PDUFA action for neladalkib in pre-treated NSCLC
H2 2026PDUFA · neladalkib · non-small cell lung cancer · Stated by company
“neladalkib (PDUFA H2 2026)” SEC
Primary completion of A Study of Cobolimab Plus Dostarlimab in Pediatric and Young Adult Participants With Cancer
2026-10-13Phase 2 topline · Cobolimab · Melanoma · Registry estimate
“Primary completion (estimated): October 13, 2026” NCT06521567
PDUFA goal date for bepirovirsen NDA in chronic hepatitis B
2026-10-26PDUFA · bepirovirsen · chronic hepatitis B · Stated by company
“The FDA has assigned 26 October 2026 as the Prescription Drug User Fee Act (PDUFA) goal date.” a1144c.htm
Primary completion of A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer
2026-11-02Phase 2 topline · Dostarlimab · Neoplasms, Rectal · Registry estimate
“Primary completion (estimated): November 2, 2026” NCT05723562
Primary completion of A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Japanese Healthy Pregnant Women
2026-11-23Phase 3 topline · dTpa · Diphtheria-Tetanus-acellular Pertussis Vaccines · Registry estimate
“Primary completion (estimated): November 23, 2026” NCT07596199
Primary completion of A Study of Neoadjuvant Dostarlimab Plus Capecitabine Plus Oxaliplatin (CAPEOX) Vs CAPEOX With Previously Untreated T4N0 or Stage III Mismatch Repair Proficient (MMRp)/Microsatellite Stable (MSS) Colon Cancer
2026-11-23Phase 2 topline · Dostarlimab · Neoplasms, Colon · Registry estimate
“Primary completion (estimated): November 23, 2026” NCT06567782
Primary completion of Extended Access of Momelotinib in Adults With Myelofibrosis
2026-12-11Phase 2 topline · MMB · Neoplasms · Registry estimate
“Primary completion (estimated): December 11, 2026” NCT03441113
Primary completion of A Study on the Immune Response and Safety of the Second Dose of an Investigational Chickenpox Vaccine When Given to Healthy Children 3 Months After a First Dose at 12 to 15 Months of Age
2026-12-14Phase 3 topline · Investigational varicella vaccine · Chickenpox · Registry estimate
“Primary completion (estimated): December 14, 2026” NCT06806137
Primary completion of A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine When Given to Healthy Children 12 to 15 Months of Age
2026-12-25Phase 3 topline · Investigational varicella vaccine_Lot 1 · Chickenpox · Registry estimate
“Primary completion (estimated): December 25, 2026” NCT06740630
Primary completion of A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant
2027-01-12Phase 2 topline · Adjuvanted RSVPreF3 vaccine · Respiratory Syncytial Virus Infections · Registry estimate
“Primary completion (estimated): January 12, 2027” NCT07092865
Primary completion of A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma
2027-01-26Phase 3 topline · FF/UMEC/VI · Asthma · Registry estimate
“Primary completion (estimated): January 26, 2027” NCT05757102
PDUFA action date for Jemperli sBLA in dMMR/MSI-H locally advanced rectal cancer
February 2027PDUFA · Jemperli (dostarlimab) · dMMR/MSI-H locally advanced rectal cancer · Stated by company
“FDA has assigned a PDUFA action date of February 2027.” a7607r.htm
Primary completion of A Study to Investigate Abdominal Symptoms With Camlipixant Compared With Placebo in Adults With Irritable Bowel Syndrome - Diarrhea (IBS-D) and Irritable Bowel Syndrome - Mixed (IBS-M)
2027-03-09Phase 2 topline · Camlipixant · Irritable Bowel Syndrome · Registry estimate
“Primary completion (estimated): March 9, 2027” NCT07519395
Primary completion of Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
2027-03-10Phase 2 topline · MenABCWY vaccine · Meningitis, Meningococcal · Registry estimate
“Primary completion (estimated): March 10, 2027” NCT05087056
Primary completion of Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
2027-03-19Phase 2 topline · Momelotinib · Primary Myelofibrosis · Registry estimate
“Primary completion (estimated): March 19, 2027” NCT06517875
Primary completion of Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
