Business
Halozyme Reports Second Quarter 2019 Results
SAN DIEGO, Aug. 6, 2019 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery
About this update from Halozyme Therapeutics, Inc.
[{"type":"text","content":"SAN DIEGO, Aug. 6, 2019 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today reported financial results for the second quarter ended June 30, 2019 and provided an update on recent corporate activities.\n\"We are very pleased with the strong progress in both pillars of our business in 2019,\" said Dr. Helen Torley, president and chief executive officer. \"ENHANZE® progress included Janssen recently submitting regulatory applications to the U.S. Food and Drug Administration and the European Medicines Agency, and our most recently announced partner, argenx, initiating its first phase 1 study utilizing the ENHANZE® drug delivery technology. In addition, we remain focused on PEGPH20, where our HALO-301 pivotal phase 3 trial in metastatic front-line pancreas cancer is on track for the announcement of topline results by December 2019.\"\nSecond Quarter 2019 and Recent Highlights Include:\nIn July 2019, ENHANZE® collaborator Janssen Biotech, Inc. (Janssen) submitted a Biologics License Application to the U.S. Food and Drug Administration and an extension application to the European Medicines Agency for the subcutaneous delivery of DARZALEX® (daratumumab) for patients with multiple myeloma. Janssen's regulatory submissions followed the announcement and subsequent presentation of positive results from its phase 3 COLUMBA study at the American Society of Clinical Oncology Annual Meeting in June 2019. The COLUMBA study investigated subcutaneously administered DARZALEX® in comparison to intravenous DARZALEX® in patients with relapsed or refractory multiple myeloma. In July 2019, argenx dosed the first subject in a phase 1 clinical trial evaluating the safety, pharmacokinetics and pharmacodynamics of efgartigimod (ARGX-113), using Halozyme's proprietary ENHANZE® drug delivery technology, triggering a $5 million payment to Halozyme. Additionally, in May 2019, argenx nominated a second target to be studied using ENHANZE® technology, a human complement factor C2 associated with the product candidate ARGX-117, which is being developed to treat severe autoimmune diseases, triggering a $10 million payment to Halozyme. In June 2019, the target number of 330 overall survival events in the HALO-301 clinical trial was reached. The company plans to conduct the fi...