRIS-PSC, a multinational, randomized, double-blind, placebo-controlled Phase 2a clinical trial of bexotegrast in patients with primary sclerosing cholangitis (PSC) and suspected moderate to severe liver fibrosis. The 320 mg...
Phase 1/2a clinical trial currently supported by a $3.0 million grant from the U.S. Department of Defense Trial will enroll children with high grade glioma and ependymoma HOUSTON, Texas — Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system...
HOUSTON, TX — Plus Therapeutics, Inc. (Nasdaq: PSTV), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Rhenium (186Re) Obisbemeda for the treatment of leptomeningeal metastases (LM) in...
HOUSTON, Texas — Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to REYOBIQ™ (rhenium Re186 obisbemeda) for the treatment of pediatric...
PARAMUS, NJ — Polaryx Therapeutics, Inc. (Nasdaq: PLYX), a clinical-stage biotechnology company developing disease-modifying therapies for rare pediatric lysosomal storage disorders (“LSDs”), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to PLX-200 for the treatment of Late-Infantile Neuronal Ceroid Lipofuscinosis (LINCL/CLN2 disease). The...
PARAMUS, N.J. — Polaryx Therapeutics, Inc. (Nasdaq: PLYX), a clinical-stage biotechnology company developing disease-modifying therapies for rare pediatric LSDs, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to PLX-200 for the treatment of Juvenile Neuronal Ceroid Lipofuscinosis (JNCL/CLN3 disease), Krabbe disease (globoid...
AMSTERDAM, the Netherlands – Polpharma Biologics, a biopharmaceutical company group focused on biosimilars development and manufacturing, today confirmed that Sandoz Tyruko® (natalizumab-sztn) is now available to patients in the United States. Tyruko® is the first and only FDA-approved biosimilar of natalizumab for the treatment of relapsing forms of multiple sclerosis (MS), and...
Gdańsk, Poland – PolTREG S.A. (Warsaw Stock Exchange: PTG) , a clinical-stage biotechnology company developing cellular therapies for a range of autoimmune diseases, today announces it has published data in International Immunopharmacology which suggest that PD-1+ T-cells are a dependable biomarker for efficacy in pediatric early-onset Type-1 diabetes (T1D) patients,...
Gdańsk, Poland – PolTREG S.A., a clinical-stage biotechnology company in Europe developing cell therapies for use in a wide range of autoimmune diseases, announced it received a Notice of Allowance from the United States Patent and Trademark Office (USPTO), covering the manufacturing of T-regulatory cells (T-reg) to treat Type-1 diabetes...