Omeros Corporation (NASDAQ:OMER), a biopharmaceutical company committed to discovering, developing and commercializing both small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system, today announced that it has initiated its Phase 3 OMS721 program for the treatment of atypical hemolytic uremic syndrome (aHUS) after meeting with the U.S. Food and Drug Administration (FDA). 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. The FDA has awarded OMS721 both orphan drug designation for the treatment of TMAs and fast-track status for the treatment of aHUS.
The OMS721 Phase 3 program will consist of one clinical trial – a single-arm (i.e., no control arm), open-label trial in patients with newly diagnosed or ongoing aHUS. The clinical package for the biologics license application (BLA) will be similar to that which formed the basis of approval for Soliris® (eculizumab). For the BLA, safety of OMS721 can be demonstrated in patients across a wide range of diseases instead of only in those with aHUS, including additional renal diseases for which Omeros is already enrolling a clinical trial. As a result, collection of safety data is not expected to delay submission of the BLA. Omeros also received agreement from FDA on its ongoing manufacturing for both the Phase 3 program and commercialization of OMS721 as well as on its nonclinical safety and toxicology plan, most of which has already been successfully completed with no significant adverse findings. Phase 3 enrollment is expected to begin later this year and patients currently being treated in the Phase 2 trial are likely to be included in the Phase 3 program.
Consistent with guidance from the FDA, Omeros plans to pursue accelerated approval for OMS721 in aHUS. Similar to fast track, to qualify for accelerated approval a drug must treat a serious condition and generally provide a meaningful advantage over available therapies. Accelerated approval allows a company to market a drug while it continues to conduct confirmatory clinical assessment to obtain full approval. Omeros believes that, based on ongoing clinical work and well-accepted data directed to the targets for OMS721 (MASP-2) and for Soliris (C5), the conditions for accelerated approval can be met for OMS721.
“The meeting with FDA represents an important milestone in the ongoing development program for OMS721 and helped to solidify further the company’s strategy to achieve commercialization,” stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “We hear from aHUS patients and their physicians that additional treatment options are needed. Omeros is dedicated to fulfilling that need and to helping these patients as quickly as possible.” (Original Source)
Shares of Omeros closed yesterday at $12.99. 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 $10.79 and its 200-day moving average is $12.89.
On the ratings front, Omeros has been the subject of a number of recent research reports. In a report issued on February 24, Maxim Group analyst Jason McCarthy reiterated a Buy rating on OMER, with a price target of $30, which represents a potential upside of 130.9% from where the stock is currently trading. Separately, on November 10, Needham’s Serge Belanger maintained a Buy rating on the stock and has a price target of $30.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason McCarthy and Serge Belanger have a total average return of -10.8% and 8.6% respectively. McCarthy has a success rate of 36.2% and is ranked #3513 out of 3698 analysts, while Belanger has a success rate of 37.0% and is ranked #724.
Omeros Corp is engaged in the discovery, development and commercialization of pharmaceutical products for inflammation, coagulopathies and disorders of the central nervous system.