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Journey Medical Corporation Announces Publication in the Journal of the American Medical Association - Dermatology of the Phase 3 Clinical Trial Results of Emrosi™ (DFD-29) to Treat Rosacea
Newsfilter· 2025-03-05 21:01
Core Insights - Emrosi™ (DFD-29) received FDA approval for treating inflammatory lesions of rosacea in adults in November 2024, with a launch expected in early spring 2025 [2][3] - The results from two Phase 3 clinical trials (MVOR-1 and MVOR-2) demonstrated the efficacy and safety of DFD-29, showing statistical superiority over Oracea® (doxycycline) and placebo [1][3] Company Overview - Journey Medical Corporation is a commercial-stage pharmaceutical company focused on marketing FDA-approved prescription products for dermatological conditions [11] - The company is based in Scottsdale, Arizona, and was founded by Fortress Biotech, Inc. [11] Clinical Trial Results - In MVOR-1, 65.0% of subjects in the DFD-29 group achieved IGA success compared to 46.1% in the Oracea group and 31.2% in the placebo group, with significant p-values of 0.01 and <0.001 respectively [4][6] - In MVOR-2, 60.1% of subjects in the DFD-29 group achieved IGA success compared to 31.4% in the Oracea group and 26.8% in the placebo group, with significant p-values of <0.001 for both comparisons [5][6] - DFD-29 showed a mean reduction of 21.3 lesions in MVOR-1 and 18.0 lesions in MVOR-2, both statistically significant compared to Oracea and placebo [4][5][6] Safety Profile - No major safety issues or serious adverse events were reported in both clinical trials, with treatment-emergent adverse events being similar across groups [3][4][5] Market Potential - Rosacea affects over 16 million Americans and approximately 415 million people worldwide, indicating a significant market opportunity for Emrosi™ [9][10]
Journey Medical Corporation to Exhibit at the 2025 American Academy of Dermatology Annual Meeting in Orlando, Florida
Globenewswire· 2025-03-04 21:01
Core Viewpoint - Journey Medical Corporation has received FDA approval for Emrosi™, a treatment for inflammatory lesions of rosacea in adults, and plans to showcase this product at the upcoming AAD Annual Meeting in March 2025 [1][2][3]. Company Overview - Journey Medical Corporation is a commercial-stage pharmaceutical company focused on marketing FDA-approved prescription products for dermatological conditions [7]. - The company currently markets seven branded and two generic products aimed at treating common skin conditions [7]. - Founded by Fortress Biotech, Inc., Journey Medical is headquartered in Scottsdale, Arizona [7]. Product Information - Emrosi™ is a modified-release formulation of Minocycline Hydrochloride, consisting of 10 mg immediate release and 30 mg extended release, and is the lowest-dose oral minocycline available [1][3]. - The product is indicated for the treatment of inflammatory lesions (papules and pustules) of rosacea in adults [4]. - Clinical outcomes for Emrosi™ are reported to be significantly superior compared to placebo and Oracea®, while maintaining a comparable safety profile [3]. Industry Context - Rosacea affects over 16 million Americans and approximately 415 million people worldwide, primarily adults aged 30 to 50 [6]. - The condition can severely impact patients' self-esteem and social interactions, with many reporting adverse effects on their professional lives [6]. Event Participation - Journey Medical will exhibit at the 2025 AAD Annual Meeting, which is a significant event in the dermatology field, featuring over 350 exhibitors and nearly 20,000 attendees [3].
Journey Medical Corporation: Emrosi's Launch Could Be A Turning Point
Seeking Alpha· 2025-01-30 14:18
Core Insights - The article emphasizes the importance of recognizing intangible assets in investment analysis, particularly in the context of technological advancements and their impact on market dynamics [2]. Group 1: Investment Philosophy - The investment approach focuses on identifying hidden value and potential in intangible assets, especially through R&D efforts [2]. - The author believes that the current technological revolution, particularly in hardware, is significant and compares it to the commercialization of the Internet [2]. Group 2: Market Trends - The article suggests that there is no current AI bubble, indicating a stable environment for investment in technology [2]. - NVIDIA is highlighted as a central player in the ongoing hardware revolution, which is expected to drive future growth [2]. Group 3: Historical Context - The author references historical technological revolutions funded by visionary investors, which have led to increased prosperity [2]. - The influence of Baruch Lev's work on the recognition of intangible assets and George Soros's insights on market bubbles is noted as shaping the author's investment perspective [2].
