Curis: FDA Removes Partial Clinical Hold On TakeAim Leukemia Study

(RTTNews) - Curis, Inc., (CRIS) announced the FDA has removed the partial clinical hold on the TakeAim Leukemia Phase 1/2 study of emavusertib. On April 4, 2022, the FDA placed a partial clinical hold on the study. Also, the recommended phase 2 dose for emavusertib as a monotherapy has been established at 300 mg BID in patients with Acute Myelogenous Leukemia or Myelodysplastic Syndromes.

James Dentzer, CEO of Curis, said: "In 2024, we expect to have updated data from the TakeAim Leukemia monotherapy study, clarification of a monotherapy registrational study design, and initial data from an azacitidine and venetoclax combination study."

Separately, Curis announced it has entered into definitive agreements led by existing investors for the purchase of 18.4 million of its shares of common stock at a purchase price of $0.82 per share in a registered direct offering priced at-the-market under Nasdaq rules. The closing is expected to occur on or about July 10, 2023.

Curis expects gross proceeds to the company from the offering to be approximately $15.1 million, before deducting fees and other offering expenses. Curis plans to use the net proceeds from the offering on research, development, working capital, and other general corporate purposes.

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