Aurinia Pharmaceuticals Has Submitted Its Investigational New Drug Application To FDA For AUR200, A Potential Therapy For B-cell Mediated Autoimmune Diseases
Portfolio Pulse from Benzinga Newsdesk
Aurinia Pharmaceuticals has submitted an IND application to the FDA for AUR200, aimed at treating B-cell mediated autoimmune diseases. Pending FDA approval, the company intends to start a Phase 1 study in H1 2024 to assess AUR200's safety, tolerability, and pharmacological properties in healthy volunteers.

December 20, 2023 | 11:02 am
News sentiment analysis
Sort by:
Descending
POSITIVE IMPACT
Aurinia Pharmaceuticals has filed an IND with the FDA for AUR200, a potential treatment for autoimmune diseases, with plans to start Phase 1 trials in early 2024 upon approval.
The submission of an IND to the FDA is a positive step forward in the drug development process, indicating progress in Aurinia's pipeline. If the FDA approves the application, it allows the company to proceed with clinical trials, which is a critical milestone. This news is likely to be viewed positively by investors, as it demonstrates advancement in the company's research and development efforts. However, the impact is not at the highest level of importance since the drug is still in early stages and actual market approval, if granted, would be several years away.
CONFIDENCE 85
IMPORTANCE 80
RELEVANCE 100