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Fortress Biotech Reports Second Quarter 2025 Financial Results and Recent Corporate Highlights
Globenewswire· 2025-08-14 20:05
Core Insights - Fortress Biotech, Inc. achieved significant milestones in Q2 2025, including the acquisition of its subsidiary Checkpoint Therapeutics by Sun Pharma, which provided approximately $28 million upfront and potential additional payments [2][3] - The FDA accepted the New Drug Application for CUTX-101 for Menkes disease, with a PDUFA goal date set for September 30, 2025 [2][6] - Journey Medical launched Emrosi™ for treating inflammatory lesions of rosacea, with commercial uptake expanding to cover 65% of U.S. commercial lives [2][5] Financial Performance - Fortress reported consolidated net revenue of $16.4 million for Q2 2025, an increase from $14.9 million in Q2 2024, primarily driven by dermatology product sales [11][18] - Consolidated cash and cash equivalents rose to $74.4 million as of June 30, 2025, up from $57.3 million at the end of 2024 [11][16] - The company recorded a net income attributable to common stockholders of $13.4 million, or $0.50 per share basic, compared to a net loss of $(13.3) million in the same quarter of the previous year [11][18] Regulatory Developments - The FDA granted Orphan Drug Designation to Mustang Bio for MB-101, enhancing the potential of the combination strategy with MB-108 for treating high-grade gliomas [6][12] - The NDA submission for CUTX-101 is under priority review, with expectations for a Priority Review Voucher upon approval [2][6] Commercial Updates - Journey Medical's Emrosi™ has seen expanded payer access, now covering over 100 million commercial lives in the U.S., up from 54 million in May 2025 [10][12] - The commercial launch of Emrosi™ began on April 7, 2025, following initial distribution and prescription filling [10][12] Corporate Developments - Fortress Biotech's subsidiary Journey Medical was added to the small-cap Russell 2000 Index and the broad-market Russell 3000 Index as of June 27, 2025 [8]
Journey Medical Corporation Announces Expanded Payer Coverage for Emrosi™
Globenewswire· 2025-07-14 12:30
Core Insights - Journey Medical Corporation has expanded payer coverage for its product Emrosi™ to 65% of commercial lives in the U.S., a significant increase from 29% in May 2025, which supports the growing prescription demand for the product [1][2] - The company emphasizes its targeted contracting strategy and strong clinical data as key drivers for the adoption of Emrosi, which is expected to become the standard of care for treating rosacea [2] Company Overview - Journey Medical Corporation is a commercial-stage pharmaceutical company focused on marketing FDA-approved prescription products for dermatological conditions, currently offering eight such products [6] - The company is based in Scottsdale, Arizona, and was founded by Fortress Biotech, Inc. [6] Product Information - Emrosi™ is indicated for the treatment of inflammatory lesions of rosacea in adults, specifically targeting papules and pustules [4] - The product is available by prescription at specialty pharmacy chains [2] Market Context - Rosacea affects over 16 million Americans and approximately 415 million people worldwide, with significant impacts on patients' self-esteem and social interactions [3] - The condition is most prevalent among adults aged 30 to 50, highlighting a substantial market opportunity for effective treatments like Emrosi [3]
Journey Medical to Join Russell 2000® and Russell 3000® Indexes
Globenewswire· 2025-06-24 12:30
Core Insights - Journey Medical Corporation will be included in the Russell 2000 and Russell 3000 Indexes effective after the close of U.S. equity markets on June 27, 2025, due to the 2025 annual Russell Index reconstitution [1][2] - The inclusion in these indexes is expected to enhance the company's visibility among investors and institutions [2] - Journey Medical's FDA-approved product, Emrosi™, for treating inflammatory lesions of rosacea, is experiencing a strong market entry, with plans to expand access and grow prescription volume [2] Company Overview - Journey Medical Corporation is a commercial-stage pharmaceutical company focused on marketing FDA-approved prescription products for dermatological conditions [6][7] - The company currently markets eight branded FDA-approved prescription drugs aimed at treating common skin conditions [6] - Founded by Fortress Biotech, Inc., Journey Medical is based in Scottsdale, Arizona [7] Market Context - The Russell 3000 Index includes the largest 3,000 U.S. public companies by market capitalization, while the Russell 2000 Index is a subset focused on small-cap companies [2] - Approximately $10.6 trillion in assets are benchmarked against Russell U.S. Indexes, which are widely utilized by investment managers and institutional investors [2]
