Company Update (NASDAQ:OMER): European Regulatory Authority Approves Clinical Investigator’s Request for Compassionate Use with Omeros Corporation’s OMS721

Omeros Corporation (NASDAQ:OMER) announced that the presiding European regulatory authority has approved the company’s investigational product OMS721 for compassionate use. 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 atypical hemolytic uremic syndrome (aHUS). TMAs are a family of rare, debilitating and life-threatening disorders characterized by excessive thrombi (clots) in the microcirculation of the body’s organs, most commonly the kidney and brain.

The two patients in the compassionate-use study suffer from aHUS and were enrolled in the first cohort of the Phase 2 clinical trial. Based on improvements across markers of disease activity in that cohort, the investigator requested that Omeros continue to provide OMS721 so that the patients could extend their treatments. Following regulatory approval, Omeros was pleased to release shipment of OMS721 to continue treatment of these patients.

Omeros’ ongoing OMS721 Phase 2 study continues to progress through its dose-ranging phase. The second cohort of patients, which received a higher dose than the first cohort, has now completed treatment. Following a pre-planned data review by internal and external physicians, if the safety data from the second cohort are acceptable, a recommendation will be made to advance as scheduled to a third cohort at an even higher dose. This third cohort could begin dosing before the end of April.

“We are pleased to extend OMS721 treatment for patients suffering with TMAs beyond the initial planned duration of the Phase 2 study,” stated Gregory A. Demopulos, M.D., Chairman and Chief Executive Officer of Omeros. “We are excited by the progress our OMS721 Phase 2 program and look forward to its continued advancement following the second-cohort data review.”¬†(Original Source)

Shares of Omeros closed yesterday at $25.56 . OMER has a 1-year high of $27.64 and a 1-year low of $9.76. The stock’s 50-day moving average is $23.59 and it’s 200-day moving average is $20.45.

On the ratings front, Omeros¬†has been the subject of a number of recent research reports. In a report issued on April 6, Wedbush analyst Liana Moussatos reiterated a Buy rating on OMER, with a price target of $61, which implies an upside of 138.7% from current levels. Separately, on March 17, MLV & Co.’s Ram Selvaraju reiterated a Buy rating on the stock and has a price target of $38.

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Liana Moussatos and Ram Selvaraju have a total average return of 48.2% and 13.6% respectively. Moussatos has a success rate of 70.2% and is ranked #5 out of 3574 analysts, while Selvaraju has a success rate of 53.8% and is ranked #297.

The street is mostly Bullish on OMER stock. Out of 5 analysts who cover the stock, 5 suggest a Buy rating . The 12-month average price target assigned to the stock is $39.80, which represents a potential upside of 55.7% from where the stock is currently trading.

Omeros Corp is engaged in the discovery, development and commercialization of pharmaceutical products for inflammation, coagulopathies and disorders of the central nervous system.

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