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Iovance Biotherapeutics, Inc. - IOVA STOCK NEWS

Welcome to our dedicated page for Iovance Biotherapeutics news (Ticker: IOVA), a resource for investors and traders seeking the latest updates and insights on Iovance Biotherapeutics stock.

Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) is a clinical-stage biopharmaceutical company dedicated to advancing and commercializing innovative cancer immunotherapies. The company specializes in tumor-infiltrating lymphocyte (TIL) therapies, which harness the body's immune system to target and eliminate cancer cells.

Core Business: Iovance’s primary focus is on developing autologous T-cell therapies designed to treat various solid tumors. Their lead candidate, lifileucel (marketed as AMTAGVI™), has recently gained FDA approval for treating advanced melanoma. This milestone marks it as the first T-cell therapy approved for a solid tumor cancer.

Clinical Trials and Achievements: Lifileucel has shown promise in clinical trials, producing durable responses in patients with metastatic melanoma. Iovance continues to explore its efficacy in other cancers including head and neck carcinoma, cervical cancer, and non-small cell lung cancer through trials like IOV-LUN-202. Preliminary data suggests significant potential benefits, with ongoing responses and durations extending over six months.

Regulatory and Market Footprint: Iovance is preparing for further U.S. regulatory approvals and is working towards global commercialization. The FDA’s recent hold on IOV-LUN-202 due to safety concerns has not affected other trials or the priority review of lifileucel in advanced melanoma.

Manufacturing and Partnerships: With manufacturing facilities like the Iovance Cell Therapy Center (iCTC) and partnerships with entities such as WuXi Advanced Therapies, Iovance is well-equipped to scale production to meet clinical and commercial demands.

Financial Overview: The company reported a net loss of $113.0 million for Q1 2024, reflecting heavy investment in R&D and commercialization efforts. Revenue from Proleukin® sales outside the U.S. contributed $0.7 million, demonstrating ongoing diversification.

Commitment to Innovation: Iovance remains committed to pioneering advancements in cell therapy, including gene-edited approaches, to extend and improve the lives of cancer patients. For more information, please visit www.iovance.com.

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Iovance Biotherapeutics, Inc. announces the successful U.S. launch of Amtagvi™, the first and only one-time, individualized T cell therapy for solid tumor cancer. The company also reports progress in regulatory submissions for Amtagvi in the European Union, United Kingdom, and Canada. Fourth quarter and full year 2023 financial results and corporate updates were shared, highlighting healthy demand and momentum for Amtagvi.
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Iovance Biotherapeutics, Inc. (IOVA) will announce its Q4 and full-year 2023 financial results on February 28, 2024. The company focuses on developing TIL therapies for cancer patients. A conference call and webcast will discuss the results and provide a corporate update.
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WuXi Advanced Therapies Receives FDA Approval for AMTAGVI, a One-Time T Cell Therapy for Solid Tumor Cancer
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Iovance Biotherapeutics, Inc. announces the pricing of an underwritten offering of 23,014,000 shares of its common stock at $9.15 per share, aiming to raise approximately $211 million.
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Iovance Biotherapeutics, Inc. announced the approval of inducement stock options for new employees. The options cover 40,450 shares with an exercise price of $9.87 per share, vesting over a three-year period.
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Iovance Biotherapeutics, Inc. announces FDA approval for novel polyclonal TIL therapies for cancer patients. The company will host a conference call and live webcast to discuss the approval.
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Iovance Biotherapeutics, Inc. (IOVA) receives FDA approval for AMTAGVI, a groundbreaking T cell therapy for advanced melanoma. AMTAGVI is the first individualized T cell therapy for solid tumor cancer, offering hope to patients with limited treatment options. The therapy deploys patient-specific TIL cells to fight cancer, achieving deep and durable responses in clinical trials. The approval is based on safety and efficacy results from the C-144-01 trial, with 31.5% of patients achieving an objective response. AMTAGVI is manufactured at the Iovance Cell Therapy Center in Philadelphia and must be administered in Authorized Treatment Centers (ATCs). Iovance is dedicated to providing access to AMTAGVI for patients with advanced melanoma through a comprehensive support program, IovanceCares.
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Iovance Biotherapeutics, Inc. announced the approval of inducement stock options for six new non-executive employees, covering 51,375 shares of common stock. The options were granted under the 2021 Inducement Plan, with an exercise price of $7.94 and vesting over a three-year period.
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Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) announced a clinical program update for LN-145 TIL therapy in non-small lung cancer (NSCLC). The FDA placed a clinical hold on the IOV-LUN-202 trial due to a recently reported Grade 5 serious adverse event potentially related to the non-myeloablative lymphodepletion pre-conditioning regimen. This has no impact on other Iovance clinical trials and is independent of the FDA’s Priority Review of the biologics license application (BLA) for lifileucel in advanced melanoma. Preliminary data for IOV-LUN-202 was reported in July 2023, showing ongoing responses and duration of response greater than six months for 71% of the confirmed responders in the trial. The BLA remains on track toward the PDUFA action date of February 24, 2024.
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Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) granted 44,175 inducement stock options to four new non-executive employees. Each option has an exercise price of $7.89 and vests over a three-year period.
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FAQ

