FDA Provides Akebia Therapeutics A Path Forward For Vadadustat: FDA Denies Formal Dispute Resolution
Portfolio Pulse from Benzinga Newsdesk
The FDA has denied Akebia Therapeutics' appeal for vadadustat but provided a path forward for resubmitting the new drug application (NDA) for treating anemia due to chronic kidney disease (CKD) in dialysis-dependent patients.
May 30, 2023 | 11:32 am
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Akebia Therapeutics' appeal for vadadustat was denied by the FDA, but the company was provided with a path forward for resubmitting the NDA.
The FDA's denial of Akebia Therapeutics' appeal for vadadustat is a setback for the company. However, the FDA has provided a path forward for resubmitting the NDA, which could potentially lead to approval in the future. This creates a neutral short-term impact on the stock price, as the denial is negative news, but the path forward for resubmission offers some hope for the company.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100