Iovance Biotherapeutics Inc (NASDAQ:IOVA) shares are trading higher by 14.3% to $8.28 Monday morning after the company announced regulatory, clinical updates for TIL therapy in advanced non-small cell lung cancer.

The company has announced positive regulatory and clinical updates for its Phase 2 IOV-LUN-202 trial in post-anti-PD-1 non-small cell lung cancer (NSCLC). The FDA provided favorable feedback on the trial design, indicating potential accelerated approval for LN-145 TIL therapy.

Preliminary analysis showed an overall response rate of 26.1% among 23 NSCLC patients treated with LN-145. Adverse events were consistent with the disease and known treatment profiles.

Iovance plans to enroll around 120 patients and expects enrollment to be completed by the second half of 2024. The FDA's Priority Review of the Biologics License Application for lifileucel in advanced melanoma remains on track, with a target action date of November 25, 2023.

According to data from Benzinga Pro, IOVA has a 52-week high of $13.44 and a 52-week low of $5.28.