Kamada Announces FDA Approval of its New In-House Rabies Virus Neutralization Testing Laboratory
Rhea-AI Summary
Kamada (NASDAQ: KMDA) received FDA approval for its new in-house Rapid Fluorescent Focus Inhibition Test (RFFIT) rabies virus neutralization laboratory at its Beit Kama, Israel plant. The lab expands Anti-Rabies potency testing for KEDRAB and KAMRAB, Kamada’s leading franchise with 2025 sales over $70 million.
The RFFIT lab is part of Kamada’s Quality Control network, is among a limited number of global facilities able to run this gold-standard test, and was also approved by Health Canada and the Israeli Ministry of Health.
Positive
- FDA approval of in-house RFFIT rabies neutralization testing laboratory
- RFFIT lab supports Anti-Rabies potency testing for KEDRAB and KAMRAB
- KEDRAB and KAMRAB 2025 sales totaled over $70 million
- Additional approvals from Health Canada and Israeli Ministry of Health
- In-house lab expected to enhance operational efficiencies per company
Negative
- None.
News Market Reaction – KMDA
In the Jun 1 session, KMDA declined 1.41%, reflecting a mild negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Fda approval Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Mar 26 | FDA center approval | Positive | +0.2% | FDA cleared San Antonio plasma center for commercial plasma sales. |
| Aug 11 | FDA center approval | Positive | +3.1% | FDA approved Houston plasma center with large annual collection capacity. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Prior FDA operational approvals for infrastructure triggered modest positive price reactions, suggesting the market typically treats these as constructive but not transformational.
Recent history for Kamada shows a series of FDA-related operational approvals. On Aug 11, 2025 and Mar 26, 2026, the company received FDA approvals for plasma collection centers in Houston and San Antonio, each tied to future plasma capacity and anticipated revenue. Those events produced small positive price moves. Today’s FDA approval of an in-house rabies virus neutralization (RFFIT) lab continues this pattern of expanding vertically integrated, FDA-cleared infrastructure.
Key Terms
rapid fluorescent focus inhibition test medical
gmp technical
antibodies medical
plasma-derived therapies medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
REHOVOT, Israel and HOBOKEN, N.J., June 01, 2026 (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 therapies field, today announced FDA approval of the Company’s new in-house Rapid Fluorescent Focus Inhibition Test (RFFIT) laboratory. RFFIT is the gold standard neutralizing test used to measure the level of rabies-neutralizing antibodies.
The new laboratory is part of Kamada’s Quality Control laboratory network and represents a significant expansion of the Company’s advanced testing capabilities for Anti-Rabies potency testing involved in the manufacture of KEDRAB® and KAMRAB®. The new laboratory is located in Kamada's plant in Beit Kama, Israel, and is one of a limited number of laboratories worldwide which can perform such tests. The new RFFIT laboratory was designed to meet stringent safety, quality and GMP standards. Prior to receiving the FDA approval, the laboratory was also approved by Health Canada and the Israeli Ministry of Health.
The RFFIT test is used by Kamada to quantify the Anti-Rabies potency throughout all key steps of KEDRAB and KAMRAB manufacturing from plasma collection and sourcing to final product release.
In 2025, Kamada’s sales of KEDRAB and KAMRAB totaled over
“Our new state-of-the-art RFFIT laboratory supports our continued progress as a leading global vertically integrated specialty plasma-derived company,” said Amir London, Kamada’s Chief Executive Officer. “The new laboratory will enable increased operational efficiencies through utilization of our in-house, highly professional capabilities supported by external testing expertise. The establishment of this lab is also a demonstration of our ongoing commitment to innovation, scientific excellence, and investment in advanced quality infrastructure.”
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. FIMI Opportunity Funds, the leading private equity firm in Israel, is the Company’s controlling shareholder, beneficially owning approximately
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 statements regarding: 1) the new state-of-the-art RFFIT laboratory supports the Company’s continued progress as a leading global vertically integrated specialty plasma-derived company, 2) the expected benefits of the Company’s new in-house RFFIT laboratory, including increased operational efficiencies through utilization of the Company’s in-house highly professional capabilities supported by external testing expertise; and (3) the Company’s ongoing commitment to innovation, scientific excellence, and investment in advanced quality infrastructure. 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 tariffs on overall international trade and specifically on sales of KEDRAB® and KAMRAB® 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
