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Iovance Stock Down on Delay in Filing for Melanoma Candidate
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Shares of Iovance Biotherapeutics, Inc. (IOVA - Free Report) 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.
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.
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity. A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
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Iovance Stock Down on Delay in Filing for Melanoma Candidate
Shares of Iovance Biotherapeutics, Inc. (IOVA - Free Report) 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 - Free Report) , Axcella Health Inc. and AVEO Pharmaceuticals Inc. , 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
Biggest Tech Breakthrough in a Generation
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity. A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
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