NEW YORK — NEW YORK (AP) — Shares of Omeros extended their surge Wednesday after the company said regulators in the U.S. and the European Union are reviewing its experimental eye-surgery drug OMS302.
THE SPARK: The Seattle company said the Food and Drug Administration and the European Medicines Agency accepted its applications for OMS302. The drug is combination of two topical medications that are used in lens replacement surgeries for cataracts and other conditions. One component causes pupil dilation and the other is an anti-inflammatory drug intended to reduce pain and irritation after surgery.
It's not clear how long the reviews will take.
THE BIG PICTURE: Omeros Corp. does not have any approved drugs and OMS302 is its most advanced product.
On Monday the company said its experimental drug OMS824 will get special incentives as regulators review the drug as a treatment for schizophrenia and Huntington's disease, a condition that causes muscle problems and later causes mental deterioration. The FDA designated OMS824 as an orphan drug when it's used as a treatment for Huntington's.
Orphan drug status is awarded to medications that are designed to treat diseases that affect fewer than 200,000 people in the U.S. and represent a major improvement in treatment. The status comes with regulatory incentives, reduced fees, a faster review by the FDA, and it means competing drugs could be blocked from the market for up to seven years.
The company is also testing OMS103HP, which is intended to reduce early pain after arthroscopic surgery, and OMS201, an anti-inflammatory drug and muscle relaxant intended for use during urology procedures.
SHARE ACTION: Omeros stock gained $1.79, or 18 percent, to $11.47 in afternoon trading. The shares have doubled in value since Sept. 13 and are close to their 52-week high of $11.85, set Oct. 17, 2012.