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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Median Duration of Response (DOR) Not Reached at 33.1 Months  of Median Study Follow Up in Cohort 2 in C-144-01 Study

Iovance Biotherapeutics Announces 33-Month Follow Up Data for Lifileucel in Advanced Melanoma at ASCO 2021 Annual Meeting

86% Overall Response Rate (ORR) and 43% Complete Response Rate in Immune Checkpoint Inhibitor (ICI) Naïve Advanced Melanoma Patients in IOV-COM-202 Clinical Study

Iovance Biotherapeutics Announces Clinical Data for Lifileucel in Combination with Pembrolizumab in Advanced Melanoma at ASCO 2021 Annual Meeting

As the FDA is requesting additional potency assay data, the potential lifileucel approval for melanoma will be delayed. Despite recent uncertainty, Iovance made a huge comeback due to the superb data for its lead franchise, lifileucel.

Iovance: Down And Rebound

Cathie Wood-led Ark Investment Management is betting that despite recent setbacks Iovance Biotherapeutics Inc (NASDAQ: IOVA) will benefit from its compelling tumor-infiltrating lymphocyte (TIL) immunotherapy. What Happened: IOVA shares have declined 32% since Tuesday after the California-based biotech startup delayed its Biologics License Application (BLA) until the first half of 2022 because of FDA feedback on its potency tests.

Why Cathie Wood Is Bullish On Iovance Biotherapeutics (IOVA)

The CEO's unexplained departure has left investors scratching their heads.

Here's Why Everyone's Talking About Iovance Biotherapeutics

A couple of the ARK exchange-traded funds run by ETF star Cathie Wood made huge purchases on Thursday.

Cathie Wood's ARK Invest Buys Over 1 Million Shares of Iovance Bio

SAN FRANCISCO, May 20, 2021 /PRNewswire/ -- Hagens Berman urges Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) investors with significant losses to submit your losses now. The firm is investigating possible securities law violations and certain investors may have valuable claims.

HAGENS BERMAN, NATIONAL TRIAL ATTORNEYS, Encourages Iovance Biotherapeutics (IOVA) Investors With Losses and Persons Who May Assist Firm's Investigation Into Possible Securities Law Violations to Contact Its Attorneys Now

Yesterday the FDA asked Iovance Biotherapeutics Inc (NASDAQ: IOVA) for more data on the assays for lifileucel US application. Now the company announced additional clinical data for lifileucel alone and in combination with pembrolizumab in advanced melanoma.

Iovance Shares Jump After Lifileucel Achieves 86% Response Rate In Melanoma Trial

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With the trading day almost halfway over, the markets had made a handy recovery on Thursday, bouncing off the lows of last week.

Merck, Micron, Nvidia, Target and More Thursday Afternoon Analyst Calls

Iovance (IOVA) announces delay in BLA submission for its lead pipeline candidate, lifileucel for metastatic melanoma due to potency assay issue.

Iovance (IOVA) Falls on Negative Lifileucel Regulatory Update

MILWAUKEE, May 20, 2021 /PRNewswire/ -- Ademi LLP is investigating possible securities fraud claims against Iovance (NASDAQ: IOVA).  The investigation results from inaccurate statements Iovance may have made regarding its financial results, business operations and prospects.

Ademi LLP Investigates Claims of Securities Fraud against Iovance Biotherapeutics, Inc.

Investors need to pay close attention to Iovance Biotherapeutics (IOVA) stock based on the movements in the options market lately.

Is the Options Market Predicting a Spike in Iovance Biotherapeutics (IOVA) Stock?

LOS ANGELES--(BUSINESS WIRE)---- $IOVA #investors--The Law Offices of Frank R. Cruz Announces Investigation of Iovance Biotherapeutics, Inc. (IOVA) on Behalf of Investors

The Law Offices of Frank R. Cruz Announces Investigation of Iovance Biotherapeutics, Inc. (IOVA) on Behalf of Investors

86% Overall Response Rate (ORR) for Lifileucel in Combination with Pembrolizumab in Immune Checkpoint Inhibitor (ICI) Naïve Advanced Melanoma Patients in IOV-COM-202 Clinical Study

Iovance Biotherapeutics Announces Clinical Data Updates for Lifileucel in Advanced Melanoma at Upcoming ASCO 2021 Annual Meeting

In a brief statement, Iovance Biotherapeutics Inc (NASDAQ: IOVA) company divulged that the FDA wants to see more data on the assays used to ensure each batch of its tumor-infiltrating lymphocyte therapy (TIL) is up to standard, in addition to what was already submitted. This FDA holdup pushed the submission of the lifileucel marketing application for melanoma in the first half of 2022, which amounts to a delay of more than a year from the original timeline of submitting in 2020.

Additional Assay Data Holdup Delays Iovance's Lifileucel Filing Again, CEO Resigns; Shares Plunge

Iovance Biotherapeutics Inc (NASDAQ: IOVA) has received regulatory feedback from the FDA on its potency assays for lifileucel. Following FDA feedback, Iovance will have to submit additional assay data and meet with the FDA in the second half of 2021.

Iovance's Lifileucel US Application Submission Pushed To 2022

SAN CARLOS, Calif., May 18, 2021 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced receipt of regulatory feedback from the U.S. Food and Drug Administration (FDA) regarding its potency assays for lifileucel. Previously, the company reported the submission of assay data to the FDA and recently the FDA provided comments regarding the data package.

Iovance Biotherapeutics Provides Regulatory Update for Lifileucel Potency Assays

Median Duration of Response Not Reached at 18.7 Months of Median Study Follow Up

Journal of Clinical Oncology Publishes Clinical Data for Cohort 2 in Iovance C-144-01 Study of Lifileucel TIL Therapy in Metastatic Melanoma

Iovance's (IOVA) first-quarter earnings lag estimates. The company is progressing well in terms of development of its lead pipeline candidate.

Iovance (IOVA) Q1 Earnings Miss Estimates, Pipeline in Focus

Iovance Biotherapeutics, Inc. (IOVA) CEO Maria Fardis on Q1 2021 Results - Earnings Call Transcript

Expanding First-in-Class TIL Cell Therapy Platform for Solid Tumors Expanding First-in-Class TIL Cell Therapy Platform for Solid Tumors

Iovance Biotherapeutics Reports First Quarter 2021 Financial Results and Corporate Updates

Updated Lifileucel Data from Cohort 2 in C-144-01 Clinical Study

Iovance Biotherapeutics to Present Clinical Data for Lifileucel in Advanced Melanoma at ASCO 2021 Annual Meeting

SAN CARLOS, Calif., April 27, 2021 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, will report its first quarter financial results on Thursday, May 6, 2021. Management will host a conference call and live audio webcast to discuss these results and provide a corporate update at 4:30 p.m. ET.

Iovance Biotherapeutics to Host First Quarter Financial Results Conference Call and Webcast on Thursday, May 6, 2021

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Iovance Biotherapeutics: The Frontier Of Novel Cancer Treatment

Median Duration of Response Not Reached at 28.1 Months  of Median Study Follow Up in Cohort 2 of C-144-01 Study

Iovance Biotherapeutics Announces Clinical Data Updates for Lifileucel in Advanced Melanoma During American Association for Cancer Research (AACR) 2021 Annual Meeting

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