Good News for Stem Cell Transplants

By Chris Lange Updated Jan 11, 4:56AM EST · Published Aug 14, 9:45AM EDT

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Good News for Stem Cell Transplants — © Pablo_K / Getty Images

Akari Therapeutics PLC (NASDAQ: AKTX) shares jumped on Wednesday after the firm announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its stem cell transplant treatment.

Specifically, the designation is for nomacopan for the treatment of hematopoietic stem cell transplant associated thrombotic microangiopathy (HSCT-TMA) in pediatric patients.

Overall, the Fast Track designation supports Akari’s plans for expedited approval of nomacopan for HSCT-TMA, with the pivotal trial expected to commence in the fourth quarter of 2019.

HSCT-TMA is an orphan condition with an estimated fatality rate of more than 80% in children with the severe disease. There are currently no approved treatments for HSCT-TMA, but there is strong evidence for the role of complement and potentially LTB4 in the etiology of the disease.

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Clive Richardson, interim CEO of Akari Therapeutics, commented:

Fast Track designation provides our HSCT-TMA clinical program a pathway for an expedited approval for nomacopan, and we plan to commence a pivotal trial in the fourth quarter of 2019. We see HSCT-TMA as a gateway into a range of other poorly treated orphan TMAs in both pediatric and adult patients, and are optimistic about the potential for nomacopan to offer an improved standard of care for these orphan conditions with high mortality rates.

Shares of Akari traded up about 30% to $2.36 early Wednesday. The 52-week trading range is $1.56 to $9.20.

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About the Author Chris Lange →

Chris Lange is a writer for 24/7 Wall St., based in Houston. He has covered financial markets over the past decade with an emphasis on healthcare, tech, and IPOs. During this time, he has published thousands of articles with insightful analysis across these complex fields. Currently, Lange's focus is on military and geopolitical topics.

Lange's work has been quoted or mentioned in Forbes, The New York Times, Business Insider, USA Today, MSN, Yahoo, The Verge, Vice, The Intelligencer, Quartz, Nasdaq, The Motley Fool, Fox Business, International Business Times, The Street, Seeking Alpha, Barron’s, Benzinga, and many other major publications.

A graduate of Southwestern University in Georgetown, Texas, Lange majored in business with a particular focus on investments. He has previous experience in the banking industry and startups.