FDA Agrees to Use of New Higher-Yielding Manufacturing Process for Nomacopan in Pivotal Clinical Studies
Akari Therapeutics Plc - American Depositary Shares (AKTX)
US:NASDAQ Investor Relations:
investor.akaritx.com/investor-relations
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Source: GlobeNewswire
NEW YORK and LONDON, Jan. 19, 2022 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where complement (C5) and/or leukotriene (LTB4) systems are implicated, today announced that the U.S. Food and Drug Administration (FDA) has agreed, via a Type C meeting, to the clinical use of nomacopan derived from a next generation manufacturing process. Nomacopan is Akari’s lead drug candidate currently in two Phase III programs. The FDA agreed that the new manufacturing process produces drug that is comparable to nomacopan from the prior manufacturing process. The new manufacturing process increases the final yield of nomacopan at least 5-fold, compared to the previous manufacturing process, which will significantly decrease future commercial cost of goods and reduce the cost of ongoing Phase II/III and future clinical development programs for nomacopan. “FD
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News
- Akari Therapeutics, Plc (NASDAQ: AKTX) is now covered by analysts at StockNews.com. They set a "sell" rating on the stock.MarketBeat
- Akari Therapeutics, Plc (NASDAQ: AKTX) is now covered by analysts at StockNews.com. They set a "sell" rating on the stock.MarketBeat
- Akari Therapeutics, Plc (NASDAQ: AKTX) is now covered by analysts at StockNews.com. They set a "sell" rating on the stock.MarketBeat
- Samir R. Patel, M.D. Appointed Interim CEO for Akari Therapeutics [Yahoo! Finance]Yahoo! Finance
- Akari Therapeutics and Peak Bio Announce Portfolio Prioritization Plan for Combined Go-Forward Merger Entity [Yahoo! Finance]Yahoo! Finance
AKTX
Sec Filings
- 5/7/24 - Form 8-K
- 5/3/24 - Form 4
- 5/1/24 - Form 425
- AKTX's page on the SEC website