DUBLIN – The EMA's Committee for Human Medicinal Products (CHMP) diverged from the FDA in its response to an application from the European arm of Emmaus Medical Inc., for approval of Xyndari, an oral formulation of the amino acid glutamine, for treating sickle cell disease.
DUBLIN – Shares in Newron Pharmaceuticals SpA dropped by as much as 20.5% Tuesday on news that preclinical toxicity findings would delay the start of pivotal trials of its candidate schizophrenia treatment evenamide by at least six months.
DUBLIN – Oxford Biomedica plc is banking £53.5 million (US$67.7 million) from a strategic investment by Novo Holdings A/S, under which the latter firm will acquire a 10.1% stake in the gene therapy firm.
DUBLIN – Dublin-based venture capital firm Fountain Healthcare Partners closed its third fund, Fountain Healthcare Partners Fund III, LP, with a raise of €118 million (US$131.5 million), which it will invest in biotech, specialty pharma and med-tech firms in Europe and, to a lesser extent, the U.S.
DUBLIN – Shares in Nuevolution AB skyrocketed by 166% Wednesday on news of a $167 million cash offer from Amgen Inc., which values the company a whole lot more than the market ever did.
DUBLIN – Quell Therapeutics Ltd., a new startup founded by the London-based biotech investment firm Syncona Ltd., has secured £35 million (US$44.5 million) in series A funding to progress the development of novel therapies based on engineering regulatory T cells (Tregs) to treat autoimmune disease and prevent organ transplant rejection.
DUBLIN – Morphosys AG took a significant step toward realizing its ambition to begin marketing its first product by mid-next year, as its CD19-directed antibody, tafasitamab (MOR-208), hit the primary endpoint of a pivotal phase II trial in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).
DUBLIN – Symphogen A/S's main shareholders are putting together a rescue package for the privately held antibody developer comprising DKK390 million (US$58.5 million) in new equity funding, combined with a DKK182 million debt-to-equity conversion. The move would involve a complete write-off of the company's existing share capital, which would cover accrued losses. All warrants would also be canceled.
DUBLIN – Meiragtx Holdings plc remains on course to move its second-generation adeno-associated virus (AAV)-based gene therapy for inherited retinal disorders arising from RPE65 (retinal pigment epithelium-specific 65 KDa protein) deficiency into a pivotal trial shortly, following a six-month readout from a phase I/II trial in which the construct met the primary endpoint of safety and tolerability and achieved statistical significance on several measures of clinical activity.
