GlaxoSmithKline PLC (GSK)

[idpickering]

Nucala COPD submission accepted by US FDA

US FDA accepts GSK's submission for the use of Nucala (mepolizumab) in COPD

https://www.investegate.co.uk/announcem ... a-/8597762

Ian.

[idpickering]

GSK's B7-H3-targeted antibody-drug conjugate, GSK'227, receives EMA Priority Medicines (PRIME) Designation in relapsed extensive-stage small-cell lung cancer.

GSK plc (LSE/NYSE: GSK) announced today that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) Designation for GSK5764227 (GSK'227), its B7-H3-targeted antibody-drug conjugate (ADC) being evaluated for the treatment of patients with relapsed extensive-stage small-cell lung cancer (ES-SCLC). The PRIME Designation supports the development of medicines with potential to offer a major therapeutic advantage for patients.[1] This is the second regulatory designation for GSK'227, following the US Food and Drug Administration's decision to grant Breakthrough Therapy Designation in August 2024[2].

https://www.investegate.co.uk/announcem ... 7-/8612443

Ian (I hold).

[idpickering]

Jemperli receives positive CHMP opinion.

GSK plc (LSE/NYSE: GSK) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended expanding the approval of Jemperli (dostarlimab) in combination with chemotherapy (carboplatin and paclitaxel) for first-line treatment of all adult patients with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy. This would include patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumours, who represent 70-75% of patients diagnosed with endometrial cancer and who have limited treatment options.

https://www.investegate.co.uk/announcem ... on/8612134

Ian.

[idpickering]

Headline results from phase III FIRST trial.

GSK announces FIRST trial met its primary endpoint of progression free survival in first line advanced ovarian cancer

https://www.investegate.co.uk/announcem ... al/8622885

Ian (I hold).

[idpickering]

GSK’s Nucala approved in China for use in CRSwNP.

GSK's Nucala (mepolizumab) approved in China for treatment of adults with chronic rhinosinusitis with nasal polyps

· Mepolizumab is the only anti-interleukin-5 approved in China for the treatment of adults with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP)

· Around 30 million people in China live with CRSwNP and experience symptoms such as sleep disturbance, breathing problems and loss of smell

· This is the third indication for mepolizumab in China for an IL-5 mediated condition

https://www.investegate.co.uk/announcem ... np/8643725

Ian (I hold).

[idpickering]

GSK ADC gets FDA breakthrough therapy designation.

GSK's B7-H3-targeted antibody-drug conjugate, GSK'227, receives US FDA Breakthrough Therapy Designation in late-line relapsed or refractory osteosarcoma.

https://www.investegate.co.uk/announcem ... on/8649620

Ian.

[idpickering]

Shingrix fully liquid accepted for US FDA review.

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has accepted for review the regulatory application of a prefilled syringe presentation of Shingrix (GSK's Recombinant Zoster Vaccine or RZV) for the prevention of shingles (herpes zoster).

The new prefilled syringe removes the need to reconstitute separate vials prior to administration, offering a convenient option for pharmacists, physicians and other healthcare professionals who administer vaccinations. The current presentation of the vaccine consists of a lyophilised (powder) antigen and a liquid adjuvant, which healthcare professionals combine prior to administering. The new presentation has the same composition as the reconstituted vaccine and the submission is based on data demonstrating comparability between the two. 1

https://www.investegate.co.uk/announcem ... ew/8657377

Ian.

[idpickering]

GSK enters agreement to acquire IDRx, Inc.

GSK plc (LSE/NYSE: GSK) and IDRx, Inc. (IDRx) today announced that they have entered into an agreement under which GSK will acquire IDRx, a Boston-based, clinical-stage biopharmaceutical company dedicated to developing precision therapeutics for the treatment of GIST. Under the agreement, GSK will pay $1 billion upfront, with potential for an additional $150 million success-based regulatory approval milestone payment. The acquisition includes lead molecule, IDRX-42, a highly selective KIT TKI being developed as a first- and second-line therapy for the treatment of GIST.

https://www.investegate.co.uk/announcem ... c-/8684208

Ian.