Business
Kamada Announces Discontinuation of its Phase 3 Inhaled AAT Clinical Trial; Reiterates 2025 Full-Year Guidance and Projects Double-Digit Growth in Revenues and Profitability in 2026
Based on the Results of a Planned Interim Futility Analysis the Inhaled AAT Trial is Unlikely to Demonstrate a Statistically Significant Benefit in its
About this update from Kamada Ltd.
[{"type":"text","content":"Based on the Results of a Planned Interim Futility Analysis the Inhaled AAT Trial is Unlikely to Demonstrate a Statistically Significant Benefit in its Primary Endpoint Kamada Continues to Supply GLASSIA®, its AAT-IV Treatment, Marketed Internationally Including in the U.S. and Canada Through a License Agreement with TAKEDAKamada Reiterates its 2025 Full-Year Revenue Guidance of $178 Million-$182 Million and Adjusted EBITDA of $40 Million-$44 Million Kamada Projects Double-Digit Growth in Revenues and Profitability in 2026; Detailed Guidance to be Provided in January 2026 Company is Focused on Pursuing Business Development Opportunities to Support Continued Long-Term GrowthManagement to Hold a Conference Call and Live Webcast Today at 8:30am ET REHOVOT, Israel and HOBOKEN, N.J., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived field, today announced that the independent Data and Safety Monitoring Board (DSMB) advised the Company that, based on a prespecified interim futility analysis, the Phase 3 InnovAATe trial of Inhaled AAT for the treatment of Alpha-1 Antitrypsin Deficiency (AATD) is unlikely to demonstrate a statistically significant benefit in its primary endpoint - lung function measured by FEV1. Based on the futility analysis outcome, the Company will discontinue the trial. The discontinuation is solely related to the low likelihood of a successful efficacy outcome and is not reflective of any safety concerns. “While we are disappointed that the trial did not pass this milestone and is being discontinued, we are well positioned to continue and support our 2026 and future growth prospects,” said Amir London, CEO of Kamada. “We are grateful for the support of the patients, physicians and all other stakeholders who participated in the trial and remain committed to the AATD community through continued supply of GLASSIA®, our leading AAT-IV treatment, marketed internationally, including in the U.S. and Canada through our license agreement with TAKEDA. As previously published, based on our consistent, strong performance during 2025, we are reiterating our full-year 2025 revenue guidance of between $178 million to $182 million and our annual a...