Galena Shares Up 50% On Regulatory Pathway For Thrombosis Treatment

Galena is currently evaluating its GALE-401 therapy for the treatment of thrombocythemia. The company confirmed the regulatory pathway to advance its therapy into a pivotal, Phase 3 trial.

End Of Phase 3 Expected Q2 2017

Galena said that after meeting with the U.S. Food and Drug Administration, it can now confirm the development program and the proposed clinical trial is appropriate for a New Drug Application filing as part of the 505(b)(2) regulatory pathway.

Galena said in a press release that its Phase 3 trial will enroll patients with essential thrombocythemia who have either failed or are intolerant to hydroxyurea, and will compare GALE-401 to the best available therapy that will include a sizable subpopulation of patients treated with anagrelide immediate release.

Galena expects to finalize the Phase 3 trial protocol and will begin the actual trial in the second quarter of 2017.

"Confirmation of the 505(b)(2) regulatory pathway and preliminary agreement with the Agency on our Phase 3 clinical trial design is a significant step forward for our late stage program," Mark W. Schwartz, Ph.D., president and chief executive officer. "Our controlled release version of anagrelide can offer a potential treatment option for patients with ET who have failed hydroxyurea. We remain on track to initiate the trial in the second quarter of 2017."

At last check in Wednesday's morning session, shares were up 53.57 percent at $3.01.