The fourth quarter of this year is set to be a big one in the biotech space, with a number of key development slated across October, November and December. We’ve scanned forward throughout numerous pipelines to find a few key companies to watch that could have some major upside potential if certain dates run in favor of their operations.
Here are two we are focusing on, and that are worth penning in to your catalyst diary with a view to picking up an exposure ahead of report time.
The two companies in focus are Keryx Biopharmaceuticals (NASDAQ:KERX) and ProQR Therapeutics NV (NASDAQ:PRQR).
So, we’ll kick things off with Keryx.
The company is a Boston, MA based biotech with a focus on renal disease. It’s lead asset is a drug called Auryxia (ferric citrate), and it’s already commercially approved by the FDA and the EMA for the treatment of a condition called hyperphosphatemia in people with chronic kidney disease (CKD) on dialysis. There’s been a bit of a supply interruption, but we won’t go in to that here in too much detail. Basically the CMO proved unreliable, and the company has had to put two fresh CMOs in place, for which it is aiming to pick up approval near term.
Anyway, Keryx Biopharmaceuticals (NASDAQ:KERX) has also conducted some trials relating to the same drug but in patients with hyperphosphatemia and CKD but who are not yet on dialysis. This would considerably expand the drug’s target patient population, and so an approval would likely inject some upside momentum into Keryx on announcement.
The company put forward what looked like some pretty strong data from an expansion trial earlier this year, and the upcoming catalyst is the supplemental NDA submission for this extended indication.
Keryx Biopharmaceuticals (NASDAQ:KERX) expects to submit this sNDA, and to quote here, early fourth quarter. We read this as some point during October, so we are looking out for the catalyst to hit press at some point over the next week or so.
Bear in mind that sentiment isn’t great surrounding this company right now, for the aforementioned supply delay reasons. As such, any upside potential on the sNDA submission announcement might be muted.
Now let’s move on to ProQR Therapeutics NV (NASDAQ:PRQR). This one’s a little different, and much earlier stage than the Keryx catalyst. The company started enrollment in a phase Ib trial investigating the safety and efficacy of its lead cystic fibrosis (CF) drug, QR-101. Additionally, there’s a then-ongoing (but now complete) trial investigating what’s called nasal potential difference (NPD), which is a key severity indicator of CF.
At the North American Cystic Fibrosis Conference (NACFC) held on October 27 – 29, 2016 in Orlando, Florida, ProQR Therapeutics NV (NASDAQ:PRQR) is set to take the stage to present data from both trials, and if there proves to be some degree of efficacy (and assuming tolerability is order) surrounding the treatment on both counts, then there’s some upside on offer for the company.
Yes, it’s early stage, but CF is a potentially rewarding market, and the above mentioned conference is a big deal. If the company can draw some eyeballs to a potentially first in class therapy, then we think there’s some momentum behind the news.
So that’s the two near term catalyst. One an early stage presentation slated for October 27-29 that is looking to demonstrate the safety and efficacy of an early stage asset, and one that could secure a large expansion on the company in questions current target market, set for (we think) sometime next week.
We’ll keep you posted.
Note: This article is written by Mark Collins and was originally published at Market Exclusive.