On March 31, 2026 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company focused on developing innovative therapies for unmet medical needs, reported that the China National Intellectual Property Administration (CNIPA) has granted Chinese Patent, titled "Targeting Kit with Splice Switching Oligonucleotides to Induce Apoptosis of Mast Cells."

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The patent, originally filed under PCT Application No. PCT/US2019/048400 and developed by North Carolina State University, strengthens Hoth’s intellectual property portfolio and provides protection in a key global market through August 27, 2039, subject to maintenance requirements.

The granted patent relates to a novel therapeutic platform utilizing splice-switching oligonucleotides designed to selectively induce apoptosis in mast cells, which play a central role in a variety of inflammatory and immunological conditions.

"This patent grant in China represents an important milestone in expanding our global intellectual property protection for this innovative platform," said Robb Knie, Chief Executive Officer of Hoth Therapeutics. "We believe this technology has broad potential across multiple indications where mast cell activity contributes to disease, and this issuance further strengthens our position as we advance development."

(Press release, Hoth Therapeutics, MAR 31, 2026, View Source [SID1234664093])

On March 31, 2026 Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter, HKEX code: 02256) reported that its independently developed, highly selective, oral small-molecule FGFR4 inhibitor irpagratinib (ABSK-011), has been granted Orphan Drug Designation (ODD) by the European Medicines Agency (EMA) for the treatment of hepatocellular carcinoma (HCC). Irpagratinib is currently being evaluated in multiple clinical studies across different regions globally. The ODD granted by the EMA is expected to strongly support the product’s clinical development, regulatory filings, and commercialization in Europe.

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Orphan Drug Designation is a key incentive established by the EMA to facilitate the development and authorisation of medicines for rare diseases. The ODD granted to irpagratinib not only reflects regulatory recognition of its potential clinical value and need, but also provides access to a range of incentives, including eligibility for protocol assistance (PA), regulatory fee reductions, and 10 years of market exclusivity after marketing authorisation—thereby providing a strong foundation for future registration and commercialization.

Primary liver cancer ranks as the third leading cause of cancer-related mortality worldwide, with HCC accounting for approximately 75%–85% of cases. Currently, immune checkpoint inhibitors (ICIs) combined with anti-angiogenic therapy have become the standard first-line treatment for advanced HCC. However, effective second-line and later-line options remain limited. Additionally, approximately 30% of HCC patients exhibit FGF19 overexpression, and this subgroup tends to derive limited benefit from first-line targeted immunotherapy combinations. As there are no approved therapies targeting the FGFR4/FGF19 signaling pathway, significant unmet medical needs remain for patients with FGF19 overexpression under the current standard of care.

Irpagratinib is a highly selective, orally administered small-molecule FGFR4 inhibitor independently developed by Abbisko Therapeutics. In prior clinical studies, irpagratinib has demonstrated favorable safety and tolerability along with antitumor activity both as a monotherapy and in combination regimens in patients with FGF19-overexpressing advanced HCC. Currently, multiple clinical trials of irpagratinib are underway globally in patients with FGF19-overexpressing advanced HCC, including studies evaluating irpagratinib in combination with different targeted-immunotherapies in the first-line setting, as well as monotherapy in the second-line and later-line settings. Among these, the pivotal registrational study of irpagratinib monotherapy administered the first patient dose in June 2025 and currently involves more than 50 clinical research centers across China, and is progressing smoothly.

In addition to the EMA ODD, irpagratinib has previously been granted ODD and Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA), as well as Breakthrough Therapy Designation (BTD) by China’s National Medical Products Administration (NMPA). Leveraging the expedited review advantages provided by these regulatory designations, Abbisko Therapeutics will continue to advance the global clinical development and regulatory filings of irpagratinib, with the goal of bringing this innovative therapy to patients with hepatocellular carcinoma worldwide as early as possible and providing a new safe and effective precision treatment option for this challenging disease.

About Irpagratinib (ABSK-011)

Irpagratinib is a highly-selective FGFR4 small molecule inhibitor designed to target overexpression of the FGF19 signaling pathway. Several epidemiological studies indicate that approximately 30% of HCC patients worldwide exhibit FGF19 overexpression. Development of targeted therapies against FGFR4 represent an innovative and novel approach to the treatment of HCC.

