In May, ROTH Capital Partners, LLC valuated biopharmaceutical company Galena Biopharma, Inc. with a "Buy" rating and a 12-month price target of $7. ROTH's valuation remains in force as Galena - which closed with a price of $2.04 on Aug. 8 - continues forward with ongoing clinical programs for NeuVax and the forthcoming launch of Abstral.
In a presentation at the American Pain Society meeting, the company highlighted its Abstral drug as a model for the REMS program for transmucosal immediate-release fentanyl products (Abstral is the only available sublingual tablet formulation of fentanyl for the breakthrough cancer pain market). ROTH continues looking forward to the launch of Abstral, which is on track to take place in the fourth quarter of 2013. Recognizing Abstral benefits from key differentiating attributes, ROTH sees two potential synergies for the product with Galena's drug development efforts: Abstral should allow for earlier detailing of physicians (especially those treating breast cancer) to build relationships for the anticipated success of the company's NeuVax vaccine; and projected revenues from Abstral could help effectively manage Galena's burn rate. While it's difficult to predict timing, ROTH believes that Galena is remaining active on the partnering front, with Leica Biosystems on board for the development of companion diagnostics and Teva Pharmaceutical Industries Ltd. on board to commercialize NeuVax in Israel.
ROTH also continues focusing on the ongoing clinical programs for NeuVax, Galena's lead development candidate, including the Phase III PRESENT study (under SPA), which is enrolling participants at more than 125 sites internationally. NeuVax is a vaccine designed to train the immune system to recognize and destroy breast cancer cells. A planned interim analysis of the PRESENT study is scheduled to occur with 70 events and is expected in either late 2013 or early 2014. ROTH believes Galena is well positioned for a successful outcome of the Phase III NeuVax PRESENT study, based on both optimized selection of the dosing regimen (including boosting) and patient population. A 300-patient randomized Phase IIb study of NeuVax in combination with Herceptin is also ongoing.
A biopharmaceutical company based in Portland, Ore., Galena Biopharma is engaged in the development of innovative, targeted oncology treatments to address major unmet medical needs in the advancement of cancer care. For more information about Galena Biopharma, visit galenabiopharma.com.
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