Halozyme soars after the FDA backs off of its cancer study

Halozyme CEO Helen Torley

Halozyme ($HALO) is back on track with a midstage trial of its in-development pancreatic cancer treatment after the FDA lifted its clinical hold on enrollment, news that sent the company's shares up as much as 20%.

In early April, the company halted enrollment in a Phase II study of PEGPH20 after its data monitoring committee (DMC) flagged a spike in blood clots and vessel blockages in the treatment arm. A week later, the FDA stepped in and made it official by clamping a clinical hold on the program.

By May, however, that same committee recommended enrollment and dosing resume under an amended protocol, the biotech said, and the agency has given it the green light to get back at it.

The study is evaluating PEGPH20 as a first-line therapy for patients with metastatic pancreatic cancer, testing the drug in combination with gemcitabine and nab-paclitaxel compared to the two other treatments alone. The study's primary endpoint, progression-free survival, remains the same under the new protocol, but Halozyme has added a second main goal of freedom from clots and blockages in response to the earlier concerns, the company said.

Halozyme had already enrolled more than 100 patients in the study, and it plans to roughly double that now that it's back up and running. From now on, however, the biotech will exclude those at higher risk of clotting.

"We are committed to the development of PEGPH20 in pancreatic cancer," CEO Helen Torley said in a statement. "Halozyme worked diligently with the FDA and the DMC to develop the plan to allow the study to restart."

Taking the brakes off PEGPH20 boosted Halozyme's shares up to around $9.50 on Thursday morning, a double-digit improvement but still well off its roughly $12 value before the halt. The biotech is down about 47% on the year.

- read the statement