New PDUFA Target Action Date of January 14, 2026 set by FDAMIAMI, Dec. 15, 2025 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) and its majority-owned subsidiary, Cyprium Therapeutics, Inc. (“Cyprium”), today announced that the U.S. Food and Drug Administration (“FDA”) has accepted the resubmission of the New Drug Application (“NDA”) for CUTX-101 (copper histidinate), intended to treat Menkes disease in pediatric patients. The resubmission has been accepted as a Class 1 resubmission a ...

Core Insights - Fortress Biotech reported quarterly earnings of $0.11 per share, significantly beating the Zacks Consensus Estimate of a loss of $0.43 per share, marking an earnings surprise of +125.58% [1] - The company posted revenues of $17.63 million for the quarter ended September 2025, which was 25.55% below the Zacks Consensus Estimate, but an increase from $14.63 million year-over-year [2] - Fortress Biotech shares have increased approximately 23% since the beginning of the year, outperforming the S&P 500's gain of 14.6% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is $0.49 on revenues of $27.49 million, while for the current fiscal year, the estimate is -$1.18 on revenues of $80.7 million [7] - The estimate revisions trend for Fortress Biotech was mixed prior to the earnings release, resulting in a Zacks Rank 3 (Hold) for the stock, indicating expected performance in line with the market [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Fortress Biotech belongs, is currently ranked in the top 36% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8]

