Timber Pharmaceuticals stock jumps as much as 83% after FDA waiver to forgo rodent study
Iryna Drozd
- Shares of micro-cap Timber Pharmaceuticals (NYSE:TMBR) soared as much as 83% on Monday after the company was granted a waiver from the U.S. Food and Drug Administration (FDA) to forgo a rodent study for its investigational treatment TMB-001.
- TMBR stock was last up 37.3% to $2.05 in mid-day trade.
- The FDA granted a dermal carcinogenicity (CARC) waiver for TMB-001, a type of isotretinoin which is a medication primarily used to treat dermatological disorders.
- The waiver allows TMBR to forgo a required two-year rodent study proving that the application of TMB-001 does not cause skin or organ carcinogenicity.
- "The CARC waiver is important because we can avoid a costly and lengthy non-clinical study, which we believe will allow us to push ahead with our TMB-001 program as quickly and efficiently as possible," TMBR CEO John Koconis said in a statement.
- TMBR is currently conducting a late-stage study of TMB-001 for the treatment of congenital ichthyosis, a family of genetic skin disorders marked by dry, scaly skin. The study has reached 70% enrollment.