Timber Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) has granted a dermal carcinogenicity (CARC) waiver for TMB-001, a topical isotretinoin formulated using the Company's patented IPEG™ delivery system. The positive opinion is based on results of a 39-week repeat dose dermal toxicity study that demonstrated no evidence of skin or organ carcinogenicity from chronic applications of TMB-001 in rodents, and allows the Company to forgo a 2-year rodent carcinogenicity study. CI is a group of rare genetic keratinization disorders that lead to dry, thickened, and scaling skin.

TMB-001 is currently being investigated in the Phase 3 ASCEND study for the treatment of moderate to severe subtypes of CI including lamellar ichthyosis and X-linked ichthyosis that affect about 80,000 people in the U.S. In 2018, the FDA awarded an Orphan Products Grant to support clinical trials evaluating TMB-001, including the Phase 3 ASCEND study. Timber has also received both Breakthrough Therapy Designation and Fast Track Status from the FDA for TMB-001.