Timber Pharmaceuticals Inc (NYSE: TMBR) surged by 34.90% to $2.01 during Monday’s early trading, following a 4.20% increase to $1.49 in the previous session. This boost in TMBR stock is attributed to a regulatory grant received by the clinical-stage biopharmaceutical company.
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What Was The Specific Approval Granted To TMBR?
Timber Pharmaceuticals (TMBR) is a dedicated company specializing in the development and distribution of treatments for uncommon and neglected skin conditions. In an exciting update, TMBR announced that the U.S. Food and Drug Administration (FDA) has granted them a dermal carcinogenicity (CARC) waiver for their groundbreaking product, TMB-001. This topical isotretinoin is formulated using TMBR’s patented IPEG delivery system.
The FDA’s positive opinion stems from a comprehensive 39-week study on repeat dose dermal toxicity, which revealed no signs of skin or organ carcinogenicity in rodents. Consequently, TMBR is now able to bypass a lengthy and costly 2-year dermal rodent carcinogenicity study. Oral isotretinoin is a familiar treatment among dermatologists but its high-dosage and chronic therapy often leads to systemic toxicity, making it intolerable for many patients.
Recognizing this limitation, Timber Pharmaceuticals is determined to provide a new topical treatment alternative for individuals grappling with moderate to severe congenital ichthyosis (CI). The CARC waiver holds significant importance for TMBR as it enables them to forgo an extensive non-clinical study, allowing them to expedite the progress of their TMB-001 program efficiently. Notably, Timber Pharmaceuticals has achieved a 70% enrollment rate in its pivotal Phase 3 ASCEND study and is actively working towards opening the final sites in Italy this month.
CI refers to a collection of rare genetic disorders characterized by abnormal keratinization, resulting in dry, thickened, and scaly skin. TMB-001 is currently undergoing investigation in the Phase 3 ASCEND study, targeting the treatment of moderate to severe subtypes of CI, including lamellar ichthyosis and X-linked ichthyosis. These specific conditions affect approximately 80,000 individuals in the United States.
How TMBR Remained Excelling?
In 2018, TMBR was granted an Orphan Products Grant by the FDA, which provided valuable support for conducting clinical trials to evaluate TMB-001, including the ongoing Phase 3 ASCEND study. Additionally, Timber Pharmaceuticals (TMBR) has received both Breakthrough Therapy Designation and Fast Track Status from the FDA for their pioneering product, TMB-001.