Shares of Halozyme Therapeutics, Inc.(NASDAQ: HALO) 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 recently traded at $15.06, up 3 percent.