Tonix Gets FDA Orphan Designation for TNX-2900 in Prader-Willi Syndrome >TNXP

By Colin Kellaher

Tonix Pharmaceuticals Holding Corp. on Thursday said the U.S. Food and Drug Administration granted orphan-drug designation to TNX-2900 for the treatment of the genetic disorder Prader-Willi syndrome.

The Chatham, N.J., clinical-stage biopharmaceutical company said the designation further validates its efforts to investigate the utility of TNX-2900 for Prader-Willi syndrome and underscores the urgent, unmet medical need for patients diagnosed with the disease, which causes life-threatening childhood obesity.

The FDA's orphan-drug program gives special status to drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S. and provides for an extended marketing exclusivity period against competition.

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