Kamada Shuts Down Phase 3 Study For Genetic Condition, Reiterates Outlook
Kamada Ltd. (NASDAQ:KMDA) on Monday said it will discontinue its Phase 3 InnovAATe trial of Inhaled AAT for Alpha-1 Antitrypsin Deficiency (AATD).
- Kamada stock is feeling bearish pressure. Why are KMDA shares down?
AATD causes emphysema when the body doesn't produce enough of the protective alpha-1 antitrypsin (AAT) protein, leading to a breakdown of the lung's air sacs (alveoli).
This genetic condition leads to the accumulation of enzymes, such as neutrophil elastase, which damage the lungs, resulting in symptoms like shortness of breath and a chronic cough.
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The move follows independent Data and Safety Monitoring Board (DSMB) advice to the company that, based on a prespecified interim futility analysis, is unlikely to demonstrate a statistically significant benefit in its primary endpoint – lung function measured by FEV1.
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.
Outlook
As previously published, the company reiterated its full-year 2025 revenue guidance of between $178 million and $182 million compared to the consensus of $ $180.66 million, with adjusted EBITDA guidance of $40 million to $44 million.
In addition, Kamada projects double-digit growth in revenues and profitability in 2026 through its commercial portfolio, including six FDA-approved specialty plasma-derived products marketed in over 30 countries, a growing biosimilar portfolio in Israel, and the expansion of plasma collection capacity.
In parallel, the company continues to focus on pursuing new commercial stage business development opportunities, leveraging its strong cash position, to support continued long-term growth.
Price Action: KMDA stock is down 5.51% at $6.69 at the last check on Monday.
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