Financials
Cash Data
- Cash FlowProfitable
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Key Stats
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
GSK Catalyst Timeline
Dated clinical, regulatory and corporate events for GSK plc
Catalyst Timeline
Dated clinical, regulatory & corporate events for GSK plc
Event history 8
Past FDA Catalysts and PDUFA Decisions
How GSK actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| 2026-10-25 | dostarlimab (Jemperli) | Phase 2 data presentation | Phase 2 |
Drug Pipeline Intelligence
| Product | Revenue | Prior period | Change |
|---|---|---|---|
| Shingles | |||
| Meningitis | |||
| RSV | |||
| Influenza |
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Belimumab Monoclonal antibodyNCT06716606 | Connective Tissue Diseases | Phase 3 | RECRUITING | 514 | Oct 23, 2030 | ||||||
| Belimumab Monoclonal antibodyMarketedNCT04179032 | Systemic Lupus Erythematosus | Phase 3 | ACTIVE NOT_RECRUITING | 4,622 | Sep 30, 2027 | ||||||
| Belimumab Monoclonal antibodyNCT06572384 | Lung Diseases, Interstitial | Phase 3 | RECRUITING | 440 | Oct 25, 2029 | ||||||
| Belimumab Monoclonal antibodyNCT05878717 | Systemic Sclerosis Associated Interstitial Lung Disease | Phase 2 | RECRUITING | 300 | Oct 25, 2029 | ||||||
| GSK5784283 Small moleculeNCT07780656 | Pulmonary Disease, Chronic Obstructive | Phase 3 | RECRUITING | 1,248 | Mar 15, 2030 | ||||||
| GSK5784283 Small moleculeNCT06748053 | Asthma | Phase 3 | ACTIVE NOT_RECRUITING | 1,215 | Sep 9, 2027 | ||||||
| GSK5784283 Small moleculeNCT07782957 | Nasal Polyps | Phase 3 | RECRUITING | 436 | Oct 30, 2029 | ||||||
| Risvutatug rezetecan ADCNCT07602855 | Neoplasms, Lung | Phase 3 | RECRUITING | 604 | Dec 24, 2029 | ||||||
| Risvutatug rezetecan ADCNCT07802704 | Neoplasms, Prostate | Phase 3 | RECRUITING | 684 | Dec 5, 2029 | ||||||
| Risvutatug rezetecan ADCNCT06551142 | Neoplasms | Phase 1 | RECRUITING | 928 | Jun 8, 2029 | ||||||
| Risvutatug rezetecan ADCNCT06885034 | Gastrointestinal Neoplasms | Phase 1 | RECRUITING | 346 | Jan 9, 2029 | ||||||
| Risvutatug rezetecan ADCNCT07602777 | Sarcoma | Phase 1 | RECRUITING | 64 | Nov 23, 2029 | ||||||
| Depemokimab Monoclonal antibodyNCT06961214 | Pulmonary Disease, Chronic Obstructive | Phase 3 | RECRUITING | 3,138 | Feb 14, 2029 | ||||||
| Depemokimab Monoclonal antibodyNCT05263934 | Eosinophilic Granulomatosis With Polyangiitis | Phase 3 | ACTIVE NOT_RECRUITING | 163 | Oct 27, 2026 | ||||||
| Depemokimab Monoclonal antibodyNCT05334368 | Hypereosinophilic Syndrome | Phase 3 | ACTIVE NOT_RECRUITING | 110 | Oct 29, 2027 | ||||||
| VH3810109 Monoclonal antibodyNCT07053384 | HIV Infections | Phase 2 | ACTIVE NOT_RECRUITING | 316 | Sep 6, 2028 | ||||||
| Efimosfermin alfa Small moleculeNCT06920043 | Metabolic Dysfunction-Associated Steatohepatitis | Phase 3 | RECRUITING | 2,162 | Jul 10, 2028 | ||||||
| Efimosfermin alfa Small moleculeNCT07791043 | Liver Diseases, Alcoholic | Phase 2 | RECRUITING | 274 | Jan 14, 2030 | ||||||
| Camlipixant Small moleculeNCT05600777 | Cough | Phase 3 | ACTIVE NOT_RECRUITING | 2,163 | Mar 17, 2027 | ||||||
| Camlipixant Small moleculeNCT07519395 | Irritable Bowel Syndrome | Phase 2 | RECRUITING | 420 | Jul 13, 2027 | ||||||
| Dostarlimab Monoclonal antibodyMarketedNCT02715284 | Neoplasms | Phase 3 | ACTIVE NOT_RECRUITING | 1,576 | Apr 14, 2028 | ||||||
| Dostarlimab Monoclonal antibodyNCT06062420 | Neoplasms, Head and Neck | Phase 3 | ACTIVE NOT_RECRUITING | 1,180 | Dec 31, 2027 | ||||||
| Dostarlimab Monoclonal antibodyNCT05565378 | Lung Cancer, Non-Small Cell | Phase 3 | ACTIVE NOT_RECRUITING | 439 | Dec 6, 2027 | ||||||
| Dostarlimab Monoclonal antibodyNCT05855200 | Colonic Neoplasms | Phase 3 | RECRUITING | 892 | Mar 27, 2031 | ||||||
| Dostarlimab Monoclonal antibodyNCT06640049 | Neoplasms, Rectal | Phase 3 | ACTIVE NOT_RECRUITING | 267 | Apr 15, 2031 |
Clinical Trial Results
Readouts, endpoints and source filings for every GSK program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
| bepirovirsen BreakthroughPriority | chronic hepatitis B | Phase 3 | 2026-05-28 | overall cure rate: 19%; cure rate low viral activity: 26%; low viral activity threshold: 1,000 U/LRead More | GSK, Ionis’ hepatitis B functional cure effectively eliminates virus in nearly 20% of patientsRead More |
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| John SmithCEO | Buy | 50,000 150,000 held | $45.50 | 01/10/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in GSK
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| KRENSAVAGE ASSET MANAGEMENT, LLC | 1.9 % (-9.5 %) | 5.07 M | 96.73 K |
GSK Institutional Ownership Trends
GSK Short Interest
Shares sold short, counted twice a month.
