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

Rhea-AI Summary

Kamada (NASDAQ: KMDA) announced it will discontinue its Phase 3 InnovAATe trial of inhaled AAT after a prespecified interim futility analysis found the study is unlikely to meet its primary endpoint of lung function (FEV1).

The company said the decision is efficacy‑related and not due to safety concerns, and it will continue supplying GLASSIA (AAT-IV) internationally, including the U.S. and Canada via its licensee TAKEDA. Kamada reiterated its 2025 revenue guidance of $178M–$182M and adjusted EBITDA guidance of $40M–$44M, and projected double-digit revenue and profitability growth in 2026, with detailed guidance to follow in January 2026. Management will host a conference call today at 8:30am ET.

Positive

• Reiterated 2025 revenue guidance of $178M–$182M
• Reiterated 2025 adjusted EBITDA guidance of $40M–$44M
• Projects double-digit revenue and profitability growth in 2026
• Continued supply of GLASSIA in U.S. and Canada via TAKEDA license

Negative

• Discontinued Phase 3 InnovAATe trial after interim futility analysis
• Primary endpoint (FEV1) unlikely to show statistically significant benefit

Key Figures

2025 revenue guidance $178M–$182M Reiterated full-year 2025 guidance

2025 adjusted EBITDA $40M–$44M Reiterated full-year 2025 guidance

Trial phase Phase 3 InnovAATe inhaled AAT trial for AATD

Primary endpoint FEV1 Lung function measure in InnovAATe trial

FDA-approved products 6 products Specialty plasma-derived portfolio marketed in over 30 countries

Market reach 30+ countries Commercial footprint of FDA-approved plasma-derived products

Conference call time 8:30 AM ET Investor call to discuss trial discontinuation and outlook

2026 outlook Double-digit growth Projected 2026 revenue and profitability growth

Market Reality Check

$7.08 Last Close

Volume Volume 55,739 versus 20-day average 71,445 (relative volume 0.78) indicates no pre-news volume spike. normal

Technical Shares at $7.08, trading slightly above the 200-day MA of $6.98 and 22.67% below the 52-week high.

Peers on Argus

KMDA was down 0.56% pre-news, while key peers like EBS (-2.06%), ETON (-2.63%), CGC (-3.36%), and AQST (-0.93%) were generally weaker, suggesting broader pressure but no momentum-flagged sector move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 10	Earnings results	Positive	+5.4%	Strong Q3 and nine-month 2025 growth with reiterated full-year guidance.
Nov 04	Clinical trial update	Positive	-3.2%	First patient enrolled in SHIELD CYTOGAM trial for CMV prevention.
Nov 03	Earnings preview	Neutral	-0.4%	Announcement of date and call details for Q3 2025 results.
Oct 29	Conference participation	Neutral	-0.4%	Planned presentation at Stifel 2025 Healthcare Conference with webcast.
Sep 02	Conference participation	Neutral	+1.4%	Participation in two September 2025 investor conferences and webcasts.

Pattern Detected

Stock reacted positively to strong earnings but showed mixed responses to clinical and conference updates, including a negative move on prior clinical news.

Recent Company History

Over the last six months, Kamada reported strong financial performance, including Q3 2025 revenue of $47.0M and adjusted EBITDA of $11.7M, and reiterated 2025 guidance of $178M–$182M revenue and $40M–$44M adjusted EBITDA. Clinical activity included initiation of the CYTOGAM SHIELD trial. Conference and scheduling updates had modest price impact. Today’s Phase 3 inhaled AAT discontinuation contrasts with these earlier growth- and pipeline-supportive updates while management again emphasizes guidance and longer-term growth.

Market Pulse Summary

This announcement combines a pipeline setback with a reaffirmed outlook. The InnovAATe Phase 3 inhaled AAT trial for AATD is being discontinued after an interim futility analysis, though no safety concerns were cited. At the same time, Kamada reiterates 2025 guidance of $178M–$182M revenue and $40M–$44M adjusted EBITDA and signals double-digit growth in 2026 driven by six FDA-approved plasma-derived products and expanded plasma collection. Future updates on new business development and guidance in January 2026 will be important to monitor.

Key Terms

interim futility analysis medical

"based on a prespecified interim futility analysis, the Phase 3 InnovAATe trial"

An interim futility analysis is a planned mid-study check of trial results to determine whether a medical study is unlikely to show the expected benefit if it continues. For investors, this matters because a futility finding can lead to stopping the trial early, saving the company money but also reducing the chance of a future product approval and revenue; think of it as a halftime assessment that decides whether continuing the game is worth the cost.

phase 3 medical

"the Phase 3 InnovAATe trial of Inhaled AAT for the treatment"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

AI-generated analysis. Not financial advice.

• 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 TAKEDA
• Kamada 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 Growth
• Management 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 adjusted EBITDA guidance of $40 million to $44 million. In addition, we project double-digit growth in revenues and profitability in 2026 through our robust commercial portfolio, including six FDA- approved specialty plasma-derived products marketed in over 30 countries, our growing biosimilar portfolio in Israel, and the expansion of our plasma collection capacity. In parallel we continue to focus on pursuing new commercial stage business development opportunities, leveraging our strong cash position, to support continued long-term growth.”

