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IOVANCE BIOTHERAPEUTICS (IOVA)

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Earnings summaries and quarterly performance for IOVANCE BIOTHERAPEUTICS.

Research analysts who have asked questions during IOVANCE BIOTHERAPEUTICS earnings calls.

Recent press releases and 8-K filings for IOVA.

Iovance Biotherapeutics Reports Strong Q4 and Full Year 2025 Revenue Growth, Amtagvi Momentum, and Pipeline Expansion
IOVA
Earnings
Revenue Acceleration/Inflection
Product Launch
  • Iovance Biotherapeutics reported total revenue of $264 million for the full year 2025, achieving 30% revenue growth in Q4 2025, driven by Amtagvi.
  • The company improved its gross margin from cost of sales to 50% in Q4 2025 and extended its cash runway into the third quarter of 2027.
  • Amtagvi is gaining positive commercial traction, with increasing demand, and is expected to reach $1 billion-plus U.S. sales at peak in melanoma alone.
  • Lifileucel received Fast Track designation for non-small cell lung cancer, with a potential launch in H2 2027, and demonstrated an unprecedented 50% confirmed response rate in advanced soft tissue sarcomas, with a registrational trial planned.
4 days ago
Iovance Biotherapeutics Reports Strong Q4 and Full Year 2025 Results, Highlights Pipeline Progress
IOVA
Earnings
Revenue Acceleration/Inflection
New Projects/Investments
  • Iovance Biotherapeutics reported full year 2025 total revenue of $264 million, a 61% increase over the prior year, driven by 112% year-over-year Amtagvi revenue growth, and ended 2025 with approximately $303 million in cash, extending its cash runway into the third quarter of 2027.
  • The company achieved a 50% margin from cost of sales in Q4 2025 and anticipates remarkable revenue growth in 2026, with Amtagvi and Proleukin having the potential to reach $1 billion-plus U.S. sales at peak.
  • The FDA granted Fast Track designation for lifileucel in previously treated non-squamous non-small cell lung cancer, with a potential accelerated approval and launch in the second half of 2027.
  • Positive early data for lifileucel in previously treated advanced soft tissue sarcomas demonstrated an unprecedented 50% confirmed response rate, leading to plans for a single-arm registrational trial.
4 days ago
Iovance Biotherapeutics Reports Strong Q4 and Full-Year 2025 Results, Highlights AMTAGVI Growth and Pipeline Progress
IOVA
Earnings
Revenue Acceleration/Inflection
Product Launch
  • Iovance Biotherapeutics reported total revenue of $264 million for the full year 2025, within guidance, with Q4 2025 product revenue at $87 million, marking approximately 30% growth from the prior quarter, primarily driven by AMTAGVI. The company also achieved a 50% gross margin from cost of sales in Q4 2025 and extended its cash runway into Q3 2027 with approximately $303 million cash at year-end 2025.
  • AMTAGVI is projected to reach over $1 billion in peak U.S. sales for melanoma alone, with the non-small cell lung cancer opportunity being seven times larger and soft tissue sarcoma offering significant additional potential. The FDA granted Fast Track designation for lifileucel in non-squamous non-small cell lung cancer, targeting a potential accelerated approval and launch in H2 2027, and positive early data showed an unprecedented 50% confirmed response rate for lifileucel in advanced soft tissue sarcomas.
4 days ago
Iovance Biotherapeutics Reports Strong Q4 and Full Year 2025 Results and Pipeline Progress
IOVA
Earnings
Guidance Update
Revenue Acceleration/Inflection
  • Iovance Biotherapeutics reported Q4 2025 total product revenue of ~$87 million, reflecting ~30% quarterly revenue growth over the prior quarter, and achieved its full year 2025 revenue guidance of ~$264 million.
  • The company's gross margin increased to ~50% in Q4 2025.
  • As of December 31, 2025, Iovance held a cash position of ~$303 million, which is expected to fund operations into the third quarter of 2027.
  • The U.S. FDA granted Fast Track Designation for lifileucel for second-line advanced non-small cell lung cancer, with a potential launch in the second half of 2027.
  • Amtagvi received approval in Canada in August 2025, and regulatory submissions are currently under review in the United Kingdom, Australia, and Switzerland.
4 days ago
IOVANCE BIOTHERAPEUTICS Reports Strong 2025 Financials and Provides Pipeline Updates
IOVA
Earnings
Guidance Update
Product Launch
  • IOVANCE BIOTHERAPEUTICS achieved Full Year 2025 revenue of ~$264M, meeting its guidance of $250M-$300M, with a Q4 2025 gross margin of 50%.
  • The company reported a cash position of $303M as of December 31, 2025, providing a cash runway into Q3 2027.
  • AMTAGVI (lifileucel), the first and only approved treatment in 2L+ advanced melanoma, demonstrated ~30% quarterly revenue growth in Q4 2025 and showed a 44% objective response rate (ORR) in real-world data.
