Omeros Corporation (NASDAQ:OMER) announced that following physician request it will provide continued supply of OMS721 for a pediatric patient with hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) who is currently receiving the drug under the company’s compassionate use program. The patient’s treating physician requested extended access to OMS721 for his 15 year-old patient given her positive results with OMS721 treatment, including discontinuation of dialysis. HSCT-TMA most commonly affects the kidneys but can also damage the lungs, gastrointestinal tract and central nervous system, and severe cases often require dialysis and carry a mortality rate in excess of 90 percent. OMS721 is Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2). In addition to its Phase 2 clinical program in TMA, OMS721 is currently in a Phase 3 program for patients suffering from atypical hemolytic uremic syndrome and in a Phase 2 program for renal diseases, including immunoglobulin A (IgA) nephropathy and membranous nephropathy.

Approximately 20,000 HSCT procedures are performed in the U.S. annually, and TMA is reported to occur in approximately 10 to 25 percent of HSCT patients. HSCT-TMA patients frequently have a complex history of disease. This pediatric patient had received a stem cell transplant to treat a rare life-threatening anemia. Following her transplant, she developed TMA. She began treatment with Soliris and improved but developed pulmonary edema so Soliris treatment was stopped. Following relapse of her HSCT-TMA, she received a low dose of Soliris and again developed pulmonary edema, again requiring discontinuation of Soliris treatment. Her TMA progressed and she developed renal failure requiring dialysis. When she began OMS721 treatment, she had been on dialysis for several months and required daily platelet transfusions.

After three weeks of OMS721 treatment the patient was able to discontinue dialysis. The frequency of platelet transfusions has been decreased by more than 50 percent despite bone marrow suppression caused by other concurrent conditions. Two measures of red blood cell destruction have also substantially improved on OMS721 treatment: her haptoglobin has normalized on OMS721 treatment and her lactate dehydrogenase (LDH) has decreased by more than 50% percent but still remains slightly elevated. All OMS721 administrations have been well tolerated by the patient, and no side effects have been observed with this treatment. The patient is also now able to spend weekends at home with her family. Because of the patient’s improvement on OMS721, her treating physician requested, and Omeros granted, an extension of the OMS721 compassionate use treatment protocol under which this pediatric patient is being treated.

“The patient, her family and her team of physicians are obviously thrilled with her improvement on OMS721,” stated Marco Zecca, M.D., Director of Pediatric Hematology/Oncology at Fondazione IRCCS Policlinico San Matteo in Pavia, Italy. “Stem cell transplant-related TMA is a devastating and often fatal condition, and this is a patient who had failed other treatment. Her response to OMS721 is impressive, underscored by her ability to stop dialysis. We appreciate receiving ongoing access to OMS721 for her treatment, and we look forward to her continued improvement and a return to a more healthy and normal life.”

“All of us at Omeros feel privileged to participate in the care of this young girl,” stated Gregory A. Demopulos M.D., Chairman and Chief Executive Officer of Omeros. “We remain committed to supporting both her and her physicians in her care and to her continued recovery. While treatment results are routinely described in numbers and statistics, this patient demonstrates the human side of our work, and it is heartening.”

Omeros’ OMS721 compassionate use program is active internationally. (Original Source)

Shares of Omeros are currently trading at $10.57, up $0.01 or 0.09%. 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 $7.57 and its 200-day moving average is $10.98.

On the ratings front, Omeros has been the subject of a number of recent research reports. In a report issued on November 17, WBB analyst Stephen Brozak reiterated a Buy rating on OMER, with a price target of $75, which represents a potential upside of 610% from where the stock is currently trading. Separately, on November 10, Maxim Group’s Jason Kolbert reiterated a Buy rating on the stock and has a price target of $19.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Stephen Brozak and Jason Kolbert have a yearly average return of 16.7% and a loss of 15.1% respectively. Brozak has a success rate of 50% and is ranked #459 out of 4256 analysts, while Kolbert has a success rate of 27% and is ranked #4169.

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 520.3% above where the stock closed yesterday.

Omeros Corp. 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.