Roth Capital 'Encouraged' by Latest GALE-401 Phase 2 Data; Affirms 'Buy' Rating on Galena Biopharma (GALE)

Roth Capital reaffirms its Buy rating and $8 price target on Galena Biopharma (Nasdaq: GALE) following publication of the company's EHA poster abstract with preliminary data from its open-label, single-arm Phase II study of GALE-401 in thrombocythemia related to MPN.

Analyst Joseph Pantginis commented, We're encouraged by these positive data and believe they further de-risk '401's clinical profile. Recall that at ASH 2014 GALE presented early data from this study at which point there were nine patients who achieved confirmed and unconfirmed CRs and PRs. GALE completed enrollment in this trial six months ahead of schedule indicating physician interest in this study and a need for improved platelet count control in this patient population. These data also help demonstrate the equivalence to the immediate release form of Anagrelide. We believe this study is a stepping stone in seeking approval via the 505(b)(2) regulatory pathway. Should this Phase II study be successful, we believe it should lead to a Phase III study in ~200 patients, followed by our projected approval of the drug in 2017. The target product profile of GALE-401 is increased tolerability compared to Anagrelide IR while maintaining efficacy, which could allow patients to achieve target platelet levels potentially enabling treatment expansion to larger and younger patient groups. Driving this potential is the pharmacokinetic profile of GALE-401. The CR version reduces the Cmax by ~70% which maintaining ~100% of the AUC (area under the curve).

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