Regenerative medicine company Mesoblast Ltd. received an early Christmas present from the FDA for approval of its allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy, Ryoncil (remestemcel-L), for steroid-refractory acute graft-vs.-host disease (SR-aGvHD) in children 2 months and older, including adolescents.
Promise Bio Ltd. emerged from stealth with $8.3 million in seed investment for its precision medicine platform, which addresses immune-mediated diseases. The funding will be used to accelerate the development of the company’s technology that analyzes proteins and their post-translational modifications to predict the treatment responses of patients with immune-mediated diseases.
Caliway Biopharmaceuticals’ lipolysis candidate, CBL-514, met all the primary and secondary efficacy endpoints in a phase IIb study for subcutaneous fat reduction, paving the way for the company to begin a global pivotal phase III study in 2025.
Candid Therapeutics Inc. and Epimab Biotherapeutics Inc. have entered a $1 billion research collaboration to discover and develop novel T-cell engager candidates for autoimmune indications.
Relation Therapeutics Ltd. has delivered the first commercial validation of its combined wet lab/in silico platform for homing in on disease-related genes in the thick of the genome, signing two collaboration agreements with GSK plc, with a potential value of $200 million per target.
Caliway Biopharmaceuticals’ lipolysis candidate, CBL-514, met all the primary and secondary efficacy endpoints in a phase IIb study for subcutaneous fat reduction, paving the way for the company to begin a global pivotal phase III study in 2025.
Sound Pharmaceuticals Inc.’s lead candidate, the anti-inflammatory SPI-1005 (ebselen), has produced positive pivotal phase III study data in treating Meniere’s disease, an inner-ear disorder that can lead to vertigo and deafness.
Relation Therapeutics Ltd. has delivered the first commercial validation of its combined wet lab/in silico platform for homing in on disease-related genes in the thick of the genome, signing two collaboration agreements with GSK plc, with a potential value of $200 million per target.
Paradigm Biopharmaceuticals Ltd. raised AU$16 million (US$10.31 million) in a placement that will allow the company to start a global phase III trial with its lead product, Zilosul (injectable pentosan polysulfate/iPPS), to treat osteoarthritis.
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