Iovance Biotherapeutics (IOVA) announced another delay for its experimental cancer drug late Tuesday and IOVA stock plummeted on Wednesday.
The biotech company is working on a potential treatment for melanoma and cervical cancer. In October, the Food and Drug Administration requested additional potency data for the drug. Late Tuesday, Iovance said it would continue developing that data, per more recent FDA feedback.
Now, Iovance said it expects to ask for approval in the first half of 2022. Previously, the company had planned to submit its application this year. And even that was a delay from initial plans for a 2020 submission, Chardan Research analyst Geulah Livshits said in a report to clients.
On the stock market today, IOVA stock tanked 39.5% to 16.33.
IOVA Stock Plummets On Delay
Iovance’s treatment uses tumor-infiltrating lymphocytes, or TIL. The FDA has never approved a TIL product, Iovance Chief Executive Maria Fardis said. The company is testing the treatment in patients who’ve worsened while receiving a medicine called a checkpoint inhibitor.
“As such, TIL product is complex by nature and alignment with FDA on a potency assay is an important step toward (application) submission,” she said in a written statement.
The FDA first requested new potency data in October. At the time, Chardan’s Livshits called the setback a “solvable (but not trivial) issue.” IOVA stock crashed more than 12% on Oct. 6, the day following the FDA’s request for additional data from what researchers call potency assays. These are tests that measure a drug’s ability to elicit a response in the body.
“We continue to believe the potency assay issue is a solvable one,” she said. “However, the one-plus year delay to initial (application) timelines is indeed not trivial. The latest update reduces the likelihood of 2022 launch or meaningful 2022 sales.”
Livshits kept her buy rating on IOVA stock, but cut her price target to 51 from 54.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
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