How Omeros Won Big on This FDA Approval

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Omeros Corp. (NASDAQ: OMER) saw its shares make a handy gain on Tuesday after the company announced that the U.S. Food and Drug Administration (FDA) granted a Breakthrough Therapy designation for OMS721 for the treatment of Immonogloblin A (IgA) nephropathy. FDA’s Breakthrough Therapy designation enables expedited development and review of a drug candidate for the treatment of a serious or life-threatening disease.

Omeros’s Phase 2 clinical trial evaluating OMS721 demonstrated an unprecedented improvement in proteinuria following only 12 weeks of OMS721 treatment, with a 77% mean reduction in urine albumin-to-creatinine ratios and a 73% mean reduction in 24-hour urine protein levels.

Currently, there is no approved treatment for IgA nephropathy. The most common primary glomerulopathy globally, it accounts for up to 10% of all dialysis patients. In the United States alone it is estimated that 120,000 to 180,000 patients have this disease. Roughly 40% of IgA nephropathy patients develop end-stage renal disease, a life-threatening condition, within 20 to 30 years following diagnosis.

At the same time, OMS721 is also being evaluated in a Phase 3 clinical program for atypical hemolytic uremic syndrome and in a Phase 2 clinical program for hematopoietic stem cell transplant-associated thrombotic microangiopathy.

Gregory A. Demopulos, M.D., board chair and chief executive of Omeros, commented:

We are pleased that FDA has granted breakthrough designation to OMS721 for IgA nephropathy and appreciate the Agency’s recognition of the potential importance of OMS721 in the treatment of this disease. OMS721 appears to be helping IgA nephropathy patients with a rapidity and magnitude not previously seen with any other therapy, and we look forward to working closely with the FDA to accelerate its development.

Excluding Tuesday’s move, the stock is up 72% year to date. Over the past 52 weeks, the stock is up only 51%.

Shares of Omeros were last seen up over 15% at $19.75 on Tuesday, with a consensus analyst price target of $36.67 and a 52-week range of $7.20 to $19.95.