Elbit Imaging (EMITF) Announces Gamida's NiCord Received FDA Breakthrough Therapy Designation
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Elbit Imaging Ltd. (Nasdaq: EMITF) announced that it was informed by Gamida Cell Ltd. ("Gamida"), an indirect associate of the Company, that U.S. Food and Drug Administration ("FDA") has granted Breakthrough Therapy Designation status to Gamida's NiCord® ("Nicord"), due to improvement in absorption of neutrophils blood cells in bone marrow transplant for patients with high risk hematological malignancies (blood cancers).
Breakthrough therapy designation is granted to a drug that is intended to treat serious or life-threatening diseases, and that preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies.
A breakthrough therapy designation entitles the company to various benefits, such as: intensive FDA guidance, involvement of senior FDA managers in the process, option for a FDA rolling review of Nicord marketing approval application in the U.S (i.e. the FDA may agree to review parts of the application file which are submitted in phases, with no obligation of filling the whole file prior to the review commencement).
Gamida is engaged in developing cellular and immune therapies for the treatment of cancer and orphan genetic diseases. Gamida's products are examined via clinical trials for treatment of patients with hematological malignancies (blood cancers) such as leukemia and lymphoma and genetic hematological diseases such as sickle cell disease and thalassemia.
At this stage, Gamida is unable to estimate the implications of the Breakthrough Therapy Designation regarding the future development of Nicord. In addition, as of today, the development of Nicord is not completed and there is no certainty that Nicord will be marketed on a commercial basis.
The Company holds approximately 89.9% of the share capital of Elbit Medical Technologies Ltd. (TASE:EMTC-M) (86.2% on a fully diluted basis) which, in turn, holds approximately 25% of the share capital in Gamida (22.5% on a fully diluted basis).
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