Kamada (KMDA) Study Result summary
Event summary combining transcript, slides, and related documents.
Study Result summary
10 Dec, 2025Discontinuation 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.
Latest events from Kamada
- Record revenue, EBITDA, and profit growth in H1 and Q2 2026, with strong outlook reaffirmed.KMDA
Q2 2026 - Q1 2026 showed stable growth and strong outlook, driven by robust demand and expansion.KMDA
Q1 2026 - Record revenue and profit growth in 2025, with strong 2026 guidance and portfolio expansion.KMDA
Q4 2025 - Sustained double-digit growth fueled by specialty plasma therapies and global expansion.KMDA
Corporate Presentation - Specialty plasma growth, global expansion, and innovation drive strong financial performance.KMDA
Wells Fargo 20th Annual Healthcare Conference 2025 - Double-digit growth in revenue and profit, with raised 2024 EBITDA guidance and strong outlook.KMDA
Q3 2024 - Double-digit growth, new plasma centers, and a pivotal inhaled AAT trial drive future upside.KMDA
Sidoti Micro-Cap Virtual Conference - H1 2024 revenue up 18% and adjusted EBITDA up 68%, with strong U.S. product demand.KMDA
Q2 2024 - Double-digit growth, new plasma centers, and late-stage pipeline drive robust outlook.KMDA
Sidoti Small-Cap Virtual Conference