Bepirovirsen accepted for priority review and granted Breakthrough Therapy Designation by the US FDA

Global Biopharmaceutical Portfolio GSK is a global biopharmaceutical company operating across Specialty Medicines, Vaccines, and General Medicines. Its commercial portfolio spans HIV, oncology, respiratory and immuno-inflammation, vaccines, and established medicines, supported by a growing late-stage pipeline and externally sourced...

Recent company news

GSKGSK plc2026-10-06 14:00 EST

ViiV Healthcare’s long-acting HIV treatment Cabenuva (cabotegravir + rilpivirine) meets primary endpoint of superior viral suppression vs. daily oral therapy in people with viremia

GSKGSK plc2026-09-15 14:21 EST

GSK to acquire potential best-in-class T cell-engager (TCE) for multiple myeloma from Chimagen Biosciences

GSKGSK plc2026-09-13 19:30 EST

GSK presents positive registrational data to potentially expand Jideytro (zidesamtinib) to first-line ROS1-positive non-small cell lung cancer

GSKGSK plc2026-09-13 08:00 EST

Ris-Rez reduced risk of death by 54% versus topotecan in patients with relapsed small cell lung cancer in China

GSKGSK plc2026-09-10 07:00 EST

GSK’s Shingrix (Recombinant Zoster Vaccine) prefilled syringe presentation approved in Japan

Stock data

Close: 46.60 USD
Market cap: 98.26B USD
Exchange: NYSE
Sector: Vaccines, Biopharma, Gene Therapy, Antibody Drugs, Small Molecule Drugs, Nucleic Acid Drugs
Location: United States

Bepirovirsen accepted for priority review and granted Breakthrough Therapy Designation by the US FDA

Related news

Jemperli (dostarlimab) accepted for priority review by the US FDA for dMMR/MSI-H locally advanced rectal cancer

Hibsago (bepirovirsen) approved in Japan as first and only functional cure for chronic hepatitis B

Revolution Medicines Announces U.S. FDA Breakthrough Therapy Designation for RASONQUE™ (daraxonrasib) in Combination with Chemotherapy for First Line Metastatic Pancreatic Cancer

U.S. FDA Accepts Teva’s New Drug Application (NDA) and Grants Priority Review for Ecopipam, a First-in-Class Investigational Therapy for Pediatric Patients with Tourette Syndrome

Intellia Therapeutics Announces FDA Acceptance of Biologics License Application with Priority Review for Lonvoguran Ziclumeran (Lonvo-z) for Hereditary Angioedema (HAE)

U.S. FDA Grants Accelerated Approval to Bristol Myers Squibb's First CELMoD Therapy ZENBEXUS™, in Combination with Daratumumab and Hyaluronidase-fihj and Dexamethasone (ZDd) for Patients with Multiple Myeloma, as Early as First Relapse

IDEAYA Biosciences Announces Successful FDA Type C Meeting for IDE849, DLL3 TOP1 ADC, on Phase 3 Registrational Trial Design for Potential Accelerated and Full Approval in Extensive Stage Small Cell Lung Cancer

U.S. FDA Approves Revolution Medicines’ RASONQUE™ (daraxonrasib), the First Broad RAS-Targeted Medicine in Metastatic Pancreatic Cancer

Enliven Therapeutics Announces FDA Alignment on ENABLE-2 Phase 3 Trial Design for Relcobatinib (ELVN-001) in Previously Treated Chronic Myeloid Leukemia

Pfizer and BioNTech Receive U.S. FDA Approval for XFG-adapted COVID-19 Vaccine

GSK plc