Regenerative medicine company Mesoblast Ltd. saw its stock shoot up 45% on the news that the U.S. FDA is satisfied with the additional data submitted from the company’s phase III study for remestemcel-L for treatment of adults with steroid-refractory acute graft-vs.-host disease (SR-aGVHD) to support filing a BLA in pediatric patients with SR-aGVHD.
Two big pharma firms placed high offers on Dec. 26 to acquire companies focused on radiopharmaceuticals and cell therapies in what Evercore ISI analysts are calling a “good sign for the end of the year.”
Japan-California startup Shinobi Therapeutics Inc. has emerged from stealth mode with a $51 million series A round to advance its first off-the-shelf induced pluripotent stem cell (iPS)-T cell therapy against glypigan-3 (GPC3)-positive cancers toward the clinic.
Japan’s PMDA has approved Aurion Biotech Inc.’s cell therapy, Vyznova, for the treatment of bullous keratopathy of the cornea, making it the first-ever approval of a cell therapy to treat corneal endothelial disease.
The University of Sydney is investing AU$478 million (US$326.5 million) to build a leading biomedical precinct to fast-track research and shorten the time between discovery and development of transformative therapies.
Oricell Therapeutics Co. Ltd. has raised $120 million in a series B financing to support development of its cell therapy pipeline and technology platform, as well as the construction of a manufacturing plant. The round was jointly led by Qiming Venture Partners and Quan Capital Management LLC.
South Korea’s Medipost Co. Ltd. is gearing up for phase III trials in the U.S. of its stem cell therapy, Cartistem, an allogeneic human umbilical cord blood-derived mesenchymal stem cell therapy for treatment of knee articular damage in patients with osteoarthritis.
Shares of Athersys Inc. fell sharply May 20 after its partner and top investor Healios K.K. reported that Multistem (invimestrocel), the experimental cell therapy they've co-developed since 2016, missed the primary endpoint of a Japanese phase II/III ischemic stroke study called Treasure. Many Athersys investors appeared to read the results as bad news for Athersys' ongoing pivotal phase III stroke study, Masters-2.
Aurion Biotech Inc. pulled down a $120 million financing to advance efforts with its lead candidate, a cell therapy for the treatment of corneal edema secondary to endothelial dysfunction (CESED).