Timber Pharmaceuticals Receives FDA Waiver for Lead Candidate; Shares Soar Nearly 50%
Timber Pharmaceuticals (NYSE American: TMBR) has received a dermal carcinogenicity (CARC) waiver from the FDA for its lead candidate, TMB-001 (topical isotretinoin) allowing the company to forgo a two-year dermal rodent carcinogenicity study.
Timber’s shares soared nearly 50% following the announcement.
Timber said the CARC waiver will allow the company to avoid a costly and lengthy non-clinical study.
The FDA’s decision 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.
Timber also announced it had reached 70% enrollment in its pivotal Phase 3 ASCEND study. The study is investigating TMB-001 for the treatment of moderate to severe subtypes of congenital ichthyosis that affect about 80,000 people in the United States.
TMB-001 has received Breakthrough Therapy designation, Orphan Drug designation and Fast Track Status from the FDA, and Orphan Drug designation from the EMA.
About Timber Pharmaceuticals
Timber Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases. The Company’s investigational therapies have proven mechanisms-of-action backed by decades of clinical experience and well-established CMC (chemistry, manufacturing and control) and safety profiles. The Company is currently focused on developing non-systemic treatments for rare dermatologic diseases including congenital ichthyosis (CI) and sclerotic skin diseases. For more information, please visit https://www.timberpharma.com/.