Financial Performance - For the three months ended September 30, 2025, net revenue was $17.6 million, up from $14.6 million for the same period in 2024, primarily driven by the sale of Journey's marketed products [217]. - For the nine months ended September 30, 2025, net revenue reached $47.2 million, compared to $42.6 million in 2024, indicating a year-over-year increase of approximately 12.9% [217]. - For the three months ended September 30, 2025, net revenue increased by 21% to $17.6 million compared to $14.6 million in the same period of 2024 [239]. - Product revenue, net for the same period was $17.0 million, up 16% from $14.6 million, driven by a $4.9 million contribution from the U.S. commercial launch of Emrosi [240]. - Net revenue for the nine months ended September 30, 2025, was $47.2 million, an 11% increase from $42.6 million in the same period of 2024 [259]. - Product revenue for the nine months ended September 30, 2025, was $45.2 million, a 6% increase from $42.5 million in the same period of 2024 [259]. - The company reported a net income of $5.9 million for Q3 2025, a turnaround from a net loss of $12.9 million in Q3 2024 [239]. - The net loss attributable to Fortress for the nine months ended September 30, 2025, was $10.8 million, a significant improvement from a loss of $39.2 million in the same period of 2024 [259]. Expenses and Cost Management - Operating expenses decreased by 33% to $24.4 million in Q3 2025 from $36.7 million in Q3 2024, primarily due to a significant reduction in research and development expenses [239]. - Research and development expenses plummeted by 98% to $208,000 in Q3 2025 from $9.4 million in Q3 2024 [244]. - Selling, general and administrative expenses decreased by $4.6 million, or 21%, to $17.4 million for the quarter ended September 30, 2025, largely due to Checkpoint's deconsolidation [254]. - Total operating expenses for the nine months ended September 30, 2025, decreased by $16.5 million, or 13%, to $112.6 million compared to $129.1 million in the same period of 2024 [259]. - Total research and development expenses decreased by $34.7 million, or 74%, to $12.3 million for the nine months ended September 30, 2025, with significant reductions across multiple entities [267]. - Selling, general and administrative expenses increased by $20.8 million, or 34%, totaling $81.7 million for the nine months ended September 30, 2025, largely due to a significant rise at Checkpoint [271]. Financing and Cash Flow - The company may require significant additional financing to develop existing and new product candidates, fund operating losses, and establish manufacturing and marketing capabilities [280]. - The company reported a net cash increase of $28.6 million for the nine months ended September 30, 2025, compared to a decrease of $22.4 million in the same period of 2024 [300]. - Net cash used in operating activities decreased by $14.1 million from the nine months ended September 30, 2024, primarily due to a decrease in net loss and changes in operating assets and liabilities [301]. - Net cash provided by financing activities increased by $26.9 million to $44.8 million for the nine months ended September 30, 2024, compared to $71.7 million for the same period in 2025 [303]. - The increase in financing activities was driven by a $24.5 million rise in proceeds from partner companies' equity offerings and warrant exercises, despite a $17.5 million decrease in proceeds from the issuance of common stock [303]. Strategic Developments - In July 2025, Journey announced that 65% of the 187 million commercial lives in the U.S. now have pharmacy benefit coverage for Emrosi [217]. - Fortress received $28.0 million from the acquisition of Checkpoint by Sun Pharma, along with eligibility for a 2.5% royalty on net sales of UNLOXCYT [217]. - Triplex is currently in a Phase 2 clinical trial with topline data anticipated in early 2026, focusing on CMV-specific immune response in HIV co-infected adults [217]. - In October 2025, Urica announced a $205 million Series A financing to support global Phase 3 clinical studies evaluating dotinurad for gout treatment [222]. - Fortress is eligible to receive up to $129 million in aggregate development and sales milestones for CUTX-101, along with royalties on net sales ranging from 3% to 12.5% [222]. - The FDA approved Emrosi for the treatment of inflammatory lesions of rosacea in November 2024, with the product launched in March 2025 [217]. - AstraZeneca's acquisition of Caelum Biosciences included potential milestone payments totaling up to $295 million, with Fortress eligible for 42.4% of these payments [222]. - The company has established strategic partnerships with leading institutions and pharmaceutical companies to enhance its product pipeline and market reach [208]. Other Financial Metrics - Interest income increased by $147,000, or 25%, to $736,000 for the quarter ended September 30, 2025 [258]. - Interest expense decreased by $3.5 million, or 56%, to $2.7 million for the quarter ended September 30, 2025, compared to $6.2 million in the same quarter of 2024 [258]. - Cost of goods sold increased by 29% to $5.8 million in Q3 2025, up from $4.5 million in Q3 2024, due to higher product-related costs [241]. - Other income increased by $20.2 million, or 446%, from a loss of $4.5 million in Q3 2024 to income of $15.7 million in Q3 2025, driven by a $15.1 million increase in the fair value of Urica's equity interest in Crystalys [258]. - Amortization of acquired intangible assets increased by $0.8 million, or 31%, to $3.2 million for the nine months ended September 30, 2025, driven by the addition of the Emrosi acquired intangible asset [262]. - Stock-based compensation expense in research and development increased by $3.3 million, or 112%, totaling $6.2 million for the nine months ended September 30, 2025, primarily due to an increase at Checkpoint [270]. - Stock-based compensation expense in selling, general and administrative increased by $6.6 million, or 49%, totaling $20.0 million for the nine months ended September 30, 2025, driven by Checkpoint's change of control [274]. - Total other income increased by $46.1 million, or 538%, resulting in income of $38.1 million for the nine months ended September 30, 2025, primarily due to a gain from the deconsolidation of Checkpoint [276]. - Interest income decreased by $309, or 14%, to $1.8 million for the nine months ended September 30, 2025 [276]. - Interest expense decreased by $2.9 million, or 26%, totaling $8.1 million for the nine months ended September 30, 2025, due to prior debt extinguishment [276]. Company Status and Obligations - As of September 30, 2025, the company reported an accumulated deficit of $730.1 million, primarily due to R&D expenses and administrative costs [278]. - The company had cash and cash equivalents of $86.2 million, with $38.6 million related to Fortress and private subsidiaries, $19.0 million to Mustang, $24.9 million to Journey, and $3.7 million to Avenue [279]. - The company has approximately $34.2 million available for sales of securities under the Mustang 2024 S-3 registration statement as of September 30, 2025 [289]. - There were no material changes in contractual obligations and commitments, including lease obligations, for the nine months ended September 30, 2025 [305]. - The company does not have minimum purchase commitments in its contracts with licensors, CROs, and CMOs, which are generally terminable upon written notice [304]. - Payments due upon termination may include fees for services provided or expenses incurred, including non-cancelable obligations [304]. - The company is classified as a "smaller reporting company" and is not required to provide certain market risk disclosures [306].

