Following the release of its Q3 financial data, Omeros Corporation (NASDAQ: OMER) saw a significant increase in the price of its shares on the US stock charts. OMER stock surged 49.64% to $6.27 per share as of the most recent check. Despite persistent difficulties, this significant rise follows a rather strong financial performance.
Profitability and Losses
Compared to the $37.8 million loss, or $0.60 per share, recorded during the same period in 2023, Omeros’ Q3 2024 net loss of $32.2 million, or $0.56 per share, was an improvement. Significant costs were made by the firm throughout the year, including a $21.2 million payment for the buyback of debt associated with term loans and a $18.4 million charge for the supply of the therapeutic ingredient narsoplimab. At the same time, Omeros paid $1.9 million in term loan transaction expenses.
Development of Narsoplimab Progress
In a noteworthy move, Omeros and the FDA met well in September to talk about the biologics license application (BLA) for narsoplimab. The meeting yielded minor feedback on the statistical analysis plan for the primary endpoint, which involves comparing patient survival in a pivotal trial to an external registry.
Omeros promptly revised and resubmitted the plan, expecting an imminent response from the FDA. Should the revised plan align with FDA expectations, the company intends to proceed with efficacy analyses, which will be integral to the resubmission of the BLA.
Plans for European Approval and Future Developments
In addition, Omeros is getting ready to submit the narsoplimab marketing authorization application (MAA) to the European Union in the first half of 2025. In addition, discussions with the FDA and European regulators in September and October focused on the Phase 3 program for zaltenibart in paroxysmal nocturnal hemoglobinuria (PNH).
Both agencies endorsed the design of the proposed studies, the dose-finding strategy, and other elements of the development plan. With regulatory guidance in place, Omeros is on track to initiate Phase 3 enrollment for zaltenibart in early 2025.
