Iovance Biotherapeutics

Iovance Biotherapeutics, Inc. is a biopharmaceutical company, which engages in the development and commercialization of cell therapies as novel cancer immunotherapy products. Its lead product candidate, LN-144 for metastatic melanoma, is an autologous adoptive cell therapy utilizing tumor-infiltrating lymphocytes (TIL), which are T cells derived from patients' tumors. The company was founded by Robert T. Brooke on September 17, 2007, and is headquartered in San Carlos, CA.

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Iovance Biotherapeutics progresses on BLA for lifileucel, faces recruitment challenges

Iovance Biotherapeutics is on track with BLA completion expected this quarter, strong pipeline progress, and manufacturing capacity expansion. Challenges include study recruitment uncertainties and the ongoing CEO search. Opportunities exist in new program data releases, European expansion, and pivotal study enrollment.

Iovance Biotherapeutics advances TIL therapy pipeline with strong financials

Iovance Biotherapeutics is on track with key milestones in TIL therapy development and commercialization.
The company's financial position is stable, with strategic investments supporting future growth.
Challenges include operational efficiency, FDA interactions, and trial progress management.
Opportunities lie in international trials, market expansion, and revenue growth post-launch.

Iovance Biotherapeutics reports Q2 loss, eyes lifileucel FDA review

Iovance Biotherapeutics faces financial challenges with a significant net loss in Q2 2023, despite positive milestones and revenue from Proleukin sales.
The company's TIL therapy pipeline shows promise with progress in key clinical trials, while opportunities exist for market differentiation and revenue growth.
Challenges include ongoing financial losses, longer timelines for pivotal studies, and potential delays in trial enrollment, requiring strategic management.

Iovance Biotherapeutics progresses on Lifileucel commercialization and pipeline expansion

Iovance Biotherapeutics is making significant strides in advancing its pipeline and commercialization efforts, with a strong focus on FDA approval for Lifileucel and expanding into key markets. The company faces challenges in labeling discussions and efficacy benchmarks but has opportunities in European marketing, new therapy programs, and potential partnerships for international growth.

Iovance Biotherapeutics excels with Amtagvi approval and clinical progress

Iovance Biotherapeutics showcased strong performance with the FDA approval of Amtagvi and progress in clinical trials, positioning the company for growth.
While facing challenges in scaling operations and regulatory hurdles, the company's focus on efficiency and clinical research strengths bode well for the future.
With opportunities in label expansion, market penetration, and revenue growth, Iovance is poised to capitalize on its innovative therapies and drive value for stakeholders.

Iovance Biotherapeutics reports Q1 loss, Amtagvi launch success

Iovance Biotherapeutics shows promising performance with a focus on Amtagvi's commercial success and pipeline advancements.
Strengths include positive reimbursement trends, successful patient selection processes, and efficient manufacturing operations.
Challenges lie in patient screening failures, financial clearance issues, and variability in bridging therapy usage.
Opportunities for growth include market expansion, high patient conversion rates, and accelerated submission processes for new therapies.

Iovance Biotherapeutics (IOVA) exceeds Q3 revenue targets, eyes global expansion

Iovance Biotherapeutics (IOVA) had a strong Q3 performance, exceeding revenue guidance and showcasing growth potential.
The company's focus on Amtagvi and global expansion presents opportunities for revenue diversification and market penetration.
Challenges lie in maintaining adoption rates, meeting revenue targets, and effectively managing increased manufacturing capacity.
Overall, IOVA's strategic initiatives position it for continued growth and success in the biopharmaceutical market.

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SAN CARLOS, Calif., Feb. 16, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, will host a conference call and live audio webcast to discuss the FDA approval announced earlier today at 4:15 p.m. ET, February 16, 2024.

Iovance Biotherapeutics to Host Conference Call and Webcast on Friday, February 16, 2024

AMTAGVI is the first FDA-approved T cell therapy for a solid tumor cancer and first treatment option for advanced melanoma after anti-PD-1 and targeted therapy

Iovance's AMTAGVI™ (lifileucel) Receives U.S. FDA Accelerated Approval for Advanced Melanoma

Iovance Biotherapeutics could commercialize its lead program soon. However, a regulatory inquiry regarding a different program is a major risk.

3 Opportunities for Iovance Biotherapeutics Stock, and 1 Risk

Iovance expects a regulatory decision on its candidate for advanced melanoma later this month. An approval would be the first for the company's innovative technology -- harnessing the body's own cells to fight cancer.

Is Iovance Biotherapeutics a Buy Before This Key FDA Decision?

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Iovance Biotherapeutics just reported a significant problem in a clinical trial. It could still get approval for more than one program, and soon.

