Xortx Therapeutics is now in the thick of things. The FDA has granted the company's drug candidate the right to accelerated approval. Now the market is waiting for a licensing deal and the start of the decisive phase III with a partner.
Xortx Therapeutics: Drug candidate receives orphan drug statusXortx Tehrapeutics (XRTX | $ 0.81 | € 0,76 | CA98420Q2071), the biotech company with listing on Nasdaq, has a potential blockbuster in its portfolio with the drug candidate X-RX-008. At the time, the company had applied for orphan drug status with the US regulatory authority FDA. This was granted at the end of April - an accolade in the industry and an important milestone for the company. In the meantime, a so-called Type D meeting has been held with the agency to discuss the details of an accelerated approval procedure, the clinical study protocol and the submitted plans for the future clinical development program. X-RX-008 is targeting a billion-dollar market. In the U.S. alone, 150,000 people are treated for cystic kidney disease. The cost of dialysis is roughly $90,000 per patient. Xortx would have chances to capture a relevant part of the market if Phase III is successful and approval is granted.
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