Journey Medical Corporation to Host Conference Call to Discuss U.S. Commercial Launch Plan for Emrosi™ (Minocycline Hydrochloride Extended Release Capsules, 40 mg) for the Treatment of Rosacea
Globenewswire· 2025-01-23 13:30
Core Viewpoint - Journey Medical Corporation is preparing for the commercial launch of Emrosi™, an FDA-approved treatment for rosacea, with a focus on establishing it as a new oral standard of care for adult patients [1][2]. Company Overview - Journey Medical Corporation is a commercial-stage pharmaceutical company that specializes in marketing FDA-approved prescription products for dermatological conditions [9]. - The company currently markets seven branded and two generic products aimed at treating common skin conditions [9]. - Founded by Fortress Biotech, Inc., Journey Medical is located in Scottsdale, Arizona [9]. Product Information - Emrosi™ (Minocycline Hydrochloride Extended Release Capsules, 40 mg) was approved by the FDA in November 2024 for treating inflammatory lesions of rosacea in adults [1]. - The product was developed in collaboration with Dr. Reddy's Laboratories Ltd. [1]. Launch Plans - The management team will host a conference call on February 5, 2025, to discuss the commercial launch plan for Emrosi, including pre-commercial activities and launch timing [1][3]. - The company is finalizing the manufacturing of launch quantities for the U.S. market and preparing its dermatology-focused sales force for the rollout [2]. Market Context - Rosacea is a chronic skin condition affecting over 16 million Americans and approximately 415 million people worldwide, primarily seen in adults aged 30 to 50 [8]. - The condition significantly impacts patients' self-confidence and social interactions, with many reporting adverse effects on their professional lives [8].
Journey Medical Corporation (DERM) Reports Q3 Loss, Tops Revenue Estimates
ZACKS· 2024-11-12 23:26
Journey Medical Corporation (DERM) came out with a quarterly loss of $0.12 per share versus the Zacks Consensus Estimate of a loss of $0.17. This compares to earnings of $0.80 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 29.41%. A quarter ago, it was expected that this company would post a loss of $0.15 per share when it actually produced a loss of $0.17, delivering a surprise of -13.33%.Over the last four quarters, the com ...
Journey Medical (DERM) - 2024 Q3 - Quarterly Report
2024-11-12 21:06
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark one) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ Commission File Number: 001-41063 JOURNEY MEDICAL CORPORATION (Exact name of registrant as specified in its chart ...
Journey Medical (DERM) - 2024 Q3 - Quarterly Results
2024-11-12 21:05
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 4, 2024 Journey Medical Corporation (Exact Name of Registrant as Specified in Charter) | --- | --- | --- | |------------------------------------|------------------------------|-----------------------| | Delaware | 001-41063 | 47-1879539 | | (State or Other Jurisdiction | (Commission Fi ...
Journey Medical Corporation Reports Third Quarter 2024 Financial Results and Recent Corporate Highlights
GlobeNewswire News Room· 2024-11-12 21:01
U.S. FDA approved Emrosi™ (Minocycline Hydrochloride Extended Release Capsules, 40 mg) for the treatment of inflammatory lesions of rosacea in adults; launch expected in late Q1 or early Q2 of 2025 Total revenues for the third quarter ended September 30, 2024 were $14.6 million SCOTTSDALE, Ariz., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or “the Company”, “we”, or “our”), a commercial-stage pharmaceutical company that primarily focuses on the selling and ...
Journey Medical (DERM) Soars 7.3%: Is Further Upside Left in the Stock?
ZACKS· 2024-11-04 13:21
Journey Medical Corporation (DERM) shares ended the last trading session 7.3% higher at $6.17. The jump came on an impressive volume with a higher-than-average number of shares changing hands in the session. This compares to the stock's 8.6% loss over the past four weeks.The FDA is slated to communicate its decision regarding Journey Medical’s regulatory filing for DFD-29, for the treatment of inflammatory lesions and erythema (redness) of rosacea in adults, today. The stock price rally is likely in anticip ...
Journey Medical Corporation Announces U.S. FDA Approval of Emrosi™ (Minocycline Hydrochloride Extended Release Capsules, 40 mg) for the Treatment of Rosacea
GlobeNewswire News Room· 2024-11-04 12:00
SCOTTSDALE, Ariz., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”), a commercial-stage pharmaceutical company that primarily focuses on selling and marketing U.S. Food and Drug Administration (“FDA”)-approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced that the FDA has approved Emrosi™ (Minocycline Hydrochloride Extended Release Capsules, 40 mg), formerly referred to as DFD-29, for the treatment of infl ...