On May 4, Bioline RX Ltd (NASDAQ:BLRX) announced the expansion stage of the Phase 2 clinical trial for BL-8040, a drug for acute myeloid leukemia, or AML. Top-line results will be announced in the fourth quarter of this year.
BioLineRx confirmed that escalated doses of BL-8040 were found to be “safe and well tolerated” in a study of 22 patients. Furthermore, the trial successfully proved that BL-8040 “continues to induce robust mobilization and leukemia cell death.”
CEO Dr. Kinneret Savitsky commented, “We are greatly encouraged by these interim results and are excited to commence the final stage of this important trial. We expect this stage to progress much more quickly than the dose-escalation stage of the trial… We look forward with much anticipation to announcing top-line results of the trial, which we expect in the fourth quarter of this year.”
BioLineRx has a robust pipeline of drugs in clinical trials. BL-1040, an acute myocardial infarction therapy, is currently in the CE mark registration trial. Similarly, BL-5010, a drug for benign skin lesions, is about to begin the CE mark registration clinical trial.
Following the announcement, Joseph Pantginis of Roth Capital affirmed a Buy rating on BioLineRx with a price target of $10.50. Shares last closed at $2.02. Pantginis commented, “We continue to be encouraged by 8040′s push forward as a potential new treatment for AML (continuing unmet medical need) and stem cell mobilization. This is part of our projection of a strong increase in investor visibility over the course of 2015.” The analyst is looking forward to the readout of BL-1040’s PRESERVATION I study in mid-2015, which targets acute myocardial infarction.
Joseph Pantginis has rated BioLineRx 15 times since July2014, earning a 71% success rate recommending the stock with a +15.8% average return BLRX rating.
Separately, Jason Kolbert of Maxim Group reiterated a Buy rating on BioLineRx with an $8 price target. Kolbert highlighted the “positive safety profile” of the escalated dose, which has “prompted BioLineRx to extend the dose escalation to another higher dose (>1.5 mg/kg), in parallel with the phase II expansion study. This could further expand the BL-8040 therapeutic window.” Kolbert concluded, “BiolineRx continues to deliver on moving BL-8040 forward for multiple indications. BL-8040 is the subject of multiple studies including several in AML, but also as a stand-alone stem cell mobilizer (phase I complete) and in the treatment of blood-cell depleting autoimmune disorders.”
Jason Kolbert has rated BioLineRx 9 times since April 2014, earning an 89% success rate recommending stocks with a +15.9% average return per recommendation.
On average, the top analyst consensus for BioLineRx on TipRanks is Strong Buy.