Journey Medical Corporation's DERM shares rose 10% on Mar 18, after the company announced that its new drug application (NDA) for its key pipeline candidate, DFD-29 capsules (40mg), to treat inflammatory lesions and erythema of rosacea in adults, has been accepted by the FDA for review.

A decision from the regulatory body is expected on Nov 4, 2024.

The NDA submission was based on positive data from Journey Medical’s two phase III studies (MVOR-1 and MVOR-2) of DFD-29 for treating rosacea. Both studies achieved the co-primary and all secondary endpoints, demonstrating statistically superior efficacy of DFD-29 over Oracea (standard of care) and placebo, as well as reduced total inflammatory lesion count. Oracea capsules are used to treat inflammation associated with rosacea in adults.

In the past year, shares of DERM have surged 150.5% against the industry’s 4.7% decline.

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The late-stage studies also demonstrated the beneficial effect of DFD-29 on erythema (redness) assessment, a key secondary endpoint of both studies. Erythema is an important sign of rosacea severity. Improving erythema is relevant to rosacea treatment.

DFD-29’s significant impact on erythema reduction could prove to be the differentiating factor over the current standard of care for rosacea. Journey Medical believes DFD-29 can potentially change the treatment paradigm for rosacea.

Management believes that DFD-29, if approved, will become the only oral medication to address both inflammatory lesions and erythema from rosacea.

Rosacea is a chronic inflammatory skin condition exhibiting symptoms like deep facial redness, acne-like inflammatory lesions (papules and pustules) and spider veins (telangiectasia). Approximately 16 million people in America suffer from this skin condition while the estimated number of people suffering from rosacea worldwide is 415 million.

Rosacea affects adults mostly in the age group of 30-50 years. It severely affects the quality of life of patients by lowering their self-confidence and self-esteem.

Journey Medical Corporation Price and Consensus

Journey Medical Corporation price-consensus-chart | Journey Medical Corporation Quote

Zacks Rank and Stocks to Consider

Journey Medical currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the drug/biotech industry are ADMA Biologics ADMA, FibroGen FGEN and Adicet Bio, Inc. ACET. While ADMA sports a Zacks Rank #1 (Strong Buy), FGEN and ACET carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.