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Akari's 2-Day Rally: What You Need To Know

Akari's 2-Day Rally: What You Need To Know

Akari Therapeutics PLC (NASDAQ: AKTX) shares are on track to reclaim the $2 level for the first time since mid-August thanks to two doses of positive tidings from the company.

Shares of the nanocap biotech were last seen advancing $6.74% to $2.06 Friday, extending the upward move seen the prior day. 

The Q2 Boost

The stock ended Thursday's session 12.21% higher on heavy volume after the biopharma reported second-quarter results that showed break-even results compared to a loss of 1 cent per share in the year-ago period.

The improvement was achieved on the back of a previously disclosed change in the fair value of stock option liabilities and forex gains, as well as lower operating expenses, according to Akari. 

Orphan Drug Designation Adds To Momentum

Akari announced Friday that its lead investigational asset nomacopan, which is currently being evaluated for four indications, has been granted orphan drug designation, or ODD, for the treatment of hematopoietic stem cell transplantation-associated thrombotic microangiopathy, or HSCT-TMA.

Incidentally, nomacopan received Fast Track designation from the FDA for the same indication in pediatric patients on Aug. 14, which led to a 62% jump in shares in a single session.

HSCT-TMA is a rare disease for which there are no approved treatments. Thrombotic microangiopathy, or TMA, is a condition where a blood clot occurs in capillaries and arterioles due to an endothelial injury.

ODD is granted to promote development of drugs that affect 200,000 or fewer U.S. patients annually and would provide significant therapeutic advantage over existing treatments.

A ODD designation vests several benefits, such as seven years of market exclusivity following marketing approval, tax credits on clinical trials conducted in the U.S., eligibility for orphan drug grants and a waiver of certain administrative fees.

Related Links:

The Daily Biotech Pulse: Genmab-Novartis Multiple Sclerosis Drug Aces Late-Stage Studies, Akari Nets Orphan Drug Designation

Biotech Stock On The Radar: MyoKardia Bets On Precision Medicine For Heart Health

Posted-In: Biotech Earnings News FDA Trading Ideas General Best of Benzinga


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