Shares of Iovance Biotherapeutics, Inc. IOVA fell about 12.4% after it announced that it will delay its biologics license application (BLA) submission to the FDA for its tumor-infiltrating lymphocyte (TIL) therapy, lifileucel, for the treatment of metastatic melanomauntil later in 2021.The BLA was initially planned to be submitted by the end of 2020. Lifileucel is being developed for the treatment of metastatic melanoma, a form of skin cancer.
However, shares of the company have gained 1.5% year to date while the industry showed no movement.
Lifileucel is Iovance’s lead pipeline candidate, which is being developed as a monotherapy for treating metastatic melanoma in the phase II C-144-01 study. It is also being evaluated for the treatment of metastatic cervical cancer in the phase II C-145-04 study. The company had been engaged in discussions with the FDA, including a recent Type B meeting, regarding the requirements and timing of certain information that would be provided as part of its BLA submission. Per the meeting, the company and the FDA were not able to agree on the required potency assay to fully define its TIL therapy, which is required as part of a BLA submission. A potency assay defines the product and hence is an important step toward the submission of the BLA.The company is working closely with the FDA to come to terms with its assays and will provide updates whenever available. However, per the company, data from its C-144-01 study supports the potential for lifileucel as a treatment for metastatic melanoma.
Lifileucel is also being evaluated for the treatment of patients with locally advanced, recurrent or metastatic cancers, including head and neck and non-small cell lung cancers. A study to investigate Iovance’s T cell therapy for blood cancers, called peripheral blood lymphocyte (PBL) therapy, is open to enrollment.
Zacks Rank & Stocks to Consider
Iovance currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector include Emergent Biosolutions Inc. EBS, Axcella Health Inc. AXLA and AVEO Pharmaceuticals Inc. AVEO, each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Emergent’s earnings per share estimates have increased from $4.03 to $6.61 for 2020 and from $5.07 to $8.42 for 2021 over the past 90 days. Shares of the company have increased 106.3% year to date.
Axcella’s loss per share estimates have narrowed from 98 cents to 97 cents for 2020 and from $2.46 to $2.25 for 2021 over the past 60 days. Shares of the company have increased 19.4% year to date.
AVEO’s loss per share estimates have narrowed from $1.68 to $1.25 for 2020 and from $1.71 to $1.22 for 2021 over the past 60 days. Shares of the company have decreased 2.6% year to date.
Iovance Biotherapeutics, Inc. Price
Iovance Biotherapeutics, Inc. price | Iovance Biotherapeutics, Inc. Quote
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