Kamada Halts Phase 3 Inhaled AAT Trial But Maintains Bullish Revenue and Profit Growth Outlook for 2026
Clinical Trial Discontinued After Futility Analysis—No Safety Concerns Identified
Kamada Ltd. announced the discontinuation of its Phase 3 InnovAATe trial investigating inhaled Alpha-1 Antitrypsin (AAT) for Alpha-1 Antitrypsin Deficiency. The decision followed an independent data monitoring board's planned interim futility analysis, which indicated the trial was unlikely to demonstrate significant improvement in lung function, its primary endpoint. Importantly, the termination is unrelated to safety and solely reflects the trial’s limited chance for efficacy.
Robust 2025 Guidance Reaffirmed and Double-Digit Growth Expected in 2026
Despite this setback, Kamada is not revising its full-year 2025 revenue or profitability guidance. The company confirmed expectations for 2025 revenue between $178 million and $182 million, alongside adjusted EBITDA in the range of $40 million to $44 million. Management also projects double-digit growth for both revenues and profits in 2026, leveraging its broad portfolio and business development initiatives. More detailed 2026 guidance is expected in January 2026.
| 2025 Revenue Guidance | 2025 Adjusted EBITDA Guidance | 2026 Growth Projection |
|---|---|---|
| $178M - $182M | $40M - $44M | Double-digit revenue & profitability growth |
Diversified Portfolio and Expansion Efforts Support Future Outlook
Kamada’s management emphasized its continued commitment to supplying GLASSIA®, the company’s intravenous AAT therapy marketed internationally in partnership with Takeda, especially in the U.S. and Canada. The commercial portfolio currently includes six FDA-approved specialty plasma-derived products sold in more than 30 countries, complemented by a growing biosimilar presence in Israel. Kamada is also ramping up its plasma collection capabilities, now operating three U.S. plasma centers, which is expected to further support commercial supply and open new growth avenues.
Business Development Remains a Priority as Company Leverages Cash Position
The company signaled its intention to actively pursue new commercial opportunities—including potential acquisitions, in-licensing deals, and collaborations—to enhance its portfolio and long-term trajectory. Management stated this strategy would help maintain positive momentum, with Kamada’s strong financial foundation and robust cash position supporting these ambitions.
Key Takeaway: Clinical Setback Does Not Diminish Long-Term Growth Prospects
While discontinuing a late-stage clinical program is never ideal, Kamada’s forward guidance, diversified product suite, and ongoing expansion plans position the company to absorb this clinical setback without altering its bullish medium-term outlook. Investors and industry watchers should look for the company’s detailed 2026 forecast in January and track further developments around portfolio expansion and new business opportunities.
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