Fate Therapeutics Up as FDA Accepts Their New Drug Application for FT516

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Over the last trading session, shares of Fate Therapeutics (FATE) closed at $25.65, up 5.58% from the previous session. As of today, the biotech stock is up nearly 119% from a low of $11.70 set in January 2019. That’s greater than the 26% gains on the iShares NASDAQ Biotechnology ETF (IBB) and the S&P 500’s gain of 33% year over year. Wall Street is looking for further strength from the company, given its strong pipeline of drug treatments.

Fate Therapeutics, Inc., a clinical-stage biopharmaceutical company, develops programmed cellular immunotherapies for cancer and immune disorders worldwide. Its immuno-oncology product candidates include FATE-NK100, a natural killer (NK) cell cancer immunotherapy comprising adaptive memory NK cells; FT500, an induced pluripotent stem cell (iPSC)-derived NK cell product candidate for the treatment of advanced solid tumors; FT516, an iPSC-derived non-cleavable CD16 engineered NK cell product candidate to treat hematologic malignancies and solid tumors; and FT596, a chimeric antigen receptor (CAR) T-cell therapy for patients with hematologic malignancies.

The company’s immuno-oncology product candidates also include FT538, an NK cell product candidate for treating multiple myeloma; and FT819, a CAR T-cell product candidate for the treatment of liquid and solid tumors.

At the moment, the stock is moving higher on sizable news.

The U.S. FDA just accepted Fate Therapeutics second Investigational New Drug (IND) application for FT516, the company’s off-the-shelf natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line engineered to express a novel CD16 Fc receptor. This is the Company’s fourth IND from its proprietary iPSC product platform cleared by the FDA, and enables the clinical investigation of FT516 in combination with monoclonal antibody (mAb) therapy across a broad range of solid tumors.

“While monoclonal antibodies are proven therapeutic agents that are often used early in the treatment of many cancers, the functional status of the patient’s NK cells has been shown to play an important role in mediating clinical activity and prolonging survival,” said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. “In particular, stable expression of the NK cell activating receptor CD16, and its binding affinity to therapeutic antibodies, are critical to promoting antibody-dependent cellular cytotoxicity. Our first-of-kind, off-the-shelf approach with FT516 enables administration of multiple doses of CD16-engineered NK cells, and we are excited to investigate the potential of FT516 to augment the clinical efficacy of monoclonal antibody therapy in the setting of solid tumors.”

Better yet, Wells Fargo upgraded the stock to Overweight with a price target of $24.

Ian Cooper’s Personal Position in ZNGA: None

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