Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.
Good morning, fellow Foolish investors! It's time to check in on the early movers in the biotech sector today.
Galena reversing course?
Shares of Galena Biopharma (NASDAQ: GALE) have soared over the past month, gaining 88%. This sudden rise has been fueled mostly by the acquisition of privately held Mills Pharmaceuticals, an upgrade from Roth Capital, and a licensing deal with Dr. Reddy's Laboratories for the company's lead clinical candidate, NeuVax. Not to mention the market's anticipation of the sales numbers for Galena's newly acquired cancer pain medication, Abstral.
Despite all this good news, Galena shares are dropping in premarket this morning, falling over 11%. This precipitous decline appears to be due to an appearance by Galena's CEO, Dr. Mark Ahn, on Jim Cramer's show Mad Money last night.
During the interview, Cramer questioned Dr. Ahn about the history of failures for drugs similar to NeuVax, saying he was skeptical about the drug's chances for approval.
So, what does this mean? My take is that Galena is building out their commercial pipeline nicely with their recent acquisitions, which should help to soften any blow from a possible NeuVax failure next year. That said, a fair amount of the company's $700 million market cap is tied to NeuVax's potential, so there is a fair amount of risk in Galena shares at these prices. But this isn't exactly news. Galena's long-term value has long been coupled to NeuVax, so you shouldn't hit the panic button over this speed bump.
Keryx receives approval for chronic kidney disease drug in Japan
Keryx Biopharmaceuticals (NASDAQ: KERX) is moving higher this morning after announcing that its orally administrated drug ferric citrate for chronic kidney disease, or CDK, was approved in Japan. According to late-stage clinical trial data, the drug is effective at lowering dangerously high phosphate levels in patients suffering from CDK. In Japan, the drug will be marketed by Japan Tobacco and Torii Pharmaceutical under the brand name Riona.
Is this a big deal? In my view, the answer is both yes and no. What's key going forward are the potential approvals for the drug in the U.S. and Europe. According to statements made by Keryx's management at the J.P. Morgan Healthcare Conference this week, the drug could potentially see approvals in both markets by year's end. As a reminder, the drug is set to be reviewed by the U.S. Food and Drug Administration on June 7 this year.
So while a Japanese approval is a nice upside and even, a potential harbinger of things to come, the real prizes are still on the horizon. The good news is that analysts at Roth Capital, among others, are optimistic about the drug's chances in the U.S. and EU, upping their price targets by no less than an eye-popping 100% from current levels, as a result . With such optimism surrounding Keryx, you might want to keep tabs on this compelling biotech story going forward.
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