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Journey Medical (DERM) Up on Update for Skin Disease Candidate
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Journey Medical Corporation (DERM - Free Report) announced that it has successfully completed a pre-NDA meeting with the FDA to decide the regulatory path forward for its pipeline candidate, DFD-29, which is being developed for the treatment of rosacea in adults.
The goal of the meeting was to discuss the NDA submission plan for DFD-29 (minocycline hydrochloride modified release capsules, 40 mg) to treat inflammatory lesions (papules and pustules) and erythema of rosacea.
Following positive feedback from the regulatory body, the company is planning to submit an NDA for DFD-29 in rosacea by the end of 2023.
Shares of Journey Medical were up 6.1% following the announcement on Dec 6. The stock has soared 217.2% year to date against the industry’s decline of 9.1%.
Image Source: Zacks Investment Research
We note that DFD-29 is a modified-release oral minocycline capsule that Journey Medical is developing in collaboration with Dr. Reddy’s Laboratories Ltd (RDY - Free Report) .
Journey Medical signed a collaboration agreement with Dr. Reddy’s in June 2021, to obtain global rights for the development and commercialization of DFD-29.
Under the agreed terms of the agreement, RDY is entitled to receive payments of up to $158 million, based on the achievement of certain developmental and commercial milestones for DFD-29. Furthermore, Dr. Reddy’s is also eligible to receive a 10-20% royalty on net sales of the product.
In July 2023, Journey Medical reported positive top-line data from two phase III studies that evaluated DFD-29 for the treatment of rosacea. Both the studies met all co-primary and secondary endpoints and no significant safety concerns were observed after the subjects completed the 16-week treatment.
Also, treatment with DFD-29 led to statistical superiority over Oracea (doxycycline) 40 mg – the standard of care, as well as placebo.
Rosacea is a chronic inflammatory skin condition exhibiting symptoms like deep facial redness, acne-like inflammatory lesions (papules and pustules) and spider veins (telangiectasia). The skin condition affects adults mostly in the age group of 30-50 years.
Zacks Rank & Other Stocks to Consider
Journey Medical currently sports a Zacks Rank #1 (Strong Buy).
In the past 60 days, the Zacks Consensus Estimate for Aquestive Therapeutics’ 2023 loss per share has narrowed from 25 cents to 7 cents. The same for 2024 has narrowed from 56 cents to 34 cents. AQST’s shares have rallied 128.4% year to date.
Aquestive Therapeutics’ earnings beat estimates in three of the trailing four quarters and missed the same in one, delivering an average surprise of 70.58%.
In the past 60 days, the consensus estimate for Puma Biotechnology’s 2023 earnings per share has improved from 67 cents to 72 cents. The same for 2024 has moved up from 55 cents to 64 cents during the same time frame. Shares of PBYI have lost 7.8% year to date.
Puma Biotechnology’s earnings beat estimates in three of the trailing four quarters and missed the same in one, delivering an average surprise of 76.55%.
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Journey Medical (DERM) Up on Update for Skin Disease Candidate
Journey Medical Corporation (DERM - Free Report) announced that it has successfully completed a pre-NDA meeting with the FDA to decide the regulatory path forward for its pipeline candidate, DFD-29, which is being developed for the treatment of rosacea in adults.
The goal of the meeting was to discuss the NDA submission plan for DFD-29 (minocycline hydrochloride modified release capsules, 40 mg) to treat inflammatory lesions (papules and pustules) and erythema of rosacea.
Following positive feedback from the regulatory body, the company is planning to submit an NDA for DFD-29 in rosacea by the end of 2023.
Shares of Journey Medical were up 6.1% following the announcement on Dec 6. The stock has soared 217.2% year to date against the industry’s decline of 9.1%.
We note that DFD-29 is a modified-release oral minocycline capsule that Journey Medical is developing in collaboration with Dr. Reddy’s Laboratories Ltd (RDY - Free Report) .
Journey Medical signed a collaboration agreement with Dr. Reddy’s in June 2021, to obtain global rights for the development and commercialization of DFD-29.
Under the agreed terms of the agreement, RDY is entitled to receive payments of up to $158 million, based on the achievement of certain developmental and commercial milestones for DFD-29. Furthermore, Dr. Reddy’s is also eligible to receive a 10-20% royalty on net sales of the product.
In July 2023, Journey Medical reported positive top-line data from two phase III studies that evaluated DFD-29 for the treatment of rosacea. Both the studies met all co-primary and secondary endpoints and no significant safety concerns were observed after the subjects completed the 16-week treatment.
Also, treatment with DFD-29 led to statistical superiority over Oracea (doxycycline) 40 mg – the standard of care, as well as placebo.
Rosacea is a chronic inflammatory skin condition exhibiting symptoms like deep facial redness, acne-like inflammatory lesions (papules and pustules) and spider veins (telangiectasia). The skin condition affects adults mostly in the age group of 30-50 years.
Zacks Rank & Other Stocks to Consider
Journey Medical currently sports a Zacks Rank #1 (Strong Buy).
A couple of other top-ranked stocks in the healthcare sector are Aquestive Therapeutics, Inc. (AQST - Free Report) and Puma Biotechnology, Inc. (PBYI - Free Report) , each sporting a Zacks Rank #1 at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, the Zacks Consensus Estimate for Aquestive Therapeutics’ 2023 loss per share has narrowed from 25 cents to 7 cents. The same for 2024 has narrowed from 56 cents to 34 cents. AQST’s shares have rallied 128.4% year to date.
Aquestive Therapeutics’ earnings beat estimates in three of the trailing four quarters and missed the same in one, delivering an average surprise of 70.58%.
In the past 60 days, the consensus estimate for Puma Biotechnology’s 2023 earnings per share has improved from 67 cents to 72 cents. The same for 2024 has moved up from 55 cents to 64 cents during the same time frame. Shares of PBYI have lost 7.8% year to date.
Puma Biotechnology’s earnings beat estimates in three of the trailing four quarters and missed the same in one, delivering an average surprise of 76.55%.