Thursday, the FDA removed the partial clinical hold on Curis Inc's (NASDAQ:CRIS) TakeAim Leukemia Phase 1/2 study of emavusertib for hematologic malignancies.

Further, the recommended phase 2 dose (RP2D) for emavusertib as a monotherapy has been established at 300 mg BID in patients with Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndromes (MDS).

More than a year ago, the FDA had placed partial clinical holds on the TakeAim Leukemia and TakeAim Lymphoma studies. 

The analyst notes that the company has a potential fast path to FDA marketing application for emavusertib monotherapy with a study of 20 patients (2L/3L) each in r/r AML patients with an FLT3 mutation and in r/r AML patients with a spliceosome mutation. 

The analyst also notes that the company could position itself in the frontline setting with a trial of 20 all-comers patients each for emavusertib combined with Vidaza and Venclexta in AML patients and for a combination yet to be determined in MDS patients. 

It forecasts a launch for emavusertib for AML/MDS in late 2027, with sales of $23.3 million that year, growing to $452 million in 2029. 

The analyst forecasts a launch for emavusertib in NHL in 2027 with sales of $30.9 million that year, growing to $303.2 million in 2029.

Price Action: CRIS shares are down 1.79% at $0.83 on the last check Friday.