Back to top

Image: Bigstock

BioLineRx Makes Regulatory Submission for Trial of BL-8040

Read MoreHide Full Article

BioLineRx Ltd. announced that it has submitted a regulatory filing required to start a phase Ib study for BL-8040 in combination with Roche Group's (RHHBY - Free Report) 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 Medical-Drugs 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 (JAZZ - Free Report) 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. , which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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%.

Zacks' 2017 IPO Watch List

Before looking into the stocks mentioned above, you may want to get a head start on potential tech IPOs that are popping up on Zacks' radar. Imagine being in the first wave of investors to jump on a company with almost unlimited growth potential? This Special Report gives you the current scoop on 5 that may go public at any time.

One has driven from 0 to a $68 billion valuation in 8 years. Four others are a little less obvious but already show jaw-dropping growth. Download this IPO Watch List today for free >>


See More Zacks Research for These Tickers


Normally $25 each - click below to receive one report FREE:


Roche Holding AG (RHHBY) - free report >>

Jazz Pharmaceuticals PLC (JAZZ) - free report >>

BioLineRx Ltd. (BLRX) - free report >>

Published in