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 Omeros Corporation (NASDAQ: OMER ) , a biopharmaceutical company focused on developing therapies to treat central nervous system disorders, jumped by as much as 16% after receiving the orphan drug designation for OMS721 from the Food and Drug Administration for complement-mediated thrombotic microangiopathies.
So what: If you recall, receiving orphan drug status affords drug developers special perks that can include: qualified clinical-trial tax credits, a period of exclusivity should their drug make it to market, and a greater potential for an accelerated approval pathway. Currently, OMS721 is being studied in an early-stage trial where, according to Omeros, at the highest dosage it, "achieved serum concentrations that resulted in a high degree of inhibition of lectin pathway activation." Omeros expects to report full phase 1 data in early 2014.
Now what: This is obviously good news for Omeros as the tax breaks are a big perk for a company that's burning through cash as it develops new products in its pipeline, but it's even better news from the standpoint of drug exclusivity (a period of seven years) if approved. Tack on the fact that Omeros recently filed a new drug application for Omidria (formerly OMS302) for use during intraocular lens replacement, including cataract surgery and refractive lens exchange, and you have a series of catalysts that could push Omeros higher in the near term. Over the long haul, it's really going to depend on how well Omidria launches if it's approved by the FDA, but the wheels are certainly spinning in the right direction at the moment.
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