Item 7.01 Regulation FD Disclosure.

On January 9, 2023, Krystal Biotech, Inc. issued a press release announcing the extension of the U.S. Food and Drug Administration review period of its Biologics License Application for beremagene geperpavec for the treatment of Dystrophic Epidermolysis Bullosa. The Prescription Drug User Fee Act goal date has been extended by three months to May 19, 2023.

A copy of the press release is filed herewith as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

This information in this Item 7.01 of this Current Report on Form 8-K shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section, or incorporated by reference in any filing.

Item 9.01 Financial Statements and Exhibits.



(d) Exhibits.

    Exhibit
      No.              Description

      99.1               Press Release, dated     January 9    , 202    3
      104              Cover Page Interactive Data file (embedded within the Inline XBRL document)

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