Galena Biopharma, Inc. (NASDAQ: GALE) saw its shares jump on Wednesday after a key U.S. Food and Drug Administration (FDA) approval. The company announced that it has confirmed the regulatory pathway to advance GALE-401 (Anagrelide Controlled Release) into a pivotal, Phase 3 trial.
After a productive meeting with the FDA, Galena has confirmed the development program and proposed clinical trial are appropriate for a New Drug Application (NDA) filing.
The Phase 3 clinical 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 (BAT) that will include a sizable subpopulation of patients treated with anagrelide immediate release.
Galena expects to finalize the Phase 3 clinical trial protocol and initiate the trial in the second quarter of 2017.
Mark W. Schwartz, Ph.D., President and CEO of Galena, commented:
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. 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.
Excluding Wednesday’s move, Galena has outperformed the broad markets with the stock up about 33% year to date.
Shares of Galena were last trading up about 25% at $2.44, with a consensus analyst price target of $7.67 and a 52-week trading range of $0.16 to $4.75.