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It's been an exciting year for BioCryst Pharmaceuticals (NASDAQ: BCRX ) . The stock has nearly quadrupled in price year to date. The small North Carolina-based company just completed a successful secondary offering. And a phase 1 study of an oral hereditary angioedema, or HAE, drug wrapped up with positive results.
What's next for BioCryst -- and can it keep the nice momentum going into next year? Here are three key catalysts that investors need to watch.
1. Peremivir NDA filing
The company expects to submit a New Drug Application, or NDA, to the U.S. Food and Drug Administration for Peremivir by the end of 2013. Peremivir is an anti-viral agent that inhibits an enzyme called neuraminidase, which is involved in spreading influenza within a host organism.
Peremivir is already used in Japan and South Korea to treat patients with influenza. But disappointing news from the interim analysis of the phase 3 study for the drug seemed to have killed the chances for moving forward in the U.S. Still, Biocryst plugged away despite the setback.
Those efforts finally paid off in July after the Biomedical Advanced Research and Development Authority, an agency within the U.S. Department of Health and Human Services, released funding under an existing contract for the company to proceed with the NDA filing. BioCryst cleared the way for the NDA submission with the FDA in late June.
2. Phase 2A results for BCX4161
BioCryst reported great results for its phase 1 study of oral HAE drug BCX4161 earlier this year. Over 87 healthy volunteers participated in the study, with all goals related to safety, tolerability, and on-target kallikrein inhibition met.
Next up is the phase 2A study, which is slated to begin this quarter. No definitive time has been announced for when this study will finish, but it's probably safe to say that it will wrap up in the first half of 2014. If initial results are positive, BioCryst shares will undoubtedly continue their winning ways of this year.
3. Potential deals
Assuming Peremivir gains FDA approval, there are several commercialization routes that BioCryst could take. The biggest customer for the drug will be the U.S. government itself, which will probably build up stockpiles of the drug to help in the event of a major flu outbreak. But look for BioCryst to try to align with one or more partners to help market Peremivir to other customers as well.
Two primary markets that the company has its eyes on are hospitals and long term care facilities. Biocryst thinks that hospitals might want to do some small-scale stockpiling of their own to treat flu patients in emergency rooms. Long-term care facilities could also seek to have the drug on hand because their elderly populations are more susceptible to the flu.
What could be even more intriguing is if Biocryst becomes the acquisition target of a larger company. Viropharma (UNKNOWN: VPHM.DL ) attracted attention in September when word leaked out that it was looking to find a buyer. Rumors floated that Sanofi (NYSE: SNY ) and Shire (NASDAQ: SHPG ) were interested.
Nothing has materialized yet on that front. However, it's important to look at why Sanofi and Shire might have mulled over such an acquisition. The biggest draw is Viropharma's HAE drug Cinryze. Viropharma reported solid results for Cinryze in the last quarter, with sales totaling over $91 million -- up 22% year-over-year.
If the phase 2 study for its own HAE drug go well, BioCryst could pop up on a few acquisition radar screens down the road. Some big players could see an advantage in scooping up BCX4161, which is taken orally rather than via injection like Cinryze.
BioCryst is in pretty good financial shape, with enough cash to take it into 2015. My view is that the developments related to the oral HAE drug BCX4161 will serve as the biggest catalyst in the days ahead, although picking up approval for Peremivir should help the stock nicely also.
Of course, there's plenty of risk. This isn't the kind of stock to bet your retirement on. But I think investors should keep a close watch on BioCryst. I wouldn't count on shares nearly quadrupling again in less than a year, but there could still be plenty of momentum left in this stock.
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