Biotech Movers: Egalet Corporation (NASDAQ:EGLT) and Neos Therapeutics, Inc. (NASDAQ:NEOS)

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Biotech Movers: Egalet Corporation (NASDAQ:EGLT) and Neos Therapeutics, Inc. (NASDAQ:NEOS)

We are midway through the week and what a week it has been so far in the biotechnology space, especially towards the smaller end of the sector. Numerous companies have put out key releases and are moving as a result of the news these releases detail. Here is a look at two of today’s biggest movers, with an analysis of what is moving each and where we expect the companies in question to go next.

The two companies we’re focusing on today are Egalet Corporation (NASDAQ:EGLT) and Neos Therapeutics, Inc. (NASDAQ:NEOS).

Interestingly, both of the companies released what amounts to polar opposite news, but both have moved (ultimately) in the same direction. Here’s what happened.

First up, Neos.

This is a company that we first looked at towards the end of last week, when it was gaining strength as markets loaded up on shares in anticipation of a PDUFA for its lead development asset, a drug called Cotempla XR-ODT for the treatment of attention-deficit/hyperactivity disorder (ADHD) in patients 6 to 17 years old. The idea behind the drug is that it is an alternative administration form of a currently available standard of care treatment in the space (which readers will probably know best as Ritalin). These patients, and especially the younger portion of them, have difficulty swallowing the pills necessary with Ritalin administration. Neos developed this asset to answer the problem. It is an orally disintegrating tablet (which is where the ODT element of the name comes from) meaning patients don’t need to swallow it – it just breaks down automatically in their mouths. The drug had a roller coaster ride to approval, having received a few knock backs from the agency in the US, but markets anticipated a positive outcome ahead of yesterday’s decision – hence the upside momentum we saw towards the end of last week.

As it turns out, these expectations were valid, but markets did not respond quite as we might have predicted. The company spiked premarket, gaining close to 15% on the approval news, but then once the normal session opened, the spike sold off and the company started to lose strength.

At the end of the day, Neos closed out around 11% down on its Monday close.

This is not a common move in the biotechnology sector. However, when a company releases this sort of thing during what amounts to the overnight session, as Neos did, it gives those with access to restricted premarket trading the opportunity to load up ahead of market open. Once the markets open up, those who took an early stake sell out into the buying wave that comes with normal session orders. If this wave is not strong enough to hold the weight of the selling, the company in question will dip – and that’s exactly what happened here.

Chances are, as we move forward, Neos will recover much of this lost strength and then start to pick up as commercialization of the asset in question commences (slated for late third quarter, early fourth quarter 2017).

Next up, Egalet.

Unlike Neos, which received a favorable decision from the Food and Drug Administration (FDA) in the US, Egalet picked up a Complete Response Letter (CRL) from the agency regarding one of its lead assets – a drug called OXAYDO tablets C-11 in two doses, 10 mg and 15 mg. For those not familiar with this one, OXAYDO is already approved as a pain management drug in patients with acute and chronic, moderate to severe pain where the use of an opioid analgesic is appropriate, having initially picked up approval back in 2015. The currently approved doses, however, are 5 mg and 7.5 mg. It is designed as an abuse deterrent asset, with a formulation that induces nasal burning if inhaled through the nose.

The company attempted to pick up approval for the above-noted 10 mg and 50 mg doses by way of a supplemental application, but the latest news means the FDA has turned the application down – at least for now.

While we don’t have any specific information as to what drove the turndown, we do know that the agency has stated that the drug in its currently approved form has not demonstrated any abuse-deterrent qualities over immediate-release oxycodone, a current standard of care treatment in the space.

Chances are, then, if the company wants to get this one approved at the doses, it is going to have to perform some comparative studies with the latter mentioned oxycodone to demonstrate superiority in abuse deterrence.

That’s not great news, and markets are responding accordingly. As things stand, Egalet is down just shy of 18% on its preannouncement market capitalization.