Curis Says FDA Places Partial Hold on Lymphoma Study

By Michael Dabaie

Curis Inc. said Monday the U.S. Food and Drug Administration placed a partial clinical hold on the company's TakeAim Lymphoma study, a Phase 1/2 trial of emavusertib in patients with B-cell malignancies.

The cancer-focused biotechnology company said this FDA notification from the FDA Division of Hematologic Malignancies 2, which regulates clinical studies in lymphoma, is separate from the notification previously received from the FDA Division of Hematologic Malignancies 1, which regulates clinical studies in leukemia.

Curis in early April said the FDA placed a partial clinical hold on the TakeAim Leukemia study.

Monday's notification extends the partial hold across both studies. "This is not unexpected, as both studies treat patients with emavusertib," the company said.

Shares fell 2%, to $1.41, premarket.

The company said it had already voluntarily paused enrollment in the TakeAim Lymphoma study in connection with the partial clinical hold on the Leukemia study.

"We reiterate our previous comments: we are committed to ensuring the safety of patients in our studies and to working collaboratively with the FDA to develop therapies that meaningfully improve and extend patients' lives," said Chief Executive James Dentzer. "Given the clinical profile of emavusertib observed to date, we are hopeful that the study can be resumed soon, after appropriate review. We continue to be confident in the potential of emavusertib to address the high unmet need of patients with B-cell cancers, AML, or MDS."

Write to Michael Dabaie at [e-mail]

(END) Dow Jones Newswires

April 11, 2022 08:41 ET (12:41 GMT)

Copyright (c) 2022 Dow Jones & Company, Inc.