XPHOZAH Granted Orphan Drug Designation By U.S. FDA For The Treatment Of Pediatric Hyperphosphatemia
Portfolio Pulse from Benzinga Newsdesk
XPHOZAH has been granted Orphan Drug Designation by the U.S. FDA for the treatment of pediatric hyperphosphatemia. This designation could potentially provide certain benefits to the drug's developer, including tax credits for clinical testing, exemption from FDA application fees, and market exclusivity for seven years post-approval.
November 15, 2023 | 9:02 pm
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Ardelyx, Inc. (ARDX) may experience a positive short-term impact due to the Orphan Drug Designation granted to XPHOZAH for pediatric hyperphosphatemia, as it could lead to market exclusivity and financial incentives.
The Orphan Drug Designation is a significant regulatory milestone that can enhance a drug's commercial prospects. For Ardelyx, Inc., this designation for XPHOZAH could lead to a competitive advantage in the pediatric hyperphosphatemia market. The benefits of the designation, such as tax credits and application fee waivers, can reduce the cost of drug development, while the seven-year market exclusivity upon approval can protect the company's market share against competitors. This news is likely to be viewed positively by investors and could lead to an increase in ARDX's stock price in the short term.
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