Curis Shares Hit 52-Week Low After FDA Places Hold on Emavusertib Study

By Chris Wack

Curis Inc. shares fell 38% to $1.52 after the company said the U.S. Food and Drug Administration placed a partial clinical hold on a leukemia-drug study.

The stock hit its 52-week low of $1.47 earlier in the session.

The Phase 1/2a study is for orally administered emavusertib as monotherapy and in combination with azacitidine or venetoclax in patients with relapsed or refractory acute myeloid leukemia or high-risk myelodysplastic syndrome.

Curis said that while the partial hold is in place, no new patients would be enrolled in the study, and current study participants benefiting from treatment may continue to be treated with emavusertib at doses of 300mg BID or lower.

With the partial hold, the FDA is requesting additional data from the study, including data related to the death of a relapsed or refractory acute myeloid leukemia patient who experienced, among several conditions, rhabdomyolysis, which has previously been identified as a dose-limiting toxicity of emavusertib.

The FDA is also requesting safety, efficacy, and other data, including data related to rhabdomyolysis and the company's determination of the recommended Phase 2 dose for emavusertib in this study.

Curis expects to provide updated guidance on the timing of discussing the potential for a rapid registrational path for emavusertib with the FDA after the partial clinical hold is resolved and the related impact on the trial can be determined.

While the partial hold doesn't affect the Phase 1/2 open-label dose escalating clinical trial investigating emavusertib in patients with B-cell malignancies, the company is pausing enrollment of new patients in the study.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

April 04, 2022 11:06 ET (15:06 GMT)

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