Maxim Group lowered its price target for Galena Biopharma (NASDAQ:GALE) to $1 from $2, citing a shift in the company’s pipeline focus. The stock closed at 46 cents on Tuesday.
At the end of June, an Independent Data Monitoring Committee stopped a Phase 3 trial of Galena’s NeuVax in early-stage breast cancer for futility.
Analyst Jason McCarthy writes that with the PRESENT trial over for now, focus has shifted towards driving GALE-401, a controlled release form of anagrelide, to a pivotal study for the treatment of essential thrombocythemia.
Galena is targeting a 505(b)(2) pathway and would likely only need to demonstrate non-inferiority to standard anagrelide in a relatively small study, with 100-to-120 patients, he added. A meeting is planned with the FDA; if approved, the study could start in the first half of 2017, with data in 2019.
Mr. McCarthy said the NeuVax window remains open. Both Phase 2 and Phase 2b combination studies of NeuVax plus Herceptin will continue following review of the PRESENT data by investigators.
In addition, it’s important to note that the immunotherapy space as a whole is moving towards “combination” approaches, he pointed out. In a small combination study with NeuVax and Herceptin, patients did better.
