Rare Pediatric Disease Priority Review Voucher (PRV) granted by FDA at approval to be transferred from Sentynl Therapeutics to Cyprium Cyprium eligible to receive tiered royalties and up to $129 million in aggregate development and sales milestones from Sentynl Therapeutics MIAMI, Jan. 13, 2026 (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 ...

Shares of Fortress Biotech Inc. (FBIO) are up over 3% at $4.40 in premarket trading on Tuesday, as its subsidiary Cyprium Therapeutics approaches a key FDA decision.CUTX-101, a subcutaneous injectable formulation of copper histidinate, developed by Cyprium and proposed for the treatment of Menkes disease, is awaiting a decision from the FDA, expected by January 14, 2025. This is the therapy's second go-around with the FDA.Last October, the U.S. regulatory agency declined to approve CUTX-101, citing observa ...

Group 1: Market Movements - Several biotech and healthcare companies experienced notable gains in after-hours trading, driven by earnings updates, guidance announcements, and broader investor sentiment [1] - FibroBiologics, Inc. (FBLG) led with a 7.68% increase, closing at $0.41, suggesting speculative interest or technical momentum [1] - Nyxoah SA (NYXH) advanced 3.94% to $5.28 after reporting preliminary results for Q4 and full year 2025, along with revenue guidance for Q1 2026 [2] - Fortress Biotech, Inc. (FBIO) climbed 6.90% to $4.49, continuing a trend of volatility despite no new news [2] - Revvity, Inc. (RVTY) gained 4.92% to close at $109.00, with investors likely reacting to a previous collaboration announcement with Eli Lilly [3] - Option Care Health, Inc. (OPCH) rose 3.28% to $33.11 after releasing preliminary unaudited financial results for Q4 and full year 2025, along with guidance for 2026 [4] - Actinium Pharmaceuticals, Inc. (ATNM) added 3.02% to close at $1.34, reflecting investor activity in the broader biotech sector [4] - Design Therapeutics, Inc. (DSGN) gained 1.97% to $9.30, indicating continued interest despite no specific news [5] Group 2: Company-Specific Developments - FibroBiologics, Inc. (FBLG) showed a significant rise without any company-specific news, indicating potential speculative interest [1] - Nyxoah SA (NYXH) provided revenue guidance for Q1 2026, which bolstered investor confidence in its growth trajectory [2] - Revvity, Inc. (RVTY) is expanding access to predictive models through a collaboration with Eli Lilly, aimed at accelerating AI-enabled drug discovery [3] - Option Care Health, Inc. (OPCH) released preliminary financial results and guidance, contributing to its positive after-hours reaction [4]

As filed with the Securities and Exchange Commission on December 15, 2025 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 FORTRESS BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 20-5157386 (State or other jurisdiction of incorporation or organization) 1111 Kane Concourse, Suite 301 Bay Harbor Islands, FL 33154 (Address, including zip code, and telephone number, includ ...

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]