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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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On May 6, 2021, Iovance Biotherapeutics (NASDAQ: IOVA) released its Q1 2021 financial results, highlighting significant progress in its TIL therapies for various cancers. The company reported a net loss of $75.4 million or $0.51 per share, with cash reserves of $610.2 million as of March 31, 2021, sufficient to fund operations into 2023. The ongoing clinical trials for lifileucel in melanoma and cervical cancer show promising response rates, including a 36.4% overall response rate in advanced melanoma. Iovance also announced an updated license agreement with NIH, enhancing its patent portfolio.

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Iovance Biotherapeutics (NASDAQ: IOVA) announced participation in several virtual conferences in May 2021, focusing on their T cell-based cancer immunotherapies. Key presentations include a fireside chat at the Truist Securities Life Sciences Summit on May 5, a talk on tumor infiltrating lymphocytes (TILs) at the Multi-Functional Cell Therapies Summit on May 6, a presentation at the PEGS Boston Virtual Conference on May 13, and a keynote at the Sachs Associates Immuno-Oncology Forum on May 19. Iovance aims to enhance treatment for solid tumors and blood cancers using TIL therapy.

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Iovance Biotherapeutics has announced key findings from clinical trials for its T cell-based therapy lifileucel at the ASCO 2021 Annual Meeting. The presentations will focus on lifileucel's efficacy for advanced melanoma, both as a standalone treatment and in combination with pembrolizumab. Two abstracts have been accepted: one evaluating the impact of prior anti-PD-1 therapy and the other assessing the safety and efficacy of the combination therapy for patients who have not previously received immune checkpoint inhibitors. The meeting is scheduled for June 4-8, 2021.

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Iovance Biotherapeutics will report its first quarter financial results on May 6, 2021, at 4:30 PM ET, followed by a conference call. The company specializes in T cell-based cancer immunotherapies, particularly tumor infiltrating lymphocyte (TIL) therapy, targeting solid tumors and blood cancers. Iovance has completed dosing in pivotal programs for metastatic melanoma and cervical cancer, and is conducting studies for non-small cell lung cancer and earlier stage cancers. Details of the conference call can be found on their website.

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Iovance Biotherapeutics (NASDAQ: IOVA) announced promising results from Cohort 2 of the C-144-01 study of lifileucel, a T cell-based therapy for advanced melanoma.

Key findings include a median duration of response not reached at 28.1 months and a 36.4% overall response rate, with 17% of patients showing deepening responses. These results demonstrate the therapy's durability in challenging cases of metastatic melanoma. The data will be presented at the AACR 2021 Annual Meeting, highlighting the potential of lifileucel for future trials in solid tumors.

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Iovance Biotherapeutics has appointed Igor Bilinsky, Ph.D., as Chief Operating Officer, effective immediately. Dr. Bilinsky brings over 20 years of experience in biotechnology, including senior roles at Oncternal Therapeutics and AmpliPhi Biosciences. His expertise in operational leadership and manufacturing is expected to enhance Iovance’s TIL cell therapy pipeline and potential commercialization. Iovance focuses on T cell-based therapies for cancer treatment, including pivotal studies in melanoma and cervical cancer.

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Iovance Biotherapeutics (NASDAQ: IOVA) has announced that long-term interim data from Cohort 2 of the C-144-01 clinical study in advanced melanoma will be presented at the AACR 2021 Annual Meeting. The presentation will focus on the efficacy of Lifileucel (LN-144), a T cell-based therapy, showing durable responses at 28-month follow-up. In addition to this oral presentation, three poster presentations will elaborate on ongoing clinical trials in solid tumors and chronic lymphocytic leukemia. The AACR meeting takes place virtually on April 10, 2021.

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Iovance Biotherapeutics has announced upcoming presentations at various virtual healthcare conferences. Key events include the Cowen 41st Annual Health Care Conference on March 3 at 1:20 p.m. ET, H.C. Wainwright Global Life Sciences Conference on March 9 at 7:00 a.m. ET, Barclays Global Healthcare Conference on March 11 at 1:50 p.m. ET, and Oppenheimer 31st Annual Healthcare Conference on March 17 at 1:10 p.m. ET. The webcasts of these presentations will be available on the Iovance website.

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Iovance Biotherapeutics (NASDAQ: IOVA) reported its Q4 and full-year 2020 financial results, showing a cash position of $635 million, expected to last into 2023. The company emphasized progress in its TIL cell therapies across various cancers, including melanoma and cervical cancer, and plans for a potential BLA submission in 2021. R&D expenses rose to $201.7 million for the year, while general and administrative expenses increased to $60.2 million. The net loss for Q4 was $68.4 million, with a full-year net loss of $259.6 million.

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Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) will release its fourth quarter and full year 2020 financial results on February 25, 2021. A conference call will follow at 4:30 p.m. EST to discuss these results. The company focuses on T cell-based cancer immunotherapies, having completed pivotal programs for metastatic melanoma and cervical cancer. Iovance is also investigating tumor infiltrating lymphocyte (TIL) therapy for non-small cell lung cancer and earlier-stage cancers. For further information, visit www.iovance.com.

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FAQ

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

The current stock price of Iovance Biotherapeutics (IOVA) is $7.38 as of December 20, 2024.

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

The market cap of Iovance Biotherapeutics (IOVA) is approximately 2.2B.

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

2.23B
276.35M
0.58%
88.54%
17.71%
Biotechnology
Biological Products, (no Disgnostic Substances)
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United States of America
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