The application includes outcomes from more than 130 patients treated under an expanded access program, supporting broader regulatory momentum for narsoplimab.

Omeros Corporation has filed a marketing authorization application (MAA) with the European Medicines Agency (EMA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA).

The MAA is based on response-evaluable analyses of patients treated with narsoplimab and a comparison of overall survival with a well-matched external control group. 

According to the company, the submission shows a 61% response rate and a three-fold improvement in overall survival in the narsoplimab cohort. 

It also incorporates outcomes from over 130 patients treated under Omeros’ expanded access program.

Following the news, H.C. Wainwright reiterated a ‘Buy’ rating and $9 price target on the stock. 

Analyst Brandon Folkes wrote that the EMA submission supports the view that Omeros “may be entering a phase of rerating” over the next 12 months, driven by potential U.S. approval, EU approval, and renewed appreciation for the broader pipeline. 

The firm expects narsoplimab to secure regulatory clearance in both regions, creating “significant value” for the company.

On Stocktwits, retail sentiment was ‘bullish’ amid ‘high’ message volume.

Retail investors voiced concerns after Omeros Corporation’s June 27 shareholder meeting, during which audio reportedly cut out during two critical questions on the company's regulatory outlook.

One user claimed that approximately 80 seconds of the meeting, covering responses to questions about the status of the biologics license application (BLA) and the FDA’s ability to meet its PDUFA timeline, were missing from both the live broadcast and its replay. 

“We, as shareholders, deserve to hear the complete responses,” they wrote, adding that Omeros has “a HUGE shareholder relations/communication problem.”

Another investor said they emailed Omeros directly, describing the audio loss during the “most important two questions regarding FDA approval” as “beyond embarrassing.” 

The user called for a full update and transcript, writing: “Please do the right thing here… Many, many investors are asking and suspicious.”

Omeros' stock has declined 67.5% so far in 2025.

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