Iovance Biotherapeutics hinted at a one-quarter delay for its melanoma treatment this week, but IOVA stock continued a two-day recovery Thursday.
The Food and Drug Administration offered "positive feedback" on Iovance's testing methods. Now, the company expects to request an additional meeting with the FDA in July and then file for approval of its drug, dubbed lifileucel, by August.
Mizuho Securities analyst Mara Goldstein says the new outlook departs from Iovance's earlier guidance. The company previously expected to file for approval in the first half of 2022 — before June 30. Still, the FDA's feedback should "outweigh the roughly one-quarter delay" in requesting approval, she said.
"The delay does add to what has been a lengthy setback, but having a concrete timeline of filing is a strong effect," Goldstein said in a report to clients.
On today's stock market, IOVA stock surged 7.6% to 18.23. That followed a 2.3% pop on Wednesday and a 4.6% drop on Tuesday, the day Iovance updated its lifileucel plans.
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 cells that patrol the body to identify abnormal cells, including cancer cells. Sometimes there are brakes in the immune system that prevent lymphocytes from destroying cancer cells. TILs take the brakes off, allowing immune cells to attack.
Iovance says lifileucel could be the first approved one-time cell therapy for a solid tumor cancer. It's also in testing with Merck's blockbuster cancer drug Keytruda for melanoma treatment.
Lifileucel has shown promise across a variety of cancers, but Iovance still needs to ask for FDA approval. This is where Goldstein is bullish. She has a buy rating and 30 price target on IOVA stock.
"We see the company's characterization of the feedback as positive, signaling a potential removal of the regulatory overhang on shares, particularly now that a measurable timeline for the FDA meeting and (approval application) filing is in the public domain," she said in another report.
IOVA stock has low ratings from IBD Digital, but shares are now easily above their 50-day moving average, according to MarketSmith.com. Shares briefly dipped below that key point on Wednesday, but managed to close above it and remained there Thursday.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
