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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 (NASDAQ: IOVA) reported its second quarter and first half 2022 results, highlighting a net loss of $99.3 million, or $0.63 per share, compared to $81.4 million, or $0.53 per share, in Q2 2021. The company is on track to submit its first Biologics License Application (BLA) for lifileucel in metastatic melanoma, having received favorable FDA feedback. Cash reserves stand at $430.9 million, sufficient to fund operations into 2024. Increased expenses in R&D and G&A are attributed to team growth and pre-commercial activities, reflecting ongoing development in their TIL therapy pipeline.

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Iovance Biotherapeutics (NASDAQ: IOVA) will release its second quarter financial results on August 4, 2022. The company is focused on developing innovative T cell-based cancer therapies, particularly its lead product candidate, lifileucel, for metastatic melanoma. This therapy aims to be the first approved one-time cell treatment for solid tumors. Management will conduct a conference call to discuss the results, with listeners able to participate via registration. Further information is accessible on Iovance's investor relations website.

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Iovance Biotherapeutics has granted inducement stock options totaling 39,400 shares to 15 new non-executive employees as of July 21, 2022. These options, part of the 2021 Inducement Plan, have an exercise price of $12.52, matching the closing stock price on the grant date. The options will vest over three years, with one-third vesting on the first anniversary of employment and the remainder in eight quarterly installments, contingent on continued employment. Iovance aims to lead in T cell-based therapies for cancer, particularly with lifileucel for metastatic melanoma.

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Iovance Biotherapeutics approved the grant of 68,225 inducement stock options to 14 new non-executive employees on June 16, 2022. These options were issued under the 2021 Inducement Plan with an exercise price of $8.13, equal to the stock's closing price on the grant date. The options will vest over three years, with one-third vesting on the first anniversary of each employee's start date. This initiative aligns with Iovance's strategy to attract talent in the competitive biotechnology sector.

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Iovance Biotherapeutics (NASDAQ: IOVA) announced the appointment of Wendy L. Dixon, Ph.D., to its Board of Directors, effective June 10, 2022. Dr. Dixon brings over 40 years of experience in the biopharmaceutical industry, having launched more than 20 major pharmaceutical products. Chairman Iain Dukes highlighted her track record in commercial leadership, essential as Iovance prepares to submit its first Biologics License Application (BLA). Dr. Dixon expressed enthusiasm for contributing to Iovance's pipeline innovation and TIL therapy, which aims to address unmet cancer treatment needs.

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Iovance Biotherapeutics (NASDAQ: IOVA) announced its senior leadership will present at several upcoming conferences in June 2022. Key events include the Jefferies Healthcare Conference on June 9, the JMP Global Healthcare Conference on June 15, and the Goldman Sachs Global Healthcare Conference on the same day. Additionally, they will participate in the Stifel Virtual Cell Therapy Conference on June 29. Live and archived webcasts will be available on their investor calendar. Iovance focuses on developing T cell-based immunotherapies for cancer, particularly its lead product candidate, lifileucel.

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On May 26, 2022, Iovance Biotherapeutics reported clinical results from its C-144-01 study for advanced melanoma patients. In Cohort 4 (n=87), the objective response rate (ORR) was 29% with three complete responses and 22 partial responses, demonstrating the potential of lifileucel therapy in heavily pre-treated patients. Median duration of response for Cohort 4 was 10.4 months. A Biologics License Application (BLA) for lifileucel is planned for submission in August 2022. The company emphasizes the significance of these results as a new treatment option for patients with unmet medical needs.

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Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) announced the grant of inducement stock options for 146,700 shares to 17 new non-executive employees on May 19, 2022. These awards fall under Iovance's 2021 Inducement Plan, which allows for equity awards to new hires. Each option has an exercise price of $14.95, the closing price on the date of grant, and will vest over three years, contingent upon continued employment. This initiative aims to strengthen talent retention as Iovance advances its innovative T cell-based cancer immunotherapies.

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Iovance Biotherapeutics (NASDAQ: IOVA) reported its Q1 2022 financial results, showing a cash position of $516.0 million, sufficient to fund operations into 2024. The company anticipates a BLA submission for its lead product lifileucel in metastatic melanoma by August 2022. Key highlights include ongoing patient enrollment for TIL therapies and FDA feedback on potency assays. However, Iovance reported a net loss of $91.6 million in Q1 2022, increasing from $75.4 million in Q1 2021, and significant R&D and administrative expense growth.

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Iovance Biotherapeutics (NASDAQ: IOVA) announced the presentation of translational data for lifileucel, targeting metastatic melanoma, at the 2022 ASCO Annual Meeting from June 3-7, 2022. The study focuses on tumor mutational burden in patients with different prior treatments with immune checkpoint inhibitors. The abstract, titled 'Tumor mutational burden in immune checkpoint inhibitor-naïve and -experienced patients treated with lifileucel,' will be featured on June 6, 2022, during the Melanoma/Skin Cancers session. Lifileucel is a promising TIL cell therapy aiming for FDA approval as a one-time treatment for 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)
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United States of America
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