Gamida Cell developed omidubicel, the nicotinamide-expanded cord blood therapy approved by the FDA in 2023 to speed neutrophil recovery after transplant in patients with blood cancers.
Gamida Cell, founded in Israel in 1998 with a plant at Kiryat Gat and later a Boston address, developed a nicotinamide-based method for expanding cord blood stem cells outside the body. Its product omidubicel (Omisirge) was approved by the FDA on 17 April 2023 to shorten neutrophil recovery and reduce infections after umbilical cord blood transplantation in patients aged 12 and over with haematologic malignancies; the current label, effective February 2026, adds a second indication in severe aplastic anaemia from age 6.
Approval did not save the company. A restructuring agreement with Highbridge Capital in March 2024 converted debt to equity on terms stating that the outstanding ordinary shares were expected to be cancelled; a Chapter 15 petition in Delaware in April 2024 recognised an Israeli debt-arrangement proceeding before the Be'er Sheva District Court, whose May 2024 judgment provided that creditors be repaid in full while shareholders' rights were voided. Nasdaq delisting took effect on 6 May 2024 and the company deregistered from SEC reporting later that month. It is now held through Ayrmid Ltd, which since November 2024 also holds the US rights to BioLineRx's motixafortide, so one owner sits behind both Israeli stem-cell-transplant products. Company facts are from the FDA approval record and the SEC filings.
An expanded umbilical cord blood graft that shortens the dangerous wait for neutrophils to return after a transplant for blood cancer, the first cell therapy approved to speed engraftment.
Motixafortide is an injection given with G-CSF before stem cell collection in people with multiple myeloma, approved in the United States in 2023, so that enough stem cells for an autologous transplant can be harvested in one or two sessions.
Shares Myelodysplastic syndromes / neoplasms (MDS), Acute myeloid leukaemia and the tag fda-oce-applicant.
Shares Myelodysplastic syndromes / neoplasms (MDS) and the tag fda-oce-applicant.
Shares Myelodysplastic syndromes / neoplasms (MDS), Acute lymphoblastic leukaemia, Acute myeloid leukaemia.
Shares Myelodysplastic syndromes / neoplasms (MDS), Acute lymphoblastic leukaemia, Acute myeloid leukaemia.
Shares Myelodysplastic syndromes / neoplasms (MDS), Acute lymphoblastic leukaemia, Acute myeloid leukaemia.
Shares Myelodysplastic syndromes / neoplasms (MDS), Acute lymphoblastic leukaemia, Acute myeloid leukaemia.
Shares Myelodysplastic syndromes / neoplasms (MDS), Acute lymphoblastic leukaemia, Acute myeloid leukaemia.
Shares Myelodysplastic syndromes / neoplasms (MDS), Acute lymphoblastic leukaemia, Acute myeloid leukaemia.