PTI stock is moving higher in Tuesday’s session following the news that Proteostasis Therapeutics Inc (NASDAQ:PTI) received orphan drug designation in the EU for PTI-428, its treatment for cystic fibrosis.
Orphan Drug Designation
Boston, Massachusetts-based Proteostasis Therapeutics stock enjoyed a rally in early trade on Tuesday after news came through that its lead candidate PTI-428 has been granted the status of an orphan drug candidate by the European Commission. The product in question is meant for the treatment of cystic fibrosis, and needless to say, it is a major breakthrough for the company.
The nature of the drug is known as a “proprietary cystic fibrosis transmembrane conductance regulatory amplifier,” and in addition to the designation by the European Commission, it has also been given Fast Track Designation by the United States Food and Drug Administration.
The designation of orphan drug status from the European Commission is perhaps the most significant news, particularly because of the fact that Proteostasis Therapeutics’ product also got positive feedback from Orphan Medical Products of the EMA Committee.
If the product is eventually approved by the European Commission, then the benefits could be considerable for Proteostasis Therapeutics. It will give the product exclusive access to the European market, help to reduce fees, and also give the product membership into the exclusive marketing authorization procedure within the European Union.
PTI stock is up over 18% and now trading at $1.26.
The Chief Executive Officer and the President of Proteostasis Therapeutics Meenu Chhabra stated, “This designation by the EC is further validation of both PTI-428’s potential and PTI’s mission to offer additional disease-modifying treatment options for CF.”
The rise in PTI stock price is understandable, but it remains to be seen whether the drug in question gets the final approval from the European Commission. Despite the pending approval, this is still a significant development for the company.
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