Trust favourite Gilead expands R&D deal with Galapagos – US biotech giant Gilead Sciences (NASDAQ: GILD) has entered into a ten-year R&D collaboration with Galapagos (Euronext/NASDAQ: GLPG) covering rights to the Belgium group’s entire development portfolio. The transformative deal includes a $3.95bn upfront payment – a new record in the industry – as well as $1.1bn in […]
Shield poised for FDA decision on Feraccru for anemia – Shield Therapeutics (STX) should hear at some point over the next two weeks whether the FDA will approve its oral iron supplement Ferracru for treatment of iron deficiency. The decision, due by 26 July, is of course important but is further complicated by a statistical issue with the […]
Morphosys takes option on Vivoryon’s QPCTL inhibitors in oncology – Germany’s Morphosys (MOR) has taken up an option to license Vivoryon’s family of inhibitors of the glutaminyl-peptide cyclotransferase-like (QPCTL) protein in oncology, in exchange for a commitment to invest €15m as part of a capital raising planned for later this year. The option covers Vivoryon’s lead compound […]
Y-mAbs confirms plans to start naxitamab filing in November – HBM-investee Y-mAbs Therapeutics (YMAB) has confirmed plans to start a rolling US filing for naxitamab for the treatment of patients its with relapsed/refractory high-risk neuroblastoma in November, after a pre-BLA meeting with the FDA. The company aims to file the clinical/safety and non-clinical portions of […]
4D Pharma starts first trial in asthma – UK microbiome biotech 4D Pharma (DDDD) has started a clinical trial of a live biotherapeutic, MRx-4DP000, in asthma, the first time such a drug concept has been tested in this condition. The double-blind, placebo-controlled Phase I/II study will enrol 90 patients whose asthma is inadequately controlled on inhaled therapy. Patients will […]
Cantargia aism for first results of key study in Q4 – Sweden’s Cantargia (CANT) expects to report the first efficacy data from lead product nidanilimab in the fourth quarter of this year, some months earlier than expected, after quickly reaching its target recruitment of 20 patients – six with non-small cell lung cancer (NSCLC) and […]
FDA surprises with controversial OK for Karyopharm’s selinexor – US Biotech Karyopharm Therapeutics (Nasdaq:KPTI) saw its stock jump 36% yesterday on news that the FDA has granted an accelerated approval to its anticancer Xpovo (selinexor), a nuclear export inhibitor, for late-line relapsed or refractory multiple myeloma (RRMM). The news surprised many specialist investors as the application […]
Oncimmune expands network with EarlyCDT Lung deal with Russia’s R-Pharm UK biotech Oncimmune (ONC) has expanded its distribution network for its lead product, the EarlyCDT Lung liquid biopsy test, with the signing of a deal with Russia’s R-Pharm JSC. The deal comes a week after Oncimmune announced an agreement with the US company, Biodesix, to commercialise the […]
Sweden’s Calliditas Therapeutics raises SEK210m Sweden’s Calliditas Therapeutics (Nasdaq Stockholm: CALTX) has raised SEK210m in a directed share issue of 3,505,291 shares at a price of SEK 60 per share, to domestic and international investors, including the US specialist investor BVF Partners, whcih invested $12m (cSEK112m) in the placing. At the same time, three of […]
Morphosys receives milestone as GSK advances RA antibody – German biotech MorphoSys (NASDAQ: MOR), a holding of International Biotechnology Trust (IBT), has received a €22m milestone payment from its licensing partner GlaxoSmithKline (GSK) in connection with the start of a Phase III trial programme with otilimab (formerly MOR103/GSK3196165) in rheumatoid arthritis (RA). GSK will conduct four […]
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