Gamida Cell surges after FDA approves cancer treatment

Gamida Cell  credit: EYal Izhar
Gamida Cell credit: EYal Izhar

Gamida Cell's Omisirge shortens treatment times and reduces risk in stem cell transplant therapies.

The US Food and Drug Administration (FDA) has approved a cancer treatment of Israeli company Gamida Cell (Nasdaq: GMDA). In response to the announcement, the company’s share price soared nearly 40% yesterday, bringing its market cap to $91 million. This is the second Israeli drug based on a new mechanism to receive approval for use in the US this year, after years of drought for approvals of new drugs. In January, MediWound received approval for its burns treatment.

Gamida Cell, which has its production facilities in Israel and is headed by Abigail Jenkins, plans to market the product independently among the clinics that carry out most of the treatments in the US in the company’s field, which is improving the chances of success of implanting a new immune system through umbilical cord blood transplantation.

In a clinical trial, Gamida Cell demonstrated that its product, Omisirge, shortens the time required to absorb the transplanted immune system from 22 days to 12 says. This is a significant saving, since this time is costly for the transplant center and dangerous for the patient, who has no active immune system. The trial also demonstrated a decline in the incidence of infections in patients and shorter hospitalization periods.

The company believes that the product will gain additional market share among those who are candidates for umbilical cord blood transplantation: transplants from a matched adult donor, from a non-matched donor, and communities that at present are not treated because no donor can be found (chiefly the African-American community).

A market survey carried out by the company found that doctors believe that the product can shorten treatment time versus a donation from a matched source and prevent side effects in comparison with a donation from a non-matched source. A comparison of the company’s clinical trial results with real world data indicates that, in comparison with a matched donor, Gamida Cell’s transplant is absorbed faster.

Gamidal Cell recently announced extensive layoffs and the suspension of development of other promising products in its pipeline in order to reach the marketing stage with sufficient cash.

The company’s advantage and disadvantage are its small market. It believes that the product could be relevant to 10,000 patients a year, in 70 medical centers that can be covered by 25 salespeople. Nineteen of these centers already have experience with the product from the clinical trials or in a pre-approval treatment program for humanitarian cases - a program considered a positive indication that approval will be granted.

In order to generate reasonable revenue, the company will have to price its product high. Will the insurance companies accept high pricing? Gamida Cell’s card in this respect is the saving in hospitalization time and in complications. In any event, obtaining insurance coverage is likely to take time, and the company will have to be prepared to finance some of the procedures itself at first, in order to help the product gain momentum.

"FDA approval of Omisirge is a major advancement in the treatment of patients with hematologic malignancies that we believe may increase access to stem cell transplant and help improve patient outcomes," said Jenkins. "We are grateful to all the clinicians, patients and the entire Gamida Cell team without whom this approval would not have been possible. We also acknowledge the key role the FDA has played in supporting the development of Omisirge and other innovative and potentially life-saving cell therapies for patients with cancer and other serious diseases."

Published by Globes, Israel business news - - on April 18, 2023.

© Copyright of Globes Publisher Itonut (1983) Ltd., 2023.

Gamida Cell  credit: EYal Izhar
Gamida Cell credit: EYal Izhar
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