Personalized Skin Cancer Therapy, Despite FDA Delay: Analysts Show Confidence In Iovance Biotherapeutics Therapy

Thursday, the FDA extended the review period for Iovance Biotherapeutics Inc's IOVA marketing application seeking accelerated approval for lifileucel for advanced melanoma.

The new target action date for a decision under the Prescription Drug User Fee Act is February 24, 2024, from November 25, 2023.

The FDA agreed to work with Iovance to expedite the remaining review for a potentially earlier approval date.

The agency says that due to resource constraints, it requires additional time to complete the Priority Review before the planned late-cycle review meeting scheduled for September 11, 2023. 

Lifileucel, if approved, will be the first and only TIL therapy for patients with advanced melanoma and the first one-time cell therapy for solid tumor cancer. 

HC Wainwright restates its confidence that Lificeucel should be approved on the new PDUFA date, given no additional difficulties. 

Despite the timeline change, the fundamentals of the product remain unchanged, and the agency appears committed to completing the process.

Mizuho suggests that, although a delay may not be viewed as favorable news, there are significant positive aspects to consider. 

Nonetheless, the analyst maintains optimism regarding the approval of lifileucel and interprets IOVA's statements regarding the PDUFA delay as indicative of a favorable outcome. 

These statements provide a stronger rationale for approval. Consequently, analysts Mara Goldstein and Jerry Gong reaffirm the Buy rating for IOVA stock.

Price Action: IOVA shares are up 18.30% at $5.49 on the last check Friday.