Shares of Omeros Corporation OMER soared higher by more than 15 percent on Tuesday after the U.S. Food and Drug Administration granted a breakthrough therapy designation to the company's treatment of Immunoglobulin A nephropathy called OMS721.
The FDA's designation provides Omeros with several positive benefits, including increased regulatory access and an opportunity for an accelerated priority review, Cantor Fitzgerald's Elemer Piros commented in a research report. The designation also helps validate the initial data demonstrated by OMS721 and increases the analyst's focus on ongoing Phase 3 programs.
Despite the encouraging update, Omeros' stock remains Neutral rated with a $15 price target, which implies notable downside from Tuesday's trading action where shares hit a new 52-week high of $19.95 (see Elemer Piros' track record).
However, the analyst may become incrementally bullish, as the company is expected to offer additional clarity and progress across its three emerging Phase 3 clinical programs with OMS721, which serves as a potential driver for the stock.
"As a reminder, OMS721 is being developed across three indications," the analyst explained. "Atypical hemolytic uremic syndrome (aHUS), hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), and IgAN."
Finally, the analyst ascribes $150 million in value to Omeros' entire pipeline and discovery platform, but there is the possibility for further upside as the company progresses in its pipeline development.
At last check, shares of Omeros were up 12.52 percent at $19.24.
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