Fate Therapeutics (NASDAQ:FATE) Azioni

Fate Therapeutics

Fate Therapeutics Inc is a clinical-stage biopharmaceutical company based in the United States. It is engaged in the development of programmed cellular immunotherapies for cancer and autoimmune disorders. The company's cell therapy pipeline is comprised of NK- and T-cell immuno-oncology programs, including off-the-shelf engineered product candidates derived from clonal master iPSC lines, and immuno-regulatory programs, including product candidates to prevent life-threatening complications in patients.

Fate Therapeutics Inc

WIIM

FATE

​Fate Therapeutics shares are trading higher after the FDA recently granted Regenerative Medicine Advanced Therapy designation to FT819.

–&nbsp; &nbsp;Recognizes potential of off-the-shelf CAR T-cell therapy to address significant unmet need and enables increased dialogue with FDA throughout the development process
–&nbsp; &nbsp;RMAT review by FDA included initial clinical safety and activity data from ongoing Phase 1 study of FT819 in SLE &nbsp;
–&nbsp; &nbsp;Additional Phase 1 clinical data of FT819 to be presented at medical conferences in 2025

Biotech

General

Fate Therapeutics Wins Regenerative Medicine Advanced Therapy Designation From FDA For FT819 To Treat Moderate To Severe Systemic Lupus Erythematosus

Stifel analyst Benjamin Burnett maintains Fate Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/FATE#NASDAQ">FATE</a>) with a Hold and lowers the price target from $5 to $3.

News

Price Target

Analyst Ratings

Stifel Maintains Hold on Fate Therapeutics, Lowers Price Target to $3

Wedbush analyst David Nierengarten reiterates Fate Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/FATE#NASDAQ">FATE</a>) with a Neutral and maintains $5 price target.

Reiteration

Wedbush Reiterates Neutral on Fate Therapeutics, Maintains $5 Price Target

Wells Fargo analyst Yanan Zhu maintains Fate Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/FATE#NASDAQ">FATE</a>) with a Equal-Weight and lowers the price target from $5 to $4.

Wells Fargo Maintains Equal-Weight on Fate Therapeutics, Lowers Price Target to $4

Needham analyst Gil Blum reiterates Fate Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/FATE#NASDAQ">FATE</a>) from Hold to Hold.

Needham Reiterates Hold on Fate Therapeuticsto Hold

Fate Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/FATE#NASDAQ">FATE</a>) reported quarterly losses of $(0.44) per share which missed the analyst consensus estimate of $(0.43) by 2.33 percent. This is a 2.22 percent increase over losses of $(0.45) per share from the same period last year. The company reported quarterly sales of $1.860 which missed the analyst consensus estimate of $1.416 million by 100.00 percent. This is a 100.00 percent decrease over sales of $1.676 million the same period last year.

Earnings

Earnings Misses

Fate Therapeutics Q4 2024 GAAP EPS $(0.44) Misses $(0.43) Estimate, Sales $1.860 Miss $1.416M Estimate

Fate Therapeutics shares are trading higher after the company unveiled its Phase 1 data for FT819 CAR T-cell therapy in systemic lupus erythematosus. Its first three patients showed rapid and sustained b-cell depletion with no dose-limiting toxicities.

Fate Therapeutics Unveils Phase 1 Data For FT819 CAR T-Cell Therapy In Systemic Lupus Erythematosus; First Three Patients Show Rapid And Sustained B-Cell Depletion With No Dose-Limiting Toxicities, One Patient Achieves Six-Month Clinical Remission Free Of Immunosuppressive Therapies; Company To Expand Dose Cohort At 360M Cells Level

Bob Valamehr, Ph.D. MBA, To Become President and CEO January 1, 2025
Scott Wolchko To Retire as President and CEO after 10 years of Leadership in Pioneering iPSC-derived Cellular Immunotherapies
SAN DIEGO, Nov. 29, 2024 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/FATE#NASDAQ">FATE</a>) ("Fate Therapeutics" or the "Company"), a clinical-stage biopharmaceutical company dedicated to bringing first-in-class induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders, today announced that Scott Wolchko, the Company's President and CEO, will retire effective December 31, 2024. Fate's current President of Research and Development (R&amp;D), Bob Valamehr, Ph.D. MBA, will assume the role of President and CEO as of January 1, 2025. Fate Therapeutics will passionately continue its mission to develop novel off-the-shelf cellular immunotherapies to broadly treat patients in need.

