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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
Globenewswire· 2025-12-08 12:00
Core Insights - Kamada Ltd. announced the discontinuation of the Phase 3 InnovAATe trial for Inhaled AAT due to an interim futility analysis indicating low likelihood of achieving statistically significant benefits in lung function [1][5] - The company remains committed to supporting the Alpha-1 Antitrypsin Deficiency (AATD) community through its existing product GLASSIA and is focused on future growth prospects despite the trial's outcome [2][5] Financial Guidance - Kamada reiterated its full-year 2025 revenue guidance of $178 million to $182 million and adjusted EBITDA guidance of $40 million to $44 million [2][5] - The company projects double-digit growth in revenues and profitability for 2026, with detailed guidance to be provided in January 2026 [2][5] Business Strategy - Kamada's growth strategy includes organic growth from its commercial activities, business development opportunities, and expansion of plasma collection operations [4][6] - The company currently operates three plasma collection centers in the U.S. and aims to enhance its marketed products portfolio through potential collaborations and acquisitions [4][6] Company Overview - Kamada is a global biopharmaceutical company specializing in products for rare and serious conditions, particularly in the specialty plasma-derived therapies field [4][6] - The company is controlled by FIMI Opportunity Funds, which owns approximately 38% of its outstanding shares [6]
Kamada to Present at the Stifel 2025 Healthcare Conference
Globenewswire· 2025-10-29 11:00
Company Overview - Kamada Ltd. is a global biopharmaceutical company specializing in products for rare and serious conditions, particularly in the specialty plasma-derived therapies field [3] - The company has a portfolio of six FDA-approved specialty plasma-derived products, including KEDRAB®, CYTOGAM®, GLASSIA®, WINRHO SDF®, VARIZIG®, and HEPAGAM B®, along with other proprietary products [3] Growth Strategy - Kamada's growth strategy is built on four primary pillars: 1. Organic growth through commercialization and life cycle management of proprietary products [3] 2. Securing new business development opportunities, including in-licensing, collaborations, and mergers and acquisitions to enhance its product portfolio [3] 3. Expanding plasma collection operations to support revenue growth and meet increasing demand for hyper-immune plasma [3] 4. Advancing the development and commercialization of additional product candidates, with a focus on unmet medical needs, such as the Inhaled AAT product candidate currently in a pivotal Phase 3 trial [3] Leadership and Events - Amir London, the CEO of Kamada, will present at the Stifel 2025 Healthcare Conference on November 12, 2025, and will be available for one-on-one investor meetings [2]
Kamada Announces FDA Approval of its Plasma Collection Center in Houston, Texas
Globenewswire· 2025-08-11 11:00
Core Insights - Kamada Ltd. has received FDA approval for its plasma collection center in Houston, Texas, allowing it to commence commercial sales of normal source plasma [1][2][3] - The Houston facility is expected to have an annual collection capacity of approximately 50,000 liters of plasma and generate estimated annual revenues of $8 million to $10 million at full capacity [2][6] - The company plans to seek approval from the European Medicines Agency (EMA) for the Houston center following the FDA approval [3][7] Company Overview - Kamada Ltd. is a global biopharmaceutical company focused on rare and serious conditions, with a portfolio that includes six FDA-approved specialty plasma-derived products [4] - The company's growth strategy includes organic growth from commercial activities, new business development, expansion of plasma collection operations, and advancing product candidates through R&D [4] - Kamada currently operates three plasma collection centers in Texas: Houston, San Antonio, and Beaumont, which collectively enhance its capacity for specialty and normal source plasma collection [3][4]