Akari Therapeutics AKTX Stock News

Akari Therapeutics PLC (NASDAQ: AKTX) is making a strong run for the top in the marke ttoday, trading on early gains of well over 30%. The gains come after the company announced that it received Fast Track designation from the FDA. Here’s what’s going on:

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AKTX Stock Heads Up On Fast Track Designation

In a press release issued in the premarket this morning, Akari Therapeutics said that the United States Food and Drug Administration has granted one of its candidates Fast Track designation.  According to the release, Nomacopan is now on the Fast Track for the treatment of hematopoietic stem cell transplant associated thrombotic microangiopathy in pediatric patients.

The Fast Track designation comes as the company is in the process of moving toward a pivotal trial. In fact, AKTX said that the trial is expected to take place in the fourth quarter of 2019.

In a statement, Clive Richardson, interim CEO at AKTX, had the following to offer:

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.

This Is Incredible News

The Fast Track designation announced today is incredibly positive news. After all, this designation is designed to facilitate the development and expedited review of new drugs that show promise in serious and life-threatening conditions with unmet medical need.

As a result, the companies producing drug candidates that are fast tracked by the FDA enjoy more communication with the FDA. This also means that the drug may qualify for a priority review, shortening the PDUFA period and potentially bringing the product to market faster.

HSCT-TMA is considered an orphan condition. Unfortunately, more than 80% of children with severe instances of the disease will pass away. Moreover, there are no approved treatmetns for the conditions. So, should the company meet all criteria, a submission and rapid review of data is likely to take place in early to mid 2020.

Nomacopan Shows Promise

It’s worth mentioning that nomacopan has shown serious promise in HSCT-TMA patients in clinical trials. In September of last year, AKTX announced that in the first two treated patients as part of a UK patient program, disease resolution was achieved.

Once the treatment was administered, the patient experienced rapid reduction of the markers of complement activation as well as noormalization of markers that are elevated in HSCT-TMA patients.

The Market Potential Here Is Incredible

Should AKTX push nomacopan to market, the potential here would be incredible. As mentioned above, there are no approved treatments that are indicated for HSCT-TMA patients. However, the market surrounding the condition is a massive one.

In fact, experts expect that the HSCT-TMA market will grow to be worth well over $37 billion annually by the year 2025. That’s a big deal, especially when you consider that Akari Therapeutics is currently trading with a sub-$50 million market cap.

With no competition on the playing field, this relatively small biotech company could have a blockbuster on its hands, should the treatment be approved. So, keep your eyes peeled as this opportunity could be huge.

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