To date, no FGFR4 inhibitor has been granted regulatory approval globally. According to Frost & Sullivan, irpagratinib is expected to become the first breakthrough treatment for the treatment of HCC patients with FGF19 overexpression.

In addition to monotherapy, Abbisko Therapeutics is exploring irpagratinib in combination with atezolizumab, an anti-PD-L1 antibody manufactured by F. Hoffmann-La Roche and Roche (China), in a Phase II study. At the the 2025 ESMO (Free ESMO Whitepaper) GI Congress, Abbisko presented clinical data showing that the combination of irpagratinib and atezolizumab achieved an objective response rate (ORR) exceeding 50% and a median progression-free survival (mPFS) of more than 7 months in FGF19-overexpressing HCC patients previously treated with immune checkpoint inhibitors.

(Press release, Abbisko Therapeutics, MAR 31, 2026, View Source [SID1234664092])

On March 31, 2026 3SBio Inc. (01530.HK) reported its 2025 annual results announcement. Fueled by the dual core engines of breakthroughs in innovative R&D and strategic global collaboration, the company delivered a high-quality performance with both quantitative and qualitative growth: annual revenue hit RMB 17.7 billion, a historic breakthrough past the RMB 10 billion mark, representing a 94.3% year-on-year (YoY) increase; net profit attributable to shareholders of the parent company reached RMB 8.48 billion, surging 305.8% YoY; adjusted net profit attributable to shareholders of the parent company stood at RMB 8.45 billion, a 264.6% YoY rise. The company’s profitability achieved a leap-forward growth, demonstrating robust growth momentum.

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In 2025, the company’s R&D expenditure amounted to RMB 1.52 billion, a 14.6% YoY increase, providing solid support for the advancement of its innovative drug pipeline. As of the end of 2025, 3SBio’s total financial resources soared to RMB 20.4 billion, its interest-bearing debt ratio dropped to 9.8%, and comprehensive financial costs contributed a positive RMB 230 million to the company, further optimizing the asset-liability structure. Abundant cash flow and a sound capital structure have fortified the financial foundation for the company’s long-term development. Adhering to its stable dividend policy, the company declared a 2025 final dividend of HKD 0.25 per share, delivering solid shareholder returns to convey confidence in its long-term growth.

During the reporting period, 3SBio entered into a global licensing collaboration with Pfizer with a total deal value of over US$6 billion, receiving an upfront payment of US$1.4 billion and a US$100 million equity investment, setting a new record for the highest upfront payment in a single out-licensing transaction for a Chinese innovative drug. Its core product TPIAO secured approval for a new indication; three novel drugs were successively approved for marketing and three products entered the New Drug Application (NDA) stage. The company has built a multi-domain innovative pipeline matrix, further consolidating its global competitiveness and leading position in core therapeutic areas, and injecting strong impetus into its high-quality development.

I. Groundbreaking Global Collaboration with Pfizer Sets a New Record for Chinese Innovative Drug Out-licensing

2025 marked a pivotal breakthrough in 3SBio’s globalization strategy, as the company entered into a global collaboration with Pfizer for its proprietary PD-1/VEGF bispecific antibody SSGJ-707—a landmark event in China’s biopharmaceutical industry.

Under the collaboration agreement, 3SBio granted Pfizer exclusive global development and commercialization rights to SSGJ-707, with the total potential deal value exceeding US$6 billion. The company is also entitled to tiered double-digit royalties based on the product’s global cumulative sales. The US$1.4 billion upfront payment plus US$100 million equity investment has set a new record for the highest upfront payment in a single out-licensing transaction of a Chinese innovative drug to date. This landmark collaboration not only attests to the high recognition of international pharmaceutical giants for the R&D quality, standards and systems of Chinese innovative drugs, but also fully demonstrates the core global competitiveness of 3SBio and even China’s biopharmaceutical innovation as a whole.

Notably, 3SBio retains the right to supply SSGJ-707 bulk drug substance for clinical and commercial use in China and across the globe. To date, the first batch of SSGJ-707 bulk drug substance for global clinical development has been successfully delivered, marking the official entry of the collaboration into the substantive implementation phase and accelerating the global commercialization progress of the product.

