Timber (TMBR) Shares Surged 57% on FDA Designation. What’s Next?

The Timber Pharmaceuticals Inc (NYSEAMERICAN: TMBR) stock price surged 60% after the US Food and Drug Administration (FDA) awarded its TMB-001 drug candidate the Breakthrough Therapy designation.

Also read: The Best Biotech Stocks Under $5 To Buy Right Now.

TMB-001 is topical isotretinoin formulated using Timber Pharma’s patented IPEG™ delivery system for treating congenital ichthyosis (CI). The breakthrough designation allows the company to fast-track the development of the drug whose initial clinical evidence must indicate that it can deliver better outcomes than existing treatments.

Timber Pharma is developing TMB-001 as a treatment for moderate to severe forms of CI, including X-linked recessive ichthyosis (XRI) and autosomal recessive congenital ichthyosis lamellar ichthyosis (ARCI-LI).

Congenital ichthyosis (CI) is a group of rare genetic keratinization disorders that cause dry, thickened, and scaling skin. Patients with XRI and ARCI-LI typically have cutaneous manifestations, including extensive, dark scaling throughout the body.

Timber had conducted a Phase 2b CONTROL study of TMB-001, which demonstrated a clinically meaningful reduction in targeted and overall severity of CI along with a favourable safety profile.

Investors cheered today’s breakthrough designation that could lead to TMB-001 being commercialized much sooner than if it did not have the designation.

John Koconis, Timber Pharmaceuticals Chairman and CEO, said: “This is a significant moment for people who are living with CI, their families and caregivers, and clinicians and researchers who have been working for years to find new treatment options for this debilitating condition,”

Adding:

“A Breakthrough Therapy designation is no small achievement. Through half of the FDA’s 2022 fiscal year, more breakthrough applications have been rejected by FDA or withdrawn (16) than have been granted (9). I am proud of our team for demonstrating the potential of TMB-001 in our Phase 2b program, and we are rapidly pushing forward with a pivotal Phase 3 clinical trial.”

TMBR shares had pulled back slightly at writing after the market opened but were still trading up 40.7%. For those interested in buying TMBR shares, I would wait for the stock to settle before buying.

*This is not investment advice. Always do your due diligence before making investment decisions.

Timber Pharma stock price.

Timber Pharma (TMBR) stock price soared 56.94% to trade at $0.4002 from Friday’s closing price of $0.2550.