Emalex Biosciences Inc. closed an upsized and oversubscribed $250 million series D funding round intended to support a soon-to-start phase III trial and preparations for potential commercialization of ecopipam, its first-in-class drug for Tourette syndrome, a neurological disorder characterized by involuntary motor and vocal tics. Read More
Abeona Therapeutics Inc. is on the road to filing a BLA with the U.S. FDA after posting positive top-line phase III data in wound healing and also to the bank with a new $35 million private placement financing. The data for EB-101, an autologous cell therapy, came from a pivotal study of treating recessive dystrophic epidermolysis bullosa, an ultra-rare connective tissue disorder. Results showed the study met its two co-primary endpoints in wound healing and for reducing pains in large, chronic wounds caused by the disorder. Read More
While weekly global and U.S. confirmed cases of COVID-19 are below each of the last two years, infectious disease experts remain on guard. There are still about 1,500 people dying around the world each day, including 350 in the U.S., and the SARS-CoV-2 virus may continue to find ways to outmaneuver current treatments and vaccines. Read More
Shares in Affimed AG gained as much as 28% during trading on Nov. 3 as the company unveiled continued good news from a phase I/II combination trial in CD30-positive lymphoma of its CD30-directed innate cell engager, AFM-13, and allogeneic natural killer (NK) cell therapy, as well as a clinical development partnership with Artiva Biotherapeutics Inc., which will provide it with access to a commercially scalable source of NK cells as the program matures. Read More
Compass Pathways plc is poised to start the first ever phase III trial of the psychedelic drug psilocybin, after getting U.S. FDA backing for a study in treatment-resistant depression. Read More
GSK plc has announced it has stopped early two pivotal phase III trials of its urinary tract infection drug, gepotidacin, for efficacy and is preparing regulatory filings for what could be the first new oral antibiotic for the disease in more than 20 years. Read More
By pairing the expression of an inhibitory ion channel with an activity-dependent promoter, researchers have developed the first on-demand gene therapy that specifically silenced hyperactive cells and prevented epileptic seizures. Read More