Leveraging Pfizer’s world-class global clinical resources, the global clinical development of SSGJ-707 is progressing at a brisk pace. Nine international multi-center clinical trials have been initiated, covering a broad spectrum of high-incidence tumors including squamous/non-squamous non-small cell lung cancer, metastatic colorectal cancer, extensive-stage small cell lung cancer, gastroesophageal junction cancer, transformed small cell lung cancer, locally advanced/metastatic hepatocellular carcinoma, locally advanced/metastatic urothelial carcinoma, and locally advanced/metastatic renal cell carcinoma. Going forward, the two parties will continue to expand the product’s indications and combination therapy regimens, fully unlocking the global clinical value and commercial growth potential of this core innovative asset.

II. Fruition of Innovation at Scale Builds a New Growth Engine

From 2025 to early 2026, 3SBio entered a period of intensive product approvals. With three novel drugs launched successively, core products gaining new indication approvals, commercialized products included in the National Reimbursement Drug List and authoritative clinical guidelines, and multiple candidates advancing to the NDA stage, the company has accelerated the translation of multi-dimensional innovation value into growth drivers, fueling sustained performance growth.

Three Novel Drugs Approved, Enriching Clinical Treatment Options

Amdokitug Injection (Yisaituo): Approved in February 2026 for the treatment of moderate-to-severe plaque psoriasis. The product features rapid onset of action as early as Week 2, leading PASI100 response at Week 12, and sustained skin lesion clearance at Week 52. It has no neutralizing antibodies detected, with an anti-drug antibody (ADA) rate of only 0.7% and a lower infection risk. A simplified maintenance dosing regimen of once every 8 weeks significantly reduces the annual dosing frequency for patients, alleviating the burden and psychological stress of long-term treatment, and substantially improving treatment adherence.
Loncipoetin Alfa Injection (NuPIAO): Approved in March 2026 as the first domestic long-acting recombinant erythropoietin (EPO) biweekly formulation (a Class 1 innovative drug), indicated for hemodialysis patients with anemia caused by chronic kidney disease who are receiving erythropoietin therapy. Boasting an ultra-long half-life of 120 hours and low immunogenicity, the product is administered intravenously, making it more suitable for hemodialysis patients. Its biweekly dosing regimen drastically cuts down the dosing frequency, significantly improving patient treatment adherence and providing a more convenient therapeutic option for clinical practice.
Eltrombopag Ethanolamine Tablets: Approved in March 2026 for the treatment of immune thrombocytopenia (ITP) and severe aplastic anemia (SAA). The product provides a new oral treatment option for patients with hematological disorders, further improving 3SBio’s commercial product portfolio in the hematology field.
Core Product Expands to New Indication, Unlocking Incremental Market Potential

Recombinant Human Thrombopoietin（TPIAO）, the world’s only commercialized recombinant human thrombopoietin product, obtained approval for a new indication in December 2025—for the treatment of chronic liver disease-related thrombocytopenia (CLDT) in patients scheduled to undergo surgery (including diagnostic procedures). This approval provides a rapid-acting, stable and safe platelet-boosting treatment for a large number of perioperative patients with chronic liver disease, further expanding the market coverage of this core product.

Commercialized Product Earns Authoritative Recognition, Accelerating Clinical Penetration

Paclitaxel Oral Solution (Liporaxel) was officially included in the 2025 CSCO Guidelines for the Diagnosis and Treatment of Gastric Cancer as a Grade I recommendation (Category 1A) for the second-line treatment of advanced gastric cancer, and was also added to the 2025 National Reimbursement Drug List. Adopting an innovative lipid self-emulsifying drug delivery technology, the product revolutionizes gastric cancer treatment from "hospital-based infusion" to "home-based oral administration", greatly improving medication convenience for patients. Its NDA for the indication of relapsed or metastatic HER2-negative breast cancer has been submitted and accepted, which is expected to further open up its market space.

