Timber Pharmaceuticals Announces FDA Grant of CARC Waiver for TMB-001

 Phase 3 ASCEND study of TMB-001 (topical isotretinoin) for the treatment of congenital ichthyosis is 70% enrolled -

Timber Pharmaceuticals, Inc. ("Timber" or the “Company”) (NYSE American: TMBR), a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases, today 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 dermal rodent carcinogenicity study.

https://finance.yahoo.com/news/timber-pharmaceuticals-announces-fda-grant-120000229.html