GSK: FDA Accepts SBLA For Jemperli With Priority Review

(RTTNews) - GSK plc (GSK, GSK.L) announced the FDA has accepted for priority review a supplemental Biologics License Application for Jemperli or dostarlimab for patients with previously untreated stage II and III mismatch repair deficient/microsatellite instability-high locally advanced rectal cancer. The FDA has assigned a PDUFA action date of February 2027. The company noted that the application is eligible for expedited review through the National Priority Voucher program.

Separately, GSK announced that Japan's Ministry of Health, Labour and Welfare has approved Hibsago or bepirovirsen, an antisense oligonucleotide, as a functional cure for chronic hepatitis B virus infection in adult patients who have received at least 6 months of prior nucleos(t)ide analogue therapy and meet pre-defined viral markers.

At last close on LSE, GSK shares were trading at 1,918.50 pence.

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