Benzinga - by Vandana Singh, Benzinga Editor.
HC Wainwright has upgraded Akebia Therapeutics Inc (NASDAQ: AKBA) from Neutral to Buy rating.
Analysts Ed Arce and Thomas Yip note that the company last week received the official minutes from the End-of-Dispute Type A meeting held with the FDA in late July.
Akebia Therapeutics expects to resubmit its New Drug Application (NDA) for vadadustat for anemia due to chronic kidney disease in adult patients on dialysis by the end of Q3 of 2023, with a potential action date projected in March 2024.
HC Wainwright says that the resubmission is a focused filing, including additional safety data collected since the original NDA, including new data from two alternate dosing studies, FOCUS and MODIFY, and over two years of post-marketing data from Japan.
On the earnings call, when the company released its Q2 earnings on Friday, the management mentioned that labeling discussions were part of the meeting, and it could include data referencing the risk of thromboembolic events and drug-induced liver injury, the two points behind the prior complete response letter.
With meeting minutes confirmation, the analysts are now highly confident in the FDA approval of vadadustat early next year.
Along with vadadustat's NDA resubmission, management also expects a regulatory opinion on vadadustat in Australia in 2023.
Price Action: AKBA shares are up 23.9% at $1.43 on the last check Monday.
Latest Ratings for AKBA
| Nov 2021 | HC Wainwright & Co. | Maintains | Buy | |
| Mar 2021 | Cantor Fitzgerald | Initiates Coverage On | Overweight | |
| Mar 2021 | HC Wainwright & Co. | Maintains | Buy |
View the Latest Analyst Ratings
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