Press Releases

Oxford BioMedica notes the US FDA Priority Review for Kymriah™ for adults with r/r DLBCL and EMA accelerated assessment for children, young adults with r/r B-cell ALL and adult patients with r/r DLBCL

Oxford, UK – 17 January 2018: Oxford BioMedica plc (“Oxford BioMedica” or “the Group”) (LSE:OXB), a leading gene and cell therapy group, today notes an announcement by Novartis that the supplemental Biologics License Application (sBLA) for Kymriah™ (tisagenlecleucel, formerly CTL019) suspension for intravenous infusion for the treatment of adult patients… Read More

Oxford BioMedica notes the primary analysis results from the pivotal JULIET trial demonstrating that Kymriah™ (tisagenlecleucel) sustained complete responses at six months in adults with r/r DLBCL, a difficult-to-treat cancer

Oxford BioMedica notes the CTL019 MAA submission to the EMA for children, young adults with r/r B-cell ALL and adult patients with r/r DLBCL

Oxford, UK – 06 November 2017… Read More

Oxford BioMedica notes the CTL019 MAA submission to the EMA for children, young adults with r/r B-cell ALL and adult patients with r/r DLBCL

Oxford, UK – 06 November 2017: Oxford BioMedica plc (“Oxford BioMedica” or “the Group”) (LSE:OXB), a leading gene and cell therapy group, today notes an announcement by Novartis confirming submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for CTL019 (tisagenlecleucel) for two indications. The application is for the treatment of children… Read More

Oxford BioMedica notes the sBLA submission to FDA for Kymriah™ in adult patients with r/r DLBCL

Oxford, UK – 31 October 2017: Oxford BioMedica plc (“Oxford BioMedica” or “the Group”) (LSE:OXB), a leading gene and cell therapy group, today notes an announcement by Novartis confirming submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for KymriahTM (tisagenlecleucel) suspension for… Read More

Oxford BioMedica to Present at Rodman & Renshaw Annual Global Investment Conference, New York

Oxford, UK – 5 September 2017: Oxford BioMedica plc (“Oxford BioMedica” or “the Group”) (LSE:OXB), a leading gene and cell therapy group, today announces that John Dawson, Chief Executive Officer, will be presenting at the Rodman & Renshaw Annual Global Investment Conference in New York on… Read More

CTL019 receives FDA approval for paediatric, young adult r/r B-cell ALL

London, UK – 30 August 2017: Oxford BioMedica plc (“Oxford BioMedica” or “the Group”) (LSE:OXB), a leading gene and cell therapy group, today notes that the US Food and Drug Administration (FDA) has approved Novartis’ CAR-T cell therapy CTL019 (tisagenlecleucel, brand name KymriahTM) for the treatment of relapsed and refractory… Read More

Interim results for the six months ended 30 June 2017

Oxford BioMedica announces a £2 million two-year collaboration co-funded by Innovate UK

The agreement is to explore a next generation gene and cell therapy manufacturing… Read More

Oxford BioMedica Announces MHRA Licence For Commercial Supply

London, UK – 07 August 2017: Oxford BioMedica plc (“Oxford BioMedica” or “the Group”) (LSE:OXB), a leading gene and cell therapy group, today announces that it has been granted a Manufacturer/Importer License (MIA), from the UK Medicines and Healthcare products Regulatory Agency (“MHRA”), to manufacture and distribute lentiviral vector material… Read More

FDA Advisory Committee Unanimously Recommends CTL019 (tisagenlecleucel) for Approval

London, UK – 13 July 2017: Oxford BioMedica plc (“Oxford BioMedica” or “the Group”) (LSE:OXB), a leading gene and cell therapy group, today notes that the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee voted unanimously 10 to 0 in favour of approval of Novartis investigational therapy CTL019… Read More

Oxford BioMedica Announces a Major Supply Agreement

Oxford, UK – 6 July 2017: Oxford BioMedica plc (LSE:OXB) (“Oxford BioMedica” or “the Group”), a leading gene and cell therapy group, today announces that it has signed an agreement with Novartis for the commercial and clinical supply of lentiviral vectors used to generate CTL019 (tisagenlecleucel) and other undisclosed Chimeric… Read More