Tonix Pharmaceuticals Receives Rare Pediatric Disease Designation From The FDA For TNX-2900 For The Treatment Of Prader-Willi Syndrome
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Tonix Pharmaceuticals (TNXP) received Rare Pediatric Disease Designation from the FDA for TNX-2900, aimed at treating Prader-Willi Syndrome (PWS), a genetic cause of life-threatening childhood obesity. This designation follows TNX-2900's Orphan Drug designation in 2022 and IND clearance in 2023. Approval of TNX-2900 could make Tonix eligible for a Priority Review Voucher, recently sold for around $100 million. The FDA's voucher program encourages development of treatments for rare pediatric diseases, with vouchers selling for significant amounts.
March 25, 2024 | 12:06 pm
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Tonix Pharmaceuticals received FDA Rare Pediatric Disease Designation for TNX-2900, targeting Prader-Willi Syndrome. This could lead to a Priority Review Voucher, enhancing the company's value.
The FDA's Rare Pediatric Disease Designation for TNX-2900 represents a significant regulatory milestone for Tonix Pharmaceuticals, potentially accelerating the drug's market approval process. Given the high value of Priority Review Vouchers, this news could positively impact TNXP's stock price in the short term by increasing investor interest and perceived company value. The historical sale prices of such vouchers underscore their potential financial benefit to Tonix, should TNX-2900 be approved.
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