Fate's (FATE) ProTmune Gets Fast Track Status, Stock Up
Zacks Investment Research | Jun 20, 2016 11:46PM ET
Fate Therapeutics, Inc.’s (NASDAQ:FATE) shares were up 19% after the company announced that it has received Fast Track designation from the FDA for ProTmune for the reduction of incidence and severity of acute graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic cell transplantation (HCT).
We note that the FDA grants Fast Track status to facilitate the development and quicken the review process for the candidates that are being developed for the treatment of serious conditions that have an unmet medical need.
Currently, Fate is evaluating ProTmune in an open-label phase I/II study for the prevention of acute GvHD and cytomegalovirus infection.
Additionally, the company announced that it has started enrolling patients in a multi-center, randomized, controlled phase I/II study evaluating ProTmune for the treatment of adults suffering from hematologic malignancies.
According to the Center for International Blood and Marrow Transplant Research, every year about 30,000 allogeneic HCT procedures are performed globally on patients afflicted with acute GvHD. Given the absence of FDA-approved preventive therapies, there remains a strong unmet need for drugs for the treatment of acute GvHD in patients undergoing HCT.
Fate is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) and Retrophin, Inc. (NASDAQ:RTRX) – both sporting a Zacks Rank #1 (Strong Buy) and Acorda Therapeutics, Inc. (NASDAQ:ACOR) – carrying a Zacks Rank #2 (Buy).
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