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Omeros Corporation (NASDAQ:OMER) took a beating to start off the month when the company revealed data from its ongoing Phase 2 clinical trial of OMS721 for the treatment of renal diseases that amounted to a shy outperformance over a placebo. That’s not what the market wanted to see.

However, amid all the sector-based selling (and the terrific beatdown we have seen in most of the equity market) over the past three weeks, OMER has held up reasonably well. Part of that might be explained by a quiet release from the company about a week ago in which it announced that OMS721 (the same asset) received orphan drug designation from the FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).

Omeros Corporation (NASDAQ:OMER) trumpets itself as a biopharmaceutical company that discovers, develops, and commercializes small-molecule and protein therapeutics, and orphan indications targeting inflammation, coagulopathies, and disorders of the central nervous system.

The company markets OMIDRIA for use in cataract surgery or intraocular lens replacement in the United States. Its clinical programs include OMS721 that is in Phase III clinical trial for treating immunoglobulin A (IgA) nephropathy, hematopoietic stem cell transplant-associated thrombotic microangiopathy (HCT-TMA), and atypical hemolytic uremic syndrome (aHUS); and in Phase II clinical trial to treat IgA nephropathy, membranous nephropathy, lupus nephritis, and complement component glomerulopathy.

The company’s clinical programs also consists of OMS824, which is in Phase II clinical trial for treating Huntington’s diseases and schizophrenia; and OMS405 that is in Phase II clinical trial to treat opioids, nicotine, and alcohol addiction. Its preclinical programs comprise OMS527 for the treatment of addiction and compulsive disorders, as well as for movement disorders; and OMS906 to treat paroxysmal nocturnal hemoglobinuria and other alternative pathway disorders.

The company’s preclinical programs also include MASP-2-small-molecule inhibitors used for the treatment of aHUS, IgAN, HCT-TMA, and age-related macular degeneration; MASP-3-small-molecule inhibitors used for the treatment of PNH and other alternative pathway disorders; G protein-coupled receptor (GPCR) platform, including GPR174 and other Class A orphan GPCRS for treating CNS, metabolic, CV, oncologic, musculoskeletal, and other disorders; and antibody platform for metabolic, CV, oncologic, musculoskeletal and other disorders.

In addition, the company has a strong balance sheet, with cash levels far exceeding current liabilities ($88.4M against $24.4M).

 

Don’t Look Now, But…

We started off by noting that OMER just hit the wires with the announcement that OMS721 has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).

According to the release, “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. OMS721 was awarded breakthrough therapy designation for the treatment of high-risk HSCT-TMA earlier this year. Thrombotic microangiopathy is a life-threatening complication of HSCT, with reported mortality of greater than 90 percent in some high-risk patients.”

This news, while obviously helpful, figures into a tape that has been defined by some heavy action, with shares of OMER dealing with some pressure, but coming back on the news to close the last five days more or less flat.

“With FDA’s granting of an additional orphan drug designation for OMS721 for stem cell transplant-associated TMA, we now have orphan designations that cover both the prevention and treatment of this disorder with OMS721 in the U.S. as well as in Europe,” stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “We continue to work with FDA and European regulators as we pursue expedited pathways to OMS721 approval in stem-cell TMA. Our objective is to make this drug — which we and leading experts believe is saving lives – available to transplanters and their patients as quickly as possible.”

Omeros Corporation (NASDAQ:OMER) generated sales of $1.7M, according to information released in the company’s most recent quarterly financial report. That adds up to a sequential quarter-over-quarter growth rate of 4.2% on the top line.





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