Shares of Iovance Biotherapeutics, Inc. (Nasdaq: IOVA) surged over 10% after the U.S. Food and Drug Administration (FDA) extended the Prescription Drug User Fee Act (PDUFA) for lifileucel due to resource constraints.
The new target action date is February 24, 2024, but the FDA has agreed to collaborate with Iovance to hasten the remaining review process, possibly leading to an earlier approval date. According to Iovance, the FDA noted no major issues, no advisory committee meeting plans, and successful facility inspections.
If granted approval, Lifileucel will mark a groundbreaking milestone as the inaugural TIL therapy for advanced melanoma patients and the first single-use cell therapy for solid tumor cancer.
$IOVA was trading at $5.21 in pre-market, up $0.57 (+12.16%).
In other news, PTC Therapeutics, Inc. (Nasdaq: PTCT) has received a negative opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) regarding the full marketing authorization of Translarna (ataluren) for treating nonsense mutation Duchenne muscular dystrophy (nmDMD). The negative opinion also impacts the renewal of conditional authorization.
The company plans to request re-examination, citing the well-established safety and efficacy of Translarna, which will remain available during the re-examination process, expected to conclude in January 2024.
In pre-market, $PTCT was trading at $26.99, down $10.40 (-27.82%)
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