Item 8.01. Other Events.



On January 12, 2021, Timber Pharmaceuticals, Inc. (the "Company") announced that the U.S. Food and Drug Administration has granted orphan drug designation to TMB-003, the Company's locally delivered formulation of sitaxsentan, for the treatment of systemic sclerosis.

A copy of the press release that discusses this matter is filed as Exhibit 99.1 hereto and incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits.






(d) Exhibits.



Exhibit No.                    Exhibit

  99.1          Press Release, dated January 12, 2021




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