 Gene therapy company Krystal Biotech KRYS has announced that the U.S. Food Drug Administration FDA has granted Orphan Drug Designation to KB407, currently in pre-clinical development for the treatment of cystic fibrosis CF.Shares in Krystal rose 5 in Mondays after-hours trading following the announcement.KB407 is an inhaled, repeat-dose gene therapy product currently in the preclinical phase with plans to file an investigational new drug IND application in 2021.We are pleased to receive Orphan Drug Designation for KB407 to treat cystic fibrosis as this is an important step forward in our efforts to address the continued unmet need in this devastating disease, said Suma Krishnan, founder and COO of Krystal.She added: We are excited by the results of the in vitro data thus far, as presented at ASGCT earlier this year, and we look forward to sharing in vivo animal data later this year.The FDAs Office of Orphan Drug Products grants Orphan Drug Designation to support the development of medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in the US.Orphan Drug Designation may allow Krystal Biotech to be eligible for a seven-year period of US marketing exclusivity upon approval of KB407, tax credits for certain clinical research costs and a waiver of the Prescription Drug User Fee Act PDUFA filing fees.Shares in Krystal are currently trading down 19 year-to-date, but the Street has a bullish Strong Buy consensus on the stocks outlook. Thats with a 68 average analyst price target, indicating upside potential of over 50.William Blair analyst Raju Prasad has a buy rating on Krystal Biotech, noting that Krystal continues to execute on its stated goals. He believes that Krystal remains undervalued at current levels given several catalysts in data presentations from multiple clinical programs anticipated in the next 12 months.Meanwhile HC Wainwright analyst Joseph Pantginis noted that promising preclinical results on KB407 were presented at the American Society of Gene Cell Therapy in May 2020.The data demonstrate in vitro, a profile of transduction efficiency and functionality of the target gene consistent with its predecessors KB103 and KB105 and provides the scientific rationale for progressing the development of this asset in CF he concluded. See KRYS stock analysis on TipRanks.Related News: Pfizer Inks Deal To Manufacture Gileads Covid-19 Remdesivir Treatment AstraZeneca Strikes First China Manufacturing Deal For Covid-19 Candidate Gilead Very Pleased With Tango Collab, Boosts Cancer Targets To 15 More recent articles from Smarter Analyst: Goldman Adds JD.com To Conviction Buy List, Lifts PT After 2Q Earnings Tiziana Spikes 25 In Pre-Market On Patent Win For Foralumab ICE To Raise 6.5B In Bond Sale For Ellie Mae; Oppenheimer Cuts Stock To Hold Wedbush Turns Bullish On Best Buy, Lifts PT 