Halozyme Therapeutics Spikes Up Following FDA News

Shares of Halozyme Therapeutics, Inc.

opened higher Wednesday following an update on meetings with the FDA. According to the company's press release, it "plans to proceed with a Phase 3 clinical study (Study 301) of its investigational new drug PEGPH20 in patients with metastatic pancreatic cancer." The company indicated that a design would be used that allows for a potential marketing application "based on either progression free survival (PFS) or overall survival." CEO Dr. Helen Torley said, "We are encouraged by the FDA's feedback and their willingness to consider a novel primary endpoint such as PFS given the high unmet medical need in high-HA metastatic pancreatic cancer. We are committed to rapidly finalizing the Phase 3 protocol and developing the companion diagnostic regulatory filings required to initiate Study 301." Halozyme Therapeutics, Inc. recently traded at $15.15, up 3.63 percent.