Kamada Ltd. (NASDAQ:KMDA) fell 8% on Monday after the company said it is discontinuing its Phase 3 trial evaluating its inhaled Alpha-1 Antitrypsin (AAT) therapy for treating Alpha-1 Antitrypsin Deficiency (AATD).
The move came after guidance from an independent Data and Safety Monitoring Board, which concluded the study was unlikely to reach statistical significance on its primary endpoint—improvement in lung function. Kamada stressed that the recommendation was tied exclusively to efficacy and not due to any safety concerns.
Even with the trial setback, the company reaffirmed its 2025 financial outlook, including projected revenue of $178 million to $182 million and adjusted EBITDA of $40 million to $44 million. Kamada also expects double-digit revenue and profit growth in 2026, with more detailed forecasts to come in January.
“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, Kamada’s CEO.
The company will continue selling GLASSIA®, its intravenous AAT therapy for AATD, which is distributed globally and marketed in the U.S. and Canada through a licensing deal with Takeda. Kamada’s commercial lineup includes six FDA-approved plasma-derived products available in more than 30 countries.
Headquartered in Israel, Kamada said it remains committed to seeking new commercial-stage opportunities as it works to sustain long-term expansion.