Omeros Corporation (OMER) Wins Pediatrics Approval, but for This Bull the Excitement Is All About OMS721 Asset

Maxim's Jason Kolbert is keeping his focus peeled to the Omeros pipeline, even though he welcomes the FDA victory for Omidria.


Omeros Corporation (NASDAQ:OMER) just got the FDA nod for Omidria in pediatrics following a 78 pediatric patient trial, with the new indication likewise offering the drug maker’s asset an added six months of domestic market exclusivity.

Maxim analyst Jason Kolbert takes the news in “positive” stride, but nonetheless, his bullish focus predominantly hinges upon the Omeros pipeline and short-term, OMS721, which was granted breakthrough status for the treatment of IgA nephropathy. OMS721 stands as the company’s lead asset, a fully human monoclonal antibody targeting MASP-2, under development to treat diseases where the lectin pathway is understood as a contributor to severe tissue injury and pathology.

Commending the FDA approval for Omidria and enthusiastic on pipeline development, the analyst reiterates a Buy rating on OMER stock with a price target of $24, which implies a nearly 27% upside from current levels. (To watch Kolbert’s track record, click here)

Kolbert highlights, “Breakthrough therapy designation was granted based on the P2 data demonstrating statistically significant improvements in proteinuria (urine protein levels), a marker of disease progression. A follow-up meeting with the FDA has confirmed proteinuria as the primary endpoint in the P3 trial and that a single-trial will be sufficient for approval (full or accelerated). Omeros has submitted for orphan designation and PRIME status from the EMA as well. The potential for OMS721 is substantial, and the case x case data is building that shows a superior product profile that can save lives.”

In a nutshell, “Omidria continues to be a cash engine (the means) and while concerns on pricing will remain an issue (at least through January) remember that it’s the means, not the ends—which for us, is pipeline development and specifically OMS721,” the analyst concludes, content with the news of Omridia approval- but “really,” it is all about OMS721 in the near-term picture.

TipRanks points to a strongly bullish analyst consensus when polling analyst expectations on OMER across the Street from the last 3 months. Out of 4 analysts polled, the majority 3 rate a Buy on Omeros stock with only 1 maintaining a Hold. Is this drug maker overvalued or undervalued? Consider the healthy return potential of nearly 59% as the stock’s consensus target price stands at $30.00.

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