What's Next for Iovance Biotherapeutics Stock?

NEW YORK , Jan. 22, 2024 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Iovance Biotherapeutics, Inc. ("Iovance" or the "Company") (NASDAQ: IOVA). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Iovance Biotherapeutics, Inc. - IOVA

Iovance's tumor infiltrating lymphocyte cell therapy candidate, lifileucel, has shown promising results in a study of melanoma patients, with a 31.4% overall response rate. Lifileucel uses a novel mechanism of action to treat stage IV melanoma and has the potential to address an unmet need in solid tumor treatment, and drive revenues >$1bn p.a. The FDA has accepted Iovance's Biologics License Application for lifileucel, with a Prescription Drug User Fee Act date set for February 24th.

Iovance: Approval For Historic Solid Tumor Targeting TIL Therapy Likely, Outlook Promising

Iovance Biotherapeutics is preparing for the extended FDA deadline to determine the approval of lifileucel for advanced melanoma treatment. The FDA has put a clinical hold on the company's Phase II study for LN-145, which has raised concerns about the approval of lifileucel. Iovance has the capacity and preparations for a successful launch of lifileucel in the US, with plans for a potential approval in Europe.

Iovance Biotherapeutics: Preparing For Volatility Around Lifileucel's Upcoming PDUFA Date

Iovance's (IOVA) surges on the anticipated FDA approval for its lead pipeline drug as the first individualized, one-time cell therapy for certain patients with melanoma.

Iovance (IOVA) Surges More Than 150% in 3 Months: Here's Why

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Iovance jumped as investors assessed the fallout of yesterday's clinical hold on its IOV-LUN-202 clinical trial following a patient's death. The company is pausing enrollment for new patients during the hold but will continue the regimen for existing patients "with additional precautions.

Why Iovance Biotherapeutics Stock Popped Today

Iovance (IOVA) is likely to pause enrollment in the phase II IOV-LUN-202 study evaluating its tumor infiltrating lymphocyte therapy, LN-145, for treating non-small cell lung cancer. Stock declines.

Iovance (IOVA) Falls After Clinical Update on Lung Cancer Drug

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The U.S. FDA placed a clinical hold on Iovance's study evaluating LN-145 TIL in treating non-small-cell lung cancer. This clinical hold came after a patient in the study died.

Why Iovance Biotherapeutics Stock Is Crashing Today

Iovance Biotherapeutics (NASDAQ:IOVA) shares plunged after it revealed that the FDA has imposed a clinical hold on its lung cancer therapy trial following the death of a patient. The patient's death is potentially linked to a pre-conditioning regimen involving a short course of chemotherapy before receiving Iovance's LN-145 TIL therapy, according to reports.

Iovance Biotherapeutics faces setback as FDA imposes clinical hold on lung cancer trial

Iovance Biotherapeutics Inc (NASDAQ:IOVA) was last seen 17.8% lower to trade at $7.31, one of the worst stock's on the Nasdaq today.

Options Traders Target Plunging Biotech Stock

Iovance Biotherapeutics Inc.'s stock IOVA, +6.59% fell 22.6% in premarket trading on Wednesday after the cancer therapy company said the U.S. Food and Drug Administration placed a clinical hold on its trial for IOV-LUN-202. The move was in response to a recently reported fatal event in its lung cancer treatment trial.

Iovance stock drops 23% in premarket trades after it halts cancer drug trial

Iovance Biotherapeutics (NASDAQ: IOVA) stock price suffered a harsh reversal on Wednesday after the company suffered a major setback. The stock, which has been in a strong uptrend, crashed by more than 30% in the pre-market session.

Iovance's IOVA stock price suffers a harsh reversal: buy the dip?

The FDA places a clinical hold on Iovance's trial of a lung cancer therapy after the company reports a death potentially related to the treatment.

Iovance Stock Plunges as FDA Puts Hold on Lung Cancer Study After Patient Death

Iovance Biotherapeutics said on Wednesday that the U.S. Food and Drug Administration has placed a clinical hold on its trial on a therapy for a type of lung cancer.

US FDA places clinical hold on Iovance's lung cancer treatment trial

The U.S. health regulator has placed a clinical hold on Iovance Biotherapeutics' trial of its experimental cell therapy in lung cancer patients after a patient death, the company said on Wednesday, sending its shares down about 20%.

US FDA puts clinical hold on Iovance's cancer therapy trial

SAN CARLOS, Calif., Dec. 27, 2023 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced a clinical program update for LN-145 TIL therapy in non-small lung cancer (NSCLC).

News for Iovance Biotherapeutics Stock (IOVA)