The biotechnology sector is in full swing for the New Year, and while the JP Morgan conference is now in the rearview mirror, there are still plenty of potential catalysts set to hit press between now and the end of January. Here are two of the releases that we are most highly anticipating, with a look at what they mean for the companies in question, and how they might impact said companies’ market capitalization going forward. The two companies in focus are FibroGen Inc (NASDAQ:FGEN) and Neurocrine Biosciences, Inc. (NASDAQ:NBIX).
So, let’s kick things off with FibroGen.
This company is developing a drug called Pamrevlumab (FG-3019) for a host of fibrosis related indications, and in its latest business update, announced that it is is set to present data from one of these studies – a pancreatic cancer study – at the American Society of Clinical Oncology (ASCO) GI conference in January. The conference takes place on January 20 (this coming Friday), but abstracts from the various presentations will hit press on January 17. As such, we are looking to tomorrow’s abstract release as potentially indicative of the market response to FibroGen’s taking the stage at ASCO GI. We don’t really need to explain why this is such an important drug for FibroGen; pancreatic cancer is one of the most deadly and aggressive cancers in the US right now, and any company that can come up with a viable treatment for the condition has the potential to draw considerable revenues on a currently unmet patient population. This one is an interesting drug, however, so it’s worth taking a quick look at its mechanism of action (MOA). It is designed to inhibit a factor called CTGF. In standard fibrotic conditions, this factor (at least, that is, excessive activity of this factor) is characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. In fibrotic cancers such as pancreatic cancer, however, CTGF promotes abnormal proliferation of stromal cells, and this provides a substrate for tumor cell adherence. Basically, overactive CTGF activity results in more aggressive pancreatic tumor activity. Through the inhibition of CTGF, therefore, the theory is that FG-3019 can inhibit tumor growth and tumor cell proliferation.
The data set to be announced derives from a phase 2 study, and the study will form the basis of a pivotal protocol if it comes out as indicative of clinical benefit. It’s an ongoing study, so the data won’t be decisive, but it will give us some indication as to what we are likely to see when topline hits.
Moving on to Neurocrine Biosciences, this company is set to put out data from a phase 2 study of its lead development asset INGREZZA at some point this week. The drug is currently under investigation as part of a couple of phase 2 trials, both of which are targeting the treatment of Tourette’s syndrome in adults. Those familiar with the company will also be aware that this drug is currently on the application for a tardive dyskensia indication, by way of an NDA that the FDA granted priority review to back in November 2016.
The two trials (or maybe a more accurate way to say that is the two indications) are not closely linked, but good news for one indication would likely result in an improvement in sentiment towards the other. As such, if the data from the Tourette’s trial comes out as indicative of clinical benefit (and perhaps more importantly, indicative of safety and tolerability) then chances are we will see some upside related not just to this study but also to the chances of a tardive dyskensia green light from the agency.
As a closing note, this second focus, the Neurocrine Biosciences study, is not guaranteed to be released this week. We are on high alert for it, but INGREZZA has been a bit hit and miss in terms of meeting its data drop targets in the past, and there’s every chance that it may be delayed by a couple of weeks or more. Whatever happens, we’re going to be ready for it, and we will bring you our interpretation as and when it hits.