WALTHAM, Mass. — Affinia Therapeutics (“Affinia”), an innovative gene therapy company with a pipeline of first-in-class and/or best-in-class adeno-associated virus (AAV) gene therapies initially for devastating cardiovascular diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) for AFTX-201, a potential best-in-class investigational...
treatment News
WALTHAM, Mass. — Affinia Therapeutics (“Affinia”), an innovative gene therapy company with a pipeline of first-in-class and/or best-in-class adeno-associated virus (AAV) gene therapies initially for devastating cardiovascular diseases, today announced that the European Medicines Agency (EMA) has granted Orphan Drug designation to Affinia for AFTX-201. AFTX-201 is a potential first-in-class...
WALTHAM, Mass. — Affinia Therapeutics (“Affinia”), an innovative gene therapy company with a pipeline of first-in-class and/or best-in-class adeno-associated virus (AAV) gene therapies initially for devastating cardiovascular diseases, today announced the approval of its clinical trial application (CTA) by Health Canada for AFTX-201, a potential best-in-class investigational genetic medicine for...
EAST HANOVER, N.J. — New data show that Afinitor(R) (everolimus) tablets significantly shrunk tumors in 33% of patients with relapsed non-Hodgkin’s lymphoma (NHL) and Hodgkin’s disease(1). Based on results from this study and other early-stage research, Novartis has initiated a Phase III trial in the most common NHL, diffuse large...
MILAN, Italy – With the decision by the U.S. Food and Drug Administration and the European Commission to grant market authorization for Waskyra™, a gene therapy to treat Wiskott-Aldrich syndrome, AGC Biologics’ Milan Cell and Gene Center of Excellence announced it will continue to support the commercial development of this vital,...
Study shows botensilimab “switches on” the body’s own T-cells to attack a common, treatment-resistant form of colorectal cancer LEXINGTON, Mass. — Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology, today presented new translational data at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The study demonstrates that botensilimab-based...
LEXINGTON, Mass. — Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced the publication of clinical results from the ovarian cancer cohort of its Phase 1b C-800-01 trial evaluating botensilimab plus balstilimab (BOT+BAL) in The Journal for ImmunoTherapy of Cancer (JITC). The peer-reviewed manuscript titled, “Botensilimab (Fc-enhanced anti–CTLA-4 antibody) plus balstilimab...
SANTA CLARA, Calif. — Agilent Technologies Inc. (NYSE: A) today announced it has received European Union (EU) certification for PD-L1 IHC 22C3 pharmDx, Code SK006, as a companion diagnostic indicated to aid in identifying patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, whose tumors express PD-L1 and who...
CAMBRIDGE, Mass. — Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and pyruvate kinase (PK) activation pioneering therapies for rare diseases, today announced its anticipated key 2025 milestones and value-driving catalysts through 2026. “2024 was marked by exceptional progress at Agios. We delivered on all our key priorities,...
CAMBRIDGE, Mass. — Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced topline results from the 52-week double-blind period of the global RISE UP Phase 3 trial of mitapivat, an oral pyruvate kinase (PK) activator, in patients aged...