Three Products in NDA Stage, Delivering Abundant Follow-up Growth Momentum

613 (Anti-IL-1β mAb): Its NDA for acute gouty arthritis was submitted and accepted in June 2025. The biologic penetration rate in China’s acute gout market remains extremely low; as the second domestic product of its class to file an NDA, it enjoys a favorable competitive landscape and is poised to address significant unmet clinical needs with promising market prospects. A Phase II clinical trial for intermittent gouty arthritis is currently underway.
611 (Anti-IL-4Rα mAb): Its NDA for moderate-to-severe atopic dermatitis in adults was submitted and accepted in February 2026. Non-head-to-head comparisons show its overall efficacy is superior to dupilumab. It supports long-acting dosing of once every two or four weeks, delivering stronger efficacy, higher patient adherence and better long-term disease control. Clinical development for additional indications including chronic rhinosinusitis with nasal polyps, chronic obstructive pulmonary disease, and adolescent and pediatric atopic dermatitis is well underway, continuously unlocking the pipeline’s growth potential.
601A (Anti-VEGF mAb): Its NDA for macular edema secondary to branch retinal vein occlusion (BRVO) was accepted in October 2025. The product demonstrates efficacy comparable to ranibizumab, with a favorable overall safety and tolerability profile, providing a new treatment option for ophthalmic clinical practice.
III. Building a Multi-Domain Innovative Pipeline Matrix to Consolidate Long-term Core Competitiveness

In 2025, 3SBio continued to ramp up R&D investment and built a rich and differentiated innovative pipeline matrix focusing on core therapeutic areas including hematology/oncology, autoimmune diseases, nephrology, dermatology, hair disorders and weight management. Multiple products are in key clinical stages with leading-edge target layouts, establishing solid technical and product barriers for the company’s long-term development.

Hematology/Oncology: Multi-pronged Layout of Bispecific/Trispecific Antibodies to Forge Differentiated Competitive Advantages

705 (Anti-PD-1/HER2 BsAb): Currently in Phase II clinical development for HER2-positive advanced solid tumors, it is the only candidate in China actively advancing clinical trials for this target, boasting significant differentiated advantages.
706 (Anti-PD-1/PD-L1 BsAb): Phase II clinical trials for advanced non-small cell lung cancer and advanced gastrointestinal tumors are ongoing, covering high-incidence tumor types with smooth clinical progress.
708 (Anti-PD-1/TGF-β BsAb), 709 (Anti-PD-1/LAG3 BsAb), SSS59 (Anti-MUC17/CD3/CD28 Tri-specific Ab) and SPGL008 (Anti-B7H3 Ab/IL15Rα sushi-IL15 Fusion Protein) for advanced solid tumors are all in Phase I clinical trials; SSS57 (Long-acting ActRIIB-Ig Trap) for myelodysplastic syndrome (MDS)-related anemia is also in Phase I. The hierarchical pipeline layout in hematology/oncology is continuously improved, reserving high-quality assets for the company’s long-term growth.
Autoimmune Diseases: Multiple Products in Key Clinical Stages, Leading Domestic R&D Progress

610 (Anti-IL-5 mAb): Under Phase III clinical development for eosinophilic asthma, it ranks first in China in terms of R&D progress for this target and is poised for early commercialization.
626 (Anti-BDCA2 Ab): Currently in Phase Ib clinical trial for systemic lupus erythematosus (SLE), addressing critical unmet clinical needs in the autoimmune disease field.
627 (Anti-TL1A mAb): Phase II clinical trial for ulcerative colitis (UC) has been initiated, laying out the company’s presence in the core inflammatory bowel disease (IBD) track.
A portfolio of early-stage pipeline assets is advancing rapidly, including 716 (Anti-OX40L/IL-31RA Bispecific Antibody for atopic dermatitis), 717 (CD3/CD19/BCMA for SLE/lupus nephritis/rheumatoid arthritis), 718 (TL1A/IL-23 for IBD), 719 (IL-4R/TSLP for asthma/chronic obstructive pulmonary disease) and 629 (IL-23R for psoriasis/IBD). These candidates fully cover mainstream and cutting-edge targets in the autoimmune disease field, building a deep technical moat for the company.
Nephrology: Focusing on Core Clinical Needs, Pioneering Domestic Layout of Emerging Targets

SSS55 (C3b-targeting Bi-functional Fusion Protein ): Phase I clinical trials have been initiated for paroxysmal nocturnal hemoglobinuria (PNH), complement-mediated kidney disease (CMKD) and periodontitis. 3SBio is the only company in China actively advancing R&D for this target, filling a critical clinical gap in the domestic market.
SSS68 (Long-acting anti-April/BAFF BsAb): Its Investigational New Drug (IND) application for IgA nephropathy has been approved in the US. As the only domestic long-acting bispecific antibody in clinical development targeting the APRIL/BAFF pathway, it features significant differentiated competitive advantages.
Dermatology, Hair Disorders & Weight Management: Forward-looking Layout in High-potential Tracks

WS2403 (Semaglutide Injection): Phase III clinical trials for the weight management indication are currently underway.
WS204 (Clascoterone): Phase III clinical trials for moderate-to-severe acne vulgaris in patients aged 12 and above are currently underway.
SSS67 (Anti-ActRIIA/ActRIIB BsAb): Its IND application for overweight/obesity has been approved in the US. As the only innovative biased bispecific antibody in China to enter the IND stage for this indication, it represents the company’s forward-looking layout in the blue ocean of metabolic disease treatment.
Remarks from Dr. Lou Jing, Chairman and CEO of 3SBio

"2025 marked the conclusion of the 14th Five-Year Plan period. Under the coordinated governance of medical insurance, healthcare and pharmaceuticals, China’s biopharmaceutical industry has witnessed several landmark changes: commercial health insurance has opened up multi-payment channels for innovative drugs, and Chinese innovative drug out-licensing deals have achieved remarkable results. Our proprietary SSGJ-707 set a new record with a 24% upfront payment ratio in its global out-licensing deal, a testament to the global competitiveness of Chinese biopharmaceutical innovation.

In 2026, the biopharmaceutical industry has been designated as a national emerging pillar industry in China. Driven by national policies, the industry is accelerating its transformation from a major pharmaceutical manufacturing country to a global pharmaceutical powerhouse, and 3SBio’s innovation potential has gained wide international recognition.

Building on over 30 years of industry expertise and accumulation, we remain committed to the principle of integrity and innovation. We will continue to deepen our layout in oncology, autoimmune diseases, nephrology and other core therapeutic areas, increase investment in cutting-edge innovation, continuously optimize our R&D pipeline, and accelerate the launch and market promotion of new products such as Liporaxel, Yisaituo and NuPIAO. Guided by our mission to ‘make innovative biopharmaceuticals accessible to all’, we will strive to bring more high-quality innovative drugs to the market at an early date, benefiting patients worldwide."

(Press release, 3SBio, MAR 31, 2026, View Source [SID1234664091])

On March 31, 2026 NJ Bio, Inc. ("NJ Bio"), a leading provider of integrated drug discovery and development services and Ajinomoto Bio‑Pharma Services ("Aji Bio‑Pharma"), a leading provider of biopharmaceutical manufacturing services and platform technologies, reported a research collaboration to expand access to AJICAP, Aji Bio‑Pharma’s site‑specific conjugation platform for NJ Bio’s discovery‑stage and early development clients. This collaboration broadens NJ Bio’s advanced antibody conjugation and linker capabilities, supporting the development of next‑generation antibody–drug conjugates (ADCs) and other targeted therapeutics.

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Through the collaboration, NJ Bio will integrate the AJICAP platform into its discovery and development workflows, offering clients a robust and highly reproducible approach for site‑specific conjugation of cytotoxic and non‑cytotoxic payloads to antibodies. AJICAP enables precise chemical modification at defined lysine residues without the need for antibody engineering, preserving antibody structure and functionality while improving pharmacokinetics, therapeutic index, and overall developability. The platform supports a range of stable, hydrophilic linker systems and is readily incorporated into drug discovery and development programs.

AJICAP technology is widely recognized for its scalability, consistency, and compatibility with standard antibody production processes. By integrating this platform, NJ Bio strengthens its position as a comprehensive partner for biopharmaceutical companies seeking end‑to‑end support, from early drug design and discovery through preclinical development.

Clients will benefit from NJ Bio’s deep expertise in medicinal chemistry, bioconjugation, and biologics development, combined with the precision, reproducibility, and flexibility of the AJICAP platform. Based on prior technical experience working with AJICAP technology, NJ Bio anticipates that this collaboration will help reduce development risk, shorten timelines, and improve overall project outcomes.

"Expanding our capabilities with AJICAP aligns strongly with NJ Bio’s mission to deliver cutting-edge, high-value solutions that accelerate our clients’ discovery programs," said Julien Dugal-Tessier, the President and Chief Scientific Officer at NJ Bio. "This collaboration enables us to offer a proven, scalable site-specific conjugation platform, expand access to AJICAP capabilities, and support the development of novel antibody-based medicines with improved efficacy and safety profiles."

"AJICAP was developed to enable precise and scalable antibody conjugation, and we are excited to extend its reach through this collaboration with NJ Bio," said Yasuyuki Otake, Corporate Executive, General Manager, Bio-Pharma Services Dept., Ajinomoto Co., Inc. "Together, we are enhancing the tools available to biopharma innovators to design and develop next-generation targeted therapies for patients."

(Press release, Ajinomoto, MAR 31, 2026, View Source [SID1234664090])

On March 31, 2026 Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty income, reported financial results and recent corporate highlights for the full-year ended December 31, 2025.

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Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, "2025 and early 2026 reflect disciplined execution across our portfolio, including monetizing assets, achieving key regulatory approvals and advancing high-value clinical programs. The acquisition of Checkpoint Therapeutics, Inc. ("Checkpoint") by Sun Pharma generated meaningful upfront capital and established a long-term royalty stream from UNLOXCYT (cosibelimab-ipdl), highlighting the strength of our business model. The FDA approval of ZYCUBO for Menkes disease, followed by the recent sale of the Rare Pediatric Disease Priority Review Voucher ("PRV") for $205 million by our majority-owned subsidiary Cyprium Therapeutics, Inc. ("Cyprium"), demonstrates our continued ability to advance our portfolio toward value-generating approvals and corporate transactions. Additionally, the progression of dotinurad into Phase 3 by Crystalys Therapeutics, to which we transferred rights to dotinurad in exchange for equity in Crystalys and a 3% royalty on dotinurad sales, supported by its Series A $205 million financing, further validates our strategy of building diversified revenue streams and creating long-term shareholder value."

Recent Corporate Highlights1:

Regulatory Updates

ZYCUBO Approved for Menkes Disease; Cyprium Sold PRV for $205 Million; Royalty and Milestone Participation Secured. In January 2026, the FDA approved ZYCUBO (copper histidinate, formerly known as CUTX-101) for the treatment of Menkes disease in pediatric patients. A PRV was issued at approval and transferred to Cyprium under its agreement with Sentynl Therapeutics, Inc. ("Sentynl"). In March 2026, Cyprium closed the sale of the PRV for gross proceeds of $205 million. Cyprium is also eligible to receive tiered royalties on net sales of ZYCUBO and up to approximately $128 million in aggregate sales milestones from Sentynl. ZYCUBO was commercially launched by Sentynl subsequent to approval.
In connection with the sale of the PRV, Cyprium redeemed all outstanding shares of its 9.375% Perpetual Preferred Stock pursuant to the previously disclosed terms of such securities.
In total, Fortress expects to receive an aggregate of at least $100 million from Cyprium pursuant to potential future dividends and intercompany agreements, including amounts owed by Cyprium to Fortress through intercompany debt, interest and accrued expenses. The amount Fortress will receive is subject to change based on various considerations including, but not limited to, Cyprium’s obligation to pay 20% of the proceeds from a PRV sale to an institute of the National Institutes of Health, Cyprium’s tax obligations on the income received from the PRV sale, any future dividends that may be approved by Cyprium’s Board of Directors, and Cyprium’s outstanding and future obligations.

Monetization Updates

Checkpoint Acquired by Sun Pharma; Fortress Establishes Long-Term Royalty Stream. In May 2025, Fortress’ subsidiary, Checkpoint, was acquired by Sun Pharmaceutical Industries, Inc. (together with its subsidiaries and/or associated companies, "Sun Pharma"). Checkpoint was acquired for an aggregate upfront payment totaling ~$355 million and ~$60 million payable in a contingent value right ("CVR"), of which Fortress received ~$28 million upfront, with the potential for an additional CVR payment of up to $4.8 million and a 2.5% royalty on future net sales of UNLOXCYT (cosibelimab-ipdl). UNLOXCYT was approved by the FDA in December 2024 to treat metastatic or locally advanced cutaneous squamous cell carcinoma ("cSCC") in patients who are not candidates for curative surgery or radiation and was commercially launched in January 2026.
Avenue Therapeutics’ Subsidiary Baergic Acquired by Axsome. In November 2025, Avenue Therapeutics, Inc.’s ("Avenue") subsidiary Baergic Bio, Inc. ("Baergic") was acquired by Axsome Therapeutics ("Axsome"). Under the terms of the purchase agreement, Baergic shareholders received a $0.3 million upfront payment (less transaction expenses) and are eligible to receive milestone payments of up to $2.5 million upon the occurrence of certain development and regulatory events for the first indication for AXS-17 (formerly known as BAER-101). Avenue, a Fortress subsidiary, is eligible to receive approximately 74% of all future milestone and royalty payments under the agreement, including up to $79 million in potential sales milestones and tiered mid-to-high single-digit royalties.
$205 Million Series A Raised by Crystalys to Advance Dotinurad Phase 3 Program. In the third quarter of 2025, Crystalys Therapeutics ("Crystalys"), in which our majority-owned and controlled subsidiary company Urica Therapeutics, Inc. ("Urica"), maintains an equity position, announced a $205 million Series A financing to support two global Phase 3 clinical studies evaluating dotinurad for gout. Urica is eligible to receive a 3% royalty on future net sales of dotinurad. Urica entered into an asset purchase agreement, royalty agreement and related agreements with Crystalys in July 2024.

Commercial Product Updates

Journey Medical Expands Commercial Footprint of Emrosi. At the end of March 2025, our partner company Journey Medical Corporation ("Journey Medical"), commercially launched Emrosi (40mg Minocycline Hydrochloride Modified-Release Capsules, consisting of 10mg immediate release and 30mg extended release pellets), also known as DFD-29, for inflammatory lesions of rosacea. Emrosi was approved by the FDA in November 2024 and is available by prescription at specialty pharmacy chains. Journey Medical reported net product revenues of $61.2 million for full-year 2025, compared to net product revenues of $55.1 million for the full year ended December 31, 2024.

Clinical Updates

Dotinurad Enters Phase 3 Development. In October 2025, the first patients were dosed in Crystalys’ two randomized, double-blind, multicenter global Phase 3 trials evaluating dotinurad, a next-generation, once daily oral, URAT1 inhibitor with potential for best-in-class safety and efficacy for the treatment of gout.
Phase 3 CARES Results for Anselamimab (CAEL-101); Regulatory Submission of Prespecified Subgroup Analysis Planned. In July 2025, AstraZeneca announced that anselamimab (formerly known as CAEL-101) did not achieve statistical significance for the primary endpoint in its Phase III Cardiac Amyloid Reaching for Extended Survival ("CARES") clinical program for Mayo stages IIIa and IIIb AL amyloidosis patients. However, the drug showed clinically meaningful improvement in a prespecified subgroup and was well tolerated. AstraZeneca indicated that the company plans to submit the prespecified subgroup analysis from the CARES trials to regulatory authorities.
Emrosi Phase 3 Data Published in JAMA Dermatology and Journal of Drugs in Dermatology. In March 2025, full results from two Phase 3 multicenter, randomized, double-blind, parallel-group, active-comparator and placebo-controlled clinical trials, Minocycline Versus Oracea in Rosacea-1 ("MVOR-1") and Minocycline Versus Oracea in Rosacea-2 ("MVOR-2"), evaluating Emrosi for the treatment of moderate-to-severe papulopustular rosacea in adults, were published in the Journal of the American Medical Association – Dermatology. The results demonstrated the efficacy, safety and tolerability of oral DFD-29 in rosacea. The full publication is available at View Source Information on such website is not a part of this release. In December 2025, results from the Phase 1 clinical trial (DFD-29-CD-006) assessing the impact of low-dose oral minocycline (commercially known as Emrosi) on skin, gastrointestinal ("GI") and vaginal microflora in healthy adults were published in the Journal of Drugs in Dermatology. The clinical trial also assessed the safety and tolerability of the treatment. The results indicate that DFD-29 administration for 16 weeks had no detectable effects on skin, GI tract or vaginal microflora and it was well tolerated in healthy adults, supporting its use as a therapeutic option for patients with moderate-to-severe rosacea.
Emrosi Phase 3 Results Presented at Scientific Meetings. In June 2025, a data analysis from the two Phase 3 multicenter clinical trials evaluating Emrosi for the treatment of moderate-to-severe papulopustular rosacea in adults was presented at the Society of Dermatology Physician Associates 2025 Summer Dermatology Conference. The analysis determined that differences in body weight did not affect the efficacy of Emrosi in the two Phase 3 trials, which supported its November 2024 FDA approval. In October 2025, efficacy data from a pooled analysis of the MVOR-1 and MVOR-2 trials were presented at the 2025 Fall Clinical Dermatology Conference and demonstrated superior efficacy in Investigator’s Global Assessment treatment success rates and inflammatory lesion counts versus both placebo and doxycycline (P<0.001 for all comparisons).
Triplex CMV Vaccine Phase 2 Update. In January 2025, the first patient was dosed in a multicenter, placebo-controlled and randomized Phase 2 clinical trial to evaluate Triplex, a cytomegalovirus ("CMV") vaccine, when administered to human leukocyte antigen matched related stem cell donors to reduce CMV events in patients undergoing hematopoietic stem cell transplantation. Triplex is being investigated in eight clinical trials and is currently in development at our subsidiary company, Helocyte, Inc.

General Corporate:

In March 2026, Fortress made aggregate prepayments on its loan with Oaktree, including a prepayment in connection with the sale of the PRV, reducing the outstanding principal balance to $15.0 million.
In February 2026, Avenue entered into an exclusive worldwide license agreement with Duke University to acquire patent and know-how rights pertaining to ATX-04 (clenbuterol), a well-characterized small-molecule β2-adrenergic agonist, in clinical development for the treatment of Pompe disease. ATX-04 is a selective β2-adrenergic agonist with human proof-of-concept data demonstrating improved muscle function and enhanced response to enzyme replacement therapy. Avenue anticipates meeting with the FDA in 2026 to discuss and align on the design of a potential single pivotal trial for ATX-04 for Pompe disease.
Journey Medical joined the small-cap Russell 2000 and the broad-market Russell 3000 Indexes, in June 2025.

Financial Results:

As of December 31, 2025, Fortress’ consolidated cash and cash equivalents totaled $79.4 million, compared to $86.2 million as of September 30, 2025, and $57.3 million as of December 31, 2024, a decrease of $6.8 million for the fourth quarter and an increase of $22.1 million for the full year.
Fortress’ consolidated cash and cash equivalents totaled $79.4 million as of December 31, 2025, and includes $35.2 million attributable to Fortress and private subsidiaries, $2.9 million attributable to Avenue, $17.3 million attributable to Mustang and $24.1 million attributable to Journey Medical. Checkpoint was acquired by Sun Pharma in May 2025.
Fortress’ consolidated net revenue totaled $63.3 million for the full year ended December 31, 2025, which included $61.2 million in net revenue generated from our marketed dermatology products. This compares to consolidated net revenue totaling $57.7 million for the full year ended 2024, which included $55.1 million in net revenue generated from our marketed dermatology products.
Consolidated research and development expenses including license acquisitions totaled $11.9 million for the full year ended December 31, 2025, compared to $56.9 million for the full year ended December 31, 2024.
Consolidated selling, general and administrative costs were $96.4 million for the full year ended December 31, 2025, compared to $87.7 million for the full year ended December 31, 2024.
Consolidated net loss attributable to common stockholders was $(1.9) million, or $(0.07) per share, for the full year ended December 31, 2025, compared to net loss attributable to common stockholders of $(55.9) million, or $(2.69) per share for the full year ended December 31, 2024.

(Press release, Fortress Biotech, MAR 31, 2026, View Source [SID1234664089])