Financial Performance - Total net revenue increased 20.5% to $17.6 million for the third quarter of 2025 compared to the third quarter of 2024[1] - Journey Medical's net product revenues for the third quarter of 2025 were $17.0 million, up from $14.6 million in the same quarter of 2024[13] - Consolidated net income attributable to common stockholders was $3.7 million, or $0.13 per share basic, for the third quarter ended September 30, 2025, compared to a net loss of $(15.0) million for the same period in 2024[14] - Net revenue for the three months ended September 30, 2025, was $17,631,000, a 20.5% increase compared to $14,629,000 for the same period in 2024[19] - Product revenue, net, rose to $17,025,000 for the three months ended September 30, 2025, compared to $14,629,000 in the prior year, marking a 16.4% increase[19] - Net income attributable to common stockholders for the three months ended September 30, 2025, was $3,675,000, compared to a loss of $15,040,000 in the same period of 2024[19] - The company reported a loss from operations of $6,811,000 for the three months ended September 30, 2025, an improvement from a loss of $22,095,000 in the same period of 2024[19] Cash and Assets - Fortress' consolidated cash and cash equivalents totaled $86.2 million as of September 30, 2025, an increase of $28.9 million year-to-date[14] - Cash and cash equivalents increased to $86,218,000 as of September 30, 2025, up from $57,263,000 at December 31, 2024, reflecting a 50.7% increase[18] - Total assets increased to $181,407,000 as of September 30, 2025, up from $144,223,000 at December 31, 2024, representing a 25.9% growth[18] Expenses and Liabilities - Consolidated research and development expenses decreased to $0.2 million for the third quarter of 2025, down from $9.4 million in the same quarter of 2024[14] - Operating expenses decreased to $24,442,000 for the three months ended September 30, 2025, down from $36,724,000 in the same period of 2024, a reduction of 33.3%[19] - Research and development expenses significantly decreased to $208,000 for the three months ended September 30, 2025, compared to $9,446,000 in the same period of 2024, a reduction of 97.8%[19] - Total liabilities decreased to $116,222,000 as of September 30, 2025, down from $145,867,000 at December 31, 2024, a decline of 20.5%[18] Strategic Developments - Fortress received approximately $28 million from the acquisition of Checkpoint Therapeutics by Sun Pharma, with potential additional payments of up to $4.8 million and a 2.5% royalty on future net sales of UNLOXCYT™[2] - Dotinurad is advancing in two Phase 3 clinical trials, with a $205 million Series A financing announced by Crystalys Therapeutics underscoring market confidence in its potential[2][11] - Fortress anticipates the resubmission of the New Drug Application for CUTX-101, which may qualify for a Priority Review Voucher upon approval[2] - Journey Medical expanded payer access to over 100 million commercial lives in the U.S. for Emrosi, compared to 54 million in May 2025[13] Capital Management - Fortress remains focused on disciplined execution and optimizing capital allocation to drive sustainable growth and deliver innovative treatments[3]

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]