2027-04-22Phase 2 topline · Bepirovirsen · Hepatitis B · Registry estimate
“Primary completion (estimated): April 22, 2027” NCT06497504
Primary completion of A Study to Assess the Safety and Immunogenicity of a Vaccine Against Malaria in Healthy Children Aged 5-60 Months
2027-04-23Phase 2 topline · RTS,S/AS01E vaccine · Malaria · Registry estimate
“Primary completion (estimated): April 23, 2027” NCT07036159
Primary completion of A Study to Assess the Effectiveness and Safety of GSK3862995B in Adults With Bronchiectasis
2027-05-04Phase 2 topline · GSK3862995B · Bronchiectasis · Registry estimate
“Primary completion (estimated): May 4, 2027” NCT07201051
Primary completion of An Interventional Study to Compare the Efficacy and Safety of Tafenoquine (TQ) and Primaquine (PQ) When Either Are Taken Together With Chloroquine (CQ) for the Treatment of P. Vivax Malaria in Indian Participants Aged 2 Years and Older
2027-05-14Phase 3 topline · Tafenoquine · Malaria, Vivax · Registry estimate
“Primary completion (estimated): May 14, 2027” NCT06666491
Primary completion of A Study on the Safety and Immune Response of a Urinary Tract Infection (UTI) Vaccine in Adults 18-64 Years of Age and Clinical Efficacy in Females 18-64 Years of Age
2027-05-31Phase 2 topline · Candidate UTI vaccine low dose formulation 1 · Urinary Tract Infections · Registry estimate
“Primary completion (estimated): May 31, 2027” NCT06702449
Primary completion of A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
2027-05-31Phase 2 topline · Daplusiran/Tomligisiran Dose Level 1 · Chronic Hepatitis B Virus Infection · Registry estimate
“Primary completion (estimated): May 31, 2027” NCT06537414
Primary completion of A Study of Momelotinib in Participants With Low-risk Myelodysplastic Syndrome
2027-07-14Phase 2 topline · Momelotinib · Myelodysplastic Syndromes · Registry estimate
“Primary completion (estimated): July 14, 2027” NCT06847867
Primary completion of A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough - China Extension
2027-08-27Phase 3 topline · BLU-5937 · Refractory Chronic Cough · Registry estimate
“Primary completion (estimated): August 27, 2027” NCT07650084
Primary completion of A Study of Dostarlimab in Participants With Untreated Locally Advanced Rectal Cancer in China
2027-10-24Phase 2 topline · Dostarlimab · Neoplasms, Rectal · Registry estimate
“Primary completion (estimated): October 24, 2027” NCT06640049
Primary completion of A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC) [EMBOLD SCLC-301]
2027-11-05Phase 3 topline · Risvutatug rezetecan (Ris-Rez) · Neoplasms, Lung · Registry estimate
“Primary completion (estimated): November 5, 2027” NCT07099898
Primary completion of A Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Participants With Advanced Sarcomas (EMBOLD Sarcoma-202)
2027-11-05Phase 2 topline · Ris-Rez · Sarcoma · Registry estimate
“Primary completion (estimated): November 5, 2027” NCT07602777
Primary completion of Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial
2027-11-24Phase 3 topline · Depemokimab · Hypereosinophilic Syndrome · Registry estimate
“Primary completion (estimated): November 24, 2027” NCT05334368
Primary completion of A Study to Investigate the Safety and Efficacy of GSK4532990 Compared With Placebo in Adult Participants Aged 18 to 70 Years With Alcohol-related Liver Disease
2027-11-26Phase 2 topline · GSK4532990 · Liver Diseases, Alcoholic · Registry estimate
“Primary completion (estimated): November 26, 2027” NCT06613698
Primary completion of A Study of Velzatinib in Participants With Metastatic and/or Unresectable GIST After Imatinib, Sunitinib, Regorafenib, and Pimitespib
2027-11-29Phase 2 topline · Velzatinib · Gastrointestinal Neoplasms · Registry estimate
“Primary completion (estimated): November 29, 2027” NCT07689201
Primary completion of Depemokimab Asthma Imaging and Bronchoscopy Sub-Study
2028-01-05Phase 3 topline · Depemokimab · Asthma · Registry estimate
“Primary completion (estimated): January 5, 2028” NCT06979323
