Iovance Biotherapeutics Inc. (NASDAQ:IOVA) is trading at a 52-week high on Thursday, despite having no news to justify the move. Year to date, the stock has surged over 200%.

• Iovance Biotherapeutics shares are testing new highs. Why did IOVA hit a new high?

The momentum seems to come from breakthrough data from Moderna Inc. (NASDAQ:MRNA) and Merck & Co Inc.‘s (NYSE:MRK) individualized cancer therapy for advanced skin cancer.

On Wednesday, the companies said that at a pre-planned interim analysis, the investigational combination delivered statistically significant and clinically meaningful improvements in recurrence-free survival and distant metastasis-free survival compared to standard Keytruda alone.

Iovance’s Amtagvi Targets Advanced Melanoma

Investors should note that in February 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Iovance’s Amtagvi (lifileucel), a one-time tumor-infiltrating lymphocyte (TIL) therapy.

It is derived from a patient’s surgically removed tumor, expanded in a lab, and then reinfused into patients.

Indication covers adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.

Iovance is also conducting TILVANCE-301, a Phase 3 trial to confirm clinical benefit.

Moderna/Merck’s intismeran autogene is an mRNA-based individualized neoantigen therapy (INT) designed specifically for each patient based on the unique set of mutations within their tumor to train and activate the immune system to recognize and fight cancer.

Iovance Reports Early Soft-Tissue Sarcoma Data

In February, Iovance shared positive early data from a pilot clinical trial for its TIL cell therapy in advanced soft-tissue sarcomas.

Among the first six evaluable patients treated with lifileucel monotherapy, the trial showed a 50% confirmed objective response rate.

Most recently, the cancer drug company reported a second-quarter loss of 11 cents per share, beating the consensus loss of 14 cents per share.

Sales reached $99.313 million, beating the consensus of $87.832 million. U.S. Amtagvi revenue reached approximately $91 million.

Iovance Biotherapeutics reaffirmed fiscal 2026 sales guidance of $350 million-$370 million versus the consensus of $362.083 million.

Analysts Raise Price Forecasts

UBS maintains Iovance Biotherapeutics with a Neutral rating and raises the price target from $4 to $7.

Mizuho reaffirms the Outperform rating for IOVA stock and raises the price target from $10 to $11.

IOVA Stock Price Activity: Iovance Biotherapeutics shares were up 9.64% at $8.76 at the time of publication on Thursday, according to Benzinga Pro data.

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