Kamada Receives FDA Approval for New RFFIT Laboratory
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 day ago
0mins
Kamada announced FDA approval of the company's new in-house Rapid Fluorescent Focus Inhibition Test, or RFFIT, laboratory. 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 Kerab and Kamrab.
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Analyst Views on KMDA
Wall Street analysts forecast KMDA stock price to rise
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 7.700
Low
13.00
Averages
14.00
High
15.00
Current: 7.700
Low
13.00
Averages
14.00
High
15.00
About KMDA
Kamada Ltd is Israel based company, focused on plasma-derived protein therapeutics with a commercial product portfolio and a late-stage product pipeline. The Company uses its proprietary platform technology and know-how for the extraction and purification of proteins from human plasma to produce Alpha-1 Antitrypsin (AAT) in a highly-purified, liquid form, as well as other plasma-derived Immune globulins.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Kamada's New Laboratory Receives FDA Approval
- Laboratory Expansion: Kamada's new RFFIT laboratory in Beit Kama, Israel, has received FDA approval, significantly enhancing the company's quality control capabilities for the production of anti-rabies drugs KEDRAB and KAMRAB, which is expected to bolster its market competitiveness in the biopharmaceutical sector.
- Sales Growth: In 2025, sales of KEDRAB and KAMRAB exceeded $70 million, making them the leading products in Kamada's portfolio of specialty plasma-derived products, and the new laboratory is anticipated to improve production efficiency, thereby supporting future sales growth.
- Quality Standards: The new laboratory meets stringent safety, quality, and GMP standards, enhancing Kamada's internal testing capabilities while leveraging external testing expertise to improve overall operational efficiency, further solidifying its leadership position in the industry.
- Strategic Investment: CEO Amir London stated that the establishment of the new laboratory reflects the company's ongoing commitment to innovation and scientific excellence, laying the groundwork for future product development and market expansion, which will drive long-term profitable growth.
See More
Kamada Receives FDA Approval for New Laboratory
- Laboratory Approval: Kamada Ltd. announced that its newly established rabies virus neutralization testing laboratory has received FDA approval, marking a significant step in enhancing the company's quality control and regulatory capabilities for its rabies immunoglobulin product KEDRAB.
- Internal Testing Capacity: The new laboratory will enable Kamada to conduct rabies virus neutralization assays internally, ensuring faster turnaround times and higher quality standards, thereby enhancing the company's competitive position in the market.
- Support for Clinical Development: This facility will not only support the commercialization of KEDRAB but also provide backing for ongoing clinical development programs and regulatory submissions, further strengthening the company's product portfolio.
- Efficiency Improvement: By reducing reliance on external testing facilities, the new laboratory will improve operational efficiency and provide greater flexibility in meeting regulatory requirements, aiding Kamada's continued expansion in infectious diseases and immunology.
See More
Kamada Releases 2026 Financial Guidance Amid Q1 Miss
- Disappointing Earnings: Kamada reported Q1 GAAP EPS of $0.07, missing expectations by $0.05, while revenue reached $45.2 million, a 2.7% year-over-year increase, but fell short of projections by $3.19 million, indicating pressure on profitability.
- Annual Guidance Affirmed: Despite the disappointing Q1 results, Kamada reaffirmed its 2026 revenue guidance of $200 million to $205 million and adjusted EBITDA guidance of $50 million to $53 million, suggesting confidence in achieving double-digit organic growth moving forward.
- Impact of Shipment Delay: The Q1 2026 results were impacted by a temporary shipment delay of a single order, which was subsequently delivered in April, highlighting challenges in supply chain management that could affect short-term performance.
- Business Development Evaluation: Kamada is actively evaluating near-term business development and M&A transactions to further enhance long-term profitable growth, indicating a proactive approach to strategic expansion and market competitiveness.
See More
Kamada Q1 Earnings Announcement Scheduled
- Earnings Release Date: Kamada (KMDA) is set to announce its Q1 earnings on May 13 before market open, with a consensus EPS estimate of $0.12, reflecting a significant year-over-year increase of 71.4%, indicating strong profitability potential.
