Here’s a look at some of the biggest movers in the biotechnology space heading into the close of the year with a discussion of what’s driving the action in each.
The two companies in our crosshairs for the session today are Agile Therapeutics, Inc., (NASDAQ:AGRX) and GW Pharmaceuticals plc (NASDAQ:GWPH).
First up, then, Agile.
Towards the end of this week, management at Agile put out news that the company had picked up a Complete Response Letter (CRL) from the FDA. The CRL is rooted in an asset called Twirla, which Agile has been trying to get approved in a target indication of female contraception. In this space right now, options (that is, SOC options) are primarily rooted in regular pills or implants. Both are not that great from a die effect perspective and – especially as relates to the pills – a pretty demanding administration regimen. Patients have to take them every day and if they miss them, it can quickly negate efficacy.
So, Twirla is a patch that is stuck to the skin and it just requires replacement one a week.
So what’s the issue?
The FDA has some concerns about adhesion (primarily), both as relates to the final product and those used in the study that underpins the NDA for the asset.
The CRL translated to a 50% collapse in the company’s market capitalization on its announcement but, here’s the thing – the company submitted some amendments to the NDA, rooted in adhesion concerns, to the agency at the start of December.
However, the FDA didn’t take this submission into consideration before issuing the CRL.
So, if the amendments cover the concerns, it’s reasonable to suggest that current prices could be a great quick turnaround discount trade as and when things get a little clearer.
The company has told markets that management intends to sit down with the FDA to discuss the CRL and – subsequent to that – should serve up an update as to where things go from here. If the amendment that Agile submitted at the start of December does turn out to have addressed the major concerns, this one’s going to turn around pretty quickly.
The meeting should take place at some point during the first quarter and we should get word of its outcome relatively quickly, so we’re looking out for some degree of recovery before the end of the quarter in question next year.
We’ll keep an eye on the situation as it plays out.
Moving on, GW Pharmaceuticals.
GW Pharmaceuticals is one of those companies that managed to buck the trend of cannabis pharmaceutical failures with a couple of major FDA approvals and that has since expanded to become one of the biggest players (if not the biggest) in the sector.
The company has, once again, got some good news in the hands of investors this week. This time around the news is rooted in a drug called Epidiolex, which GW is trying to get approved in a target indication of what are called Lennox-Gastaut syndrome (LGS) and Dravet syndrome. These are two epilepsy-related conditions that primarily affect children and the drug in question is specifically designed to target one of the major symptoms of both conditions – seizures. These seizures can be violent and extremely unpleasant and will, in most cases, occur frequently in sufferers, so frequent to the point that they can be considered debilitating.
So the latest news relates to an NDA for Epidiolex, which the company submitted earlier this year. The news details the fact that the FDA has accepted the NDA for review and – alongside the acceptance – has put the application up for Priority Review.
What does this mean?
Well, the acceptance isn’t an approval, it’s merely the agency’s way of saying that it considers the application complete in more of a box-checking manner, but it’s a step forward, so it’s positive.
The major element of this news, however, is the Priority Review. This designation brings the review time down to 6 months (from the standard 8-10), meaning the company could have its asset in the hands of patients far sooner than might otherwise be the case under a standard review period.
So what’s next?
Now it’s all about PDUFA. The date to watch is June 27, 2018.