Kamada announces FDA acceptance of Inhaled AAT program path forward
Kamada Ltd. - Ordinary Shares (KMDA)
Last kamada ltd. - ordinary shares earnings: 2/12 07:00 am
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Source: GlobeNewswire
REHOVOT, Israel, April 16, 2019 (GLOBE NEWSWIRE) -- Kamada Ltd. (Nasdaq & TASE: KMDA), a plasma-derived protein therapeutics company, today announced receipt of a letter from the U.S. Food and Drug Administration (FDA or the Agency) stating that the Company has satisfactorily addressed the concerns and questions regarding its Inhaled Alpha-1-Antitrypsin (Inhaled AAT) program for the treatment of Alpha-1 Antitrypsin Deficiency (AATD), previously communicated by the Agency. This most recent response from the FDA in connection with the development plan for Inhaled AAT follows positive scientific advice received in July 2018 from the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) in Europe. Kamada intends to conduct a unified global pivotal Phase 3 clinical trial in the U.S. under an Investigational New Drug (IND) application and in Europe under a Clinical Trial Authorization (CTA) in order to submit marketing applications for regulatory appro
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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