- Revenue Expectations: The anticipated revenue for Q1 is $48.39 million, representing a 10.0% year-over-year growth, showcasing Kamada's ongoing growth potential in the biopharmaceutical sector despite competitive pressures.
- Historical Performance Review: Over the past two years, Kamada has beaten EPS and revenue estimates 75% of the time, demonstrating financial stability and market confidence in the company's performance.
- Estimate Revision Dynamics: In the last three months, EPS estimates have seen one upward and one downward revision, while revenue estimates have experienced three downward revisions, indicating a cautious market outlook on Kamada's future performance.
See More
Kamada Secures Tax Ruling for Dividend Distribution
- Dividend Announcement: Kamada announced a cash dividend of $0.25 per share, totaling approximately $14.4 million, to be paid on April 7, 2026, to shareholders of record as of March 23, 2026, demonstrating the company's commitment to shareholder returns.
- Tax Ruling Impact: The ruling from the Israel Tax Authority allows eligible Nasdaq shareholders to benefit from a reduced withholding tax rate, which is expected to enhance actual returns for shareholders and bolster investor confidence.
- Compliance Requirements: Nasdaq shareholders must submit necessary documentation to the Tax Agent by May 9, 2026, to qualify for the reduced withholding tax rate, making compliance critical to managing their tax liabilities effectively.
- Appointment of Tax Agent: Kamada appointed IBI Trust Management as the tax agent to facilitate the tax-related processes for dividend distribution, aiming to streamline procedures and enhance shareholder convenience.
See More
Kamada Receives FDA Approval for San Antonio Plasma Center
- FDA Approval: Kamada's plasma collection center in San Antonio, Texas, has received FDA approval following an on-site inspection in February 2026, marking a significant milestone in the company's expansion into the U.S. market.
- Capacity and Revenue Potential: The center features 50 donor beds and can produce up to 50,000 liters annually at full capacity, with projected annual revenues of $8 to $10 million, significantly enhancing the company's revenue base and market competitiveness.
- International Expansion Plans: Following FDA clearance, Kamada plans to pursue EMA inspection and approval, demonstrating the company's strategic intent to expand in global markets and further diversify its revenue streams.
- Future Growth Expectations: Kamada forecasts double-digit profitable growth in 2026, and with its biosimilars pipeline, the company is positioned for sustained profitability and enhanced market standing in the future.
See More
Kamada's New Laboratory Receives FDA Approval
- Laboratory Expansion: Kamada's new RFFIT laboratory in Beit Kama, Israel, has received FDA approval, significantly enhancing the company's quality control capabilities for the production of anti-rabies drugs KEDRAB and KAMRAB, which is expected to bolster its market competitiveness in the biopharmaceutical sector.
- Sales Growth: In 2025, sales of KEDRAB and KAMRAB exceeded $70 million, making them the leading products in Kamada's portfolio of specialty plasma-derived products, and the new laboratory is anticipated to improve production efficiency, thereby supporting future sales growth.
- Quality Standards: The new laboratory meets stringent safety, quality, and GMP standards, enhancing Kamada's internal testing capabilities while leveraging external testing expertise to improve overall operational efficiency, further solidifying its leadership position in the industry.
- Strategic Investment: CEO Amir London stated that the establishment of the new laboratory reflects the company's ongoing commitment to innovation and scientific excellence, laying the groundwork for future product development and market expansion, which will drive long-term profitable growth.
See More
Kamada Receives FDA Approval for New Laboratory
- Laboratory Approval: Kamada Ltd. announced that its newly established rabies virus neutralization testing laboratory has received FDA approval, marking a significant step in enhancing the company's quality control and regulatory capabilities for its rabies immunoglobulin product KEDRAB.
- Internal Testing Capacity: The new laboratory will enable Kamada to conduct rabies virus neutralization assays internally, ensuring faster turnaround times and higher quality standards, thereby enhancing the company's competitive position in the market.
