USFDAApr 30, 2026, 08:09 AM
OMER YARTEMLEA FDA Approved; Zaltenibart Deal
AI Summary
Omeros Corporation announced the FDA approval of YARTEMLEA (narsoplimab) for TA-TMA, a first-in-class therapy, with commercial launch beginning in January 2026. The company also completed the sale of zaltenibart to Novo Nordisk for $240 million upfront, with potential for up to $2.1 billion plus royalties. These achievements, along with a registered direct offering, enabled a significant strengthening of the balance sheet, reducing aggregate principal debt by 46.7% to $87.9 million by December 31, 2025, and increasing cash to $171.8 million. The company also advanced its PDE7 inhibitor, oncology, and infectious disease programs.
Key Highlights
- YARTEMLEA (narsoplimab) received FDA approval on December 23, 2025, for TA-TMA.
- Commercial launch of YARTEMLEA in the U.S. market began in January 2026.
- Sold zaltenibart to Novo Nordisk for $240M upfront, potential $2.1B total plus royalties.
- Aggregate principal debt reduced by 46.7% to $87.9M as of December 31, 2025.
- Cash, cash equivalents, and short-term investments totaled $171.8M.
- Received over $4M from NIDA for PDE7 inhibitor program (OMS527).
- OncotoX-AML program advanced, with first-in-human trial slated for late 2027.
- T-CAT infectious disease platform made substantial strides in 2025.