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., Sept. 07, 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 that senior leadership plans to present at the 2023 Wells Fargo Healthcare Conference:

Iovance Biotherapeutics to Present at 2023 Wells Fargo Healthcare Conference

Iovance Biotherapeutics, Inc. has a deep pipeline of cancer immunotherapies, but has faced delays and issues with duration of response. The company's lead asset, lifileucel, is being tested in multiple trials for different indications. Underwhelming data from a phase 2 study and poor duration of response in other trials have hurt Iovance Biotherapeutics stock.

Iovance: November PDUFA, But A History Of Delays And Underwhelming Data

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Iovance (IOVA) reports mixed second-quarter results as earnings beat estimates but sales miss the mark.

Iovance (IOVA) Posts Narrower-Than-Expected Loss in Q2

Iovance Biotherapeutics (IOVA) came out with a quarterly loss of $0.47 per share versus the Zacks Consensus Estimate of a loss of $0.81. This compares to loss of $0.63 per share a year ago.

Iovance Biotherapeutics (IOVA) Reports Q2 Loss, Lags Revenue Estimates

FDA Priority Review of Biologics License Application (BLA) on Track for Lifileucel in Advanced Melanoma with Prescription Drug User Fee Act (PDUFA) Action Date of November 25, 2023

Iovance Biotherapeutics Reports Second Quarter and First Half 2023 Financial Results and Corporate Updates

Oral Presentation of Cohort 3A Data from IOV-COM-202 Phase 2 Clinical Trial of LN-145 in Combination with Pembrolizumab in Anti-PD1-naïve Advanced (metastatic or unresectable) Non-Small Cell Lung Cancer (NSCLC) Oral Presentation of Cohort 3A Data from IOV-COM-202 Phase 2 Clinical Trial of LN-145 in Combination with Pembrolizumab in Anti-PD1-naïve Advanced (metastatic or unresectable) Non-Small Cell Lung Cancer (NSCLC)

Iovance Biotherapeutics to Present Clinical Data for Tumor Infiltrating Lymphocyte (TIL) Therapy at IASLC 2023 World Conference on Lung Cancer

SAN CARLOS, Calif., July 24, 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, will report its second quarter 2023 financial results on Tuesday, August 8, 2023. 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 Second Quarter 2023 Financial Results Conference Call and Webcast on Tuesday, August 8, 2023

Offering Includes Exercise in Full of the Underwriters' Option to Purchase an Additional 3 Million Shares of Common Stock Offering Includes Exercise in Full of the Underwriters' Option to Purchase an Additional 3 Million Shares of Common Stock

Iovance Biotherapeutics Announces Closing of $172.5 Million Common Stock Public Offering

Based on feedback from the FDA, Iovance's (IOVA) ongoing mid-stage study on LN-145 in NSCLC could support approval under the accelerated pathway. IOVA also reports encouraging preliminary data.

Iovance (IOVA) Gets Positive FDA Feedback on Lung Cancer Drug

Iovance is close to launching its first in-house developed therapy. The company recently purchased cancer drug Proleukin from Clinigen Limited.

Why Iovance Biotherapeutics Stock Is Dropping Tuesday

Iovance Biotherapeutics (NASDAQ: IOVA ) stock is sliding lower on Tuesday after the company announced details of a public share offering. According to a press release, Iovance Biotherapeutics is selling 20 million shares of IOVA stock at a price of $7.50 per share.

Why Is Iovance Biotherapeutics (IOVA) Stock Down 10% Today?

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Futures on the Nasdaq inched higher Tuesday morning. Viridian fell despite announcing some favorable early results from a clinical trial.

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WD-40 shares climb after earnings top estimates, Iovance stock slumps on offering, and other stocks on the move

SAN CARLOS, Calif., July 10, 2023 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (Nasdaq: IOVA) (“Iovance” or “Company”), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (“TIL”) therapies for patients with cancer, today announced the pricing of an underwritten public offering of 20,000,000 shares of its common stock at a public offering price of $7.50 per share. The gross proceeds from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by Iovance, are expected to be approximately $150 million. In addition, Iovance has granted the underwriters a 30-day option to purchase up to 3,000,000 additional shares of common stock at the public offering price, less the underwriting discounts and commissions. The offering is expected to close on or about July 13, 2023, subject to customary closing conditions.