Options Data
Option Volume
Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026-10-30 | ||||||||||||
Real-Time Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last | Vol | OI | Last | Vol | OI | |
| No data available | ||||||
Calls vs Puts by Expiry
Competitive positioning
How GSK ranks across every disease it competes in
GSK News
Hibsago (bepirovirsen) Approved in the US for the Treatment of Chronic Hepatitis B (CHB)
GSK's Hibsago (bepirovirsen) has received FDA approval for treating chronic hepatitis B. This first-in-class therapy shows a 19% functional cure rate in clinical trials, significantly higher than the current standard of care. Patients can complete treatment in six months, with self-administration options available after the initial dose.
Read more →GSK Canada and the pan-Canadian Pharmaceutical Alliance sign Letter of Intent for Blenrep for the treatment of relapsed or refractory multiple myeloma
GSK Canada has signed a Letter of Intent with the pan-Canadian Pharmaceutical Alliance for Blenrep, aimed at treating adult patients with relapsed or refractory multiple myeloma. This agreement is a crucial move towards securing public drug plan coverage across Canada, allowing eligible patients access to this innovative treatment. GSK aims to collaborate with provinces to facilitate patient access, addressing the ongoing challenges faced by multiple myeloma patients.
Read more →Jideytro (zidesamtinib) approved in the US for previously treated ROS1-positive non-small cell lung cancer
GSK has received FDA approval for Jideytro (zidesamtinib), a selective ROS1 inhibitor, for adults with previously treated ROS1-positive non-small cell lung cancer (NSCLC). This approval is based on the ARROS-1 phase I/II trial, which showed significant and durable responses in patients. Jideytro is GSK's first lung cancer treatment and aims to improve patient outcomes by addressing resistance mutations and brain metastases.
Read more →Utebzi (tebipenem pivoxil) approved in the US for adults with complicated urinary tract infections (cUTIs)
GSK's Utebzi (tebipenem pivoxil) has been approved in the United States for the treatment of complicated urinary tract infections (cUTIs) in adults. This approval marks a significant advancement in antibiotic therapies, providing healthcare professionals with a new option to manage these infections. The introduction of Utebzi is expected to enhance patient care in this area.
Read more →GSK’s AREXVY Associated With Reductions in Certain RSV-Related Risks Including Heart Attack, Stroke and Severe Flare-Ups of COPD and Asthma, Real World Study Shows
GSK presented new data at RSVVW'26 showing that its RSV vaccine, AREXVY, significantly reduces the risk of RSV-related hospitalizations and associated cardiovascular events in adults aged 60 and older. The study demonstrated a 75.6% effectiveness against hospitalization and notable reductions in severe COPD and asthma flare-ups. These findings contribute to the understanding of RSV's impact on health outcomes.
Read more →GSK Awards $2M in COiMMUNITY Initiative Grants to Help Close Vaccination Gaps, Commits $3M for 2026
GSK has announced the recipients of its COiMMUNITY Initiative grants, awarding $2 million to 16 organizations aimed at improving vaccination rates in the U.S. The initiative, now in its third year, will also allocate $3 million in 2026 for projects focused on vaccine communication and delivery. Various organizations, including The J.A.M.I.E. Group and Immunize Colorado, will utilize these funds to address barriers to immunization.
Read more →GSK Announces Recipients of Linked by Lupus: Optimal Care Initiative Grants Nearing $1 Million
GSK has announced the recipients of the Linked by Lupus: Optimal Care Initiative grant, awarding nearly $1 million to support organizations focused on improving the lives of those affected by lupus. The initiative aims to enhance awareness, diagnosis, and treatment options for lupus patients. Thirteen grantees were selected for their innovative community-led programs. GSK emphasizes its commitment to fostering a connected lupus community.
