Why Bio-Path Shares Are Moving Higher In Premarket Tuesday?

The FDA has signed off Bio-Path Holdings Inc's BPTH Investigational New Drug (IND) application for BP1002 in refractory/relapsed acute myeloid leukemia (AML) patients.
In Phase 1/ 1b trial, six evaluable patients will be treated with BP1002 monotherapy in a standard 3+3 design, with a starting dose of 20 mg/m2.
The approved treatment cycle is two doses per week over four weeks, resulting in eight doses administered over twenty-eight days.
The Phase 1b portion of the study will commence after the completion of BP1002 monotherapy cohorts. It will assess the safety and efficacy of BP1002 in combination with decitabine in refractory/relapsed AML patients.
Related content: Benzinga's Full FDA Calendar
Price Action: BPTH shares are up 35.50% at $7.71 during the premarket session on the last check Tuesday.