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FATE

Fate Therapeutics

$22.04

0.11 (0.50%)

08:17
01/13/20
01/13
08:17
01/13/20
08:17

Fate Therapeutics announces expansion of FT516 clinical investigation

Fate Therapeutics announced that the U.S. Food and Drug Administration has allowed its second Investigational New Drug application for FT516, the Company's off-the-shelf natural killer cell product candidate derived from a clonal master induced pluripotent stem cell 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 therapy across a broad range of solid tumors. FT516 expresses a novel high-affinity, non-cleavable variant of CD16 that enhances its binding to therapeutic antibodies and prevents its down-regulation, which can significantly inhibit anti-tumor activity. A publication by scientists from the Company, the University of Minnesota, and the University of California, San Diego in the journal Blood, entitled "Pluripotent stem cell-derived NK cells with high-affinity non-cleavable CD16a mediate improved anti-tumor activity," highlights preclinical proof-of-concept data for FT516. In the published studies, iPSC-derived NK cells expressing hnCD16 were shown to have superior therapeutic properties in vitro, including maintenance of CD16 expression and increased levels of cytokine production upon activation, compared to peripheral blood NK cells sourced from healthy donors. In an in vivo systemic tumor model of human lymphoma, treatment with iPSC-derived hnCD16 NK cells plus anti-CD20 mAb resulted in a significant improvement in survival compared to treatment with anti-CD20 mAb alone or in combination with peripheral blood NK cells sourced from healthy donors. Additionally, iPSC-derived hnCD16 NK cells plus anti-HER2 mAb also conveyed a survival benefit in a xenograft model of SKOV-3 ovarian carcinoma. FT516 is the first-ever cell therapy in the world derived from a genetically engineered pluripotent stem cell cleared for clinical testing. The Company intends to initiate clinical investigation of FT516 in combination with tumor-target antibody therapy in solid tumors later this year. The Company is currently conducting an open-label, multi-dose Phase 1 clinical trial of FT516 as a monotherapy for the treatment of acute myeloid leukemia and in combination with CD20-directed mAbs for the treatment of advanced B-cell lymphoma.

FATE Fate Therapeutics
$22.04

0.11 (0.50%)

12/09/19
12/09/19
UPGRADE

Fly Intel: Top five analyst upgrades
Catch up on today's top five analyst upgrades with this list compiled by The Fly: 1. Qorvo (QRVO) and Skyworks (SWKS) double upgraded to Buy from Underperform at BofA/Merrill. 2. Fate Therapeutics (FATE) upgraded to Outperform from Market Perform at Wells Fargo with analyst Jim Birchenough citing this weekend's update for the company's iPSC-derived NK-cell therapeutics pipeline, initial data for iPSC NKcell therapies FT500 and FT516, and updated comments on CD19 CAR-NK therapeutic FT596. 3. Wingstop (WING) upgraded to Conviction Buy from Buy at Goldman Sachs with analyst Katherine Fogertey saying while the shares are up over 30% over the past year, they have lagged the S&P 500 by over 30% since August 22 and now trade at a discount to peers. 4. Huntsman (HUN) and Fortive (FTV) upgraded to Buy from Neutral at Citi. 5. Dow Inc. (DOW) and Kraton (KRA) upgraded to Buy from Hold at SunTrust. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
12/30/19
MZHO
12/30/19
NO CHANGE
Target $33
MZHO
Buy
Fate Therapeutics price target raised to $33 from $27 at Mizuho
Mizuho analyst Mara Goldstein raised her price target on Fate Therapeutics to $33 and kept her Buy rating, saying she is positive on the company's iPSC-derived NK cell portfolio driving its valuation. The analyst contends that Fate Therapeutics' American Society of Hematology presentations were "validating" for its technology, given the expectations of the transition of the company's candidates into the clinic over the next 12-24 months.
01/09/20
BMOC
01/09/20
DOWNGRADE
Target $22
BMOC
Market Perform
Fate Therapeutics downgraded to Market Perform from Outperform at BMO Capital
BMO Capital analyst Do Kim downgraded Fate Therapeutics to Market Perform from Outperform with an unchanged price target of $22. The "clean" iPSC safety and positive FT516 efficacy expectations are fully reflected in the shares, Kim tells investors in a research note. The analyst sees greater downside risk to 2020 clinical updates and views the Fate's IPSC opportunity as fairly valued.
01/09/20
01/09/20
DOWNGRADE

Fly Intel: Top five analyst downgrades
Catch up on today's top five analyst downgrades with this list compiled by The Fly: 1. Tesla (TSLA) downgraded to Neutral from Outperform at Baird wiht analyst Ben Kallo saying Tesla's risk/reward is more balanced following the recent stock appreciation. 2. Boeing (BA) downgraded to Hold from Buy at Berenberg with analyst Andrew Gollan saying the grounding of the 737 Max has lasted "far longer" than expected, and Boeing's decision to halt production adds uncertainty regarding the plane's restoration timing and costs. 3. Fate Therapeutics (FATE) downgraded to Market Perform from Outperform at BMO Capital with analyst Do Kim saying the "clean" iPSC safety and positive FT516 efficacy expectations are fully reflected in the shares. 4. Organigram (OGI) downgraded to Market Perform from Outperform at Raymond James. 5. Trupanion (TRUP) downgraded to Hold from Buy at Stifel with analyst Jonathan Block saying he continues to believe in the long-term story surrounding medical insurance for companion animals. However, the stock has run in a short period of time, and the competitive landscape may possibly intensify, which could exert more demands on out-year pet acquisition cost. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.

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