GSK (GSK) News Today

GSK PLC Sponsored ADR (GSK) shares have come under pressure after a U.S. FDA advisory panel voted against approval of its blood cancer drug Blenrep in combination studies, raising doubts over its oncology strategy and prompting more than a 6% slide in recent trading. Offsetting some of the weakness, the FDA approved a new prefilled-syringe presentation of its blockbuster shingles vaccine Shingrix, which should streamline administration and support uptake. Below is a breakdown of the key developments:

• Positive Sentiment: FDA approves prefilled-syringe presentation of SHINGRIX, removing the need for vial reconstitution and enhancing convenience for healthcare providers. US FDA approves pre-filled version of GSK’s shingles vaccine
• Neutral Sentiment: GSK’s Linerixibat is poised to address substantial unmet need for pruritus in primary biliary cholangitis patients, according to Spherix Global Insights, though commercial timing remains undefined. GSK’s Linerixibat Poised to Address Substantial Unmet Need…
• Neutral Sentiment: GSK and Iteos Therapeutics report promising Phase 3 study results in non-small cell lung cancer, highlighting progress in their oncology collaboration but with no immediate regulatory catalysts. GSK and Iteos Therapeutics’ Promising Phase 3 Study on NSCLC Treatment
• Negative Sentiment: An FDA Oncology Drugs Advisory Committee voted against approving Blenrep combinations for relapsed/refractory multiple myeloma, concluding the benefit/risk profile is unfavorable at tested dosages. GSK shares fall after blood cancer drug likely headed for U.S. rejection
• Negative Sentiment: Shares slid over 6% following the advisory panel’s rejection, wiping roughly £3 billion off GSK’s market value amid renewed questions about its oncology pipeline. GSK shares slide 6% after US panel rejects key cancer drug combination
• Negative Sentiment: MarketBeat notes a 5.7% decline in GSK stock, prompting investor debate over whether to trim positions as near-term oncology setbacks weigh on sentiment. GSK (NYSE:GSK) Shares Down 5.7% - Should You Sell?