AVEROA Submits Marketing Authorisation Application to the European Medicines Agency Seeking Approval of AVA1014 for Treating Complications Associated with Chronic Kidney Disease [Yahoo! Fi...
Akebia Therapeutics, Inc. (AKBA)
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Source: Yahoo! Finance
the submission of a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for Ferric Citrate Coordination Complex (AVA1014), an oral iron-based compound for patients suffering from Chronic Kidney disease (CKD). Ferric Citrate Coordination Complex (AVA1014) was licensed from Akebia Therapeutics, Inc. (Akebia) in December 2022. Since then, Averoa has revised the clinical package and the regulatory strategy using all clinical studies and recent scientific publications to address the specific needs of the European market. The MAA submission is supported by three pivotal clinical studies performed by Akebia. The EMA will review the accepted application under the centralised marketing authorisation procedure and a decision on a potential approval is expected in 2025. This centralised procedure means that a single marketing authorisation application can be submitted to the European Union (EU), and, if approved, allows Averoa to market and make Ferric Citrate Co
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News
- Akebia Therapeutics to Report First Quarter 2024 Financial Results and Discuss Recent Business HighlightsPR Newswire
- Akebia Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)PR Newswire
- Akebia Therapeutics, Inc. (NASDAQ: AKBA) was downgraded by analysts at StockNews.com from a "buy" rating to a "hold" rating.MarketBeat
- When Can We Expect A Profit From Akebia Therapeutics, Inc. (NASDAQ:AKBA)? [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
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