BioSpace News Archive

-- New Drug Application (NDA ) accepted for review by U.S. Food and Drug Administration (FDA) for avacopan in ANCA -associated vasculitis with PDUFA goal date of July 7, 2021 -- -- Marketing Authorization Application (MAA) validated by the European Medicines Agency (EMA) for avacopan in ANCA-associated vasculitis -- -- T opline data from AURORA Phase II clinical trial of avacopan in Hidradenitis Suppurativa (HS) leads to Company plans

PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immuno-oncology company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology, today announced that its VERSATILE-002 Phase 2 clinical trial evaluating the combination of PDS0101 and KEYTRUDA®

Third Quarter 2020 Results : Record Revenue of $101.7 million, growing more than 880% year-over-year Record Billable tests delivered approximately 1.04 million, growing more than 4,800% year-over-year Gross Margin improved approximately 19 percentage points sequentially and approximately 12 percentage points year-over-year; cost per test improved approximately 42% sequentially Non-COVID Revenue grew 57% sequentially

Reports record Breast Products net sales of $15.3 million, representing 54% sequential growth and 2 1 % year over year growth Results driven by U.S. recovery and market outperformance in the core breast products segment

Cerecor Inc., a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare and orphan diseases, announced recent business progress and third quarter results for 2020.

Cara Therapeutics, Inc. (Nasdaq: CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors (KORs), today announced financial results and operational highlights for the third quarter ended September 30, 2020.

Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced financial results for the third quarter 2020 and recent business progress.

Homology Medicines, Inc. (Nasdaq: FIXX), a genetic medicines company, announced today financial results for the third quarter ended September 30, 2020, and highlighted recent accomplishments.

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients

TriNetX, the global health research network that revolutionizes clinical research and enables discoveries through the generation of real-world evidence (RWE), announced the most recent publication of clinical research data utilizing the company’s network.