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Kamada Study Result summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Study Result summary8 Dec, 2025
Discontinuation of Phase 3 Inhaled AAT InnovAATe Trial
Phase 3 InnovAATe trial of inhaled AAT for Alpha-1 Antitrypsin Deficiency discontinued after interim futility analysis showed low likelihood of meeting the primary endpoint for lung function improvement (FEV1); decision based on efficacy, not safety concerns, and no safety issues identified.
All participating sites are being informed, and the study is being closed in an organized manner.
Ongoing Commercial Activities and Product Portfolio
Continues to supply GLASSIA (AAT-IV treatment) internationally, including the U.S. and Canada, via a license agreement, demonstrating ongoing commitment to the Alpha-1 community.
Commercial portfolio includes six FDA-approved specialty plasma-derived products marketed in over 30 countries and a growing biosimilar portfolio in Israel.
Expanding plasma collection operations with three centers in Texas to support product demand and sales to other manufacturers.
Financial Impact and Outlook
Annual study costs of $5–$6 million will be eliminated after early 2026, with no offsetting costs expected; savings will flow directly to the bottom line and positively impact EBITDA.
Reiterates 2025 full-year revenue guidance of $178–$182 million and adjusted EBITDA of $40–$44 million.
Projects double-digit revenue and profitability growth in 2026, with detailed guidance to be provided in early January.
Detail business development focus
Elaborate on 2026 growth drivers
How does plasma collection support growth?
When will trial cost savings impact EBITDA?
Describe new commercial stage opportunities
What is the long-term Alpha-1 strategy post-trial?
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Frequently asked questions
Kamada Ltd. is a globall biopharmaceutical company that focuses on the development, production, and marketing of plasma-derived protein therapeutics. The company is known for its specialty in products designed for rare diseases, operating across two main segments: Proprietary Products and Distribution. Kamada's diverse product range includes treatments for conditions such as immune thrombocytopenic purpura, hepatitis B, varicella, and Alpha-1 Antitrypsin Deficiency (AATD), among others. Additionally, it has developed specific immunoglobulins for various applications, including rabies and diseases caused by Rh-negative in the fetus. Kamada markets its products through strategic partnerships and distributors internationally, including collaborations with Takeda Pharmaceuticals Company Limited, PARI GmbH, and Kedrion Biopharma. The company prides itself on its industry-leading manufacturing capabilities and a robust development pipeline aimed at addressing unmet medical needs. Kamada Ltd. is headquartered in Rehovot, Israel, and its shares are listed on the Nasdaq.
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