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# Palvella Therapeutics Gains Fast Track for PTX-022
- URL: https://www.fdaweb.com/palvella-therapeutics-gains-fast-track-for-ptx-022/
- Published: 2018-11-12T12:00:00.000Z
- Updated: 2026-09-15T00:43:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142797

FDA has granted Palvella Therapeutics a fast track designation for its lead product candidate [PTX-022](https://www.globenewswire.com/Tracker?data=kJ4q3zIFFB79t6V1x4vL6kHBTIynxrwQBseBYWxGeYb8PdBQQzAxuKsKAii1RKSmsWtnMBlgyaENBUZ%5F2N7eSWxO1RrUfsL-Os-E91zisbg=&ref=fdaweb.com) (rapamycin topical formulation) for treating pachyonychia congenita (PC), a rare, chronically debilitating and lifelong monogenic disease. With PC, mutations of genes responsible for keratin production lead to dysregulated keratinocyte proliferation, increased skin fragility and impaired skin barrier function on the plantar aspects of the feet, according to the company. The condition leads to difficulty with ambulation, requiring the use of either ambulatory aids or alternative forms of mobility such as crawling on hands and knees. Currently, the company is planning a Phase 2/3 clinical study for the therapy.