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Biopharma Kamada Ltd (KMDA) has announced that the initial vials of its plasma-derived immunoglobulin (IgG) product for Covid-19 have received the green light for compassionate use in Israel.
The company has now completed manufacturing of the first batch of its plasma-derived IgG product, using its approved proprietary IgG platform technology, and additional production is ongoing.
In addition, Kamada’s proposed clinical protocol for a Phase 1/2 clinical trial was submitted to the Israeli Ministry of Health, and the company expects to initiate the study during the third quarter of this year.
To expand its clinical development program to the U.S., Kamada is working with Kedrion Biopharma. The companies intend to hold a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) early in the third quarter in order to obtain FDA’s acceptance of the proposed clinical development program.
Kedrion is currently collecting Covid-19 convalescent plasma from U.S. recovered patients at 23 FDA-approved centers across the United States that will be used by Kamada to manufacture additional batches of the product.
““We believe that Kamada and Kedrion, two leaders in plasma-derived protein therapeutics, are uniquely positioned to make a positive impact in the treatment of COVID-19 patients” commented Amir London, Kamada’s CEO. “To the best of our knowledge, Kamada is the first company globally to complete manufacturing of a plasma-derived IgG product for the treatment of COVID-19.”
Shares in Kamada are currently trading up 23% year-to-date, and are rising in Wednesday’s pre-market trading. The stock has a Moderate Buy consensus with recent buy ratings from HC Wainwright and Jefferies. (See KMDA stock analysis on TipRanks)
HC Wainwright’s Andrew Fein recently reiterated his bullish stance on Kamada, citing the company’s alpha-1 antitrypsin (AAT) program. “We continue to believe the inhaled formulation could offer a potentially preferable means of delivery compared to Glassia, the company’s intravenous (IV) therapy for AATD patients” he explained. Fein’s $11 price target indicates further upside potential of 31%.
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