Biotech Movers And Shakers: Nivalis Therapeutics Inc (NVLS) And Amicus Therapeutics, Inc. (FOLD)

It’s time to take a look at those stocks that really moved over the last twenty-four hours or so in biotech, and there are plenty to go at. It’s been a big week for data so far (the conference schedule heats up around the winter period) and all the data hitting press is translating to some considerable volatility in and around the companies involved. So, with this in mind, here are two of the week’s biggest movers, and a look at what’s behind the action (and as a bonus, what we expect next).

The two companies we are going to be looking at are Nivalis Therapeutics Inc (NASDAQ:NVLS) and Amicus Therapeutics, Inc. (NASDAQ:FOLD). For this report, both companies have taken a hit on a news-related volume increase.

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So, first, Nivalis Therapeutics Inc (NASDAQ:NVLS).

At market close on Monday, Nivalis was trading for a little over $6.20 a share. As things stand midway though the U.S east coast’s afternoon, it’s available for just $2.58 – a close to 60% decline across the session, and looking likely to deepen before the session closes out. The decline comes on the back of a report detailing data from its lead cystic fibrosis asset.

The drug in question is called cavosonstat, and it was under investigation in the above mentioned CF indication as part of a phase II trial. The primary endpoint of the trial was an improvement in lung function (which, surrogate endpoints aside, is the gold standard in any CF trial) and the drug failed to demonstrate any stat sig benefit against this endpoint. The drug was well tolerated (this isn’t a surprise) and management has stated that it will continue to investigate the potential use of cavosonstat. Take this with a pinch of salt. It’s an attempt to lessen the severity of the impact of the data missing so badly, and we expect that there will be no further development of this one going forward – especially in a CF indication.

Unfortunately for Nivalis Therapeutics Inc (NASDAQ:NVLS), this was the company’s lead candidate, and its future now looks pretty uncertain. The company has a decent amount of cash on hand (circa $16 million at last count) and $50 million worth of short term investments, so there’s room for advancing a lower pipeline asset near term, but it will struggle to do this while still maintaining its market cap, even in the wake of the recent decline.

Second, we’re looking at Amicus Therapeutics, Inc. (NASDAQ:FOLD).

This one’s a different situation, but it’s still a weighty decline. The company is down more than 20% from its Monday close, and again, the trend looks very much to the downside. The decline is rooted in an update surrounding the company’s Fabry Disease asset, Galafold, and specifically, the drug’s commercialization in the U.S. It’s already available in Europe, and has the potential to be a solid earner in that market, but the U.S is the real target, and markets were expecting a potentially near term FDA nod. However, the company just announced that the FDA wants to see data on gastrointestinal symptoms associated with the drug, and this is going to extend any potential approval by at least a couple of years.

Amicus Therapeutics, Inc. (NASDAQ:FOLD) expects to kick off a trial to collect the data at some point next year, with results collected in 2019, and – by proxy – a submission not put forward until at least early 2020.

This is disappointing for those looking for a short-term turnaround, but it’s also important from a capital perspective. This trial is likely going to run into the tens of millions of dollars for the company, and all the while it is going to be relying on revenues from just the European market. Shareholders are going to have to pick up the tab, by way of dilution, and that’s why the company has taken such a hit. It’s not just a time delay, but it’s one that could be (and will be) costly on a number of fronts.

Note: This article is written by Mark Collins and was originally published at Market Exclusive.