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.
Highlights
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/.
Disclaimer
This communication was produced by Prism MarketView, an affiliate of PCG Advisory Inc., (together “PCG”). PCG is an integrated investor relations, communications and strategic advisory firm. The information contained on this is ‘Paid Advertising’ for purposes of Section 17(b) of the Securities Act of 1933, as amended (together with the rules and regulations there under, the “Securities Act”). “PCG” and its affiliates are compensated by respective clients for publicizing information relating to its client’s securities. For more information in terms of compensation received for services provided by PCG, see the pertinent advertising materials relating to the respective client. By accessing this Site and any pages thereof, you agree to be bound by the Terms of Use and Privacy Policy…