Primary completion of A Study to Test the Safety and Effectiveness of GSK5764227, Alone or With Other Treatments, in Participants With Advanced Gastrointestinal Cancers That Cannot be Surgically Removed (EMBOLD PanGI-201)
2028-01-10Phase 2 topline · Risvutatug Rezetecan · Gastrointestinal Neoplasms · Registry estimate
“Primary completion (estimated): January 10, 2028” NCT06885034
Primary completion of A Study on the Immune Response and Safety of an Investigational Combined Measles, Mumps, Rubella and Varicella Vaccine, When Administered as Intramuscular Injection to Healthy Children 15 Months to 6 Years of Age
2028-02-28Phase 3 topline · MMRVNS · Measles · Registry estimate
“Primary completion (estimated): February 28, 2028” NCT07406360
Primary completion of A Study to Investigate Mocertatug Rezetecan Compared With Chemotherapy in Participants With Endometrial Cancer After Platinum-based Chemotherapy and Immunotherapy (BEHOLD-Endometrial01)
2028-02-29Phase 3 topline · Mocertatug rezetecan · Neoplasms, Endometrial · Registry estimate
“Primary completion (estimated): February 29, 2028” NCT07286331
Primary completion of A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH
2028-03-29Phase 3 topline · Efimosfermin alfa · Non-alcoholic Fatty Liver Disease · Registry estimate
“Primary completion (estimated): March 29, 2028” NCT07221227
Primary completion of A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella Disease and Typhoid Fever in Infants
2028-04-27Phase 2 topline · Low dose of iNTS-TCV · Salmonella Infections · Registry estimate
“Primary completion (estimated): April 27, 2028” NCT07286370
Primary completion of A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy
2028-05-30Phase 3 topline · IDRX-42 · Gastrointestinal Neoplasms · Registry estimate
“Primary completion (estimated): May 30, 2028” NCT07218926
Primary completion of A Study on the Efficacy of a Vaccine Against Influenza in Adults ≥65 Years of Age
2028-06-09Phase 3 topline · mRNA Seasonal Flu vaccine · Influenza, Human · Registry estimate
“Primary completion (estimated): June 9, 2028” NCT07805707
Primary completion of A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma
2028-06-30Phase 3 topline · Dostarlimab · Neoplasms, Head and Neck · Registry estimate
“Primary completion (estimated): June 30, 2028” NCT06256588
Primary completion of A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monotherapy and in Combination Treatments
2028-08-03Phase 2 topline · Belantamab · Multiple Myeloma · Registry estimate
“Primary completion (estimated): August 3, 2028” NCT05714839
Primary completion of A Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Compared With Placebo in Adult Participants With Alcohol-related Liver Disease (ALD)
2028-08-11Phase 2 topline · Efimosfermin alfa · Liver Diseases, Alcoholic · Registry estimate
“Primary completion (estimated): August 11, 2028” NCT07791043
Primary completion of A Study to Investigate the Safety and Preliminary Efficacy of GSK5460025 Alone or in Combination With Other Anti-cancer Agents in Participants With Solid Tumors
2028-09-28Phase 2 topline · GSK5460025 · Neoplasms, Colorectal · Registry estimate
“Primary completion (estimated): September 28, 2028” NCT07213609
Primary completion of A Study to Investigate the Efficacy and Safety of GSK5784283 Compared With Placebo in Participants With Uncontrolled Asthma (PERSIST ASTHMA-1)
2029-02-15Phase 3 topline · GSK5784283 · Asthma · Registry estimate
“Primary completion (estimated): February 15, 2029” NCT07780643
Primary completion of A Study to Assess the Efficacy and Safety of GSK5784283 (Felcorekibart) Compared With Placebo in Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
2029-03-06Phase 3 topline · GSK5784283 · Nasal Polyps · Registry estimate
“Primary completion (estimated): March 6, 2029” NCT07782957
Primary completion of Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer
2029-03-19Phase 3 topline · Dostarlimab · Colonic Neoplasms · Registry estimate
