Proteostasis Therapeutics Inc (NASDAQ: PTI) is having an incredibly strong start to the trading session in the pre-market hours this morning, and for good reason. The company announced that it has received overwhelmingly positive news from the United States Food and Drug Administration (FDA). Of course, this led to excitement among investors who are pushing the stock for the top. Today, we’ll talk about the news, what we’re seeing from the stock, and what we’ll be watching for with regard to PTI ahead.
PTI Climbs On FDA News
As mentioned above, Proteostasis Therapeutics is having an incredibly strong start to the trading session in the pre-market hours after announcing that it has received positive news from the FDA. In a press release issued in the after-hours session last night, the company announced that the FDA has granted Breakthrough Therapy Designation for PTI-428.
PTI-428 is a treatment that is a cystic fibrosis transmembrane conductance regulator (CFTR) amplifier. Breakthrough Therapy Designation is overwhelmingly positive news. The designation is only given to drugs that treat serious or life-threatening diseases where there is a significant unmet medical need. This designation will ultimately speed up the path to approval as well as put the company in more contact with the FDA regarding approval. In a statement, Meenu Chhabra, President and CEO at PTI, had the following to offer:
We believe the Breakthrough Therapy Designation for PTI-428 reflects the strength of the recent Phase 2 study results for our amplifier, a novel and proprietary class of CFTR modulators… PTI-428 can potentially be added to current and future standards of care, offering the potential for improvement in pulmonary function for patients with cystic fibrosis. We look forward to working closely with the FDA as we advance our clinical programs for PTI-428, including as part of our proprietary triple combination with PTI-801 and PTI-808, our third generation corrector and potentiator, respectively.
What We’re Seeing From The Stock
As investors, one of the first lessons that we learn is that the news moves the market. In this particular case, the news proved to be overwhelmingly positive. After all, with Breakthrough Therapy Designation under their belt, the company now has a fast track to take PTI-428 to market. So, it’s no surprise to see that the stock is making a run for the top. Of course, our partners at Trade Ideas were the first to alert us to the gains. At the moment (8:54), PTI is trading at $5.86 per share after a gain of $1.72 per share (41.55%) 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 company’s ongoing development of PTI-428 as well as the rest of their pipeline. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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