Omeros Stock Soars 80% on Landmark FDA Drug Approval
YARTEMLEA becomes the first and only therapy for a rare, life-threatening complication of stem-cell transplants, marking a pivotal win for the company.
Shares of Omeros Corporation (NASDAQ: OMER) skyrocketed more than 80% in Tuesday trading after the U.S. Food and Drug Administration (FDA) approved its drug YARTEMLEA, the first-ever treatment for a dangerous and often fatal complication of stem-cell transplants.
The Seattle-based biopharmaceutical company saw its stock price climb by $7.02 to $15.77, shattering its previous 52-week high and pushing its market capitalization to over $674 million. The dramatic surge followed the agency's approval of YARTEMLEA for treating transplant-associated thrombotic microangiopathy (TA-TMA) in adult and pediatric patients aged two years and older.
TA-TMA is a rare but life-threatening condition that can occur after hematopoietic stem cell transplants, where small blood clots form in the body's capillaries and small arteries, leading to organ failure. Prior to this approval, there were no authorized treatments for the condition, representing a significant unmet medical need. The FDA's decision positions YARTEMLEA, also known as narsoplimab-wuug, as a first-in-class therapy.
"The approval removes a significant overhang for Omeros, allowing investors to refocus on the value proposition of YARTEMLEA and the company's broader pipeline," noted Brandon Folkes, an analyst at H.C. Wainwright, in a research note published Tuesday. The sentiment was echoed across Wall Street, with the average analyst price target for Omeros standing at $28.00, suggesting significant potential upside even after the day's rally.
Omeros confirmed it plans a U.S. commercial launch for YARTEMLEA in in January 2026. The company also announced it will host a conference call for investors and analysts on December 29, 2025, to discuss the approval and its commercialization strategy in detail.
The path to approval has been a multi-year journey for Omeros. YARTEMLEA, a human monoclonal antibody targeting a key protein in the immune system, had previously received a Breakthrough Therapy designation from the FDA, a status reserved for drugs intended to treat a serious condition where preliminary evidence indicates substantial improvement over available therapy.
Before today's approval, Omeros had a trailing twelve-month earnings per share of -$2.00, reflecting the high research and development costs typical of a clinical-stage biotech firm. With YARTEMLEA's validation, the company's financial outlook now shifts toward its commercial execution capabilities. Investors will be keenly watching the drug's launch and initial sales figures as a measure of Omeros's ability to capitalize on its landmark regulatory achievement and penetrate a market with no existing competition.