Galena Biopharma (GALE): FDA Pathway Lowers the Last Hurdle for GALE-401 - FBR

FBR Capital analyst,Vernon Bernadino, reiterated his Outperform rating on shares of Galena Biopharma (NASDAQ: GALE) after the company announced that its late-stage program with GALE-401 (anagrelide controlled release) as a treatment for essential thrombocythemia (ET) conforms with the FDA's view, providing a pathway to approval.

The analyst believes that the for a single, pivotal Phase III trial should sufficiently support GALE-401's New Drug Application (NDA) filing under the 505(b)(2) regulatory pathway. He also expects that this Phase III trial will enroll ET patients who have either failed, or are intolerant of, hydroxyurea, the current standard of care (SOC) for ET.

The analyst expects the company to evaluate GALE-401 against the best available therapy (BAT), including patients who were treated with anagrelide immediate release.

No change to the $11 PT.

For an analyst ratings summary and ratings history on Galena Biopharma click here. For more ratings news on Galena Biopharma click here.

Shares of Galena Biopharma closed at $0.21 yesterday.

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