Omeros Corporation (NASDAQ:OMER) announced that it has received scientific advice from the European Medicines Agency (EMA) in connection with the company’s OMS721 Phase 3 program for the treatment of atypical hemolytic uremic syndrome (aHUS). Based on this EMA advice, the company plans to run the same, single Phase 3 clinical program to support OMS721 marketing approval applications in both the U.S. and in theEuropean Union for the treatment of aHUS. OMS721 is Omeros’ lead human monoclonal antibody in its mannan-binding lectin-associated serine protease-2 (MASP-2) program for the treatment of thrombotic microangiopathies (TMAs), including aHUS and hematopoietic stem cell transplant-related (HSCT) TMAs, and for the treatment of complement-related renal diseases. Omeros plans to commercialize OMS721 initially for administration as a subcutaneous injection.
The company met with the EMA’s Scientific Advice Working Party earlier this month to discuss the requirements for a successful European Marketing Authorization Application (MAA) for OMS721 in the treatment of aHUS. The advice provided to Omeros by the EMA is generally consistent with that received from the U.S. Food and Drug Administration (FDA) earlier this year and will allowOmeros to submit applications for approval in the U.S. and in the European Union based on a single data set, which includes the results from one pivotal clinical trial – a single-arm (i.e., no control arm), open-label study in patients with newly diagnosed or ongoing aHUS. As also agreed with the FDA, the EMA will allow the safety of OMS721 to be demonstrated in patients with diseases other than aHUS. Patient enrollment numbers required for European approval are consistent with Omeros’ plans for accelerated approval in the U.S.
Initiation of enrollment in the aHUS Phase 3 clinical trial is planned for late this year. The Phase 3 program will include patients from the Phase 2 TMA trial. In addition to the ongoing trial in patients with aHUS, Phase 2 trials are currently underway evaluating OMS721 in patients with (1) HSCT-related TMAs, (2) thrombotic thrombocytopenic purpura or (3) complement-related renal disease. In the U.S., OMS721 has received both orphan designation for the treatment of TMAs and fast-track status for the treatment of aHUS, and the company plans to request orphan designation in Europe.
“We are pleased with the advice that we received from EMA, which further solidifies the company’s strategy to commercialize OMS721,” stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “FDA’s and EMA’s advice are consistent and outline a clear and feasible Phase 3 development path for OMS721. We look forward to completing the single Phase 3 trial for both regulatory agencies and to making OMS721 widely available to patients with aHUS.” (Original Source)
Shares of Omeros are currently trading at $11.51, up $0.32 or nearly 3%. OMER has a 1-year high of $30.23 and a 1-year low of $8.90. The stock’s 50-day moving average is $11.01 and its 200-day moving average is $12.08.
On the ratings front, Omeros has been the subject of a number of recent research reports. In a report issued on June 29, FBR analyst Thomas Yip reiterated a Buy rating on OMER. Separately, on June 14, WBB’s Stephen Brozak maintained a Buy rating on the stock and has a price target of $75.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Thomas Yip and Stephen Brozak have a total average return of 65.2% and 15.8% respectively. Yip has a success rate of 39.1% and is ranked #34 out of 4087 analysts, while Brozak has a success rate of 51.6% and is ranked #522.
The street is mostly Bullish on OMER stock. Out of 4 analysts who cover the stock, 4 suggest a Buy rating . The 12-month average price target assigned to the stock is $75.00, which represents a potential upside of 570.2% from where the stock is currently trading.
Omeros Corp. is a clinical stage biopharmaceutical company, which engages in the discovering, developing and commercializing products 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. The company also has a deep and diverse pipeline of preclinical programs as well as a platform capable of unlocking new drug targets.