Kamada Announces Withdrawal of European Marketing Authorization Application for Inhaled Alpha-1 Antitrypsin for Treatment of Alpha-1 Antitrypsin Deficiency Disease
Kamada Ltd. - Ordinary Shares (KMDA)
Last kamada ltd. - ordinary shares earnings: 2/12 07:00 am
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Source: GlobeNewswire
REHOVOT, Israel, June 22, 2017 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ:KMDA) (TASE:KMDA), a plasma-derived protein therapeutics company focused on orphan indications, today announced that the Company has withdrawn the Marketing Authorization Application (MAA) for its proprietary inhaled Alpha-1 Antitrypsin (AAT) therapy for the treatment of Alpha-1 Antitrypsin Deficiency (AATD) with the European Medicines Agency (EMA). Following extensive discussions with the EMA during recent months, Kamada concluded that the EMA does not view the data submitted to date as sufficient for approval of the MAA, and that the supplementary data needed for approval requires an additional clinical trial. While the post-hoc data provided by the Company from the European clinical trial showed a statistically significant and clinically meaningful improvement in lung function, the EMA was of the opinion that an overall positive conclusion on the effect of inhaled AAT to treat AATD could not be reached based
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News
- Kamada Ltd. (NASDAQ:KMDA) Q4 2023 Earnings Call Transcript [Yahoo! Finance]Yahoo! Finance
- Kamada Reports Strong Fiscal Year and Fourth Quarter 2023 Financial Results, and Provides Full-Year 2024 Guidance Representing Double-Digit Growth in Revenue and Profitability [Yahoo! Finance]Yahoo! Finance
- Kamada Issues 2024 CEO Letter to ShareholdersGlobeNewswire
- Kamada Reports Strong Fiscal Year and Fourth Quarter 2023 Financial Results, and Provides Full-Year 2024 Guidance Representing Double-Digit Growth in Revenue and ProfitabilityGlobeNewswire
- Kamada to Announce Fourth Quarter and Fiscal Year 2023 Financial Results, and Provide 2024 Financial Guidance on March 6, 2024GlobeNewswire
KMDA
Earnings
- 3/6/24 - Beat
KMDA
Sec Filings
- 3/6/24 - Form 6-K
- 3/6/24 - Form 20-F
- 2/28/24 - Form 6-K
- KMDA's page on the SEC website