“Primary completion (estimated): March 19, 2029” NCT05855200
Primary completion of A Study of Investigational RSV/hMPV Combination and Investigational hMPV Vaccines in Younger and Older Adults
2029-04-05Phase 2 topline · RSV/hMPV_V low dose vaccine · Respiratory Syncytial Virus Infections+Metapneumovirus · Registry estimate
“Primary completion (estimated): April 5, 2029” NCT07628049
Primary completion of eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Inflammation
2029-04-30Phase 3 topline · Depemokimab · Pulmonary Disease, Chronic Obstructive · Registry estimate
“Primary completion (estimated): April 30, 2029” NCT07177339
Primary completion of A Study to Investigate the Efficacy and Safety of GSK5784283 Compared With Placebo in Participants With Uncontrolled Asthma (PERSIST ASTHMA-2)
2029-05-04Phase 3 topline · GSK5784283 · Asthma · Registry estimate
“Primary completion (estimated): May 4, 2029” NCT07782996
Primary completion of A Study to Investigate the Efficacy and Safety of GSK5784283 (Felcorekibart) Compared With Placebo in Participants With Moderate to Very Severe COPD (PERSIST COPD-1)
2029-07-20Phase 3 topline · GSK5784283 · Pulmonary Disease, Chronic Obstructive · Registry estimate
“Primary completion (estimated): July 20, 2029” NCT07780669
Primary completion of A Study to Investigate the Efficacy and Safety of GSK5784283 (Felcorekibart) Compared With Placebo in Participants With Moderate to Very Severe COPD (PERSIST COPD-2)
2029-07-20Phase 3 topline · GSK5784283 · Pulmonary Disease, Chronic Obstructive · Registry estimate
“Primary completion (estimated): July 20, 2029” NCT07780656
Primary completion of Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA-2)
2029-08-21Phase 3 topline · Depemokimab · Pulmonary Disease, Chronic Obstructive · Registry estimate
“Primary completion (estimated): August 21, 2029” NCT06961214
Primary completion of A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tissue Disease
2029-08-30Phase 3 topline · Belimumab · Lung Diseases, Interstitial · Registry estimate
“Primary completion (estimated): August 30, 2029” NCT06572384
Primary completion of A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease
2029-08-30Phase 3 topline · Belimumab · Systemic Sclerosis Associated Interstitial Lung Disease · Registry estimate
“Primary completion (estimated): August 30, 2029” NCT05878717
Primary completion of A Study of Risvutatug Rezetecan in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) [EMBOLD Prostate-302]
2029-12-05Phase 3 topline · Risvutatug rezetecan (Ris-Rez) · Neoplasms, Prostate · Registry estimate
“Primary completion (estimated): December 5, 2029” NCT07802704
Primary completion of A Study to Investigate Mocertatug Rezetecan Compared With Standard of Care in Participants With Platinum-resistant Ovarian Cancer (BEHOLD-Ovarian01)
2029-12-17Phase 3 topline · Mocertatug rezetecan · Ovarian Neoplasms · Registry estimate
“Primary completion (estimated): December 17, 2029” NCT07286266
Primary completion of A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Chinese Participants With Primary Advanced or Recurrent Endometrial Cancer (EC)
2030-03-31Phase 2 topline · Dostarlimab · Neoplasms, Endometrial · Registry estimate
“Primary completion (estimated): March 31, 2030” NCT07108270
Primary completion of A Study to Investigate Mocertatug Rezetecan With Bevacizumab Compared With Platinum Doublet With Bevacizumab in Participants With Platinum-sensitive Ovarian Cancer (BEHOLD-Ovarian02)
2030-05-21Phase 3 topline · Mocertatug rezetecan (Mo-Rez) · Ovarian Neoplasms · Registry estimate
“Primary completion (estimated): May 21, 2030” NCT07684612
Primary completion of A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Standard of Care in Participants With Relapsed-Refractory Multiple Myeloma (RRMM)
2030-08-30Phase 2 topline · Belantamab mafodotin · Multiple Myeloma · Registry estimate
“Primary completion (estimated): August 30, 2030” NCT07227311
