GSK Stock Price, News, Filings & Events — Gsk Plc

Gsk Plc's lead asset is Risvutatug rezetecan (Ris-Rez), which targets relapsed small cell lung cancer (SCLC). It is an antibody-drug conjugate (ADC) that works by delivering a cytotoxic agent directly to cancer cells, thereby reducing the risk of death in patients with this type of cancer. Ris-Rez is currently in the pivotal phase III clinical stage. For more details, you can read the recent news here.

Here are several of GSK plc’s most material clinical‐stage pipeline assets with known data, including their development phase , indication , any partners , and the next expected readout or regulatory milestone as of mid-September 2026. Information is drawn from GSK’s public filings and announcements. Some assets may have uncertain timelines. --- | Asset | Phase | Indication | Partner(s) (if any) | Next Expected Readout / Milestone | |---|---|---|---|---| | Depemokimab (Exdensur) | Phase III (completed for certain indications) / Regulatory | • Severe asthma with type-2 inflammation<br • Chronic rhinosinusitis with nasal polyps (CRSwNP)<br • Eosinophilic Granulomatosis with Polyangiitis (EGPA)<br • Hypereosinophilic Syndrome (HES) | Internal GSK (no announced external partner) | • For EGPA (OCEAN study, NCT05263934): primary completion by 29 September 2026 (gsk-studyregister.com) <br • Regulatory decisions: Japan already approved (Jan 6, 2026) for asthma & CRSwNP; in the EU, positive CHMP opinion issued Dec 2025; full EC decision expected Q1 2026 (gsk.com) | | Camlipixant (also known as BLU-5937) | Phase III trials (CALM-1 & CALM-2) | Refractory Chronic Cough (RCC) – adults | Internal GSK (acquired via Bellus Health) | • Readouts reported: CALM-1 met its primary endpoint (week 12), CALM-2 did not (week 24) on primary endpoint. Based on mixed results, GSK has terminated further development in RCC as of July 2026. Thus, no future readout expected in RCC indication. (gsk.com) | | Cabotegravir (Ultra-Long-Acting Formulations) | Registrational / Late-stage clinical (Phase IIb t...

The information regarding Gsk Plc's cash position, quarterly burn, and runway in months is missing from the provided context. Therefore, I cannot provide an answer to this question.

The information regarding specific trial readouts for Gsk Plc (BCE.LSE) in the next 12-18 months is not available in the provided context. Details such as endpoints, prior data, and implications for the stock are also missing.

Here’s an informed estimate of the clinical success probability and peak addressable market for GSK plc’s most advanced “lead” programs, focusing particularly on daprodustat (oral HIF-PHI for anemia in CKD) and HS-20089 (a B7-H4-targeted ADC in gynecologic/solid tumours). Because “lead program” isn’t officially defined by GSK, these are chosen based on phase (Phase III or registrational‐ready), novelty, and revenue expectations. --- Clinical Success Probability GSK’s internal benchmarks (shared by R&D leadership) assign typical phase‐based success rates of 10% for Phase I ⇒ approval, 25% for Phase II ⇒ approval, and 65-70% for Phase III ⇒ approval, subject to adjustment for mechanism of action, competitive landscape, and data robustness. (gsk.com) | Program | Indication & MoA | Clinical Phase | Adjusted Probability of Success | |---|---|---|---| | Daprodustat (oral HIF-prolyl hydroxylase inhibitor) – treating anemia in patients with CKD, both dialysis‐dependent and non-dialysis settings. MoA already approved in multiple countries. | Phase III / approved in some settings | 70% – adjusted down slightly since cardiovascular safety is key and competition with existing ESAs and HIF-PHIs is increasing. Estimate 60-65% | | HS-20089 (ADC targeting B7-H4 with TOPO inhibitor payload) – ovarian & endometrial cancers; also solid tumours. Novel ADC, promising preclinical and early clinical data but higher attrition. | Phase I/II to early Phase II / pre-registrational pending later-phase readouts | 20-30% – typical for oncology ADCs in this phase; could move up if early data is compel...

Here are several major recent and material partnership / licensing / collaboration agreements for GSK plc (Ticker: GSK on LSE, ISIN GB00BN7SWP63), with details on upfronts, milestones, royalty tiers, and how much they de-risk GSK’s model: --- Key Deals Summary | Partner / Program | Deal Type | Upfront / Initial Payments | Milestones (Development / Regulatory / Sales) | Royalty / Tiered Royalties | De-risking for GSK (guaranteed vs contingent amounts) | |-------------------|-----------|----------------------------|--------------------------------------------------|-----------------------------|---------------------------------------------------------| | CureVac (mRNA vaccines: influenza, COVID-19, avian flu) | Restructured licensing agreement (GSK acquires full rights) | €400 million upfront to CureVac (gsk.com) | Up to €1.05 billion in development, regulatory, and sales milestones (gsk.com) | Tiered royalties in the high single-digit to low teens on net sales (gsk.com) | High de-risking: large upfront plus guaranteed rights over all candidates; major part of payments delegated to milestones (contingent) | | CureVac / BioNTech patent litigation settlement | Licensing / settlement amendment tied to existing license | $370 million upfront settlement to GSK; $320 million in cash, rest in amendment value (gsk.com) | Includes royalty flow obligations from Pfizer/BioNTech US mRNA vaccine sales; future milestone / royalty change outside US (gsk.com) | GSK will receive a 1% royalty on future US sales of influenza, COVID-19 (etc.) mRNA vaccine products by Pfizer/BioNTech (gsk.com)...

The information regarding Gsk Plc's composition-of-matter IP expiration on key products and any biosimilar/generic exposure in the next 5 years is missing from the provided context.

Here’s a summary of what has been found regarding whether GSK plc (ISIN GB00BN7SWP63, Ticker GSK on LSE) has ever received a CRL (Complete Response Letter), clinical hold, label warning, or REMS requirement — and whether there are any ongoing FDA/EMA issues. --- ✅ Confirmed REMS and Label Warnings - BLENREP (belantamab mafodotin-blmf) , an antibody-drug conjugate developed by GSK for relapsed/refractory multiple myeloma: - Has a US REMS (Risk Evaluation and Mitigation Strategy) due to ocular toxicity . Requirements under REMS include certified prescribers, patient counseling, ophthalmic monitoring before each dose, patient enrollment, and certified healthcare settings for dispensing. (dailymed.nlm.nih.gov) - Includes a boxed warning for changes in corneal epithelium, alterations in vision including potential severe vision loss, and other ocular adverse events. (dailymed.nlm.nih.gov) - The FDA, in November 2022, requested withdrawal of the US marketing authorization for BLENREP monotherapy, following failure of the DREAMM-3 phase III confirmatory trial to meet the requirements of the Accelerated Approval pathway. However, the REMS program continued for patients already enrolled. (gsk.com) --- ⚠️ CRLs / FDA Rejections / Other Regulatory Setbacks - Exdensur (depemokimab-ulaa) — GSK submitted a BLA (Biologics License Application, BLA-761458) for severe asthma and CRSwNP (chronic rhinosinusitis with nasal polyps). On December 16, 2025 , FDA issued a Complete Response Letter (CRL) : it cited deficiencies in clinical data (e.g. missing secondary endpoints, concerns about patien...