Kamada Ltd. (NASDAQ: KMDA) announced that it will discontinue its Phase 3 InnovAATe trial of inhaled alpha‑1 antitrypsin (AAT) for Alpha‑1 Antitrypsin Deficiency (AATD). The decision follows an interim futility analysis by an independent Data and Safety Monitoring Board that found the study was unlikely to meet its primary endpoint of a statistically significant improvement in forced expiratory volume in one second (FEV1). The company emphasized that the discontinuation is driven solely by the low probability of success and does not reflect any safety concerns.
The halt removes a projected $2 billion market opportunity from Kamada’s pipeline, tightening the company’s future revenue trajectory. While the company’s existing portfolio of FDA‑approved plasma‑derived products remains robust, the loss of a potentially high‑margin inhaled therapy represents a significant strategic setback. Kamada’s guidance for full‑year 2025 revenue ($178 million to $182 million) and adjusted EBITDA ($40 million to $44 million) remains unchanged, underscoring management’s confidence that the core business can absorb the loss.
Kamada’s Q3 2025 results provide context for the guidance. Revenue rose 13% year‑over‑year to $47.0 million, driven by strong demand for its flagship product GLASSIA® and growth in its distribution segment. Adjusted EBITDA increased 34% to $11.7 million, reflecting disciplined cost management and a favorable product mix. The company’s first‑nine‑month revenue of $135.8 million and adjusted EBITDA of $34.2 million also show double‑digit growth, reinforcing the outlook for 2025.
CEO Amir London highlighted that, despite the disappointment of the trial’s termination, Kamada remains focused on its 2026 and future growth prospects. He noted the company’s expanding biosimilar portfolio in Israel, the opening of a new plasma‑collection site in San Antonio, Texas in March 2025, and FDA approval of its Houston, Texas center in August 2025. London emphasized continued supply of GLASSIA® to the Alpha‑1 community and reiterated that the company’s commercial portfolio is positioned to support the guidance.
The company’s strategic emphasis on plasma‑collection expansion and biosimilar development is intended to offset the lost upside from the InnovAATe program. By increasing raw‑material supply and entering new markets, Kamada aims to sustain revenue growth and maintain profitability, while the existing product lines provide a stable foundation for the coming years.
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