Here’s What Just Moved Zogenix, Inc. (NASDAQ:ZGNX) And Novo Nordisk (NYSE:NVO)


Zogenix, Inc. (NASDAQ:ZGNX) is the big mover this week, with the company running on the release of some clinical trial data. The data derives from a phase III study of what Zogenix calls ZX008 – a drug designed to treat patients with Dravet syndrome, which is also known as severe myoclonic epilepsy of infancy (SMEI). Dravet syndrome is a form of epilepsy that often affects children and, right now, there’s essentially no treatment for patients with the condition. It’s characterized by frequent seizures and the seizures are unpredictable but often triggered by hot temperatures or fever.

So there’s an established unmet need – how did the drug perform?

Well, in short, very well. The above-mentioned seizures are generally regarded as the yardstick in this sort of investigation, with various frequency and severity measurements used to establish improvement or otherwise. In this instance, the trial was set up to measure mean monthly convulsive seizures compared to placebo and, specifically, a reduction in this monthly number, as a primary endpoint.

As per the results, patients taking ZX008 achieved a 63.9% reduction in seizures compared to placebo. That’s the primary endpoint hit. An additional measurement that looked at the median percent reduction in monthly convulsive seizure frequency also beat out on placebo, coming in at a 72.4% reduction in patients taking the drug as compares to a reduction of just 17.4% in patients that received placebo. P-values on both metrics came in as statistically significant and the safety profile of the drug in this trial was relatively clean.

So what’s next?

This program is split into two pivotal trials, one as outlined above and a second phase III in the same indication. The company is planning to submit registration applications in the US and Europe that are supported by both studies, so now focus turns to the second study and its topline release, which is slated for during the first half of next year.

If we see the data hit press in line with the numbers we’ve already seen, the drug will have a very strong chance of gaining approval in the US and Europe. This, as mentioned, is a large unmet need and any hint of efficacy (assuming safety is no issue) would likely have been enough to underscore a solid approval application. With the numbers as strong as they are however, and especially if the secondary phase III follows suit, things look good.

At the close of play on Friday, Zogenix went for a little over $35 a share having picked up a 172% run during the session.

Another event of note in the biotechnology space right now is the latest announcement by big pharma drugmaker Novo Nordisk (NYSE:NVO). The company just told markets that the FDA has approved a registration application for Fiasp (fast-acting insulin aspart) for the treatment of adults with diabetes.

Novo is already one of a couple of leaders in the diabetes space, but with a range of alternative approaches to treatment set to hit markets over the coming decade, the company is trying to innovate on its already approved insulin therapies in an attempt to maintain its leadership position.

In this instance, Novo has taken its NovoLog asset and added what’s called niacinamide (vitamin B3). The addition of this B3 helps speed up the rate of absorption, meaning it can be taken at the beginning of a meal or within 20 minutes after starting a meal, as the insulin will appear in the blood approximately 2.5 minutes after dosing.

The company first applied for approval on this Fiasp asset back in 2016 and it’s already approved in Europe. It’s also already approved in Canada but not for use in insulin pumps. The initial application, however, was rejected, with the FDA issuing a complete response letter (CRL) citing certain concerns over administration as being at the root of the rejection. Novo collected some data in an attempt to overcome the concerns and resubmitted, which led to the just announced approval.

Novo is a $120 billion behemoth, so a drug approval isn’t going to move it to the same scale as the above Zogenix, but the company has still been able to pick up a couple of percentage points on the news and currently trades for around $48.83 a share.

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