Regulatory and Financial Challenges Loom for Aurinia Pharmaceuticals Despite FDA and EC Approvals

Aurinia Pharmaceuticals (AUPH) has disclosed a new risk, in the Regulation category.

Aurinia Pharmaceuticals faces significant regulatory risks despite having FDA and EC approvals for its drugs. The ongoing regulation by these agencies requires rigorous compliance with record-keeping, adverse event reporting, and current Good Manufacturing Practices (cGMPs), which can result in unannounced inspections and potential disruptions. Furthermore, unforeseen safety issues may lead to the withdrawal of drug approvals or additional restrictions, impacting market availability. Additionally, international price controls could negatively affect the company’s revenues and royalty payments, adding financial pressure.

The average AUPH stock price target is $11.00, implying 45.70% upside potential.

To learn more about Aurinia Pharmaceuticals’ risk factors, click here.