Gamida Cell Ltd.: directors' dealings · United States · SEC (Form 4)

About Gamida Cell Ltd.

Gamida Cell Ltd. is a specialty biopharmaceutical company focused on allogeneic cell therapies and hematology/transplant medicine. The company is listed on the NASDAQ market in the United States, and its profile is shaped by a highly focused commercial and scientific strategy rather than by a broad diversified drug portfolio. Gamida Cell’s historical roots are tied to Jerusalem, Israel, while the U.S. remains the key commercial and regulatory market for its approved products and FDA-driven expansion plans. ([gamida-cell.com](https://www.gamida-cell.com/?utm_source=openai)) Founded in 1998, the company has spent more than two decades building expertise around its proprietary nicotinamide (NAM) technology, which is designed to enhance and expand cells for potential therapeutic use. Management describes Gamida Cell as a cell therapy pioneer with deep capabilities across research, development, manufacturing, and commercialization. That long operating history matters because it supports the company’s credibility in a field where clinical differentiation, manufacturing reproducibility, and regulatory execution are critical. ([gamida-cell.com](https://www.gamida-cell.com/who-we-are/?utm_source=openai)) The commercial story today is centered on two FDA-approved products in the U.S.: OMISIRGE (omidubicel-onlv) and APHEXDA (motixafortide). OMISIRGE is a nicotinamide-modified allogeneic hematopoietic progenitor cell therapy derived from cord blood. It is indicated for adults and pediatric patients 12 years and older with hematologic malignancies following myeloablative conditioning, as well as for patients with severe aplastic anemia following reduced-intensity conditioning. APHEXDA is approved in combination with filgrastim to mobilize hematopoietic stem cells into peripheral blood for collection and subsequent autologous transplantation in multiple myeloma. Together, these products define the company’s current revenue opportunity and its position in transplant-supportive hematology. ([gamida-cell.com](https://www.gamida-cell.com/our-therapies/?utm_source=openai)) From a competitive standpoint, Gamida Cell operates in a niche but high-barrier segment. The company’s moat is built on clinical data, regulatory approvals, and operational know-how rather than scale. It also has a wholly owned, fully licensed GMP manufacturing facility in Israel and a strategic partnership with RoslinCT for future OMISIRGE manufacturing in Hopkinton, Massachusetts, underscoring the importance of U.S.-based supply chain capacity and the complexity of cell therapy manufacturing. In practical terms, Gamida Cell competes as a specialized transplant and cell-therapy platform against larger hematology players with broader commercial reach. ([gamida-cell.com](https://www.gamida-cell.com/our-rd/?utm_source=openai)) Recent developments have been particularly important. In December 2025, the FDA approved OMISIRGE for severe aplastic anemia, expanding the product’s addressable patient population beyond hematologic malignancies. In February 2026, the FDA also approved a labeling supplement that removed the “do not open until thaw” instruction from the package insert and cassette labeling, a relatively small but operationally relevant update. For investors in French-speaking markets, Gamida Cell therefore remains a NASDAQ-listed U.S. biotech with a concentrated product base, a strong regulatory narrative, and a growth profile tied to commercial uptake, manufacturing scalability, and continued label expansion. ([gamida-cell.com](https://www.gamida-cell.com/press_release/fda-approves-omisirge-as-first-approved-cell-therapy-to-treat-severe-aplastic-anemia/?utm_source=openai))