What is the current stock price of Iovance Biotherapeutics (IOVA)?

The current stock price of Iovance Biotherapeutics (IOVA) is $8.55 as of November 22, 2024.

What is the market cap of Iovance Biotherapeutics (IOVA)?

The market cap of Iovance Biotherapeutics (IOVA) is approximately 2.6B.

What does Iovance Biotherapeutics specialize in?

Iovance Biotherapeutics specializes in developing tumor-infiltrating lymphocyte (TIL) therapies, which are a form of autologous T-cell therapy aimed at treating solid tumors.

What is lifileucel, marketed as AMTAGVI™?

Lifileucel, marketed as AMTAGVI™, is an autologous T-cell therapy that has recently gained FDA approval for treating advanced melanoma.

What recent regulatory challenges has Iovance faced?

The FDA placed a clinical hold on the IOV-LUN-202 trial due to a fatal adverse event. However, this hold does not affect other Iovance trials or the FDA’s priority review of lifileucel in advanced melanoma.

Who are Iovance's key manufacturing partners?

Iovance partners with WuXi Advanced Therapies for the manufacturing and analytical testing of AMTAGVI. They also have their own Iovance Cell Therapy Center (iCTC) in Philadelphia.

What are the financial highlights for Iovance in Q1 2024?

Iovance reported a net loss of $113.0 million for Q1 2024, with revenue from Proleukin® sales contributing $0.7 million. The company continues to invest heavily in research, development, and commercialization efforts.

Which cancers are Iovance's TIL therapies being tested for?

Besides metastatic melanoma, Iovance’s TIL therapies are being tested for head and neck carcinoma, cervical cancer, non-small cell lung cancer, and potentially other tumor types like ovarian, breast, bladder, and colorectal cancer.

How does Iovance's TIL therapy work?

Iovance's TIL therapy involves harvesting and expanding a patient’s own tumor-infiltrating lymphocytes in a lab, then reinfusing billions of these cells to fight cancer.

What is the significance of the FDA approval of AMTAGVI™?

The FDA approval of AMTAGVI™ is significant as it marks the first T-cell therapy for a solid tumor, providing a new treatment option for patients with advanced melanoma.

What future plans does Iovance have for lifileucel?

Iovance plans to expand the use of lifileucel into other cancer indications and is currently conducting the TILVANCE-301 Phase 3 trial to support further regulatory approvals and broader market access.

Where can I find more information about Iovance Biotherapeutics?

More information about Iovance Biotherapeutics can be found on their official website at www.iovance.com.

Iovance Biotherapeutics, Inc.

Nasdaq:IOVA

IOVA Rankings

IOVA Stock Data

2.58B
276.51M
0.53%
88.05%
19.61%
Biotechnology
Biological Products, (no Disgnostic Substances)
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United States of America
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