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Sep 30, 2023
Iovance Q3 2023 Earnings Report
Iovance reported Q3 2023 financial results and corporate updates, with the FDA Priority Review of BLA on track for lifileucel in advanced melanoma.
Key Takeaways
Iovance Biotherapeutics reported a net loss of $113.8 million for the third quarter of 2023, with revenue of $0.5 million from Proleukin® sales. The company's cash, cash equivalents, investments and restricted cash totaled $427.8 million as of September 30, 2023, which is expected to fund operations into 2025.
FDA Priority Review of BLA for lifileucel in advanced melanoma is on track with a 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.
The company is prepared to rapidly serve the U.S. melanoma community immediately following an FDA approval.
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