GSK · Company research
14 upcoming catalysts · 0 phase 2+ trials on file
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Camlipixant US regulatory submission planned for H2 2026, expected in the second half of 2026 (no exact date yet). A company milestone for GSK (Camlipixant (P2X3 antagonist) for Refractory chronic cough): a step in the program rather than a decision or a data readout.
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GSK expects to report results from its Phase III (OCEAN) study of Exdensur (depemokimab) for Eosinophilic granulomatosis with polyangiitis in the second half of 2026 (no exact date yet). This is the first look at whether the drug did what the company hoped.
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Jemperli AZUR-1 US regulatory submission in dMMR locally advanced rectal cancer, expected in the second half of 2026 (no exact date yet). A company milestone for GSK (Jemperli (dostarlimab) for dMMR locally advanced rectal cancer): a step in the program rather than a decision or a data readout.
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The FDA is expected to decide in the second half of 2026 (no exact date yet) whether to approve GSK’s Jemperli (dostarlimab) for dMMR locally advanced rectal cancer. Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.
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GSK expects to report results from its Phase IIb registrational (EXTEND4M) study of Cabotegravir ultra-long-acting (ViiV) for HIV pre-exposure prophylaxis in the second half of 2026 (no exact date yet). Phase IIb registrational (EXTEND4M) is a study designed to support approval.
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The FDA is expected to decide in the second half of 2026 (no exact date yet) whether to approve GSK’s Arexvy (RSVPreF3 OA) for RSV prevention, immunocompromised adults aged 18+. Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.
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GSK expects Japanese regulators to decide on Bepirovirsen for Chronic hepatitis B in the second half of 2026 (no exact date yet). An approval lets the company start selling it in that market.
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Bexsero infant MenB US submission; Blenrep DREAMM-8 China submission, expected in the second half of 2026 (no exact date yet). A company milestone for GSK (Bexsero; Blenrep for Meningococcal B (infants); 2L+ multiple myeloma): a step in the program rather than a decision or a data readout.
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Mo-Rez (B7-H4 ADC) three additional Phase III starts in ovarian/endometrial cancer, expected in the second half of 2026 (no exact date yet). A company milestone for GSK (Mocertatug rezetecan (Mo-Rez) for Platinum-sensitive ovarian, 1L maintenance ovarian, 1L maintenance pMMR endometrial): a step in the program rather than a decision or a data readout.
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The FDA is expected to decide in Nov 2026 (no exact date yet) whether to approve GSK’s Neladalkib (NVL-655) for ALK-positive NSCLC, TKI-pretreated. Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.
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The FDA is expected to decide in the first half of 2027 (no exact date yet) whether to approve GSK’s Cabotegravir ultra-long-acting (ViiV) for HIV pre-exposure prophylaxis. Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.
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GSK expects European regulators to decide on Bepirovirsen for Chronic hepatitis B in the first half of 2027 (no exact date yet). An approval lets the company start selling it in that market.
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Exdensur EGPA submissions (US/EU/CN/JP) and Jideytro 1L ROS1+ NSCLC US submission, expected in the first half of 2027 (no exact date yet). A company milestone for GSK (Exdensur (depemokimab); Jideytro (zidesamtinib) for EGPA; treatment-naive NSCLC): a step in the program rather than a decision or a data readout.
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GSK expects to report results from its Phase III (EMBOLD-SCLC-301) study of Risvutatug rezetecan (Ris-Rez, HS-20093) for Relapsed extensive-stage small cell lung cancer during 2027 (no exact date yet). This is the first look at whether the drug did what the company hoped.
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The FDA’s decision on GSK’s Bepirovirsen (antisense oligonucleotide; with Ionis) for Chronic hepatitis B (functional cure) was due on Oct 26, 2026. The outcome isn’t recorded here yet — the linked source has the latest.
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GSK reported results from its Phase III study of Risvutatug rezetecan (Ris-Rez) for Relapsed/refractory osteosarcoma on Jul 28, 2026. The study met its main goal.
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GSK reported results from its Phase 1/2 study of Camlipixant for Refractory chronic cough on Jul 17, 2026. The results were mixed.
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GSK reported results from its Phase II (registrational) study of Jemperli (dostarlimab) for Stage II/III dMMR/MSI-H locally advanced rectal cancer on Jul 13, 2026. The study met its main goal.
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GSK reported results from its Phase III study of Risvutatug rezetecan (Ris-Rez) for Advanced or relapsed small-cell lung cancer on Jul 10, 2026. The study met its main goal.
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The FDA approved GSK’s Bepirovirsen for Chronic hepatitis B on Apr 28, 2026. That clears it for sale in the US.
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The FDA approved GSK’s Arexvy (RSV vaccine, adjuvanted) for Prevention of RSV lower respiratory tract disease, adults 18-49 at increased risk on Mar 13, 2026. The company can now sell it in that market.
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