Primary completion of A Study of Efficacy and Safety of Depemokimab Compared With Placebo in Adults and Adolescents With at Risk Type 2 Asthma
2030-09-23Phase 3 topline · Depemokimab · Asthma · Registry estimate
“Primary completion (estimated): September 23, 2030” NCT07456033
Primary completion of A Study to Investigate Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)
2030-10-16Phase 3 topline · Efimosfermin alfa · Metabolic Dysfunction-associated Steatohepatitis · Registry estimate
“Primary completion (estimated): October 16, 2030” NCT07704892
Primary completion of A Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Who Are Ineligible for Autologous Stem Cell Transplantati
2031-04-28Phase 3 topline · Belantamab mafodotin · Multiple Myeloma · Registry estimate
“Primary completion (estimated): April 28, 2031” NCT06679101
Primary completion of A Study to Investigate Velzatinib Compared With Imatinib in Adult Participants With Previously Untreated Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (StrateGIST Frontline)
2032-08-30Phase 3 topline · Velzatinib · Gastrointestinal Stromal Neoplasms · Registry estimate
“Primary completion (estimated): August 30, 2032” NCT07585266
Primary completion of A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Cyclophosphamide, Bortezomib, and Dexamethasone in Adult Participants With Newly Diagnosed Amyloid Light Chain (AL) Amyloidosis
2033-01-12Phase 2 topline · Belantamab mafodotin · Amyloidosis · Registry estimate
“Primary completion (estimated): January 12, 2033” NCT07224672
Primary completion of A Pivotal Clinical Study to Investigate the Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)
2033-06-23Phase 3 topline · Efimosfermin alfa · Metabolic Dysfunction-associated Steatohepatitis · Registry estimate
“Primary completion (estimated): June 23, 2033” NCT07701993
Primary completion of A Study to Assess the Immune Response and Safety of a Vaccine Against Influenza in Adults 18 Years of Age and Older
Completed 2026-05-11Phase 2 topline · Flu mRNA (Formulation A) · Influenza, Human · Completed, results pending
“Primary completion (actual): May 11, 2026” NCT07121192
Primary completion of A Dose Finding Study With an Anti-TSLP Antibody (GSK5784283) in Adults Aged 18 to 75 Years of Age With Uncontrolled Asthma
Completed 2026-07-14Phase 2 topline · GSK5784283 · Asthma · Completed, results pending
“Primary completion (actual): July 14, 2026” NCT06748053
Primary completion of A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease
Completed 2026-07-20Phase 3 topline · RSVPreF3 OA vaccine · Respiratory Syncytial Virus Infections · Completed, results pending
“Primary completion (actual): July 20, 2026” NCT07220109
Primary completion of A Study on the Safety, Reactogenicity, and Immune Response to the GVGH iNTS-GMMA Vaccine Against Invasive Nontyphoidal Salmonella in Adults, Children, and Infants
Completed 2026-08-06Phase 2 topline · iNTS-GMMA Dose C · Salmonella Infections · Completed, results pending
“Primary completion (actual): August 6, 2026” NCT06213506
Primary completion of A Study to Evaluate the Immune Response and Safety of an Influenza Vaccine in Adults 18 Years of Age and Above
Completed 2026-08-24Phase 2 topline · Flu mRNA (Formulation B1) · Influenza, Human · Completed, results pending
“Primary completion (actual): August 24, 2026” NCT07204964
Primary completion of A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Healthy Japanese Adolescents Aged 11 Years to <13 Years
Completed 2026-09-04Phase 3 topline · dTpa vaccine · Diphtheria-Tetanus-acellular Pertussis Vaccines · Completed, results pending
“Primary completion (actual): September 4, 2026” NCT07596173
Primary completion of A Platform Study of Novel Immunotherapy Combinations as First-Line Treatment in Participants With PD-L1 Positive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck- GALAXIES H&N-202
Completed 2026-09-10Phase 2 topline · Dostarlimab · Neoplasms, Head and Neck · Completed, results pending
“Primary completion (actual): September 10, 2026” NCT06062420