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Journey Medical (DERM) Up as FDA Accepts Skin Disease Drug NDA
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Journey Medical Corporation's (DERM - Free Report) 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.
Image Source: Zacks Investment Research
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.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2024 earnings per share (EPS) has increased from 22 cents to 30 cents. During the same period, the estimate for ADMA’s 2025 EPS has increased from 32 cents to 50 cents. In the past year, shares of ADMA have surged 93.2%.
ADMA beat on earnings in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 85%.
In the past 30 days, the Zacks Consensus Estimate for FibroGen’s 2024 loss per share has narrowed from $1.14 to $1.09. During the same period, the estimate for FibroGen’s 2025 loss per share is pegged at 6 cents. In the past year, shares of FGEN have plunged 89.2%.
FGEN beat on earnings in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 2.26%.
In the past 30 days, the Zacks Consensus Estimate for Adicet Bio’s 2023 loss per share has remained constant at $3.39. During the same period, the consensus estimate for Adicet’s 2024 loss per share has remained constant at $1.81. In the past year, shares of ACET have plunged 69.6%.
ACET beat on earnings in two of the trailing four quarters and missed the mark in the other two, delivering an average negative surprise of 8.36%.
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Journey Medical (DERM) Up as FDA Accepts Skin Disease Drug NDA
Journey Medical Corporation's (DERM - Free Report) 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.
Image Source: Zacks Investment Research
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 - Free Report) , FibroGen (FGEN - Free Report) and Adicet Bio, Inc. (ACET - Free Report) . 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.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2024 earnings per share (EPS) has increased from 22 cents to 30 cents. During the same period, the estimate for ADMA’s 2025 EPS has increased from 32 cents to 50 cents. In the past year, shares of ADMA have surged 93.2%.
ADMA beat on earnings in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 85%.
In the past 30 days, the Zacks Consensus Estimate for FibroGen’s 2024 loss per share has narrowed from $1.14 to $1.09. During the same period, the estimate for FibroGen’s 2025 loss per share is pegged at 6 cents. In the past year, shares of FGEN have plunged 89.2%.
FGEN beat on earnings in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 2.26%.
In the past 30 days, the Zacks Consensus Estimate for Adicet Bio’s 2023 loss per share has remained constant at $3.39. During the same period, the consensus estimate for Adicet’s 2024 loss per share has remained constant at $1.81. In the past year, shares of ACET have plunged 69.6%.
ACET beat on earnings in two of the trailing four quarters and missed the mark in the other two, delivering an average negative surprise of 8.36%.