- Support for Clinical Development: This facility will not only support the commercialization of KEDRAB but also provide backing for ongoing clinical development programs and regulatory submissions, further strengthening the company's product portfolio.
- Efficiency Improvement: By reducing reliance on external testing facilities, the new laboratory will improve operational efficiency and provide greater flexibility in meeting regulatory requirements, aiding Kamada's continued expansion in infectious diseases and immunology.
See More
Kamada Releases 2026 Financial Guidance Amid Q1 Miss
- Disappointing Earnings: Kamada reported Q1 GAAP EPS of $0.07, missing expectations by $0.05, while revenue reached $45.2 million, a 2.7% year-over-year increase, but fell short of projections by $3.19 million, indicating pressure on profitability.
- Annual Guidance Affirmed: Despite the disappointing Q1 results, Kamada reaffirmed its 2026 revenue guidance of $200 million to $205 million and adjusted EBITDA guidance of $50 million to $53 million, suggesting confidence in achieving double-digit organic growth moving forward.
- Impact of Shipment Delay: The Q1 2026 results were impacted by a temporary shipment delay of a single order, which was subsequently delivered in April, highlighting challenges in supply chain management that could affect short-term performance.
- Business Development Evaluation: Kamada is actively evaluating near-term business development and M&A transactions to further enhance long-term profitable growth, indicating a proactive approach to strategic expansion and market competitiveness.
See More
Kamada Q1 Earnings Announcement Scheduled
- Earnings Release Date: Kamada (KMDA) is set to announce its Q1 earnings on May 13 before market open, with a consensus EPS estimate of $0.12, reflecting a significant year-over-year increase of 71.4%, indicating strong profitability potential.
- Revenue Expectations: The anticipated revenue for Q1 is $48.39 million, representing a 10.0% year-over-year growth, showcasing Kamada's ongoing growth potential in the biopharmaceutical sector despite competitive pressures.
- Historical Performance Review: Over the past two years, Kamada has beaten EPS and revenue estimates 75% of the time, demonstrating financial stability and market confidence in the company's performance.
- Estimate Revision Dynamics: In the last three months, EPS estimates have seen one upward and one downward revision, while revenue estimates have experienced three downward revisions, indicating a cautious market outlook on Kamada's future performance.
See More
Kamada Secures Tax Ruling for Dividend Distribution
- Dividend Announcement: Kamada announced a cash dividend of $0.25 per share, totaling approximately $14.4 million, to be paid on April 7, 2026, to shareholders of record as of March 23, 2026, demonstrating the company's commitment to shareholder returns.
- Tax Ruling Impact: The ruling from the Israel Tax Authority allows eligible Nasdaq shareholders to benefit from a reduced withholding tax rate, which is expected to enhance actual returns for shareholders and bolster investor confidence.
- Compliance Requirements: Nasdaq shareholders must submit necessary documentation to the Tax Agent by May 9, 2026, to qualify for the reduced withholding tax rate, making compliance critical to managing their tax liabilities effectively.
- Appointment of Tax Agent: Kamada appointed IBI Trust Management as the tax agent to facilitate the tax-related processes for dividend distribution, aiming to streamline procedures and enhance shareholder convenience.
See More
Kamada Receives FDA Approval for San Antonio Plasma Center
- FDA Approval: Kamada's plasma collection center in San Antonio, Texas, has received FDA approval following an on-site inspection in February 2026, marking a significant milestone in the company's expansion into the U.S. market.
- Capacity and Revenue Potential: The center features 50 donor beds and can produce up to 50,000 liters annually at full capacity, with projected annual revenues of $8 to $10 million, significantly enhancing the company's revenue base and market competitiveness.
- International Expansion Plans: Following FDA clearance, Kamada plans to pursue EMA inspection and approval, demonstrating the company's strategic intent to expand in global markets and further diversify its revenue streams.
- Future Growth Expectations: Kamada forecasts double-digit profitable growth in 2026, and with its biosimilars pipeline, the company is positioned for sustained profitability and enhanced market standing in the future.
See More
