BioLineRx Makes Regulatory Submission For Trial Of BL-8040
Zacks Investment Research | May 23, 2017 05:23AM ET
BioLineRx Ltd. (NASDAQ:BLRX) announced that it has submitted a regulatory filing required to start a phase Ib study for BL-8040 in combination with Roche Group's (OTC:RHHBY) Tecentriq (atezolizumab).
We note that Tecentriq is an anti-PDL1 cancer immunotherapy for the maintenance treatment of patients with acute myeloid leukemia (AML) who have achieved complete response following induction therapy.
BL-8040 is a short peptide for the treatment of acute myeloid leukemia, solid tumors and stem cell mobilization.
Notably, BioLineRx’s shares have lost 4.3% year to date against the Zacks classified industry’s gain of 7.1%.
BioLineRx's one of the leading therapeutic candidate is BL-8040, which has successfully completed a phase IIa study for relapsed/refractory AML and is in the midst of a phase IIb study as an AML consolidation treatment and is expected to initiate a phase III study in stem cell mobilization for autologous transplantation.
We note that In Apr 2017, Jazz Pharmaceuticals plc (NASDAQ:JAZZ) announced that it has completed the rolling submission of a new drug application (NDA) to the FDA, seeking approval for its experimental candidate, vyxeos (cytarabine and daunorubicin liposome injection) for the treatment of AML. It should be noted that Vyxeos enjoys Breakthrough Therapy designation and was even granted Orphan Drug status by the FDA and the European Commission for AML.
Zacks Rank
BioLineRx currently holds a Zacks Rank #2 (Buy). Another better-ranked stock in the health care sector includes VIVUS, Inc. (NASDAQ:VVUS) , which sports a Zacks Rank #1 (Strong Buy). You can see .
VIVUS’ loss per share estimates narrowed from 50 cents to 39 cents for 2017 over the last 60 days. The company posted positive earnings surprises in all of the four trailing quarters, with an average beat of 233.69%.
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