Proteostasis Therapeutics Inc (NASDAQ: PTI) is having an overwhelmingly strong start to the trading session this morning, and for good reason. The company announced that it has received Fast Track designation from the FDA surrounding a triple combination clinical program the company is working on. Of course, this is overwhelmingly positive news as it leads to various regulatory benefits for PTI. So, it’s no surprise that the stock is making a run for the top in the market today. Below, we’ll talk about:
- The Fast Track Designation;
- what we’re seeing from PTI as a result,
- risks to consider when investing in this stock;
- and what you should be watching for ahead.
PTI Announces Fast Track Designation
As mentioned above, Proteostasis Therapeutics is having an incredibly strong start to the trading session this morning after announcing that it has received Fast Track Designation from the United States Food and Drug Administration (FDA). In a press release issued early this morning, the company announced that the FDA has granted the Fast Track Designation for the company’s triple combination program that was designed for the treatment of cystic fibrosis (CF).
In the release, PTI broke down the triple combination treatment, explaining that it includes a novel cystic fibrosis transmembrane conductance regulator (CFTR) amplifier, third generation corrector and potentiator. These three pieces of the treatment are known as PTI-428, PTI-801 and PTI-808 respectively.
In January, PTI announced the protocol for the triple combination clinical study. In today’s release, the company reminded investors that it plans on initiating this clinical trial in the current quarter. The company said in the release that the study has received a high strategic fit score from the Therapeutics Development Network (TDN) and the Clinical Trial Network (CTN). In a statement, Meenu Chhabra, President and CEO at PTI, had the following to offer:
Fast Track designation represents another positive step for the development of our triple combination therapy and underscores the serious unmet need that remains for the vast majority of CF patients… We believe this designation, together with other recent designations from regulators and CF organizations following review of our results with PTI-428, PTI-801 and PTI-808, is recognition of the potential of these programs in this disease. We believe combinations of CFTR modulators hold the promise of improving treatment efficacy for different segments of the CF population, including F508del heterozygotes and F508del homozygotes, where patients have limited access to treatment, are underserved by existing treatments or see a declining benefit in lung function over time.
What We’re Seeing From The Stock As A Result
At the end of the day, traders and investors alike know that the news moves the market. When it comes to the news released by Proteostasis Therapeutics, the release proved to be overwhelmingly positive. So, it’s no surprise that we’re seeing an overwhelmingly positive reaction in the market to match. Of course, our partners at Trade Ideas were the first to alert us to the gains. Currently (7:57), PTI is trading at $5.05 per share after a gain of $0.60 per share or 13.48% 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 PTI. In particular, we’re interested in following the story surrounding the triple combination treatment as well as the company’s continued work with regard to the rest of its robust pipeline. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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