It’s been a busy quarter in the biotechnology space, but it’s not over yet. This month promises to bring with it a flurry of end of quarter catalysts, each of which has the potential to inject some serious momentum into the stocks in question. Here’s a look at two such companies, with a look at what’s driving the action and what we expect.
First, then, Bioline.
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 Pharmaceuticals, Inc. (NASDAQ:AMAG)?
This company is developing a drug called Feraheme in an indication of adults with iron deficiency anemia (IDA). For those not familiar with this condition, as its name suggests, its associated with a lack of sufficient iron in the body. In the body, iron becomes a part of the hemoglobin and myoglobin. Hemoglobin carries oxygen through the blood to tissues and organs. Myoglobin helps your muscle cells store oxygen. In patients with iron deficiency, these processes lack functionality. Feraheme is a type of iron and AMAG has developed an injectable tool that is designed to introduce it into the blood, where it can get to work in place of the standard iron that would otherwise be there.
So, the drug is in a phase III trial right now, and the trial is expected to complete this quarter. Top line should follow shortly after, meaning – just as with Bioline RX Ltd (NASDAQ:BLRX) – there’s only a few weeks left at the outside for the numbers to hit press.
If we see en efficacy readout, and assuming the device comes out as safe (and the iron tolerable) then this one will be submitted (as part of a supplemental new drug application – SNDA) at some point during the second half of the year. sNDA’s often have quicker resolutions than the traditional NDA registration applications, so we’re looking at early 2018 as a potential commercialization target.
This one is also trying to replace an already established standard of care treatment – in this instance, a drug called Injectafer. It’s marketed by a company called Vifor Pharmaceuticals, and generates around $350 million annually, which gives readers some idea of the potential for AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) if and when it can bring this asset to market.
Note: This article is written by Mark Collins and was originally published at Market Exclusive.