Monday, November 26, 2018

Halozyme Changes Primary Endpoint For HALO-301 To Overall Survival


Halozyme Therapeutics, Inc., (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today announced that prior to data analysis, the FDA has agreed to Halozyme’s request to change the primary endpoint of the HALO-301 study to the single primary endpoint of overall survival (OS). As a result, the previously planned interim analysis will not be conducted. The company will host a webcast and conference call today at 5 p.m.Eastern / 2 p.m. Pacific to discuss this change in further detail.
HALO-301 is a phase 3 global, randomized, double-blind placebo controlled clinical trial evaluating investigational new drug PEGPH20 as a first-line therapy for potential treatment of patients with metastatic pancreas cancer.
Webcast and Conference Call
Halozyme will webcast a conference call today at 5 p.m. ET / 2 p.m. PT to discuss the HALO-301 statistical plan. Dr. Helen Torley, president and chief executive officer, will lead the call, which will be webcast live through the “Investors” section of Halozyme’s corporate website and a replay will be available following the close of the call. To access the webcast and additional documents related to the call, please visit www.halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. The call may also be accessed by dialing (877) 410-5657 (domestic callers) or (334) 323-7224 (international callers) using passcode 387156. A telephone replay will be available after the call by dialing (877) 919-4059 (domestic callers) or (334) 323-0140 (international callers) using replay ID number 49634758.

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