Read more →Samsung Biologics Expands U.S. Manufacturing Capabilities with Strategic Acquisition of Human Genome Sciences from GSK
Samsung Biologics has announced the acquisition of Human Genome Sciences from GSK, marking its first U.S.-based manufacturing site in Rockville, Maryland. This strategic acquisition, valued at $280 million, aims to enhance production capacity and support a resilient supply chain for critical biologic medicines. The deal is expected to close by the end of Q1 2026, retaining over 500 employees at the site.
Read more →Nucala (mepolizumab) approved by US FDA for use in adults with chronic obstructive pulmonary disease (COPD)
Nucala (mepolizumab) has been approved by the FDA as an add-on treatment for adults with inadequately controlled COPD and an eosinophilic phenotype, based on positive trial results showing significant reduction in exacerbations.
Read more →Blujepa (gepotidacin) approved by US FDA for treatment of uncomplicated urinary tract infections (uUTIs) in female adults and paediatric patients 12 years of age and older
The US FDA has approved Blujepa (gepotidacin) for treating uncomplicated urinary tract infections in female adults and pediatric patients. This first-in-class antibiotic shows promise against recurrent infections and has demonstrated efficacy in pivotal trials compared to existing treatments.
Read more →US FDA expands Jemperli (dostarlimab) plus chemotherapy approval to all adult patients with primary advanced or recurrent endometrial cancer as the first and only immuno-oncology-based treatment to show an overall survival benefit
The FDA has expanded the approval of Jemperli (dostarlimab) plus chemotherapy for adult patients with primary advanced or recurrent endometrial cancer, showing a 31% reduction in risk of death. This treatment now includes the majority of endometrial cancer cases, providing a significant survival benefit.
Read more →ViiV Healthcare announces U.S. FDA approval of Dovato (dolutegravir/lamivudine) for adolescents living with HIV
ViiV Healthcare announced FDA approval of Dovato for adolescents aged 12 and older living with HIV. This marks the first oral, two-drug, single-tablet regimen for this demographic, aiming to improve treatment options for young people with HIV.
Read more →US FDA grants regular approval for Jemperli for the treatment of patients with recurrent or advanced mismatch repair-deficient endometrial cancer
The FDA has granted full approval for Jemperli to treat patients with recurrent or advanced mismatch repair-deficient endometrial cancer, based on positive outcomes from the GARNET trial. The treatment shows a significant overall response rate and duration of response, although some adverse reactions were noted.
Read more →LRA Congratulates GSK on FDA Approval of Benlysta® (belimumab) for Children with Lupus Nephritis
The FDA has approved belimumab (Benlysta®) as the first treatment for children aged 5 to 17 with lupus nephritis, marking a significant advancement in pediatric lupus care. The Lupus Research Alliance celebrates this milestone, highlighting their role in funding the research that contributed to the drug's development.
Read more →ViiV Healthcare announces US FDA approval of Triumeq PD, the first dispersible single tablet regimen containing dolutegravir, a once-daily treatment for children living with HIV
ViiV Healthcare has received FDA approval for Triumeq PD, the first dispersible single tablet regimen for children with HIV. This approval enhances treatment options for pediatric patients and reflects ViiV's commitment to developing age-appropriate formulations for young children living with HIV.
Read more →GSK receives FDA accelerated approval for JEMPERLI (dostarlimab-gxly) for adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumors
GSK's JEMPERLI (dostarlimab-gxly) received FDA accelerated approval for treating adult patients with dMMR recurrent or advanced solid tumors. The approval is based on positive trial results, showing a 41.6% objective response rate and a median duration of response of 34.7 months, although continued approval depends on further clinical verification.
Read more →GSK announces FDA approval for Nucala (mepolizumab) for use in adults with chronic rhinosinusitis with nasal polyps
GSK announced FDA approval for Nucala (mepolizumab) as the first anti-IL-5 therapy for adults with chronic rhinosinusitis with nasal polyps. This approval offers a new treatment option for over 5 million affected patients, providing an alternative to surgery and addressing significant unmet medical needs.
Read more →FDA grants accelerated approval for GSK’s JEMPERLI (dostarlimab-gxly) for women with recurrent or advanced dMMR endometrial cancer
The FDA has granted accelerated approval for GSK's JEMPERLI (dostarlimab-gxly) for women with recurrent or advanced dMMR endometrial cancer, based on promising results from the GARNET study, which showed a 42% overall response rate and significant durability of response.
Read more →ViiV Healthcare announces FDA approval of Cabenuva (cabotegravir, rilpivirine), the first and only complete long-acting regimen for HIV treatment
ViiV Healthcare announced FDA approval of Cabenuva, the first complete long-acting regimen for HIV treatment, allowing virologically suppressed adults to maintain viral suppression with only 12 dosing days per year. The approval is based on pivotal studies showing high patient preference and effectiveness compared to daily oral regimens.
Read more →FDA approves GSK's BENLYSTA as the first medicine for adult patients with active lupus nephritis in the US
The FDA has approved GSK's BENLYSTA for treating adult patients with active lupus nephritis, marking it as the first medication for this condition. The approval is based on positive results from the BLISS-LN study, which showed significant improvements in patient outcomes.
Read more →