For decades, treatment options for osteoarthritis have followed a familiar path: As cartilage deteriorates and pain worsens, conservative therapies eventually give way to joint replacement surgery. Australian regenerative medicine company Integrant Pty Ltd. wants to change that trajectory. Rather than replacing damaged joints, the Sydney-based company is building a platform designed to regenerate cartilage and preserve joint function by combining biologics, medical devices and artificial intelligence.
Pending talks with regulators, Satellos Bioscience Inc. may seek accelerated approval in Duchenne muscular dystrophy (DMD) for SAT-3247, which yielded positive results in the adult phase II Trailhead study. Shares of Toronto-based Satellos (NASDAQ:MSLE) closed July 8 at $8.98, up 77 cents, or 9.4%, after the firm made public six-month interim data from Trailhead.
Neuracle Medical Technology Co. Ltd. is seeking a Shanghai IPO that could make it China’s first publicly listed invasive brain-computer interface (BCI) company, months after winning approval for the country’s first invasive BCI system.
Ready or not, the future has arrived. Novel AI and brain-computer interface (BCI) systems are no longer confined to the realm of science fiction. As an increasingly intertwined human-machine model moves closer to adoption in real-world clinical and military practice, technological advances are sparking concerns over public health, ethics and national security.
Decades of research are helping unravel the “black box” of the brain. The second article in BioWorld’s series on the Brain-Computer Interface (BCI) field looks at how simultaneous breakthroughs in AI technology are pushing the BCI field from a theoretical concept to a potential real-world, clinical option for individuals, particularly in China where the National Medical Products Administration greenlighted the world’s first invasive BCI system – Neuracle Medical Technology Co. Ltd.’s Neural Electronic Opportunity – for clinical use in March 2026.
Neither of Cynata Therapeutics Ltd.’s pivotal trials for its Cymerus stem cell platform met the primary endpoints, with no statistically significant differences between active and control groups on primary or key secondary efficacy measures, CEO Kilian Kelly told investors during a June 22 conference call.
Edgewise Therapeutics Inc. is pulling in $1.55 billion up front by selling its muscular dystrophy business, including its fast skeletal myosin inhibitor, sevasemten (EDG-5506), to Servier SA. The deal is potentially worth up to $2.65 billion when including a potential $1.1 billion in milestone payments.
A new strategy aims to improve gene therapy for Pompe disease by optimizing both the genetic component that restores the function of a deficient lysosomal enzyme and the vector that delivers it to the target tissue while avoiding the liver. The findings suggest that combining an optimized transgene with a targeted capsid could significantly enhance the effectiveness of gene therapy for Pompe disease.
Showing a significant efficacy signal in a phase II trial, Relay Therapeutics Inc.’s zovegalisib (RLY-2608) achieved a 60% volumetric response in patients with PIK3CA-driven vascular anomalies (VAs). The isoform-selective PI3Ka inhibitor is in late-stage clinical trials with various combinations for P13Ka-mutated, HR+/HER2- advanced breast cancer, with VAs representing a second indication for which Leerink Partners analyst Andrew Berens forecasts $2.8 billion in peak revenues.
How the U.S. FDA might view the latest Duchenne muscular dystrophy (DMD) phase III data with gene therapy RGX-202 became the question for Regenxbio Inc., shares of which (NASDAQ:RGNX) closed May 14 at $6.25, down 38%, or $3.80, after the results were made public.