OMEROmeros Corporation (NASDAQ:OMER) announced that it has filed an application for orphan drug designation with the U.S. Food and Drug Administration (FDA) for OMS721 in the treatment of immunoglobulin A (IgA) nephropathy (also known as Berger’s disease). IgA nephropathy leads to end-stage renal disease in up to 40 percent of patients. Orphan drug designation is granted to treatments that target conditions affecting 200,000 or fewer U.S. patients per year. Orphan-designated drugs are eligible for financial incentives and regulatory advantages such as a faster approval process and additional market exclusivity. OMS721 is Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of the complement system.

FDA earlier granted orphan designation for OMS721 in thrombotic microangiopathies (TMAs), including atypical hemolytic uremic syndrome (aHUS) and hematopoietic stem cell-associated TMA (HSCT-TMA). Based on positive Phase 2 data in renal diseases, Omeros also recently filed forFDA fast track designation for OMS721 in IgA nephropathy. The company already has received fast track designation for OMS721 in aHUS.

In addition to positive Phase 2 data in IgA and membranous nephropathies, Omeros has reported positive data from Phase 2 clinical trials in both aHUS and HSCT-TMA. Following guidance fromFDA and from the European Medicines Agency, Omeros plans to open enrollment for its single Phase 3 trial in patients with aHUS later this year. Based on discussions with the FDA, the company is pursuing breakthrough therapy designation for OMS721 in IgA nephropathy and in HSCT-TMA, neither of which has any approved treatment. Omeros plans to initiate OMS721 Phase 3 programs in both IgA nephropathy and HSCT-TMA next year. (Original Source)

Shares of Omeros closed yesterday at $8.65, up $0.34 or 4.09%. OMER has a 1-year high of $16.80 and a 1-year low of $7.20. The stock’s 50-day moving average is $10.06 and its 200-day moving average is $11.23.

On the ratings front, Omeros has been the subject of a number of recent research reports. In a report released yesterday, Maxim analyst Jason Kolbert reiterated a Buy rating on OMER, with a price target of $19, which represents a potential upside of 120% from where the stock is currently trading. Separately, on October 27, Cantor’s Elemer Piros reiterated a Buy rating on the stock and has a price target of $21.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason Kolbert and Elemer Piros have a yearly average loss of -17.9% and a return of 0.8% respectively. Kolbert has a success rate of 24% and is ranked #4022 out of 4165 analysts, while Piros has a success rate of 39% and is ranked #1820.

Overall, 5 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $65.50 which is 657.2% above where the stock closed yesterday.

Omeros Corp. engages in the development and commercialization of small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies, and disorders of the central nervous system. Its products are derived from its proprietary PharmacoSurgery platform designed to improve clinical outcomes of patients undergoing arthroscopic, ophthalmological, urological, and other surgical and medical procedures.