Shares of Amgen, Inc. (NASDAQ:AMGN) ended Friday session in red amid volatile trading. The shares closed down -0.36 points or -0.21% at $169.77 with 2.08 million shares getting traded. Post opening the session at $170.55, the shares hit an intraday low of $168.91 and an intraday high of $171.05 and the price vacillated in this range throughout the day. The company has a market cap of $127.10 billion and the numbers of outstanding shares have been calculated to be 748.36 million shares.
Amgen, Inc. (AMGN) on Sept. 1, 2016 announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for BLINCYTO® (blinatumomab) to include new data supporting the treatment of pediatric patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This indication is approved under accelerated approval, and continued approval may be contingent upon verification of clinical benefit in subsequent trials.
The approval is based on results from the Phase 1/2 ‘205, an open-label, multicenter, single-arm trial, which evaluated the efficacy and safety of BLINCYTO in pediatric patients with relapsed or refractory B-cell precursor ALL.
About Study ‘205
Study ‘205 evaluated the safety and efficacy of BLINCYTO in a Phase 1/2 open-label, multicenter, single-arm study in 93 pediatric patients with relapsed or refractory B-cell precursor ALL (second or later bone marrow relapse, any marrow relapse after allogeneic hematopoietic stem cell transplantation [alloHSCT], or refractory to other treatments and had >25 percent blasts in bone marrow). Treatment in this study has been completed and subjects are being monitored for long-term efficacy.
About BLINCYTO® (blinatumomab)
BLINCYTO is a bispecific CD19-directed CD3 T cell engager (BiTE®) antibody construct that binds specifically to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T cells.
BLINCYTO was granted breakthrough therapy, priority review and orphan drug designations by FDA, and is now approved in the U.S. for the treatment of Ph- relapsed or refractory B-cell precursor ALL.
Shares of Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) ended Friday session in red amid volatile trading. The shares closed down -1.96 points or -1.56% at $123.67 with 1.08 million shares getting traded. Post opening the session at $126.29, the shares hit an intraday low of $123.56 and an intraday high of $126.29 and the price vacillated in this range throughout the day. The company has a market cap of $27.68 billion and the numbers of outstanding shares have been calculated to be 224.25 million shares.
Alexion Pharmaceuticals, Inc. (ALXN) on August 30, 2016 announced that the European Commission has granted orphan drug designation (ODD) to ALXN1007, a novel anti-inflammatory monoclonal antibody targeting complement protein C5a, for the treatment of graft-versus-host disease (GVHD). Alexion is currently investigating ALXN1007 in patients with acute GVHD of the lower gastrointestinal tract (GI-GVHD), a severe and life-threatening rare autoimmune disease that can occur as a complication of stem cell or bone marrow transplantation.
“Acute GI-GVHD is a devastating disease in which about one-third of severely affected patients die within the first six months following transplant despite best available care,” said Martin Mackay, Ph.D., Executive Vice President and Global Head of R&D at Alexion. “We are pleased that ALXN1007 has received orphan drug designation in the EU, recognizing the urgent need for an effective treatment for GVHD and the potential of ALXN1007 to improve response rates in patients facing this severe and life-threatening disorder.”