Fate Therapeutic Stock Price, News & Analysis

Fate Therapeutics (NASDAQ: FATE) has announced that it will present clinical data from its Phase 1 trial of FT819, an off-the-shelf CD19-targeted CAR T-cell therapy, for systemic lupus erythematosus (SLE) at the EULAR 2025 Congress in Barcelona. The study evaluates FT819's safety and activity using either a fludarabine-free conditioning regimen or maintenance therapy without conditioning.

The company will deliver an oral presentation on treating refractory SLE with their iPSC-derived therapy, along with two poster presentations focusing on next-generation CAR T-cells and CAR-NK cell therapy. These presentations highlight Fate's innovative approaches, including Sword and Shield technology and multi-antigen targeting, aimed at eliminating the need for conditioning chemotherapy and enabling outpatient treatment.

Fate Therapeutics (NASDAQ: FATE), a clinical-stage biopharmaceutical company focused on iPSC-derived cellular immunotherapies, has granted restricted stock units (RSUs) to two new non-executive employees. The RSUs, representing 30,400 shares of common stock, were approved by the Compensation Committee and granted under the Company's Amended and Restated Inducement Equity Plan. The grants comply with Nasdaq Listing Rule 5635(c)(4) and will vest over four years, with 25% vesting annually, contingent on continued employment.

Fate Therapeutics announced five presentations featuring their innovative iPSC-derived off-the-shelf CAR T-cell therapy platform at the upcoming ASGCT Annual Meeting in New Orleans. The highlight is an oral presentation on FT522, their groundbreaking CD19-targeted CAR NK cell product for B-cell lymphoma treatment.

Key developments include:

• First product incorporating Alloimmune Defense Receptor (ADR) technology, designed to eliminate the need for conditioning chemotherapy
• Four additional poster presentations covering applications in autoimmune diseases, hematological malignancies, and solid tumors
• Introduction of FT836, a novel MICA/B-targeting CAR T-cell therapy for solid tumors

The presentations will showcase both clinical and preclinical data, demonstrating the company's progress in developing chemotherapy-free cell therapies across multiple indications.

Fate Therapeutics (NASDAQ: FATE) has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for its FT819 therapy, an off-the-shelf CAR T-cell treatment for moderate to severe systemic lupus erythematosus (SLE).

The RMAT designation was granted based on initial clinical safety and activity data from an ongoing Phase 1 study. The trial evaluates a fludarabine-free conditioning regimen with either bendamustine or cyclophosphamide alone, followed by a single FT819 dose. The company is currently expanding dosing to up to 10 patients at 360 million cells and assessing safety at 900 million cells.

The development is supported by a $7.9 million grant from the California Institute of Regenerative Medicine. Additional Phase 1 clinical data will be presented at medical conferences in 2025. The RMAT designation enables expedited development and review, including potential accelerated approval pathways and priority review.

Fate Therapeutics (NASDAQ: FATE), a clinical-stage biopharmaceutical company focused on iPSC-derived cellular immunotherapies for cancer and autoimmune diseases, has announced new employee inducement awards. The company granted restricted stock units (RSUs) for 32,200 shares of common stock to two newly-hired non-executive employees on April 1, 2025.

The grants, approved by the Compensation Committee under the Company's Amended and Restated Inducement Equity Plan, will vest over four years, with 25% vesting annually on each grant date anniversary. The awards comply with Nasdaq Listing Rule 5635(c)(4) and are contingent on continuous employment through each vesting date.

VALERIO THERAPEUTICS, a French pharmaceutical company headquartered in Paris, has disclosed information regarding its board members' positions in other companies as of March 19, 2025. The company, which operates with a share capital of €21,610,998.20, is structured as a société anonyme (French public company) with a board of directors. The company's registered office is located at 49 boulevard du Général Martial Valin in Paris's 15th arrondissement.

Fate Therapeutics (NASDAQ: FATE) reported its Q4 and full year 2024 financial results, highlighting significant progress in its clinical programs. The company has initiated Phase 1 dose expansion for its FT819 off-the-shelf CAR T-cell product in SLE patients, using a fludarabine-free conditioning regimen.

Key developments include successful treatment of the first patient with FT819 without conditioning chemotherapy, completion of a Type D FDA meeting enabling expansion to additional autoimmune diseases, and advancement of the FT825/ONO-8250 program in solid tumors. The company presented promising clinical data for both FT819 and FT825 programs at major medical conferences.

Financial highlights:

• Cash position: $306.7 million as of December 31, 2024
• Q4 2024 revenue: $1.9 million
• Operating expenses: $63.6 million
• Projected runway through year-end 2026