Apellis Pharmaceuticals Inc (NASDAQ: APLS) is having a great start to the trading session this morning, and for good reason. The company announced that it has received Fast Track designation from the FDA for one of its clinical candidates. As you could imagine, the news excited investors, pushing the stock on a run for the top. Today, w’ell talk about:
- The designation;
- what we’re seeing from APLS stock as a result; and
- what we’ll be watching for ahead.
APLS Gains On Fast Track Designation
As mentioned above, Apellis Pharmaceuticals is having a great start to the trading session this monring after announcing Fast Track Designation. In a press release issued early this morning, the company announced the designation surrounding APL-2.
APL-2 is the company’s novel inhibitor of complement factor C3. The treatment is being developed as a potential option for patients with paroxysmal nocturnal hemoglobinuria, also known as PNH. At the moment, the treatment is being assessed in a Phase 3 active comparator trial in patients with PNH who remain anemic despite treatment with eculizumab.
The Fast Track designation is overwhelmingly positive news for APLS. After all, this designation ultimately shortens the path to potential approval, as well as provides the company with further support from the FDA throughout the development process.
In a statement, Pascal Deschatelets, PhD, Co-Founder and CEO at APLS, had the following to offer:
We are very pleased that the FDA recognizes the potential for APL-2 to help every patient with PNH. We believe that APL-2 has the potential to be a best in class treatment for all PNH patients.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to work in the market is that the news leads to moves. When it comes to Apellis Pharmaceuticals, the news proved to be overwhelmingly positive. After all, Fast Track designation will shorten the path to potential approval, provide the company with further support from the FDA and strengthen the exclusivity period should the drug be approved. So, it’s not suprrising to see that excited investors are pushing the stock on a run for the top. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currnetly (8:00), APLS is trading at $15.00 per share after a gain of $1.15 per share or 8.30% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on APLS. In particular, we’re interested in following the story surrounding the company’s continued work to bring APL-2 to market considering the Fast Track designation that was announced today. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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