Analyst Holds Steady On Curis As FDA Removes Partial Clinical Hold On Leukemia Study

Thursday, the FDA removed the partial clinical hold on Curis Inc's 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. 

In August 2022, Curis resumed enrollment of additional patients in the monotherapy phase of the TakeAim Leukemia study, but a partial hold remained for the combination therapy phase (Phase 1b) and the study's expansion phase (Phase 2a) until Phase 1a is complete and the FDA approves proceeding to the next phases.

HC Wainwright reiterates its Buy rating but lowers the price target to $6 from $9 due to slightly pushing back the launch expectations for AML/MDS and the dilution associated with the recent capital raise. 

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.