Study Result
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Kamada (KMDA) Study Result summary

Event summary combining transcript, slides, and related documents.

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Study Result summary

10 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.

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