Iovance Biotherapeutics, Inc. Announces Pricing of Its Public Offering of $150 Million of Common Stock

Iovance Biotherapeutics, Inc. had a positive Type B Pre-Phase 3 meeting with the FDA, whereby IOV-LUN-202 trial will be allowed for Accelerated Approval of LN-145 for the treatment of NSCLC patients. Positive preliminary results achieved in registrational single-arm phase 2 IOV-LUN-202 trial, which used LN-145 to treat patients with NSCLC; Median duration of response not achieved and 26.1% objective response rate. The global non-small cell lung cancer therapeutics market is expected to reach $43.71 billion by the end of 2026.

Iovance Biotherapeutics: More Than A One-Shot Wonder

SAN CARLOS, Calif., July 10, 2023 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (Nasdaq: IOVA) (“Iovance” or “Company”), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (“TIL”) therapies for patients with cancer, today announced that it intends to offer and sell $150 million of shares of its common stock, subject to market and other conditions, in an underwritten public offering. All of the shares in the offering are to be sold by Iovance. Iovance intends to grant the underwriters a 30-day option to purchase an additional $22.5 million of shares of common stock at the public offering price, less the underwriting discounts and commissions.

Iovance Biotherapeutics, Inc. Announces Proposed Public Offering of Common Stock

Iovance Biotherapeutics Inc (NASDAQ:IOVA) was last seen up 2.4% at $7.42, after the U.S. Food and Drug Administration (FDA) said a late-stage study of its experimental lung cancer therapy , LN-145 TIL, could be acceptable for accelerated approval.

Biotech Stock Pops on Reaction to Experimental Therapy

Positive FDA Feedback Supports IOV-LUN-202 Trial Design for Accelerated Approval  of TIL Therapy in Post-Anti-PD-1 Advanced Non-Small Cell Lung Cancer (NSCLC)

Iovance Biotherapeutics Announces Regulatory and Clinical Updates for TIL Therapy in Advanced Non-Small Cell Lung Cancer

SAN CARLOS, Calif., June 20, 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, will host an investor conference call and webcast to discuss lifileucel TIL therapy and the emerging melanoma treatment landscape on June 26, 2023, at 5:00 p.m.

Iovance Biotherapeutics to Host Virtual Roundtable with Key Opinion Leaders to Discuss Melanoma Treatment Landscape

Iovance (IOVA) announces randomizing the first patient in the TILVANCE-301 study evaluating the safety and efficacy of its lifileucel/Keytruda combo therapy in frontline advanced melanoma patients.

Iovance (IOVA) Updates on Combo Drug in Advanced Melanoma Study

Global Trial of Iovance TIL Therapy Lifileucel in Combination with Pembrolizumab Global Trial of Iovance TIL Therapy Lifileucel in Combination with Pembrolizumab

Iovance Biotherapeutics Announces First Patient Randomized in Phase 3 TILVANCE-301 Trial in Frontline Advanced Melanoma

SAN CARLOS, Calif., June 09, 2023 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced that senior leadership plans to present at the Jefferies Global Healthcare Conference:

Iovance Biotherapeutics to Present at Jefferies Global Healthcare Conference

Iovance Biotherapeutics (IOVA) reported earnings 30 days ago. What's next for the stock?

Why Is Iovance Biotherapeutics (IOVA) Up 7.9% Since Last Earnings Report?

Iovance is a cell therapy pioneer with a shot at a first ever approval for this drug class in a solid tumor cancer. Data from Iovance's pivotal study looks relatively strong and the FDA has finally accepted the company's BLA after pushing for more data first time around. The delays submitting its BLA have cost Iovance a large chunk of its market cap valuation, which once stood >$4bn - if lifileucel is approved Iovance may recapture that value.

News for Iovance Biotherapeutics Stock (IOVA)