Core Insights - Fortress Biotech reported a 20.5% increase in total net revenue, reaching $17.6 million for Q3 2025 compared to Q3 2024 [1] - The acquisition of Checkpoint Therapeutics by Sun Pharma resulted in Fortress receiving approximately $28 million at closing, with potential additional payments and royalties [1][2] - Dotinurad, a next-generation URAT1 inhibitor, is progressing in two Phase 3 clinical trials, supported by a $205 million Series A financing from Crystalys Therapeutics [1][2] Financial Performance - Fortress' consolidated net revenue for Q3 2025 was $17.6 million, up from $14.6 million in Q3 2024, with $17.0 million generated from dermatology products [11][19] - Consolidated net income attributable to common stockholders was $3.7 million, or $0.13 per share basic, compared to a net loss of $(15.0) million, or $(0.76) per share basic, in Q3 2024 [11][19] - Consolidated cash and cash equivalents increased to $86.2 million as of September 30, 2025, from $57.3 million at the end of 2024 [11] Corporate Developments - Fortress' Chairman highlighted strategic milestones, including the acquisition of Checkpoint and Baergic, reinforcing the company's diversified business model [2] - Journey Medical Corporation launched Emrosi™, achieving strong operational performance and expanded payer coverage, with net product revenues of $17.0 million in Q3 2025 [2][6] - The FDA issued a Complete Response Letter for CUTX-101, but the company plans to resubmit the NDA shortly [7] Clinical and Regulatory Updates - Dotinurad is advancing in two Phase 3 trials for gout treatment, with potential for best-in-class safety and efficacy [2][7] - Emrosi™ demonstrated statistical and clinical superiority over Oracea® and placebo for treating rosacea, as presented at the Fall Clinical Dermatology Conference [7] - The acquisition of Baergic by Axsome includes potential milestone payments and royalties, with Avenue Therapeutics eligible to receive approximately 74% of future payments [3]

Core Insights - Journey Medical Corporation reported third quarter 2025 net revenues of $17.6 million, a 21% increase year-over-year from $14.6 million in Q3 2024, driven by the commercial launch of Emrosi™ [3][6] - Emrosi™ total prescriptions surged by 146% compared to the second quarter of 2025, generating $4.9 million in net revenues for the third quarter [1][3] - The company anticipates significant operating leverage from the growth of Emrosi and its established dermatology commercial infrastructure [3] Financial Results - Gross margin improved to 67.4% in Q3 2025, compared to 69.4% in Q3 2024, influenced by higher revenues from Emrosi and Qbrexza, despite a favorable one-time adjustment in the previous year [6] - Selling, general and administrative (SG&A) expenses rose to $12.1 million in Q3 2025, a 6% increase from $11.4 million in Q3 2024, primarily due to operational activities related to Emrosi's launch [6] - The net loss for Q3 2025 was $2.3 million, slightly improved from a net loss of $2.4 million in Q3 2024, translating to $(0.09) per share [6][17] Recent Corporate Highlights - Emrosi's clinical differentiation was validated through a pooled Phase 3 efficacy analysis, showing statistically significant superiority over Oracea® and placebo [3][12] - The company expanded payer access for Emrosi to over 100 million commercial lives in the U.S. as of July 2025, up from 54 million in May 2025 [12] - Journey Medical's cash and cash equivalents increased to $24.9 million as of September 30, 2025, compared to $20.3 million at the end of 2024 [6]

Core Insights - Urica Therapeutics, a subsidiary of Fortress Biotech, has initiated Phase 3 trials for dotinurad, a new oral treatment for gout, marking a significant advancement in its clinical development program [1][3] Group 1: Clinical Trials - The RUBY study will evaluate dotinurad's safety and efficacy in approximately 500 patients with hyperuricemia associated with gout, with participants receiving the drug once daily for up to 64 weeks [4] - The TOPAZ study will assess dotinurad in about 250 patients with tophaceous gout, with a treatment duration of up to 76 weeks [5] Group 2: Market Context - Gout is a prevalent form of inflammatory arthritis caused by excess uric acid, leading to severe pain and inflammation, with a significant treatment gap for patients not responding to first-line therapies [6] - There are currently no suitable second-line treatment options available in the U.S. or E.U., highlighting a critical unmet need in the market [6] Group 3: Company Developments - Fortress Biotech has achieved significant milestones, including two FDA approvals and a substantial acquisition, enhancing its portfolio and potential revenue streams [3] - Urica holds a minority equity position in Crystalys and is entitled to a 3% royalty on future net sales of dotinurad, indicating a strategic financial interest in the drug's success [3]

Core Viewpoint - Urica Therapeutics, a subsidiary of Fortress Biotech, has initiated two Phase 3 clinical trials for dotinurad, a new oral treatment for gout, which could address significant unmet medical needs in this area [1][3]. Clinical Trials - The RUBY study will evaluate dotinurad's safety and efficacy in approximately 500 patients with hyperuricemia associated with gout, with participants receiving the drug once daily for up to 64 weeks [4]. - The TOPAZ study will assess dotinurad in about 250 patients with tophaceous gout, with a treatment duration of up to 76 weeks [5]. Company Developments - Fortress Biotech's Executive Chairman highlighted the initiation of these trials as a major milestone, building on recent successes including two FDA approvals and a significant acquisition [3]. - Fortress received approximately $28 million upfront from the acquisition of Checkpoint Therapeutics by Sun Pharma, with potential future payments and royalties [3]. Market Context - Gout is characterized by painful inflammation due to excess uric acid, and there is a notable treatment gap for patients who do not respond to first-line therapies [6]. - Current treatment options in the U.S. and E.U. are limited, indicating a critical need for new therapies like dotinurad [6]. Company Overview - Fortress Biotech focuses on acquiring and advancing biopharmaceutical assets to enhance shareholder value through various revenue streams [7]. - The company has a diverse portfolio, including eight marketed products and multiple development programs across therapeutic areas such as oncology and rare diseases [8].

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]

Core Insights - Journey Medical Corporation reported total revenues of $15.0 million for the second quarter of 2025, showing a slight increase from $14.9 million in the same quarter of the previous year [5] - Emrosi™ generated net sales of $2.8 million in its first full quarter on the market, indicating strong initial adoption and prescription ramp [2][5] - The company joined the Russell 2000® and Russell 3000® Indexes in June 2025, reflecting its growth and market presence [2][11] Financial Results - Total net product revenues for the second quarter of 2025 were $15.0 million, compared to $14.9 million in the prior year quarter [5] - Gross margin increased to 67% in Q2 2025 from 61% in Q2 2024, attributed to lower product costs and a favorable sales mix [5] - Selling, general and administrative expenses rose to $11.9 million in Q2 2025, up from $10.3 million in Q2 2024, primarily due to costs associated with the Emrosi launch [5] - The net loss for the second quarter was $3.8 million, or $(0.16) per share, compared to a net loss of $3.4 million, or $(0.17) per share, in the prior year [5][16] - At the end of Q2 2025, the company had $20.3 million in cash and cash equivalents, unchanged from December 31, 2024 [5] Recent Corporate Highlights - In July 2025, Journey Medical expanded payer access for Emrosi to over 100 million commercial lives in the U.S., up from 54 million in May 2025 [4] - The full commercial launch of Emrosi began on April 7, 2025, and has shown strong traction in the market [4] - Emrosi was featured in a segment on "The Balancing Act®" on Lifetime TV, highlighting treatment options for managing rosacea [11]

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]

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]

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].

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]