BioLineRx Ltd (BLRX)

[midastouch017]

First, then, Bioline.

https://tinyurl.com/h9e99ps

This company is a development stage biotechnology entity working to bring a drug called BL-8040 to market across a host of different indications. Oncology (as an immunotherapy agent), AML and stem cell mobilization/transplantation all fall within the scope of the asset’s target therapy types, and the next 12 months promises to deliver catalysts associated with all three types. The one we’re focusing on right now, however, is the latter – SCM/T. Bioline is carrying out a phase II study in allogenic transplantation right now, one that started early last year, and the company is set to read out partial results at some point during Q1. That gives Bioline RX Ltd (NASDAQ:BLRX) just a couple of weeks to get the data out.

Why is this a potential market moving release?

Because the asset basically accounts for the company’s entire valuation, and while it’s not the lead indication (the oncology indications take centre stage at the moment), any indication of efficacy from this phase II will be supportive of efficacy translation into the other trials.

So what are we looking for?

Well, the company hasn’t been overly clear on exactly what the partial data means, and it comes a full six months before the earliest threshold for top line from the study, but we can look for any suggestion that the drug works as indicative of success come top line release. Specifically, we’re looking for any numbers that fall in line with the primary endpoint of the study, which in this instance, is number of donors that mobilize ≥ 2 x 10^6 CD34+ cells/kg of recipients’ weight after a single injection of BL-8040 after no more than two leukapheresis collections.

The current standard of care in this indication is not great – it’s a heavy injection schedule and around 50%-70% of patients are considered poor mobilizers. If Bioline can get its drug through this phase II, then there’s a clear path to standard of care replacement.

So that’s Bioline RX Ltd (NASDAQ:BLRX), what about AMAG Pharm

https://tinyurl.com/h9e99ps