Omeros Corporation (NASDAQ:OMER) announced that it has requested fast track designation from the U.S. Food and Drug Administration (FDA) for the development of OMS721 for the treatment of patients with immunoglobulin A (IgA) nephropathy (also known as Berger’s disease). The company recently reported positive data (p = 0.017) from the company’s Phase 2 clinical trial of OMS721 for the treatment of kidney disorders, including IgA nephropathy, none of which currently have an approved treatment and all of which frequently lead to end-stage renal disease and dialysis. OMS721 significantly improved key endpoints of renal function and patients achieved partial remission with just 12 weeks of dosing. With similar outcomes in additional patients, the company plans to pursue accelerated approval. 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’s fast track program streamlines the development of drugs intended to treat serious or life-threatening conditions and that have the potential to address unmet medical needs. Fast track drugs are eligible for more frequent and timely meetings with FDA to discuss the development plan and to ensure that data needed for approval are collected appropriately. Drugs in the fast track program typically are granted priority review status and their respective New Drug Applications are accepted and reviewed by the FDA as rolling submissions. If granted, fast track designation is expected to expedite Omeros’ Phase 3 program for OMS721 in IgA nephropathy, which is planned to initiate next year.
FDA already has granted fast track designation for OMS721 in patients with atypical hemolytic uremic syndrome (aHUS) and orphan designation for OMS721 in patients with thrombotic microangiopathies (TMAs), including aHUS and hematopoietic stem cell-associated TMAs (HSCT-TMAs). In addition to positive Phase 2 data in IgA nephropathy and membranous nephropathy,Omeros has reported positive data from Phase 2 clinical trials in both aHUS and HSCT-TMAs. Following guidance from FDA 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 also pursuing breakthrough therapy designation for OMS721 in IgA nephropathy and in HSCT-TMAs, neither of which has any approved treatment. (Original Source)
Shares of Omeros closed last Friday at $7.85, down $0.14 or -1.75%. 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 $10.13 and its 200-day moving average is $11.29.
On the ratings front, Omeros has been the subject of a number of recent research reports. In a report issued on October 27, Cantor Fitzgerald analyst Elemer Piros reiterated a Buy rating on OMER, with a price target of $21, which represents a potential upside of 168% from where the stock is currently trading. Separately, on October 19, FBR’s Thomas Yip reiterated a Buy rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Elemer Piros and Thomas Yip have a yearly average return of 1.4% and a loss of 29.2% respectively. Piros has a success rate of 38% and is ranked #1633 out of 4178 analysts, while Yip has a success rate of 15% and is ranked #4023.
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 734% above where the stock closed last Friday.
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.