Akebia and Otsuka tweak design of late-stage vadadustat studies, marketing approval in Japan may be 2021; shares down 2% [Seeking Alpha]
Akebia Therapeutics, Inc. (AKBA)
Last akebia therapeutics, inc. earnings: 3/10 07:49 am
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Source: Seeking Alpha
Akebia and Otsuka tweak design of late-stage vadadustat studies, marketing approval in Japan may be 2021; shares down 2%In anupdate to investors, Akebia Therapeutics (AKBA-1.6%) announces that it and commercialization partner Mitsubishi Tanabe Pharma have changed the designs of two Japan-based Phase 3 studies, FO2RWARD and TRILO2GY, evaluating vadadustat in patients with anemia associated with dialysis-dependent chronic kidney disease ((DD-CKD)).FO2RWARD will now include a broader dialysis population and larger sample size with once-daily and 3x/week dosing. It is designed to inform ESA (erythropoietin stimulating agent)-switching protocols. The study will be initiated next quarter with top-line data expected by year-end/early 2019.TRILO2GY will also include a larger sample size and once-daily and 3x/week dosing. It is designed to inform switching from Amgen's Epogen (epoetin alfa) and Aranesp (darbepoetin alfa) and Vifor Pharma'sMircera (methoxy PEG-epoetin beta). The study will laun
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News
- AVEROA Submits Marketing Authorisation Application to the European Medicines Agency Seeking Approval of AVA1014 for Treating Complications Associated with Chronic Kidney Disease [Yahoo! Finance]Yahoo! Finance
- Akebia Therapeutics, Inc. (NASDAQ: AKBA) was upgraded by analysts at StockNews.com from a "hold" rating to a "buy" rating.MarketBeat
- Akebia Therapeutics, Inc. (NASDAQ: AKBA) was downgraded by analysts at StockNews.com from a "buy" rating to a "hold" rating.MarketBeat
- Buy Vafseo's Approval: A New Chapter For Akebia Therapeutics In Anemia Management [Seeking Alpha]Seeking Alpha
- Akebia Therapeutics, Inc. (NASDAQ: AKBA) was upgraded by analysts at StockNews.com from a "hold" rating to a "buy" rating.MarketBeat
AKBA
Earnings
- 3/14/24 - Beat
AKBA
Sec Filings
- 4/25/24 - Form ARS
- 4/25/24 - Form DEFA14A
- 4/25/24 - Form DEF
- AKBA's page on the SEC website