Monday proved a huge day for healthcare stock Timber Pharmaceuticals (NYSE:TMBR). At one point, the stock was up over 83%. Though it backtracked over the course of Monday afternoon, it spent much of that time up in double-digit style. What gave this micro-cap such an explosive burst up? A new word from the Food & Drug Administration that just sped up the process of Timber’s latest dermatological advances proved more than enough.
The FDA issued what’s known as a dermal carcinogenicity waiver for rodent testing on TMB-001, the newest entrant from Timber Pharmaceuticals. TMB-001 is an isotretionoin that works to tackle skin problems. Under normal circumstances, TMB-001 would have to go through a two-year process of being tested on rodents to prove that it doesn’t cause carcinogenicity in the skin or organs of rodents. However, the FDA’s waiver means that process is off the table, and it can advance much more rapidly than it would have with that two-year speed bump in the way.
The FDA was willing to grant the waiver thanks to a successful 39-week repeat-dose dermal toxicity study. That study showed that there wasn’t any skin or organ carcinogenicity to speak of, and with that study in hand, the FDA figured a two-year study in rodents wasn’t really needed anymore. Timber, for its part, is hitting the ground running. It’s already setting up a Phase 3 ASCEND study, and enrollment is so far up around the 70% mark.
The news comes at a good time for Timber Pharmaceuticals stock. Looking at the last three months of trading, it had been on a downward slope for much of that time until hitting an uneven plateau at around $1.40 per share. It stuck close to that figure until earlier today when news of the FDA waiver hit, and shares shot up.
