Halozyme said the FDA lifted the clinical hold on patient enrollment and dosing of PEGPH20 in its ongoing Phase 2 trial evaluating the treatment in patients with stage IV metastatic pancreatic cancer. The FDA has allowed the study to resume under an amended protocol, and Halozyme expects patient enrollment to restart after Independent Review Boards review and approve the change protocol.
"We are committed to the development of PEGPH20 in pancreatic cancer. Halozyme worked diligently with the FDA and the DMC to develop the plan to allow the study to restart," said President and CEO Dr. Helen Torley in a company statement. "We are pleased to be able to continue enrolling patients in this clinical program as there remains a significant need for new treatment options for pancreatic cancer patients."
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