RoslinCT and Ayrmid partner to manufacture Omisirge® for FDA-approved indication
Wednesday, December 17, 2025
RoslinCT and Ayrmid have expanded their strategic partnership to support the commercial manufacture of Omisirge® (omidubicel-onlv) following its approval by the US Food and Drug Administration for a second indication in severe aplastic anaemia (SAA).
Severe aplastic anaemia (SAA) is a rare, life-threatening blood disorder in which the bone marrow fails to produce enough red cells, white cells, and platelets. This leads to fatigue, infections, and bleeding, and often requires stem cell transplantation or immunosuppressive therapy.
Omisirge® was previously approved for use in patients with haematologic malignancies. The additional FDA approval follows positive clinical trial outcomes and extends the therapy’s application to patients with severe aplastic anaemia, increasing its clinical reach.
Omisirge® is a nicotinamide-modified, allogeneic haematopoietic progenitor cell therapy derived from a young donor source and designed for ease of infusion. With the new indication, the therapy is expected to play a wider role in the treatment of serious blood disorders, while the expanded partnership supports scalable and reliable manufacturing.
Under the new commercial supply agreement, RoslinCT will carry out technology transfer and provide commercial manufacturing support for Omisirge® at its cGMP-compliant cell therapy facility in Hopkinton, Massachusetts.
The expanded arrangement is intended to strengthen long-term supply and support the product’s use across a broader group of patients with haematological conditions.
Source: businesswire.com
