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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.

Rhea-AI Summary
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA): FDA Priority Review of Biologics License Application (BLA) for lifileucel in advanced melanoma is on track for potential approval and launch in 2023. The company reported second quarter and first half 2023 financial results, including corporate updates. The TIL program for post-Anti-PD-1 non-small cell lung cancer is advancing into registrational development.
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Iovance Biotherapeutics announced the oral and poster presentations of clinical and preclinical data for tumor infiltrating lymphocyte (TIL) therapies at the IASLC 2023 World Conference on Lung Cancer. The presentations will include data from the Phase 2 clinical trial of LN-145 in combination with pembrolizumab in anti-PD1-naïve advanced non-small cell lung cancer (NSCLC).
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Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) will report its second quarter 2023 financial results on August 8, 2023. The company focuses on developing polyclonal tumor infiltrating lymphocyte therapies for cancer patients. A conference call and live webcast will be held at 4:30 p.m. ET. Registration is required to participate.
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Iovance Biotherapeutics, Inc. announced the approval of the grant of inducement stock options to 8 new non-executive employees. The options cover an aggregate of 71,800 shares of Iovance's common stock and have an exercise price of $7.62. The options vest over a three-year period, with one-third of the shares vesting on the first anniversary of the employee's start date and the remaining shares vesting in eight quarterly installments over the next two years.
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Iovance Biotherapeutics has closed an underwritten public offering of 23 million shares of its common stock at a price of $7.50 per share, raising $172.5 million. The company plans to use the proceeds for various purposes, including preparing for the commercial launch of lifileucel and supporting ongoing clinical programs.
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Iovance Biotherapeutics, Inc. announces the pricing of an underwritten public offering of its common stock at $7.50 per share, with expected gross proceeds of approximately $150 million. The company intends to use the proceeds for various purposes including the commercial launch of lifileucel and the expansion of TIL and immune checkpoint inhibitors.
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Iovance Biotherapeutics receives positive FDA feedback for IOV-LUN-202 trial design in post-anti-PD-1 NSCLC. Preliminary data shows a 26.1% objective response rate with a disease control rate of 82.6%. Enrollment of approximately 120 patients expected to be complete by H2 2024.
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Iovance Biotherapeutics has announced the randomization of the first patient in its Phase 3 trial for TIL therapy lifileucel in combination with pembrolizumab. The trial aims to evaluate the efficacy of this combination in frontline advanced melanoma. This trial is expected to provide important insights into the Iovance platform approach for TIL and anti-PD-1 therapy combinations in solid tumors.
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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)
Link
United States of America
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