Management

Fate Therapeutics Announces Leadership Transition; Scott Wolchko To Retire As President And CEO, Bob Valamehr To Become President And CEO January 1, 2025

U.S. stocks were lower, with the Dow Jones index falling more than 100 points on Wednesday.
Shares of Iris Energy Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/IREN#NASDAQ">IREN</a>) rose sharply during Wednesday's session on the heels of the company's first-quarter financial results. Multiple analysts raised price <a href="https://www.benzinga.com/quote/IREN/earnings">targets following the print</a>.
After the market close on Tuesday, Iris reported first-quarter Bitcoin (CRYPTO: <a class="ticker" href="https://www.benzinga.com/quote/btc/usd">BTC</a>) mining revenue of $49.6 million. The company reported a 28% increase in AI Cloud Services revenue quarter-over-quarter to $3.2 million.
Iris Energy shares jumped 30.8% to $12.51 on Wednesday.
Here are some other big stocks recording gains in today's session.
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<li>Agora, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/API#NASDAQ">API</a>) gained 26.1% to $5.98.</li>
<li>Arrowhead Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARWR#NASDAQ">ARWR</a>) shares gained 20.9% to $25.45 following FY 2024 results.</li>
<li>Murano Global Investments Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNO#NASDAQ">MRNO</a>) jumped 18.4% to $11.13.</li>
<li>Kingsoft Cloud Holdings Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/KC#NASDAQ">KC</a>) gained 17.1% to $6.99.</li>
<li>Urban Outfitters, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/URBN#NASDAQ">URBN</a>) shares surged 16% to $46.58 following third-quarter earnings. Citigroup upgraded the stock to Buy following the report.</li>
<li>Bit Digital, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BTBT#NASDAQ">BTBT</a>) gained 14.4% to $4.2802.</li>
<li>Fate Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/FATE#NASDAQ">FATE</a>) gained 14.4% to $3.0650.</li>
<li>Hut 8 Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HUT#NASDAQ">HUT</a>) shares jumped 12.8% to $27.56.</li>
<li>Archer Aviation Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ACHR#NYSE">ACHR</a>) gained 12.2% to $8.10.</li>
<li>MINISO Group Holding Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MNSO#NASDAQ">MNSO</a>) climbed 7.2% to $18.66.</li>
<li>Bloom Energy Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BE#NYSE">BE</a>) shares gained 5.8% to $27.69.</li>
<li>Ambarella, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMBA#NASDAQ">AMBA</a>) gained 5% to $71.82 after the company on Tuesday reported a year-over-year increase in third-quarter revenue results..</li>
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Now Read This: 
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<li><a href="https://www.benzinga.com/24/11/42213467/urban-outfitters-to-rally-around-47-here-are-10-top-analyst-forecasts-for-wednesday">Urban Outfitters To Rally Around 47%? Here Are 10 Top Analyst Forecasts For Wednesday</a></li>
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$BTC

ACHR

AMBA

ARWR

BTBT

IREN

MNSO

MRNO

URBN

Iris Energy, Arrowhead Pharmaceuticals, Urban Outfitters And Other Big Stocks Moving Higher On Wednesday

Needham analyst Gil Blum reiterates Fate Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/FATE#NASDAQ">FATE</a>) with a Hold.

Needham Reiterates Hold on Fate Therapeutics

Trading Ideas

Fate Therapeutics Shares Halted On Circuit Breaker To Upside, Stock Now Up 70.8%

Fate Therapeutics shares are trading higher after the company presented 6-month follow-up data on the first patient treated in its Phase 1 Autoimmunity study.

