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.
What: Shares of biopharmaceutical company Omeros (OMER 1.93%) surged 15% today after announcing that the New Drug Application, or NDA, for its experimental eye-surgery drug, OMS302, has been confirmed for filing by U.S. and European regulators.
So what: The stock has soared in 2013 on growing enthusiasm for OMS302, and today's news only reinforces the notion that it does fulfill an unmet medical need. In fact, Wedbush analyst Liana Moussatos recently noted that OMS302 would be the only treatment combining pain relief and pupil dilation that also met the FDA's new replacement surgery requirements, giving investors plenty of good vibes over the drug's blockbuster potential.
Now what: Analysts expect the FDA to make an approval decision on OMS302 in the middle of next year.
"The acceptance for filing of our NDA by the FDA and validation of our MAA by the EMA mark important milestones on the path toward the commercial launch of OMS302 expected in 2014," said Chairman and CEO Gregory Demopulos.
So while the stock might be too hot and risky for average investors, biotech-savvy Fools might want to take a closer look at Omeros' seemingly bright prospects.