Journey Medical Corporation Announces Emrosi™ Featured on “The Balancing Act” Airing on Lifetime TV
Globenewswire· 2025-06-09 12:30
Core Viewpoint - Journey Medical Corporation is enhancing the visibility of its FDA-approved product Emrosi™ through a feature on "The Balancing Act," aimed at educating patients and healthcare providers about its benefits in treating rosacea [2][3]. Company Overview - Journey Medical Corporation (Nasdaq: DERM) is a commercial-stage pharmaceutical company focused on marketing FDA-approved prescription products for dermatological conditions [8]. - The company currently markets eight FDA-approved prescription drugs targeting common skin conditions and is based in Scottsdale, Arizona [8]. Product Information - Emrosi™ (40 mg Minocycline Hydrochloride Modified-Release Capsules) is the lowest-dose oral minocycline available, approved by the FDA in November 2024 for treating inflammatory lesions of rosacea in adults [2]. - Emrosi offers an effective treatment option with a favorable safety profile and is available by prescription at specialty pharmacy chains [2]. Industry Context - Rosacea is a chronic inflammatory skin condition affecting over 16 million Americans and approximately 415 million people worldwide, primarily seen in adults aged 30 to 50 [4]. - The National Rosacea Society reports that over 90% of rosacea patients feel their condition lowers their self-confidence, with significant impacts on social and professional interactions [4].
Fortress Biotech Reports First Quarter 2025 Financial Results and Recent Corporate Highlights
Globenewswire· 2025-05-15 20:05
Core Insights - Fortress Biotech, Inc. has initiated the commercial launch of Emrosi™ for treating inflammatory lesions of rosacea in adults, following FDA approval in November 2024 [4] - The company reported a net loss of $(12.7) million, or $(0.48) per share, for Q1 2025, an improvement from a net loss of $(17.9) million, or $(1.04) per share, in Q1 2024 [12][18] - Fortress' subsidiary Checkpoint Therapeutics is set to be acquired by Sun Pharma, with expected upfront cash payment of approximately $28 million and potential future royalties [3][2] Financial Results - Fortress' consolidated cash and cash equivalents increased to $91.3 million as of March 31, 2025, up from $57.3 million at the end of 2024, marking a $34 million increase [12][14] - Consolidated net product revenue for Q1 2025 was $13.1 million, slightly up from $13.0 million in Q1 2024 [9][18] - Research and development expenses for Q1 2025 totaled $3.9 million, a significant decrease from $24.8 million in Q1 2024 [12][18] Regulatory Updates - The FDA accepted the New Drug Application for CUTX-101 for Menkes disease, with a PDUFA goal date of September 30, 2025 [2][8] - UNLOXCYT, an anti-PD-L1 antibody developed by Checkpoint, was approved by the FDA in December 2024 for treating patients with metastatic or locally advanced cutaneous squamous cell carcinoma [8] Commercial Product Updates - Emrosi was launched by Journey Medical Corporation, with initial prescriptions filled at the end of March 2025 [4][18] - Full results from two Phase 3 clinical trials evaluating Emrosi were published, demonstrating its efficacy and safety for treating moderate-to-severe papulopustular rosacea [18] Corporate Highlights - Fortress has a robust pipeline with multiple late-stage programs and newly approved products, positioning the company for continued revenue growth [2] - The acquisition of Checkpoint by Sun Pharma is expected to enhance patient access to Checkpoint's products and create significant monetization opportunities for Fortress [3][2]