At the end of last week, a couple of companies in the biotechnology space served up some key regulatory updates and moved considerably on the back of their respective releases. Here is a look at both with a discussion of what happened and what comes next for each.
The two companies in focus for the session today are Recro Pharma, Inc. (NASDAQ:REPH) and Neurocrine Biosciences, Inc. (NASDAQ:NBIX).
Let’s kick things off with Recro.
On Friday, the company gave markets and update as to the progress of a drug called meloxicam along its development pathway. Specifically, we learned that the FDA has set a PDUFA date of May 26, 2018 for the drug’s New Drug Application (NDA), which is seeking approval as a 30 mg dosing in a target indication of the management of moderate to severe pain.
Many reading might already be familiar with this drug. It has been approved for the treatment of the symptoms of osteoarthritis and rheumatoid arthritis (so, as a pain management asset) since the 1990s and was developed by (and is now marketed by) Boehringer Ingelheim.
The approved formulation, however, is an oral administration drug. Because of its poor water solubility, the oral formulation takes a long time to take effect and – as such – can’t be used as a rapid onset drug.
In the formulation that Recro is trying to get approved, the administration type is intravenous (IV), which should (theoretically, at least) dramatically increase speed of onset and – in turn – allow the drug to be used for patients that need pain relief quickly.
So that’s the idea and – as mentioned – the company has an NDA with the FDA right now that’s chasing approval in this rapid onset pain management indication.
The data on which the application is based is pretty strong and with this being an asset that’s already commercially available (and has been that way for a couple of decades or more) there should really be any immediate safety concerns. Sure, it’s an IV formulation, so the increased strength and risk associated with this admin type adds an element of uncertainty to the equation, but it’s not a major problem.
Interestingly, the market response to the news that the FDA has set up a PDUFA date for the drug hasn’t been that positive. The company closed down on Friday a few percentage points and is trading for a circa 6% discount to its Thursday intraday highs.
Chances are we will see some degree of loading ahead of PDUFA, however, in anticipation of the drug picking up regulatory approval in the US come decision day.
Next up, Neurocrine.
Again, this one is an FDA update but, this time around, the drug in question is a step ahead of Recro’s asset. It’s called Ingrezza and it is targeting a condition called tardive dyskinesia (TD). Indeed, this one is already approved in this indication and has been since April this year, but the company has been trying to get a stronger dose past the FDA than that which was previously green-lighted.
And the latest news from Neurocrine tells us the company has been successful in doing just that.
At the end of last week, we learned that the FDA has approved an 80mg dose of the drug, twice that which was previously approved (a 40mg dose). Tardive dyskinesia is associated with involuntary movements of the tongue, lips, face, trunk, and extremities and is generally a result of (or more accurately, a side effect of) antipsychotic medications. The approval of Ingrezza earlier this year brought a much-needed option to the market for patients with the condition, who previously didn’t really have any treatments available to them, but the low dose formulation is only effective for a limited portion of the patient population.
With the stronger dose now available, not only does the portion of the TD population for which low dose Ingrezza isn’t enough have a chance at symptom relief but Neurocrine has a much wider target patient population to go after in the US. Everybody wins.
Again, there’s a good chance we will see this company continue to appreciate moving forward as it increases topline with the fresh asset.