27-year-old African American-Asian Woman with Active Lupus Nephritis Achieved DORIS Clinical Remission; Patient Remains On-study, in Clinical Remission, and Free of All Immunosuppressive Therapies
Patient Treated with Fludarabine-free Conditioning and Single-dose FT819; Favorable Safety Profile with No Grade ≥3 Adverse Events and No Events of CRS, ICANS, or GvHD
Reconstituted B Cell Compartment Predominantly Consists of Naïve, Non-class Switched B Cells with Deep Depletion of Aberrant B Cells and Plasmablasts, Indicative of Immune Reset
Second Treatment Arm Adding FT819 to Maintenance Therapy without Conditioning Chemotherapy Opened for Enrollment
SAN DIEGO, Nov. 18, 2024 (GLOBE NEWSWIRE) -- &nbsp;Fate Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/FATE#NASDAQ">FATE</a>), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders, today presented initial clinical and translational data from the first patient treated in its FT819 Phase 1 Autoimmunity study for moderate-to-severe systemic lupus erythematosus (SLE) at the American College of Rheumatology (ACR) Convergence being held in Washington, D.C. The patient, a 27-year-old African American-Asian woman diagnosed with lupus nephritis (LN) over ten years ago, received fludarabine-free conditioning followed by a single dose of FT819. The patient achieved DORIS (definition of remission in&nbsp;SLE) clinical remission and LLDAS (low lupus disease activity state) as of Month 6 follow-up. The patient continues on-study, in clinical remission, and free of all immunosuppressive therapies as of a data cutoff date of November 11, 2024. FT819 is the Company's off-the-shelf, CD19-targeted, 1XX CAR T-cell product candidate comprised of CD8αβ+ T cells with a memory phenotype and high CXCR4 expression to promote tissue trafficking.

Fate Therapeutics Presents 6-Month Follow-Up Data On First Patient Treated In Phase 1 Autoimmunity Study With Fludarabine-Free Conditioning And FT819 Off-The-Shelf, 1XX CAR T-Cell Product Candidate At ACR Convergence

Fate Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/FATE#NASDAQ">FATE</a>) reported quarterly losses of $(0.40) per share which beat the analyst consensus estimate of $(0.42) by 4.76 percent. This is a 13.04 percent increase over losses of $(0.46) per share from the same period last year. The company reported quarterly sales of $3.07 million which beat the analyst consensus estimate of $1.32 million by 132.00 percent. This is a 58.13 percent increase over sales of $1.94 million the same period last year.

Earnings Beats

Fate Therapeutics Q3 EPS $(0.40) Beats $(0.42) Estimate, Sales $3.07M Beat $1.32M Estimate

<ul>
<li>Novel H2CasMab-2 Antigen Binding Domain Shown to Preferentially Target HER2 Expressed on Tumor Cells in Preclinical Studies</li>
<li>Initial Low-Dose Cohort of FT825 / ONO-8250 as Monotherapy Shows Favorable Safety Profile in Phase 1 Solid Tumor Study</li>
<li>Peripheral Blood from First Three Patients Demonstrates CAR T-cell Expansion with Maintenance of Activated State at Day 8 Following Treatment</li>
</ul>

Reported Saturday, Fate Therapeutics Showcases Cancer-Selective HER2-Targeting Profile Of FT825/ONO-8250 CAR T-Cell Therapy For Advanced Solid Tumors At SITC 2024

HC Wainwright &amp; Co. analyst Raghuram Selvaraju reiterates Fate Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/FATE#NASDAQ">FATE</a>) with a Neutral and maintains $5 price target.

HC Wainwright & Co. Reiterates Neutral on Fate Therapeutics, Maintains $5 Price Target

Health Care

Press Releases

Fate Therapeutics Presents New Phase 1 Clinical Data of FT819 Off-the-shelf, CAR T-cell Product Candidate for Systemic Lupus Erythematosus

Fate Therapeutics Reports New Employee Inducement Awards Under Nasdaq Listing Rule 5635(c)(4)

Fate Therapeutics to Present at Upcoming Investor Conferences

Fate Therapeutics Reports New Employee Inducement Award Under Nasdaq Listing Rule 5635(c)(4)

Fate Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Business Updates

Stem Cell Stocks on the Rise: Companies Driving the $48 Billion Market Boom

Stem Cell Innovators: 4 Companies Advancing Regenerative Medicine

Fate Therapeutics Receives Regenerative Medicine Advanced Therapy (RMAT) Designation from FDA for FT819 to Treat Moderate to Severe Systemic Lupus Erythematosus (SLE)

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Fate Therapeutics

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