Conference Call Details
Kamada's management will host an investment community conference call on Monday, December 8, at 8:30am Eastern Time to discuss the content of this release and answer questions. Shareholders and other interested parties may participate in the call by dialing 1-877-407-0792 (from within the U.S.), 1-809-406-247 (from Israel), or 1-201-689- 8263 (International) using conference I.D. 13757493. The call will be webcast live on the internet at: https://viavid.webcasts.com/starthere.jsp?ei=1746163&tp_key=515cc2901b.

About Kamada
Kamada Ltd. (the “Company”) is a global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived therapies field. The Company’s strategy is focused on driving profitable growth through three primary growth pillars: First, organic growth from its commercial activities, including continued investment in the commercialization and life cycle management of its proprietary products, which include six FDA-approved specialty plasma-derived products: KEDRAB®, CYTOGAM®, GLASSIA®, WINRHO SDF®, VARIZIG® and HEPAGAM B®, as well as KAMRAB®, KAMRHO (D)® and two types of equine-based anti-snake venom products, and the products in the distribution segment portfolio, mainly through the launch of several biosimilar products in Israel. Second: the Company aims to secure significant new business development, in-licensing, collaboration and/or merger and acquisition opportunities, which are anticipated to enhance the Company’s marketed products portfolio and leverage its financial strength and existing commercial infrastructure to drive long-term growth. Third: the Company is expanding its plasma collection operations to support revenue growth through the sale of normal source plasma to other plasma-derived manufacturers, and to support its increasing demand for hyper-immune plasma. The Company currently owns three operating plasma collection centers in the United States, in Beaumont Texas, Houston Texas, and San Antonio, Texas. The Company is leveraging its manufacturing, research and development expertise to advance the development and commercialization of additional product candidates, targeting areas of significant unmet medical need. FIMI Opportunity Funds, the leading private equity firm in Israel, is the Company’s controlling shareholder, beneficially owning approximately 38% of the outstanding ordinary shares.

Cautionary Note Regarding Forward-Looking Statements
This release includes forward-looking statements within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, including (among others) statements regarding: 1) 2025 full-year revenue guidance of $178 million-$182 million and adjusted EBITDA of $40 million-$44 million, 2) projection of double-digit growth in revenues and profitability in 2026; 3) positive prospects regarding our robust commercial portfolio; 4) expansion of our plasma collection capacity; and 5) intentions to focus on pursuing business development opportunities to support continued long-term growth. Forward-looking statements are based on Kamada’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to the evolving nature of the conflicts in the Middle East and the impact of such conflicts in Israel, the Middle East and the rest of the world, the impact of these conflicts on market conditions and the general economic, industry and political conditions in Israel, the U.S. and globally, effect of potential imposed tariff on overall international trade and specifically on Kamada’s ability to continue maintaining expected sales and profit levels in light of such potential tariff, the effect on establishment and timing of business initiatives, and other risks detailed in Kamada’s filings with the U.S. Securities and Exchange Commission (the “SEC”) including those discussed in its most recent Annual Report on Form 20-F and in any subsequent reports on Form 6-K, each of which is on file or furnished with the SEC and available at the SEC’s website at www.sec.gov. The forward-looking statements made herein speak only as of the date of this announcement and Kamada undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

CONTACTS:
Chaime Orlev
Chief Financial Officer
IR@kamada.com

Brian Ritchie
LifeSci Advisors, LLC
212-915-2578
britchie@LifeSciAdvisors.com

FAQ

Why did Kamada (KMDA) discontinue the Phase 3 InnovAATe inhaled AAT trial on December 8, 2025?

An independent DSMB's prespecified interim futility analysis concluded the trial was unlikely to demonstrate a statistically significant benefit on the primary endpoint (FEV1).

Does the trial discontinuation mean safety concerns for Kamada's inhaled AAT trial (KMDA)?

No; the company said the discontinuation was related to low likelihood of efficacy and was not reflective of any safety concerns.

What 2025 financial guidance did Kamada (KMDA) reaffirm on December 8, 2025?

Kamada reiterated full‑year 2025 revenue guidance of $178M–$182M and adjusted EBITDA guidance of $40M–$44M.

What growth does Kamada (KMDA) project for 2026 after the Phase 3 trial discontinuation?

The company projects double‑digit growth in revenues and profitability in 2026 and will provide detailed guidance in January 2026.

Will Kamada (KMDA) continue supplying its AAT product after the trial stop?

Yes; Kamada will continue to supply GLASSIA (AAT‑IV) internationally, including the U.S. and Canada through its license agreement with TAKEDA.

When is Kamada's management conference call to discuss the December 8, 2025 announcement?

Management will host a conference call on December 8, 2025 at 8:30am ET with a live webcast available online.