The error in phase III data reported in late October that sank Galera Therapeutics Inc.’s stock (NASDAQ:GRTX) has been corrected, prompting share values to nearly double on Dec. 14. The error, according to J. Mel Sorensen, Galera’s president and CEO, had resulted in a false “p” value, leading the company to report the study had failed to achieve statistical significance on its primary endpoint. He called the programming error that caused the confusion “quite subtle.”
Two trials presented at the annual meeting of the American Society of Hematology (ASH) showed that treatment with the antithrombin inhibitor fitusiran reduced the bleeding rate in patients with severe hemophilia by roughly 90%, regardless of whether they had type A or B, and whether they had developed antibodies to recombinant clotting factors.
Orca Bio Inc. reported at the American Society of Hematology that cancer patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT) who received its Orca-T cell therapy product achieved higher rates of survival without experiencing either relapse or chronic graft-vs.-host (GvHD) disease than those who received a conventional graft.
LONDON – There was a substantial fall in neutralization titers against the Omicron variant of SARS-CoV-2 in the stored sera of people who had received two doses of either Astrazeneca plc’s or Pfizer Inc./Biontech SE’s COVID-19 vaccines, with some samples failing to neutralize the virus at all, according to the latest data from the U.K. Com-Cov study.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Active Biotech, Aeromics, Angion, Beigene, Carrick, Clene, Eucure, Gilead, Immunic, Moderna, Obseva, Roche, Simcere, UCB, Vifor.
Core presentations at the 63rd meeting of the annual American Society of Hematology (ASH) began Saturday morning with the presentation of three studies focused on non-Hodgkin lymphomas and one on multiple myeloma (MM). Each approach used the immune system as a cancer fighter but employed different mechanisms of action. Two of them successfully used CAR T therapies as treatment.
Stereotaxis Corp. reported positive results showing its robotic magnetic navigation (RMN) system significantly reduces the incidence of silent cerebral embolism (SCE) in patients undergoing atrial fibrillation (AF) ablation vs. hand-held catheters. The prospective, multicenter study is believed to be the first to compare AF ablation using RMN with manual control and to highlight the benefit in lowering SCE risk.
Angion Biomedica Corp. CEO Jay Venkatesan said his firm is ransacking phase II data for “a clear and consistent trend” toward benefit with ANG-3777 before going to the next stage of development with the hepatocyte growth factor mimetic for patients undergoing cardiac surgery involving cardiopulmonary bypass who are at risk for developing acute kidney injury. A decision is due early next year.
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