DURHAM, N.C. — Atsena Therapeutics, a clinical-stage gene therapy company focused on bringing the life-changing power of genetic medicine to reverse or prevent blindness, today announced the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation to ATSN-101, the company’s investigational gene therapy being evaluated in...
treatment News
SAN DIEGO – aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, today announced that the last patient has completed their last visit in the company’s Phase 1b/2a clinical trial of its lead therapeutic candidate, ATYR1923, in...
SAN DIEGO – aTyr Pharma, Inc. (Nasdaq: LIFE), a clinical stage biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, today announced positive results from its Phase 1b/2a double-blind, placebo-controlled clinical trial of its lead therapeutic candidate, ATYR1923, in 37 patients with pulmonary sarcoidosis,...
SAN DIEGO, Calif. — aTyr Pharma, Inc. (Nasdaq: ATYR) (“aTyr” or the “Company”), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s meeting request to...
SAN DIEGO, Calif. — aTyr Pharma, Inc. (Nasdaq: ATYR) (“aTyr” or the “Company”), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced topline results from the Phase 3 EFZO-FIT™ study of efzofitimod in 268 patients with pulmonary...
Audentes Therapeutics (Nasdaq: BOLD), a biotechnology company focused on developing and commercializing gene therapy products for patients living with serious, life-threatening rare diseases, today announced positive interim data from the first dose cohort of ASPIRO, a Phase 1/2 clinical trial of AT132 in patients with X-Linked Myotubular Myopathy (XLMTM). ASPIRO is a...
CAMBRIDGE, Mass. & SHANGHAI – Detailed results from the Phase III AENEAS trial showed that treatment with aumolertinib resulted in a clinically significant improvement in progression-free survival (PFS) as compared to gefitinib in first-line treatment of patients with Stage IIIB or IV non-small cell lung cancer (NSCLC) with the most...
VICTORIA, British Columbia & ROCKVILLE, Md. – Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (the Company) announced today that the Company’s licensing partner, Otsuka Pharmaceutical Europe Ltd. (OPEL), filed an initial Marketing Authorization Application (MAA) for voclosporin for the treatment of lupus nephritis (LN) to the European Medicines Agency (EMA)....
ROCKVILLE, Md. & EDMONTON, Alberta — Aurinia Pharmaceuticals Inc. announced today the submission of its Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) for AUR200, a potential next generation therapy for B-cell mediated autoimmune diseases. Upon receiving FDA clearance to proceed with proposed research, Aurinia...
Fairfield, N.J. — A two-day virtual event on March 15th and 16th will bring together more than 350 patients, caregivers, hepatologists, primary care providers, patient advocacy organizations and industry representatives all with one goal in mind—find solutions to improve health outcomes for all those suffering from rare autoimmune liver diseases....