  • The company's pipeline includes lifileucel for NSCLC, which has Fast Track Designation from the U.S. FDA with a potential launch in 2H27, and a Phase 2 registrational trial for advanced soft tissue sarcomas is set to commence in 2Q 2026.
4 days ago
Iovance Biotherapeutics Announces Positive Early Data for Lifileucel in Advanced Sarcomas
IOVA
New Projects/Investments
  • Iovance Biotherapeutics announced positive early data from a pilot clinical trial of lifileucel in patients with advanced undifferentiated pleomorphic sarcoma (UPS) or dedifferentiated liposarcoma (DDLPS).
  • The trial demonstrated a 50% Objective Response Rate (ORR) by RECIST v1.1 among the first six evaluable patients, who had advanced disease and were refractory to prior therapy.
  • Based on these results, Iovance plans to commence a single arm registrational trial in second-line advanced UPS and DDLPS in the second quarter of 2026 and will engage with the FDA for an accelerated approval path.
  • UPS and DDLPS are aggressive soft tissue sarcomas impacting more than 8,000 patients annually in the U.S. and Europe, representing a significant unmet medical need.
4 days ago
AlphaTON Capital Executes Option Agreement to Sell iOx Therapeutics
IOVA
M&A
New Projects/Investments
  • AlphaTON Capital Corp. (ATON) has executed a binding call option agreement with Immunova, LLC, granting Immunova the option to acquire iOx Therapeutics Limited, a wholly owned subsidiary of AlphaTON.
  • Upon exercise of the option, AlphaTON would be entitled to an upfront cash payment, 10% equity of the acquiring entity, milestone payments potentially exceeding $100 million, and single-digit royalties on future net sales.
  • iOx's lead candidate, PORT-2 (IMM60), a liposomal iNKT cell agonist, has been evaluated in advanced melanoma and metastatic NSCLC patients in Phase 1/2 studies, showing biomarker evidence of immune activation and preliminary anti-tumor activity.
  • AlphaTON Capital plans to continue advancing its mesothelioma program (TT-4) and is progressing a new Telegram-oriented, AI-driven biotech initiative for rare cancers.
Feb 17, 2026, 8:15 PM
Iovance Biotherapeutics Announces Positive Real-World Data for Amtagvi in Advanced Melanoma
IOVA
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
  • Iovance Biotherapeutics announced real-world data for its commercial product Amtagvi® (lifileucel), the first one-time T cell therapy for solid tumor cancer, demonstrating a best-in-class profile in patients with advanced melanoma.
  • In a real-world retrospective study of 41 evaluable patients, Amtagvi achieved a physician-assessed confirmed objective response rate (ORR) of 44% and a disease control rate of 73%.
  • The real-world ORR of 44% improved upon the 31% ORR from the C-144-01 clinical trial that supported its February 2024 FDA accelerated approval, with a 52% ORR observed in patients treated earlier (two or fewer lines of therapy).
Feb 5, 2026, 10:15 PM
Iovance Biotherapeutics' Market Sees Significant Growth Projections
IOVA
New Projects/Investments
Product Launch
Revenue Acceleration/Inflection
  • The global autologous cell therapy market was valued at $10.12 billion in 2024 and is projected to reach $44.55 billion by 2033, growing at a CAGR of 17.90% from 2025 to 2033.
  • In February 2024, the FDA approved Iovance Biotherapeutics' Amtagvi (lifileucel) for advanced melanoma, marking the first autologous cell therapy supported for a solid tumor.
  • North America accounts for over 44% of the global autologous cell therapy market, with the U.S. market alone projected to surpass $17.14 billion by 2034.
  • Hospitals and clinics are central to the market, capturing over 47% and expected to administer more than 60% of autologous cell therapies by 2025.
Jan 27, 2026, 6:43 PM
Iovance Biotherapeutics Reiterates FY2025 Revenue Guidance and Provides Clinical Updates
IOVA
Guidance Update
Product Launch
Revenue Acceleration/Inflection
  • Iovance Biotherapeutics, Inc. expects to achieve its full-year 2025 revenue guidance range of $250 to $300 million in the first full calendar year of Amtagvi sales.
  • As of September 30, 2025, the company reported a cash position of $307 million, which is expected to fund operations into Q2 2027.
  • Amtagvi, the first FDA-approved one-time T-cell therapy for a solid tumor cancer, has demonstrated a ~50% response rate in real-world patients with previously treated advanced melanoma.
  • Clinical trials for Lifileucel in non-small cell lung cancer (NSCLC) showed an Objective Response Rate (ORR) of 25.6% in the IOV-LUN-202 study and 64.3% ORR in the IOV-COM-202 Cohort 3A for ICI-naïve NSCLC, with median Duration of Response (mDOR) not reached in either study.
Jan 9, 2026, 12:35 PM