GSK (LSE:GSK) won FDA approval for Jideytro to treat ROS1+ advanced NSCLC after prior ROS1 inhibitors, citing strong ARROS‑1 responses including brain mets and resistance mutations, even as mixed late‑stage cough data halted camlipixant trials and the company readies Q2 results.
Previous Week Recap
- GSK FDA Approves ROS1+ NSCLC Drug: GSK's Jideytro (zidesamtinib) won FDA approval for adults with ROS1+ advanced/metastatic NSCLC after prior ROS1 inhibitor. ARROS-1 showed responses including brain mets and resistance mutations.
- Camlixant Cough Trials Halted: GSK halted camlipixant cough trials after mixed late‑stage results: one high‑dose study reduced cough, another missed its endpoint. Shares slid ~2–4.5% on the announcement.
- ARROS-1 ROS1 NSCLC Responses: GSK's ARROS-1 trial enrolled 117 ROS1‑positive NSCLC patients; objective response rate 44%. Six‑month DOR 82%, 12‑month DOR 69%. Responses seen in brain metastases and ROS1 resistance mutations.
- GSK Q2 2026 Results Preview: GSK plc Sponsored ADR (GSK) set to report Q2 2026 results for period ending June 30. Consensus revenue ~$10.98B (up 3% YoY) and EPS ~$1.24 per share.
- EMA Accepts Bexsero Label Update: GSK said the EMA accepted its filing to update Bexsero's label, proposing a single-dose booster from age 10+ for those vaccinated in infancy in countries with infant MenB programs.
- GSK Shares Trades On Block Listing: GSK plc: 31¼p ordinary shares admitted to trading under block listings, effective July 24, 2026, linked to the GlaxoSmithKline 2022 Share Save employee plan.
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