Financial Data and Key Metrics Changes - Total revenues for Q3 2025 were $17.6 million, a 21% increase from $14.9 million in Q3 2024, driven by the successful launch of Emrosi [13][18] - Gross margin decreased to 67.4% in Q3 2025 from 69.4% in Q3 2024, but showed steady improvement from 63.5% in Q1 to 67.1% in Q2 [14][15] - GAAP net loss was $2.3 million, or $0.09 per share, compared to a loss of $2.4 million, or $0.12 per share, in the same period last year [15] - EBITDA improved from a loss of $1 million in Q3 2024 to a loss of $500,000 in Q3 2025, while adjusted EBITDA was positive at $1.7 million [16] Business Line Data and Key Metrics Changes - Emrosi contributed $4.9 million in Q3 2025, a 75% increase compared to Q2 2025, with total prescriptions growing approximately 146% [5][6] - Legacy products, including Qbrexa, Accutane, and Amzeeq, saw a 16% year-over-year decline in revenue due to generic competition impacting Accutane [5] - Amzeeq's total prescription growth indicates strong commercial execution, with a one-to-one ratio of refills to new prescriptions [8][9] Market Data and Key Metrics Changes - Over $100 million of the $187 million commercial lives currently have access to Amzeeq, with successful contracting with two of the three largest GPOs [7] - The number of unique prescribers for Emrosi increased by approximately 50% to over 2,700, demonstrating substantial progress in product adoption [9] Company Strategy and Development Direction - The company aims to position Emrosi as the standard of care for rosacea treatment, targeting peak annual net sales of over $200 million in the U.S. and over $300 million globally [18] - Focus on disciplined expense management and margin expansion to improve profitability and sustain revenue growth [16][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving sustainable EBITDA positivity in Q4 2025, indicating a transformational year for the company [18] - Positive physician feedback on Emrosi suggests strong initial adoption and potential for continued growth [8][50] Other Important Information - The company is actively participating in key dermatology medical conferences to build awareness and momentum for Emrosi [9][10] - The copay assistance program is currently bridging the gap until broader health plan formulary adoption occurs [7] Q&A Session Summary Question: Usage of patient assistance program for Amzeeq - Management noted that the copay assistance program will see reduced reliance as reimbursement improves, with significant gains expected in 2026 [22][23] Question: Focus on breadth vs. depth of prescribers - The strategy involves both expanding the number of prescribers and increasing the volume of prescriptions from existing prescribers, with expectations for a snowball effect as confidence builds [25][26] Question: Revenue per script fluctuations - Management acknowledged variability in gross to net revenue due to early-stage dynamics and expected improvements with the addition of the third GPO in early 2026 [33][34] Question: Launch curve perspective - All indicators suggest a positive and potentially accelerating launch curve, with expectations for increased new prescriptions and refills [40][41] Question: Accutane's performance amidst generic competition - Management indicated that Accutane appears stable, with a recent uptick in performance, although competition remains a factor [42] Question: Retention rate of prescribers - No specific retention data was provided, but management noted ongoing trial and adoption among new prescribers [46][50] Question: Qbrexa's growth management - Qbrexa is expected to maintain single-digit growth year-over-year, with effective management of the overlap with Amzeeq [51]

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].

Group 1 - Fortress Biotech Inc. is under investigation by Pomerantz LLP for potential securities fraud or unlawful business practices involving its officers and/or directors [1] - On October 1, 2025, Fortress and its subsidiary, Cyprium Therapeutics, received a Complete Response Letter (CRL) from the U.S. FDA regarding the New Drug Application for CUTX-101, citing cGMP deficiencies at the manufacturing facility [1] - Following the announcement of the CRL, Fortress's stock price dropped by $1.14 per share, representing a decline of 30.81%, closing at $2.56 per share on the same day [1] Group 2 - Pomerantz LLP is recognized as a leading firm in corporate, securities, and antitrust class litigation, with a history of fighting for victims of securities fraud and corporate misconduct [2] - The firm has a legacy of recovering multimillion-dollar damages awards for class members over its 85 years of operation [2]

Core Viewpoint - Fortress Biotech Inc. is under investigation for possible securities fraud following a significant stock price drop after the FDA issued a Complete Response Letter regarding its New Drug Application for CUTX-101, citing manufacturing deficiencies [3]. Group 1: Legal Actions - The Portnoy Law Firm has initiated an investigation into Fortress Biotech Inc. and may file a class action on behalf of investors [1]. - Investors are encouraged to contact the Portnoy Law Firm to discuss their legal rights and options for pursuing claims to recover losses [2]. Group 2: Company Developments - On October 1, 2025, Fortress Biotech and its subsidiary, Cyprium Therapeutics, announced the FDA's Complete Response Letter related to CUTX-101, which noted cGMP deficiencies at the manufacturing facility [3]. - Following the announcement of the CRL, the stock price of Fortress Biotech experienced a decline [3].