Omeros Corporation (NASDAQ:OMER) shot up more than 60% in pre-market trading on Tuesday after the pharmaceutical company announced additional positive data for OMS721 in its Phase 2 clinical trial.
OMS 721 is a pipeline therapy that aims to treat thrombotic microangiopathies, or TMAs, which Omeros describes as a “family of rare, debilitating and life-threatening disorders characterized by excessive thrombi (clots) – aggregations of platelets – in the microcirculation of the body’s organs, most commonly the kidney and brain.”
Omeros is testing OMS 721 in three cohorts with varying doses. Data from the first cohort was released in February and today the company announced data from its second, mid-dose cohort and data from its third, high-dose cohort. Out of the three patients treated in the second group, two of them have aHUS, or atypical hemolytic uremic syndrome. These two patients received the mid-dose of the pipeline drug and experienced a 47% increase in mean platelet count; an 86% decrease in mean schistocyte count; and a 71% increase in mean haptoglobin.
This read-out of positive data comes one day after Omeros announced its intention to file a patent infringement suit against Par Pharmaceutical, Inc and Par Sterile Products, LLC; its subsidiary company. Omeros is filing the lawsuit based on Par’s Abbreviated New Drug Application, or ANDA, which is filing to commercialize a generic version of Omidria; Omeros’s FDA-approved drug for use during eye surgery. Omeros owns 34 global patents in relation to Omidria and the company is “highly confident in its patent estate.” On July 27, Omeros received a notice from Par requesting to market the generic version and addressing the ANDA in accordance with a drug price competition law that encourages the development of generic drugs. However, Omeros has patents on the drug reaching as far as 2033.
Analysts were quick to weigh in on the pharmaceutical company following the news.
Today, Maxim analyst Jason Kolbert reiterated a Buy rating on the stock with a $30 price target in response to both the positive data and the lawsuit. In regards to the new data, Kolbert believes “the specificity, efficacy and safety profile of OMS721 is differentiating.” He adds, “There have been no confirmed clinically meaningful drug-related adverse events in any clinical trials with OMS721.” The analyst concluded, “Physician-requested compassionate use is ongoing, and all patients in the compassionate-use program are reported by their physicians to be doing well.”
Although Kolbert does not voice his sentiments about the lawsuit over Omidria, he calculates “modest” revenues for the drug of $150 million in 2024. He notes that the drug is now in “full launch mode.”
Thomas Yip of MLV & Co. also weighed in on Omeros on today, reiterating a Buy rating on the pharmaceutical company with a $38 price target. Yip discussed the company’s new positive data, noting, “While this positive dataset represents a small sample size and a larger trial would be necessary to confirm these preliminary findings, these data should set a positive tone as Omeros plans to begin Phase III discussions with the FDA later this year.” Although Soliris, a drug by Alexion, is currently the only FDA-approved treatment for aHUS, Yip believes “OMS721 could overtake Soliris as the leader in aHUS.”
Lastly, Yatin Suneja of Cowen & Co. reiterated an Outperform rating on the company, though the analyst did not provide a price target. Suneja commented on Omeros’s new data, noting that although the study only covered three patients, the data is “compelling and show[s] that ‘721 could potentially have a role in aHUS.” The analyst highlights four takeaways from the study, first noting the “clear clinical benefit observed across TMA disease markers in all three aHUS patients” and secondly noting the improved platelet count in all three patients. Third, Suneja observed, “one aHUS patient was dialysis-free throughout OMS721 treatment, while no new dialysis was required for the other two patients, is an evidence of a significant clinical benefit.” Lastly, the analyst noted that the study was only 28 days so it is “possible that re-treatment and/or longer duration of treatment could be associated with even more profound benefit.”
According to TipRanks, four analysts have rated Omeros in the last three months. All four of them are bullish on the stock with an analyst consensus of Strong Buy. As of this writing, the average 12-month price target for OMER is $49.25, marking a 108% potential upside from where the stock is currently trading.