What’s going on with LEGN?
Legend Biotech (LEGN) shares were slightly down after the biopharmaceutical company applied for a Marketing Authorization Application with the European Medicines Agency for its cilta-cel treatment for patients with relapsed and/or refractory multiple myeloma. Shares of LEGN were down 0.37% to $30 per share on Friday morning.
Cilta-cel, an investigative therapy for the blood cancer, that generated positive results in a Phase 1b/2 CARTITUDE-1 study. The submission to the EMA was filed by Janssen-Cilag International N.V., an affiliate of Janssen Biotech, Inc., Legend’s collaborator on cilta-cel.
What does it mean Legend Biotech?
The European Medicines Agency’s Committee for Medicinal Products for Human is fast-tracking Legend’s application, as the Cilta-cel treatment presents major public health interest and therapeutic innovation. Cilta-cel also received Priority Medicines designation from EMA, and a Biologics License Application for approval of the treatment in the U.S. is under review by the U.S. Food and Drug Administration.
“Today’s submission is a testimony to the promising results we have seen from the CARTITUDE-1 study showing the efficacy and safety of cilta-cel for treating patients with multiple myeloma who are heavily pretreated and in need of treatment options,” said Ying Huang, PhD, CEO and CFO of Legend Biotech. “We are proud of our collaboration with Janssen and look forward to bringing this personalized treatment to patients in the EU following the accelerated assessment.”
LEGN has a Fundamental Rank of 79. Find out what this means to you and get the rest of the rankings on LEGN!
Legend Biotech Corp is a clinical-stage biopharmaceutical company. It is engaged in the discovery and development of novel cell therapies for oncology and other indications. The firm's lead product candidate, LCAR-B38M/JNJ-4528, is a chimeric antigen receptor, or CAR, T cell therapy is for the treatment of multiple myeloma. Geographically, the company generates a majority of its revenue from North America.
