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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.

News

Iovance Biotherapeutics Announces Clinical Program Update for LN-145 in Non-Small Cell Lung Cancer

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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 Reports Inducement Grants under NASDAQ Listing Rule 5635(c)(4)

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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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Iovance Biotherapeutics Reports Inducement Grants under NASDAQ Listing Rule 5635(c)(4)

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Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) announced the approval of inducement stock options for new non-executive employees. The options cover 59,950 shares, with an exercise price of $4.40 and vesting over a three-year period. The awards were granted under Iovance’s 2021 Inducement Plan, in accordance with Nasdaq Listing Rule 5635(c)(4).
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Iovance Biotherapeutics Reports Third Quarter and Year-to-Date 2023 Financial Results and Corporate Updates

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Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) reports FDA Priority Review of Biologics License Application (BLA) for lifileucel in advanced melanoma on track for PDUFA date of February 24, 2023. Positive regulatory feedback supports lifileucel regulatory submissions in Europe and Canada in 2024. Onboarding completed at approximately 30 Authorized Treatment Centers (ATCs) in preparation for potential U.S. commercial launch of lifileucel as first approved TIL therapy.
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Iovance Biotherapeutics to Host Third Quarter and Year-to-Date 2023 Financial Results Conference Call and Webcast on Tuesday, November 7, 2023

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Iovance Biotherapeutics, Inc. will report its Q3 and year-to-date 2023 financial results on November 7, 2023. The company focuses on developing novel polyclonal tumor infiltrating lymphocyte therapies for cancer patients. A conference call and live audio webcast will be held at 4:30 p.m. ET to discuss the results and provide a corporate update. The webcast can be accessed on the company's website.
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Iovance Biotherapeutics to Present Clinical and Pre-Clinical Data for Tumor Infiltrating Lymphocyte (TIL) Therapies at Society for Tumor Immunotherapy of Cancer’s (SITC) 38th Annual Meeting

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Iovance Biotherapeutics announced the publication of abstracts for poster presentations at the SITC Annual Meeting. The four-year analysis of the C-144-01 trial showed lifileucel TIL therapy demonstrated durable efficacy with a four-year overall survival rate of 22.2%. The longest response was ongoing at 59.9 months. Treatment-emergent adverse events were consistent with known safety profiles.
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Iovance Biotherapeutics Reports Inducement Grants under NASDAQ Listing Rule 5635(c)(4)

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Iovance Biotherapeutics grants inducement stock options to new non-executive employees
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Iovance Biotherapeutics to Present Clinical and Pre-Clinical Data for Tumor Infiltrating Lymphocyte (TIL) Therapies at Society for Tumor Immunotherapy of Cancer’s (SITC) 38th Annual Meeting

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Iovance Biotherapeutics presents clinical data and trial design for tumor infiltrating lymphocyte (TIL) therapies at SITC Annual Meeting. Long-term efficacy and safety of lifileucel TIL cell therapy in patients with advanced melanoma reported. TIL with IL-12 show superior antitumor activity. Phase 3 study of lifileucel TIL therapy combined with pembrolizumab in progress.
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Iovance Biotherapeutics Reports Inducement Grants under NASDAQ Listing Rule 5635(c)(4)

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Iovance Biotherapeutics grants inducement stock options to new employees
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U.S. Food and Drug Administration Updates Prescription Drug User Fee Act (PDUFA) Action Date for Lifileucel for the Treatment of Advanced Melanoma

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Iovance Biotherapeutics extends PDUFA date for lifileucel to Feb 24, 2024 due to FDA resource constraints. FDA agrees to expedite remaining review. No major issues found. All facility inspections completed. No advisory committee meeting planned. Positive data supports accelerated approval. TILVANCE-301 trial on track.
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FAQ

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

The current stock price of Iovance Biotherapeutics (IOVA) is $5.91 as of January 15, 2025.

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

The market cap of Iovance Biotherapeutics (IOVA) is approximately 1.8B.

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.
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Iovance Biotherapeutics, Inc.

Nasdaq:IOVA

IOVA Rankings

#2046 Ranked by Market Cap
N/A Ranked by Dividends

IOVA Stock Data

1.80B
276.34M
0.58%
88.33%
19.47%
Biotechnology
Biological Products, (no Disgnostic Substances)
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United States of America
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