Iovens biotherapeutics The IOVA indicated a one-quarter delay in melanoma treatment this week, but IOVA stocks continued their two-day recovery on Thursday.
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The Food and Drug Administration has provided a “positive response” to Iovan’s test method. Now, the company expects to request an additional meeting with the FDA in July and then file for approval of its drug, dub lififelusel, by August.
Mizuho Securities analyst Mara Goldstein says the new outlook deviates from Iovens’ previous guidelines. The company had previously expected to file for approval in the first half of 2022 – before June 30. However, the FDA’s response to the request for approval should be “more than a one-quarter delay,” he said.
In a report to clients, Goldstein said, “The delay adds to the long haul, but having a specific timeline for filing has a strong effect.”
In today’s stock market, IOVA stock rose 7.6% to 18.23. It followed a 2.3% pop on Wednesday and a 4.6% drop on Tuesday, the day Iovance updated its lifeline plan.
IOVA Stock: First-in-class treatment?
Lifileucel belongs to a class of drugs called tumor-infiltrating lymphocytes, or TILs. Lymphocytes are a type of white blood cell that patrols the body to detect abnormal cells, including cancer cells. Sometimes there is a breakdown in the immune system that prevents lymphocytes from destroying cancer cells. TIL stops the break, which allows the immune cells to attack.
Iovens says that lififucell may be the first approved one-time cell therapy for a solid tumor cancer. The test is also going on MarkIts (MRK) blockbuster cancer drug Ketruda for the treatment of melanoma.
Lifileucel has shown promise across a variety of cancers, but Iovance still needs to ask for FDA approval. This is where Goldstein is bullish. The IOVA stock has a buy rating and a price target of ৷ 30
“We view the company’s response as positive, indicating the possible removal of regulatory overhangs on shares, especially now that there is a measurable deadline in the public domain for FDA meetings and (approval request) filing,” he said in another report.
IOVA stocks have lower ratings than IBD Digital, but shares are now easily above their 50-day moving average, according to MarketSmith.com. Shares sank briefly below that key point on Wednesday, but were able to close above that and remained there on Thursday.
Follow Alison Gatlin on Twitter @IBD_AGatlin.
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