BioSpace News Archive

− Initiates Clinical Study of Biannual Dosing Regimen of Investigational Vutrisiran in hATTR Patients with Polyneuropathy, with Data Expected in 2022 Potentially Supporting sNDA Submission – − Introduces New ATTR Program Aimed at Achieving Annual Dosing Regimen with Highly Potent and Reversible Effects; Expected IND Filing at or Around Year-end 2022 –

BLA submission for omidubicel, a potentially life-saving treatment for patients with blood cancers in need of stem cell transplant, expected in fourth quarter of 2021 Pre-commercial and manufacturing activities underway to support potential launch of omidubicel in 2022 Phase 1/2 clinical trial of allogeneic, off-the-shelf GDA-201 in NHL planned with IND submission anticipated in the second half of 2021

Startup’s AI technology increases breast cancer screening compliance and empowers radiologists to interpret results faster, improving patient experience and outcomes

BriaCell Therapeutics Corp., a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer, announced that Dr. William V. Williams, President & CEO of BriaCell, is scheduled to participate in the following virtual conferences

STALICLA SA, a Swiss clinical stage biopharmaceutical company leading omics-based precision medicine drug development for patients with neurodevelopmental disorders, announced the appointment of Baltazar Gomez-Mancilla, MD, PhD, to the position of Chief Medical Officer.

Cerecor Inc., a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare and orphan diseases, announced that the U.S. Food and Drug Administration has granted Fast Track designation to CERC-002 for treatment of hospitalized patients with COVID-19.

OVAL Phase 3 registration-enabling study investigating VB-111 in patients with platinum-resistant ovarian cancer remains on track in spite of COVID-19, with over 260 patients enrolled; next DSMC review expected 3Q21

Nurix Therapeutics, Inc., a biopharmaceutical company developing targeted protein modulation drugs, announced that members of Nurix management team will participate in the following conferences in May

Interim Phase 2 data indicate that CNM-Au8 has a homeostatic effect on brain bioenergetics and support its potential to drive meaningful neurological functional improvements in MS patients

Applied Therapeutics, Inc., a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, reported financial results for the first quarter ended March 31, 2021.