NetworkNewsBreaks – Processa Pharmaceuticals, Inc.’s (PCSA) PCS499 Receives Orphan Drug Designation from FDA to Treat Necrobiosis Lipoidica

June 25, 2018 13:49:55

Processa Pharmaceuticals (OTC: PCSA) recently announced that the U.S. Food and Drug Administration (“FDA”) has granted Orphan Drug Designation to its leading clinical compound, PCS499, to treat Necrobiosis Lipoidica (“NL”). Presently, there is no FDA approved treatment for NL and no known biotech or pharma companies are currently developing a drug for NL. “We are very pleased that PCS499 has received Orphan Drug Designation from FDA for the treatment of NL. NL can have a major impact on the quality of life of patients and PCS499 will be the first treatment targeted to this condition. We plan to begin our clinical studies in 2018 and to accelerate the development of PCS499 in order to provide clinical benefit to NL patients as soon as possible,” Processa Pharmaceuticals CEO Dr. David Young stated in the news release.

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About Processa Pharmaceuticals, Inc.

Processa Pharmaceuticals, Inc was founded in 2017 in Hanover, Maryland, with a mission to develop products that can improve the survival and/or quality of life for patients who have a high unmet medical need. The company acquired the assets of Promet Therapeutics, LLC in October of 2017 and has assembled a proven regulatory science product development team, management team, and Board of Directors. The Processa Team’s expertise is in developing drug products from IND enabling studies to NDA submission. The company’s combined scientific, development and regulatory experience has resulted in more than 30 drug approvals by the FDA (including drug products targeted to orphan disease conditions) and 100 FDA meetings.  For more information, visit the company’s website at

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