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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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-3.47%
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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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1.31%
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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 grants inducement stock options to new non-executive employees
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0.91%
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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 grants inducement stock options to new employees
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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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13.58%
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Iovance Biotherapeutics to present at Wells Fargo Healthcare Conference
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-3.17%
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Iovance Biotherapeutics grants inducement stock options to new employees
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Iovance Biotherapeutics, Inc. (NASDAQ: IOVA): FDA Priority Review of Biologics License Application (BLA) for lifileucel in advanced melanoma is on track for potential approval and launch in 2023. The company reported second quarter and first half 2023 financial results, including corporate updates. The TIL program for post-Anti-PD-1 non-small cell lung cancer is advancing into registrational development.
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Iovance Biotherapeutics, Inc.
Nasdaq:IOVA
IOVA Rankings
IOVA Stock Data
2.89B
210.92M
0.56%
89.18%
16.6%
Biological Product (except Diagnostic) Manufacturing
Manufacturing
United States of America
SAN CARLOS
About IOVA
iovance biotherapeutics is focused on the development and commercialization of novel cancer immunotherapies based on tumor infiltrating lymphocytes (til). this approach, also known as adoptive t-cell therapy, was initially developed by dr. steven a. rosenberg at the national cancer institute (nci). in phase 2 clinical trials conducted at the nci, 56% and 24% of patients treated with this technology were reported by nci to have achieved objective and complete response criteria, respectively. our lead product candidate is an autologous, ready-to-infuse cell therapy, that has demonstrated distinctive efficacy in the treatment of metastatic melanoma. in addition to metastatic melanoma, carcinoma of the head and neck and cervical cancer our til therapy technology is potentially applicable to many other tumor types, including ovarian, breast, bladder, colorectal and other cancers. as we continue advancing our current clinical programs through the introduction of manufacturing and logistical