Wedbush today maintained an Outperform rating on Omeros Corp. (NASDAQ: OMER) and raised its price target to $32.00 (from $28.00). The change comes as the FDA accepts OMS302 for review.
"With a July 2013 submission and our anticipation of a 10-month U.S. review for the OMS302 NDA, we estimate a PDUFA date in May 2014. This timeline works with our July 2014 U.S. launch date for OMS302. Omeros also indicated that EU approval could also occur in 2014," said analyst Liana Moussatos.
"Given the stellar clinical results from both Phase 3 trials, we do not anticipate any delays and expect a first pass approval. Both Phase 3 trials achieved statistical significance for the primary endpoints. The first Phase 3 trial had a primary endpoint of maintenance of mydriasis (pupil dilation) and achieved statistical significance of p