By Chris Wack

Timber Pharmaceuticals shares were up 60% to $2.39 Monday after the U.S. Food and Drug Administration granted a dermal carcinogenicity waiver to TMB-001, a topical isotretinoin using the company's patented IPEG delivery system.

The stock is still down 86% over the past 12 months.

The clinical-stage biopharmaceutical company, which is focused on rare and orphan dermatologic diseases, said the positive FDA opinion allows it to forgo a two-year dermal rodent carcinogenicity study and 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.

TMB-001 is currently being investigated in a Phase 3 study evaluating its potential for the treatment of moderate to severe subtypes of congenital ichthyosis, including lamellar ichthyosis and X-linked ichthyosis, which affect about 80,000 people in the U.S.

The FDA has also awarded TMB-001 breakthrough therapy designation, fast track status, and an orphan products grant to support clinical trials evaluating TMB-001, including the Phase 3 study.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

June 05, 2023 09:55 ET (13:55 GMT)

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