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Biotech Stocks Facing FDA Decision In September

Mesoblast Limited
Mesoblast Limited

After a strong FDA panel backing, Mesoblast Limited’s (MESO) Ryoncil, proposed for the treatment of steroid-refractory acute graft versus host disease in children, awaits the final decision on September 30, 2020.

Ryoncil is comprised of culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor and is designed to be administered to patients in a series of intravenous infusions.

Steroid-refractory acute graft versus host disease is a potentially life-threatening complication of an allogeneic bone marrow transplant for blood cancer. Incyte Corp.’s (INCY) Jakafi is the first and only FDA-approved treatment for patients with steroid-refractory acute graft-versus-host disease (GVHD) to date.

On August 13, the FDA's Oncologic Drugs Advisory Committee had voted 9 to 1 recommending approval of Ryoncil. Although the FDA usually follows the recommendations of its advisory committees, it is not required to do so.

Ryoncil is already marketed in Japan for the treatment of children and adults with acute Graft Versus Host Disease, under the brand name Temcell, by Mesoblast's licensee JCR Pharmaceuticals Co. Ltd.

MESO closed Wednesday’s (Aug.26, 2020) trading at $18.33, up 3.79%.