BioSpace News Archive

NervGen Pharma Corp. (TSXV: NGEN) (OTCQX: NGENF), a clinical stage biotech company dedicated to developing innovative solutions for the treatment of nervous system damage, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation

Applied BioMath (www.appliedbiomath.com), the industry-leader in providing model-informed drug discovery and development (MID3) support to help accelerate and de-risk therapeutic research and development (R&D), today announced their participation at the 6th Clinical Trials on Alzheimer’s Disease (CTAD) occurring October 24-27, 2023 in Boston, MA.

Alkermes’ mission is to research, develop and commercialize important new medicines for patients suffering from complex medical conditions, including those who are often unfairly marginalized or stigmatized because of their illness.

Advanced Infusion Care, a division of AIS Healthcare, announced an agreement to conduct a joint study with Grifols, a leading global provider of essential plasma-derived and transfusion medicines, to observe the effects of subcutaneous immunoglobulin products on individuals living with primary immune deficiencies.

The Alzheimer’s Drug Discovery Foundation’s (ADDF) Diagnostic Accelerator (DxA) today announced the launch of SpeechDx, the first longitudinal study aimed at creating the largest repository of speech and voice data to help accelerate the detection, diagnosis and monitoring of Alzheimer’s disease.

XVIVO Perfusion AB On October 14, 2023 Duke University Hospital in Durham, N.C., performed the first heart transplant in the U.S. using XVIVO’s Non-Ischemic Heart Preservation device and solution as part of the PRESERVE clinical trial: A Prospective, Multi-center, Single-Arm, Open-Label Study of Hearts Transplanted after Non-Ischemic Heart PRESERVation from Extended Donors.

CymaBay Therapeutics, Inc. (NASDAQ: CBAY) announced today the presentation of findings from its post-hoc analysis of the Phase 3 ENHANCE study of seladelpar for the treatment of primary biliary cholangitis (PBC), showing baseline intensity of patient-reported pruritus was associated with higher levels of serum IL-31.

Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that it is scheduled to report third quarter results on November 2, 2023 at 4:00 PM Eastern Time.

Xtant Medical Holdings, Inc. announced that it has acquired the nanOss production operations from RTI Surgical, Inc., a leading CDMO in regenerative medicine.

Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for rare and ultrarare diseases, today announced the closing of its previously announced underwritten public offering of 9,833,334 shares of its common stock.