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Journey Medical (DERM) Up on Rosacea Candidate's Positive Data
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Shares of Journey Medical Corporation (DERM - Free Report) gained 22.2% on Jun 13 after the company reported that the phase I study of DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) in healthy adults achieved its primary endpoints.
The phase I study assessed the impact of DFD-29 on the microbial flora of healthy adults. The study also assessed the safety and tolerability of the treatment.
The study enrolled healthy, adult subjects (30 males and 30 females) in a 2:1 randomization between DFD-29 and placebo. Treatment was administered once daily orally over 16 weeks. Microbiological samples were collected from the skin (forehead), stool and vagina at multiple time points throughout the study. The study achieved all its primary objectives and no significant safety issues were noted during the study.
Data showed that treatment with DFD-29 for 16 weeks had no significant negative impact on the normal microbial flora and did not induce significant bacterial resistance. Additionally, treatment with DFD-29 did not cause any major proliferation of opportunistic organisms. The results indicate that DFD-29 can be safely used for up to 16 weeks with no significant risk of microbiota suppression or the development of resistance.
The phase III program for the candidate consists of two multicenter, randomized, double-blind, parallel-group, active-comparator and placebo-controlled clinical trials, MVOR-1 (Minocycline versus Oracea in Rosacea-1) and MVOR-2 (Minocycline versus Oracea in Rosacea-2). These studies are expected to support a new drug application (NDA) submission in the United States and a Marketing Authorization Application in Europe. The combined enrollment target of 640 total adult patients with moderate to severe papulopustular rosacea (PPR) was achieved in the trials; one trial enrolled patients in the United States and the other enrolled patients in both the United States and Europe.
The primary objective is to evaluate the safety, efficacy and tolerability of DFD-29 compared with placebo for the treatment of PPR. The secondary objective is to evaluate the safety, efficacy and tolerability of DFD-29 compared to Oracea (Doxycycline Capsules, 40 mg).
Journey Medical expects top-line data from the phase III clinical trials shortly, with an NDA filing expected in the second half of 2023.
DFD-29 is being developed for treating PPR in collaboration with Dr. Reddy’s Laboratories Ltd. (RDY - Free Report) . Journey Medical obtained global rights for the development and commercialization of DFD-29, including in the United States and Europe, from Dr. Reddy’s Laboratories, Ltd. in June 2021. Dr. Reddy’s has retained certain rights to the program in select markets, including Brazil, Russia, India and China. Journey Medical also agreed to fund and oversee the phase III clinical trials.
Shares of Journey Medical have gained 3.1% in the year so far against the industry’s 0.5% decline.
Image Source: Zacks Investment Research
Journey Medical is a majority-owned subsidiary of Fortress Biotech, Inc. Its current portfolio includes eight branded and three authorized generic prescription drugs for dermatological conditions that are actively marketed in the U.S.
Zacks Rank and Stocks to Consider
Journey Medical currently has a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector are Ligand Pharmaceuticals (LGND - Free Report) and Novartis (NVS - Free Report) . While Ligand sports a Zacks Rank #1 (Strong Buy), NVS carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 30 days, earnings estimates for LGND have increased by 46 cents per share to $5.25. LGND topped earnings estimates in two of the last four quarters and missed in the remaining two, the average surprise being 21.50%.
Over the past 60 days, NVS’ earnings estimates have increased to $6.72 from $6.57 for 2023. Novartis surpassed estimates in all the trailing four quarters, the average surprise being 5.15%.
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Journey Medical (DERM) Up on Rosacea Candidate's Positive Data
Shares of Journey Medical Corporation (DERM - Free Report) gained 22.2% on Jun 13 after the company reported that the phase I study of DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) in healthy adults achieved its primary endpoints.
The phase I study assessed the impact of DFD-29 on the microbial flora of healthy adults. The study also assessed the safety and tolerability of the treatment.
The study enrolled healthy, adult subjects (30 males and 30 females) in a 2:1 randomization between DFD-29 and placebo. Treatment was administered once daily orally over 16 weeks. Microbiological samples were collected from the skin (forehead), stool and vagina at multiple time points throughout the study. The study achieved all its primary objectives and no significant safety issues were noted during the study.
Data showed that treatment with DFD-29 for 16 weeks had no significant negative impact on the normal microbial flora and did not induce significant bacterial resistance. Additionally, treatment with DFD-29 did not cause any major proliferation of opportunistic organisms. The results indicate that DFD-29 can be safely used for up to 16 weeks with no significant risk of microbiota suppression or the development of resistance.
The phase III program for the candidate consists of two multicenter, randomized, double-blind, parallel-group, active-comparator and placebo-controlled clinical trials, MVOR-1 (Minocycline versus Oracea in Rosacea-1) and MVOR-2 (Minocycline versus Oracea in Rosacea-2). These studies are expected to support a new drug application (NDA) submission in the United States and a Marketing Authorization Application in Europe. The combined enrollment target of 640 total adult patients with moderate to severe papulopustular rosacea (PPR) was achieved in the trials; one trial enrolled patients in the United States and the other enrolled patients in both the United States and Europe.
The primary objective is to evaluate the safety, efficacy and tolerability of DFD-29 compared with placebo for the treatment of PPR. The secondary objective is to evaluate the safety, efficacy and tolerability of DFD-29 compared to Oracea (Doxycycline Capsules, 40 mg).
Journey Medical expects top-line data from the phase III clinical trials shortly, with an NDA filing expected in the second half of 2023.
DFD-29 is being developed for treating PPR in collaboration with Dr. Reddy’s Laboratories Ltd. (RDY - Free Report) . Journey Medical obtained global rights for the development and commercialization of DFD-29, including in the United States and Europe, from Dr. Reddy’s Laboratories, Ltd. in June 2021. Dr. Reddy’s has retained certain rights to the program in select markets, including Brazil, Russia, India and China. Journey Medical also agreed to fund and oversee the phase III clinical trials.
Shares of Journey Medical have gained 3.1% in the year so far against the industry’s 0.5% decline.
Image Source: Zacks Investment Research
Journey Medical is a majority-owned subsidiary of Fortress Biotech, Inc. Its current portfolio includes eight branded and three authorized generic prescription drugs for dermatological conditions that are actively marketed in the U.S.
Zacks Rank and Stocks to Consider
Journey Medical currently has a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector are Ligand Pharmaceuticals (LGND - Free Report) and Novartis (NVS - Free Report) . While Ligand sports a Zacks Rank #1 (Strong Buy), NVS carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 30 days, earnings estimates for LGND have increased by 46 cents per share to $5.25. LGND topped earnings estimates in two of the last four quarters and missed in the remaining two, the average surprise being 21.50%.
Over the past 60 days, NVS’ earnings estimates have increased to $6.72 from $6.57 for 2023. Novartis surpassed estimates in all the trailing four quarters, the average surprise being 5.15%.