Omeros Corporation (OMER) Announces FDA Orphan Drug Designation for OMS721 for Treatment of IgA Nephropathy


Omeros Corporation (NASDAQ:OMER) announced that OMS721 has received orphan drug designation from the FDA for the treatment of Immunoglobulin A (IgA) nephropathy. 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. IgA nephropathy is the most common primary glomerulopathy globally, with an estimated 120,000 to 180,000 cases in the U.S. alone, and accounts for up to 10 percent of all dialysis patients. Up to 40 percent of individuals with the disease develop end-stage renal disease, a life-threatening condition, within 20 years following diagnosis.

As previously reported, Phase 2 clinical trial results with OMS721 in IgA nephropathy patients show unprecedented reductions in urine protein levels during and following treatment with OMS721. Elevated urinary protein is highly correlated with poor outcomes in patients with IgA nephropathy. Following review of these data, FDA in June granted OMS721 breakthrough therapy designation for the treatment of IgA nephropathy. Omeros plans to begin enrolling patients in its Phase 3 registration trial in IgA nephropathy later this year.

“Working with FDA, we are initiating another Phase 3 program for OMS721 – this one in IgA nephropathy, which has been granted both breakthrough and orphan designations,” stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “This marks the second Phase 3 program for OMS721, joining our ongoing aHUS program that already has received fast track status from FDA. A third Phase 3 program for OMS721 could be added as well this year in stem cell transplant-associated thrombotic microangiopathy that, together with aHUS, has been granted orphan designation. Focused on bringing OMS721 to market as quickly as possible, we are excited about its prospects and the benefits that we expect OMS721 will provide for patients across a wide range of serious and life-threatening disorders.”

FDA grants orphan designation to promote the development of a drug that is expected to have significant therapeutic advantage over existing treatments that target a condition affecting 200,000 or fewer U.S. patients annually. It qualifies a company for benefits that apply across all stages of drug development, including seven years of market exclusivity following marketing approval, tax credits on U.S. clinical trials, eligibility for orphan drug grants, and waiver of certain administrative fees.

Shares of Omeros are currently trading at $21.06, up $0.56 or 2.71%. OMER has a 1-year high of $27.09 and a 1-year low of $7.20. The stock’s 50-day moving average is $21.86 and its 200-day moving average is $15.58.

On the ratings front, OMER has been the subject of a number of recent research reports. In a report issued on August 2, Maxim analyst Jason Kolbert reiterated a Buy rating on the stock, with a price target of $24, which implies an upside of 17% from current levels. On June 13, Cantor’s Elemer Piros reiterated a Hold rating on the stock and has a price target of $15.

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 -14.1% and -0.3% respectively. Kolbert has a success rate of 31% and is ranked #4579 out of 4625 analysts, while Piros has a success rate of 44% and is ranked #3361.

Overall, one research analyst has assigned a Hold rating and 3 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 $40.25 which is 96.3% above where the stock opened today.

Omeros operates as a biopharmaceutical company committed to discovering, developing, and commercializing small-molecule and protein therapeutics for large market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system.