CAMBRIDGE, Mass. – Epizyme, Inc. (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to EZM0414, the Company’s novel, first-in-class, oral SETD2 inhibitor, as an investigational agent for the treatment...
treatment News
COPENHAGEN, Denmark – Genmab A/S (Nasdaq: GMAB) announced today that EPKINLY® (epcoritamab-bysp) in combination with rituximab and lenalidomide (EPKINLY + R2) was approved by the U.S. Food and Drug Administration (FDA) for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The approval is based on results from the pivotal Phase...
LONDON, England & BASEL, Switzerland — Epsilogen, a global leader in the development of immunoglobulin E (IgE) antibodies to treat cancer, and Lonza, a global development and manufacturing partner to the pharma, biotech and nutrition industries, today announced successful completion of Good Manufacturing Practice (“GMP”) manufacturing of MOv18 IgE, Epsilogen’s...
LA JOLLA, Calif. — Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced positive topline data from the Type B portion of the Phase 1b EQUALISE study evaluating itolizumab in lupus nephritis patients. The data suggests high complete...
CAMBRIDGE, Mass. – Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, today announced new preclinical data demonstrating that its lead cell therapy candidate, ERNA-101, in combination with PD-1 blockade, drives complete tumor clearance and 100% long-term survival in syngeneic ovarian...
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi announced positive Phase 3 results for a Libtayo® (cemiplimab) combination treatment were presented today during a late-breaking session at the European Society for Medical Oncology Virtual Congress 2021. The trial, which met its primary overall survival (OS) endpoint and all key secondary endpoints, assessed the investigational use of...
SOUTH SAN FRANCISCO, Calif. and VANCOUVER, Canada – ESSA Pharma Inc. (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, today announced the presentation of updated dose escalation data from its Phase 1/2 study evaluating masofaniten (formerly EPI-7386) in combination with enzalutamide. ...
EMERYVILLE, Calif. — Estrella Immunopharma, Inc. (NASDAQ: ESLA), a clinical stage biopharmaceutical company developing CD19 and CD22-targeted ARTEMIS® T-cell therapies to treat cancer and autoimmune diseases, today announced that the first patient has been dosed in the second cohort of its dose escalation study of Phase I/II STARLIGHT-1 trial for EB103,...
BRIGHTON, UK – ETD001, an investigational inhaled therapy for cystic fibrosis (CF), has demonstrated encouraging results in a small clinical trial, improving lung function more effectively than a placebo in patients who were not taking CFTR modulators. The findings were announced by Enterprise Therapeutics, the company developing the treatment. The...
DEER PARK, Ill. — Eton Pharmaceuticals (Nasdaq: ETON), an innovative pharmaceutical company focused on developing, acquiring, and commercializing products to address unmet needs in patients suffering from rare diseases, today announced the commercial availability of Nitisinone Capsules for the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary...