On February 26, 2026 BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) reported financial results for the full year ended December 31, 2025, and provided a business update.

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"2025 was fundamentally transformative for BioCryst. We achieved full-year profitability for the first time in the company’s history, driven by strong commercial execution that delivered the highest level of new patient prescriptions in the U.S. since the initial launch of ORLADEYO, even as the treatment landscape continued to evolve. We also advanced key business development initiatives that streamlined our operations and further strengthened our leadership position in hereditary angioedema. We entered 2026 with strong momentum, completing the acquisition of Astria Therapeutics to grow our HAE portfolio to meet the needs of more patients, while adding to our long-term growth trajectory well into the next decade," said Charlie Gayer, President and Chief Executive Officer of BioCryst.

Business Updates

In October 2025, the company completed the sale of its European ORLADEYO business to Neopharmed Gentili S.p.A. The transaction enabled BioCryst to simplify its operating structure and sharpen its strategic focus on its core U.S. business.

In December 2025, the company received FDA approval for the ORLADEYO pellet formulation for patients ages 2 to <12 with HAE, making it the first and only targeted oral prophylactic therapy for children living with HAE.

In January 2026, the company completed its acquisition of Astria Therapeutics, Inc., initially announced in October 2025. Through the transaction, BioCryst added navenibart to its HAE portfolio. Navenibart is an injectable, long-acting, monoclonal antibody inhibitor of plasma kallikrein currently in Phase 3 clinical development for HAE prophylaxis.

The navenibart Phase 3 program is currently enrolling and is on track to support regulatory filing by the end of 2027. The program consists of the ALPHA-ORBIT Phase 3 trial and the ORBIT-EXPANSE long-term trial. ALPHA-ORBIT is a randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of navenibart over a six-month treatment period, with dosing arms every three months (Q3M) and every six months (Q6M). After completing ALPHA-ORBIT, eligible participants may continue into the ORBIT-EXPANSE trial, in which all participants will receive navenibart in either Q3M or Q6M regimens.

New positive, interim results from the long‑term, open‑label ALPHA‑SOLAR trial show sustained, robust HAE attack suppression with navenibart administered every three and six months. The mean and median HAE attack rate reductions from baseline were 92% and 97% in the Q3M dosing arm and 90% and 97% in the Q6M dosing arm. Long-term data up to 24 months show durable efficacy and a favorable safety profile for both dosing regimens. BioCryst will present these results in a late-breaking presentation, and other abstracts, at the 2026 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Philadelphia, February 27–March 2, 2026.

A Phase 1 trial of BCX17725, an investigational KLK5 inhibitor for the treatment of Netherton syndrome, is currently enrolling and has begun dosing patients. The company expects to report data from this program in up to 12 patients by the end of 2026.
Full Year 2025 Financial Results

Non-GAAP figures are provided with adjustments, as applicable, for the sale of the European ORLADEYO business, stock-based compensation, workforce reduction costs, and transaction-related costs. Management believes that the presentation of these non-GAAP figures can provide greater transparency into the financial results of core, ongoing operations and improve comparability across reporting periods by excluding both the impact of divestitures and other items that can vary significantly across time periods.

Total revenues were $874.8 million and operating profit was $341.0 million for the full year 2025, compared to total revenues of $450.7 million and an operating loss of $2.5 million for the full year 2024. On October 1, 2025, BioCryst sold its European ORLADEYO business, resulting in the recognition of $243.3 million of revenue related to the license of intellectual property to Neopharmed Gentili S.p.A. On a non-GAAP basis, total revenues were $592.9 million (+45% y-o-y) and operating profit was $214.2 million (+198% y-o-y).

Research and development expenses, excluding stock-based compensation expense, in 2025 were $136.6 million (-5% y-o-y) on a GAAP basis and $133.0 million (-5% y-o-y) on a non-GAAP basis. Research and development expenses included increases in program costs for BCX17725 and avoralstat driven by manufacturing and clinical activities as we advance our Phase 1 studies, as well as increased IND-enabling activities across our early-stage pipeline programs. These increases were offset by lower personnel related costs and the close out of the Factor D program.

Sales and marketing expenses, excluding stock-based compensation expense, in 2025 were $177.1 (+16% y-o-y) million on a GAAP basis and $144.1 million (+23% y-o-y) on a non-GAAP basis. The increase was driven by distribution costs primarily attributed to increased sales, process development costs, the transition of certain safety and regulatory support roles from research and development due to commercial progression, pediatric launch support and other compensation expenses related to strong ORLADEYO sales performance.

General and administrative expenses, excluding stock-based compensation expense, in 2025 were $116.0 million (+45% y-o-y) on a GAAP basis and $85.0 million (+21% y-o-y) on a non-GAAP basis. The increase was driven by compensation, headcount growth in certain functions, and the transition of certain quality support roles from research and development to general and administrative in connection with ORLADEYO’s continued commercial progression.

Stock-based compensation increased due to a modification to extend the post-termination exercise period of certain vested stock option awards at the time of retirement for certain individuals to the original expiration date and an increase in restricted stock unit awards granted.

Interest expense was $78.9 million for the full year 2025 (-20% y-o-y). The decrease was primarily driven by the payoff of the Pharmakon Term Loan in 2025 and a decrease in the effective interest rate during the period in which the debt was outstanding in 2025. The payoff of the Pharmakon Term Loan, totaling $323.7 million, resulted in a one-time loss on extinguishment of debt of $17.3 million for the full year 2025.

Other income was $12.1 million for the full year 2025, which was primarily comprised of the impacts from the sale of our European ORLADEYO business. There was no other income for the full year 2024.

Cash, cash equivalents, restricted cash and investments totaled $337.5 million at December 31, 2025. Net cash utilization for the full year 2025 was $5.4 million. Excluding the impacts of the payoff of the Pharmakon loan and related expenses totaling $333.6 million and the net proceeds from the sale of our European ORLADEYO business to Neopharmed Gentili S.p.A. totaling $243.0 million, there was $85.2 million of cash generated during 2025.

Financial Outlook for 2026
The company maintained its expectation for full year 2026 global net ORLADEYO revenue to be between $625 million and $645 million and for full year 2026 total revenue, including RAPIVAB (peramivir injection), to be between $635 million and $660 million.

The company also maintained its expectation for full year 2026 non-GAAP operating expenses, excluding stock-based compensation, restructuring, and transaction-related costs, to be between $450 million and $470 million.

Item As of February 26, 2026 As of January 12, 2026
ORLADEYO revenue Unchanged $625 million to $645 million
Total revenue Unchanged $635 million to $660 million
Non-GAAP operating expense Unchanged $450 million to $470 million

Conference Call and Webcast
BioCryst management will host a conference call and webcast at 8:30 a.m. ET today to discuss the financial results and provide a corporate update. The live call may be accessed by dialing 1-844-481-2942 for domestic callers and 1-412-317-1866 for international callers. A live webcast and replay of the call will be available online in the investors section of the company website at www.biocryst.com.

(Press release, BioCryst Pharmaceuticals, FEB 26, 2026, View Source [SID1234663060])

On February 26, 2026 Amphista Therapeutics ("the Company" or "Amphista"), a leader in the discovery and development of next generation non-cereblon/VHL targeted protein degradation (TPD) medicines, reported new data at the Keystone Symposia on Proximity Based Biology and Therapeutics: Targeted Protein Degradation and Beyond in Banff, AB, Canada, 23-26 February.

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In an oral presentation titled "Expanding Targeted Glue Applications for Clinical Use by Recruiting Novel E3 Ligases", Louise Modis, Chief Scientific Officer at Amphista outlined the translation of Amphista’s Targeted Glue technology from discovery to clinical development. It showcased how the Company’s target-first approach and proprietary chemistry is delivering differentiated and advanced molecular glue degraders beyond traditional cereblon/VHL-based approaches.

The presentation built on insights shared at the TPD & Induced Proximity Summit in October 2025, demonstrated how Amphista is leading the rational discovery and development of molecular glue degraders functioning via novel E3 ligases, including DCAF16, FBXO22 and DCAF11 into clinically viable oral therapeutics.

Louise provided new data from Amphista’s Targeted Glue pipeline, which exemplifies the exquisite selectivity, deep and sustained target degradation, and exceptional degradation kinetics that can be achieved in vivo with this innovative approach. Amphista’s progress is underpinned by its proprietary Eclipsys platform technology which combines high-resolution CryoEM of ternary complexes, geometric deep learning, advanced folding algorithms and cheminformatics to rationalize and enhance molecular glue degrader development. The therapeutic potential of Amphista’s chemistry is further expanded by its compatibility with degrader-antibody conjugate (DAC) approaches.

Louise Modis, Chief Scientific Officer of Amphista Therapeutics, said: "We have made significant progress in advancing our Targeted Glue technology toward clinical application. This presentation at Keystone demonstrates how Amphista’s mechanistically differentiated approach of recruiting the most structurally efficient E3 ligase – including DCAF16, FBXO22 and now DCAF11 – translates into exceptional molecular properties, tissue distribution and degradation of the target. We have now demonstrated that we can successfully and reproducibly harness multiple novel E3 ligases beyond cereblon/VHL with advanced drug-like degraders. We’re excited to share data on AMX-883, our first clinical candidate, alongside innovations in degrader-antibody-conjugates and CNS-penetrant degraders that further expands the therapeutic opportunity for our Targeted Glue technology."

Presentation details:

Title: Expanding Targeted Glue Applications for Clinical Use by Recruiting Novel E3 Ligases
Date and Time: Wednesday 25 February 2026, 8:00–11:00 AM MST (UTC-7)
Presenter: Louise Modis, Chief Scientific Officer, Amphista Therapeutics

(Press release, Amphista Therapeutics, FEB 26, 2026, View Source [SID1234663059])

On February 26, 2026 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, reported financial results for the fourth quarter and full year ended December 31, 2025 and recent business highlights related to the commercial launch of Vafseo (vadadustat) as well as its robust pipeline.

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"Vafseo commercial trends are showing marked improvement in early 2026, built on the solid foundation we created for the brand in its first year of launch," said John P. Butler, Chief Executive Officer of Akebia. "Patient access to Vafseo therapy now stands at 290,000 patients, and early data points to improved patient adherence rates, which we believe are enhanced as a result of dialysis organizations deciding to implement observed dosing protocols. These dynamics, along with the building evidence of clinical differentiation, are expected to drive significant Vafseo revenue growth in 2026 and beyond as we work toward our goal to make Vafseo standard of care for treating anemia due to CKD in patients on dialysis. Separately, we are advancing our pipeline in rare kidney disease and actively enrolling patients into the Phase 2 trial of praliciguat in FSGS. We expect to initiate an open-label rare kidney disease basket study with our tissue-targeted complement inhibitor, AKB-097, in the second half of 2026 with initial data expected in 2027. Through these efforts, we remain steadfast in working to better the lives of people impacted by kidney disease."

Vafseo Q4 2025 Commercial Updates

•Total number of prescribers increased to approximately 800 in Q4, representing an increase of 10% over the number of prescribers in Q3.
•Broadened customer base as approximately 25% of new patients in Q4 originated from dialysis organizations other than U.S. Renal Care (USRC), an increase from less than 10% in Q3.
•Patient demand was approximately $11 million. This approximately $1 million decline in demand versus Q3 was driven by fewer patient starts, which Akebia believes was a result of providers at select dialysis organizations anticipating the initiation of new in-center observed dosing protocols.
•Within centers that adopted an in-center observed dosing protocol in Q4, first refill adherence rates improved to 91% in Q4 from 75% in the first 9 months of 2025 with daily dosing.
2025 Vafseo Post Marketing Clinical Development Achievements

•In November at the American Society of Nephrology Kidney Week 2025, Dr. Glenn M. Chertow presented a post-hoc analysis of data from the INNO2VATE trials comparing dialysis patients taking vadadustat or darbepoetin alfa for CKD-related anemia. The data demonstrated statistically significant favorable outcomes in the hierarchical composite endpoint of all-cause mortality and hospitalization in patients treated with vadadustat compared to patients in the erythropoietin stimulating agent (ESA) control group.
•In July, enrolled the first patient in VOCAL, a Phase IIIb trial evaluating three times weekly (TIW) dosing of Vafseo versus ESAs, which is expected to report topline data in Q4 2026. The VOCAL trial of approximately 350 total patients also contains a sub-study of Vafseo’s impact on red blood cell characteristics.
•In June, USRC completed enrollment in VOICE, a large Phase IV trial of over 2,100 patients evaluating Vafseo TIW against standard-of-care ESAs using a hierarchical composite endpoint of all-cause mortality and all-cause hospitalization. VOICE topline results are expected in early 2027.

Rare Kidney Disease and Early-Stage Pipeline Progress

•Initiated a Phase 2 clinical trial of praliciguat, an oral, once-daily soluble guanylate cyclase (sGC) stimulator being evaluated for the treatment of biopsy-confirmed FSGS, a rare kidney disease, and dosed the first patient in December 2025. Akebia expects to enroll approximately 60 patients in this trial.
•In November 2025, Akebia acquired a humanized anti-C3d monoclonal antibody fusion protein from Q32 Bio Inc. which is designed to act as a complement inhibitor through a tissue-targeted mechanism. A Phase 2 open-label rare kidney disease basket study is expected to start in the second half of 2026 evaluating AKB-097 in IgA nephropathy, lupus nephritis and C3 glomerulopathy. The study will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and effects on disease-relevant biomarkers, including proteinuria and measures of kidney function. Initial data is expected in 2027.

•Akebia plans to initiate a Phase 1 study of AKB-9090 in healthy volunteers. The study is expected to begin in the first half of 2026 with topline data expected by the end of the year. The initial target indication for AKB-9090 is the treatment of acute kidney injury associated with cardiac surgery.

Financial Results

•Revenues: Total revenues were $57.6 million in the fourth quarter of 2025 compared to $46.5 million in the fourth quarter of 2024, and $236.2 million for the full-year 2025 compared to $160.2 million for the full-year 2024. These increases were driven by sales of Vafseo, which was launched in the U.S. in January 2025, and an increase in Auryxia (ferric citrate) sales volumes.
◦Vafseo net product revenues were $6.2 million in the fourth quarter of 2025 and $45.8 million for the full-year 2025.

◦Auryxia net product revenues were $48.1 million in the fourth quarter of 2025 compared to $44.4 million in the fourth quarter of 2024, and $181.5 million for the full-year 2025 compared to $152.2 million for the full-year 2024. We expect generic competition for Auryxia to expand this year beyond the current authorized generic competition and therefore expect Auryxia revenues to decrease in 2026 as compared to 2025 Auryxia revenues.

◦License, collaboration and other revenues were $3.3 million in the fourth quarter of 2025 compared to $2.1 million in the fourth quarter of 2024, and $8.9 million for the full-year 2025 compared to $8.0 million for the full-year 2024.
•COGS: Cost of goods sold was $12.5 million in the fourth quarter of 2025 compared to $20.4 million in the fourth quarter of 2024, and $39.5 million for the full-year 2025 compared to $63.2 million for the full-year 2024. COGS in both periods was driven by higher Auryxia sales volumes in 2025, and was impacted by the elimination in 2025 of a quarterly $9.0 million non-cash intangible amortization charge that Akebia incurred through the fourth quarter of 2024. In addition, COGS for the full-year 2024 included a $12.3 million benefit due to our ability to sell inventory previously written-down as excess inventory. Of note, Vafseo-related COGS in both periods was derived from pre-launch inventory, which does not include the full cost of manufacturing as a portion of those inventory-related expenses were recorded as research and development expenses in the period incurred prior to Vafseo’s approval in the U.S.

•R&D Expenses: Research and development expenses were $26.6 million in the fourth quarter of 2025 compared to $11.8 million in the fourth quarter of 2024, and $62.4 million for the full-year 2025 compared to $37.7 million for the full-year 2024. The increase in expenses in both periods was driven by increased clinical trial activities related to Vafseo and our other product candidates, higher headcount related costs, as well as by a $12.8 million charge incurred during the fourth quarter of 2025 related to acquired in-process R&D costs associated with the acquisition of AKB-097 from Q32 Bio Inc.
•SG&A Expenses: Selling, general and administrative expenses were $26.1 million in the fourth quarter of 2025 compared to $27.7 million in the fourth quarter of 2024, and $107.5 million for the full-year 2025 compared to $106.5 million for the full-year 2024.
•Net Loss: Net loss was $12.2 million in the fourth quarter of 2025 compared to a net loss of $22.8 million in the fourth quarter of 2024. Net loss was $5.3 million for the full-year 2025 compared to $69.4 million for the full-year 2024. The decrease in net loss in both periods was driven by the increase in net product revenues, which was partially offset by higher expenses.

•Cash Position: Cash and cash equivalents as of December 31, 2025, were approximately $184.8 million compared to $51.9 million as of December 31, 2024. Akebia expects its existing cash resources and cash from operations will be sufficient to fund its current operating plan for at least two years.

Conference Call

Akebia will host a conference call on Thursday, February 26, 2026 at 8:00 a.m. EST to discuss fourth quarter and full year 2025 earnings. To access the call, please register by clicking on this Registration Link, and you will be provided with dial in details. To avoid delays and ensure timely connection, we encourage dialing into the conference call 15 minutes ahead of the scheduled start time.

A live webcast of the conference call will be available via the "Investors" section of Akebia’s website at: View Source/." target="_blank" title="View Source/." rel="nofollow">View Source An online archive of the webcast can be accessed via the Investors section of Akebia’s website at View Source approximately two hours after the event.

(Press release, Akebia, FEB 26, 2026, View Source [SID1234663058])

On February 26, 2026 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, reported its financial results for the fourth quarter and full year ended 2025 and provided a corporate update.

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"2025 was a year of strong business execution and continued momentum in each of our potential best-in-class programs and positioned us for an exciting 2026 with important milestones and data readouts expected from each program," stated Dr. Neal Walker, Chief Executive Officer and Chair of the Board of Directors of Aclaris. "2026 started with derisking events for two of our key programs, ITK and ATI-052; this included compelling ATI-052 interim Phase 1a SAD/MAD results showing strong safety and tolerability profiles, robust target engagement reinforcing the potency of the compound even at very low doses, and the opportunity for extended dosing supported by dose proportional pharmacokinetic and pharmacodynamic profiles. Since then, we have initiated two Phase 1b POC trials with ATI-052, with top line results expected from both trials in the second half of this year. With a strong cash position and several meaningful catalysts across our biologics and ITK pipeline expected this year, including top line results from the Phase 2 trial of our anti-TSLP monoclonal antibody bosakitug in AD, we are looking forward to an exciting and productive year."

Fourth Quarter 2025 Highlights and Recent Updates

Pipeline:

Biologics: Antibody Franchise

Provided Positive Interim Results of Phase 1a Single (SAD) and Multiple Ascending Dose (MAD) Trial of Investigational Bispecific Anti-TSLP/IL-4Rα Antibody ATI-052; Complete Top Line Results from SAD and MAD Cohorts Expected in the Second Quarter of 2026: ATI-052 was well tolerated and demonstrated a favorable safety profile across all single and multiple ascending dose cohorts in this Phase 1a trial. Interim results included a dose proportional pharmacokinetic (PK) profile and concentration-dependent pharmacodynamics (PD) validating the potency and specificity of the compound, including robust target engagement and near complete target occupancy even at very low doses. These results support the potential for up to every three months dosing. Additional SAD and MAD results from this trial are expected in the second quarter of 2026. (press release here)
Announced Initiation of Two Phase 1b Proof-of-Concept (POC) Trials of ATI-052: Following positive interim Phase 1a SAD/MAD results, the Company has initiated Phase 1b POC studies in AD and asthma. Top line results from both trials are expected in the second half of 2026. (press releases here and here)
Planning Underway for Phase 2b Program for ATI-052: Planning is ongoing for a Phase 2b program encompassing asthma and AD as potential first indications. The Company expects to initiate this program in the second half of 2026.
Confirmed Expectation of Top Line Results in the Second Half of 2026 from Ongoing Phase 2 Trial of Investigational Anti-TSLP Monoclonal Antibody Bosakitug: This randomized, double-blind, placebo-controlled Phase 2 trial is designed to evaluate bosakitug in approximately 96 patients with moderate-to-severe AD.
Oral Inhibitors: ITK Franchise

Aclaris’ Lead ITK Inhibitor ATI-9494 Advancing Toward Expected Investigational New Drug (IND) Application in the Second Half of 2026: Aclaris’ lead ITK inhibitor candidate ATI-9494 has demonstrated potent blockade of Th1 and Th2 responses, a prolonged half-life, and high potency against ITK, potentially enabling low drug burden, dosing flexibility, and once daily (QD) administration across a broad range of disease indications. Aclaris intends to file an IND for ATI-9494 in the second half of 2026.
ATI-2138, a Potent and Selective Investigational Inhibitor of ITK and JAK3, Demonstrated Rapid and Sustained Hair Regrowth in Validated Murine Model of Severe Alopecia Areata (AA), Further Validating Best-in-Class Potential: ATI-2138 and ritlecitinib were assessed compared to control in a reversal model of murine alopecia universalis, the most severe AA phenotype. ATI-2138 demonstrated potential best-in-class results including rapid, near complete, and sustained hair regrowth compared to control and ritlecitinib including mean hair regrowth of 93% for ATI-2138 at week 6 (end of study) compared to 78% for the same dose of ritlecitinib. Mice receiving control showed no improvement in hair regrowth. The Company is completing the assessment of additional indications that are relevant to the dual pharmacology and mechanism of action, including certain alopecias and other inflammatory disorders. (press release here)
Financial Results

Liquidity and Capital Resources

As of December 31, 2025, Aclaris had cash, cash equivalents and marketable securities of $151.4 million compared to $203.9 million as of December 31, 2024. The Company believes that its cash, cash equivalents and marketable securities will be sufficient to fund its operations into the second half of 2028, without giving effect to any potential business development transactions or financing activities, or trial execution costs associated with its planned Phase 2b program for ATI-052.

Fourth Quarter and Full Year 2025

Net loss was $19.8 million for the fourth quarter of 2025 compared to $96.6 million for the fourth quarter of 2024. Net loss was $64.9 million for the year ended December 31, 2025 compared to $132.1 million for the year ended December 31, 2024.

Total revenue was $1.3 million for the fourth quarter of 2025 compared to $9.2 million for the fourth quarter of 2024. The decrease was primarily driven by the achievement of a commercial milestone under the license agreement with Eli Lilly and Company in the fourth quarter of 2024. Total revenue was $7.8 million for the year ended December 31, 2025 compared to $18.7 million for the year ended December 31, 2024.

Research and development (R&D) expenses were $16.6 million for the quarter ended December 31, 2025 compared to $9.0 million for the prior year period. The increase was primarily due to higher product candidate manufacturing costs and preclinical and clinical development expenses for bosakitug and ATI-052, and preclinical development expenses for ATI-9494. For the year ended December 31, 2025, R&D expenses were $52.6 million compared to $33.6 million for the year ended December 31, 2024.

General and administrative (G&A) expenses were $5.6 million for the quarter ended December 31, 2025 compared to $5.0 million for the prior year period. The increase was primarily due to higher compensation-related expenses and legal expenses. For the year ended December 31, 2025, G&A expenses were $22.0 million compared to $22.2 million for the year ended December 31, 2024.

Licensing expenses were $0.9 million for the quarter ended December 31, 2025 compared to $8.6 million for the prior year period. The decrease was primarily due to a milestone achieved during the fourth quarter of 2024, the entirety of which was payable to a third party. For the year ended December 31, 2025, licensing expenses were $5.2 million compared to $12.7 million for the year ended December 31, 2024.

Revaluation of contingent consideration resulted in a $0.4 million charge for the quarter ended December 31, 2025 compared to a $1.3 million gain for the prior year period. For the year ended December 31, 2025, revaluation of contingent consideration resulted in a charge of $2.3 million compared to a $2.5 million charge for the year ended December 31, 2024.

During the quarter and year ended December 31, 2024, the Company recorded $86.9 million of in-process research and development expenses, representing the fair value of consideration expensed in connection with the in-license of bosakitug (ATI-045) and ATI-052, as well as transaction costs incurred.

(Press release, Aclaris Therapeutics, FEB 26, 2026, View Source [SID1234663057])

On February 26, 2026 The European Organisation for Research and Treatment of Cancer (EORTC) reported that it has activated the first site for the EORTC-2361-GUCG RENALUT clinical trial. This phase II, single-arm, multicentre study investigates the potential of Pluvicto (177Lu]Lu‑PSMA‑617) as a new treatment option for patients with metastatic clear cell renal cell carcinoma (ccRCC) who have progressed after one or two previous systemic therapies.

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About ccRCC
Clear cell renal cell carcinoma is the most common subtype of kidney cancer and is often driven by mutations in the Von Hippel-Lindau (VHL) gene, contributing to the tumours highly vascular nature. Most patients today receive combinations or sequences of immunotherapy and targeted therapies, such as VEGFR tyrosine kinase inhibitors. However, after progression on these regimens, options are limited. This highlights the need for new therapeutic strategies for patients in later lines of treatment.

About the RENALUT study
The RENALUT trial explores a novel therapeutic approach for metastatic ccRCC by leveraging radioligand therapy (RLT) targeting PSMA (prostate-specific membrane antigen). Although PSMA is best known for its role in prostate cancer, it is also expressed in the tumour neovasculature of ccRCC, making it a promising therapeutic target1. PSMA‑targeted imaging has shown strong performance in identifying metastatic ccRCC, supporting the idea that PSMA‑directed therapy with [177Lu]Lu‑PSMA‑617 may also be an effective treatment for this disease2,3. By building on the established use of [177Lu]Lu‑PSMA‑617 in metastatic castration resistant prostate cancer, RENALUT aims to determine whether this approach can benefit ccRCC patients who have exhausted standard treatments and currently face very limited options.

Participating sites and collaboration
The activation of the first site marks a significant milestone for this innovative trial, which will involve 11 centres across Europe. The study is led by EORTC’s Genito-Urinary Cancer Group (GUCG) and supported by a network of international collaborators.

By exploring PSMA-targeted RLT in ccRCC, RENALUT aims to address an urgent unmet need and pave the way for future treatment strategies in kidney cancer.

(Press release, EORTC, FEB 26, 2026, View Source [SID1234663053])