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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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])

On February 26, 2026 GENFIT (Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, reported its fourth quarter 2025 revenues and cash position results1 and provides a corporate update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

I. Cash position

As of December 31, 2025, the Company’s cash and cash equivalents amounted to €101.1 million compared with €81.8 million as of December 31, 2024 and €119.0 million as of September 30, 2025.

In 2025, cash utilization is mainly the result of our research and development efforts in our Acute on-Chronic Liver Failure (ACLF) franchise (notably VS-01, NTZ/G1090N, SRT-015, CLM-022, and VS-02 HE), as well as GNS561 in cholangiocarcinoma (CCA). Cash utilization is offset notably by the €26.55 million milestone received in July 2025 (invoiced in May 2025) upon pricing and reimbursement approval of Iqirvo (elafibranor) in Italy, the third major European country to do so, as part of our long-term strategic partnership with Ipsen (the "Ipsen Agreement") signed in December 2021.

In January 2026, GENFIT exercised its option to receive (and did in fact receive) the second installment of the Royalty Financing agreement totaling €30.0 million. Both this amount, as well as the first commercial milestone of €17.0 million ($20.0 million) that GENFIT will receive as part of the Ipsen Agreement, are not included in cash and cash equivalents as of December 31, 2025.

We expect that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements beyond the end of 2028, enabling the Company to further develop its R&D pipeline focused on ACLF and support general corporate purposes. This is based on current assumptions and programs and does not include exceptional events. This estimation assumes (i) our expectation to receive significant future commercial milestone revenue pursuant to the Ipsen Agreement and Ipsen meeting its sales-based thresholds and (ii) drawing down the third and final, optional installment under the Royalty Financing agreement.

Revenue
Revenues for 2025 amounted to €65.4 million compared to €67.0 million for the same period in 2024.

Revenue Year ended
(in € millions) 31/12/2024 31/12/2025
Royalty revenue 2.7 21.8
Milestone revenue 48.7 43.6
Revenue initially deferred from the Licensing Agreement (Ipsen) 15.3 -
Revenue from the Part B Transition Services Agreement (Ipsen) 0.1 -
Other revenue 0.2 -
TOTAL 67.0 65.4
Royalty revenue is entirely attributable to worldwide sales of Iqirvo (elafibranor), which amounted to $208 million in 2025.

Milestone revenue in 2025 is comprised of two milestones:

GENFIT’s first commercial milestone of €17.0 million ($20.0 million) after Ipsen’s Iqirvo exceeded the $200 million threshold in its first full year of net sales, and
GENFIT’s milestone of €26.55 million upon pricing and reimbursement approval of Iqirvo (elafibranor) in Italy, the third major European country to do so.
II. Corporate update and program highlights

Acute On-Chronic Liver Failure (ACLF)

The key highlight for this pipeline segment in the fourth quarter 2025 was the progress of our lead program, G1090N, which generated preliminary Phase 1 data readout showing a safety profile and a robust anti-Inflammatory activity evidenced through functional ex vivo assays on blood samples from study participants and cirrhotic donors. As communicated earlier, GENFIT will engage with regulatory authorities to determine the best approach for progressing to a Phase 2 proof-of-concept in inflammatory conditions such as ACLF, where systemic immune dysregulation is a critical driver of disease progression.

Other assets developed to address the unmet medical need in ACLF continued their preclinical evaluation during the fourth quarter of 2025 to fully assess their potential before advancing into clinical development.

Cholangiocarcinoma (CCA)

The main highlight in this indication in the fourth quarter of 2025 was the highly encouraging early data delivered from the ongoing Phase 1b study evaluating investigational drug GNS561 with a MEK inhibitor (MEKi) in KRAS mutated CCA, positioning this novel combination as a potential new therapeutic approach for difficult-to-treat cancers. Phase 1b dose escalation continues as planned to confirm the activity signal, with new data for next patient cohorts and recommended Phase 2 combination doses expected in the first half of 2026. Phase 2 initiation remains targeted for the second half of 2026.

Ipsen’s Iqirvo (elafibranor) in Primary Biliary Cholangitis (PBC) and Primary Sclerosing Cholangitis (PSC)

PBC: Iqirvo’s net sales for the fourth quarter 2025 amounted to $88 million, bringing full-year 2025 sales to $208 million, triggering the first commercial milestone payment to GENFIT one year ahead of schedule.

PSC: Ipsen confirmed the initiation of the first and only global Phase 3 clinical trial, addressing a significant unmet medical need, as no approved therapies currently exist for this severe and progressive disease. PSC represents a substantial untapped market opportunity, comparable in size to second line PBC. Should Iqirvo ultimately receive regulatory approval for this indication, GENFIT would be eligible for additional milestone payments as well as additional double‑digit royalties.

(Press release, Genfit, FEB 26, 2026, https://ir.genfit.com/news-releases/news-release-details/genfit-reports-fourth-quarter-2025-financial-information-and [SID1234663075])

On February 26, 2026 TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, reported completion of enrollment into Cohort C of the ALLOHA study. Patients in Cohort C are being treated using the new commercial-ready manufacturing process. The Company also announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) applications for TSC-102-A01 and TSC-102-A03 for patients with HLA types A*01:01 and A*03:01, respectively.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are excited about the potential of TSC-101 to treat residual disease and prevent relapse in patients undergoing hematopoietic cell transplantation," said Gavin MacBeath, Ph.D., Chief Executive Officer. "We have now enrolled over ten patients in Cohort C of the ALLOHA study where we are treating patients with our new commercial-ready manufacturing process. We look forward to sharing data from this cohort in the second quarter of this year, prior to launching our Phase 3 study. We are also pleased to announce that the FDA has cleared our IND applications for TSC-102-A01 and TSC-102-A03, and we look forward to initiating a Phase 1 trial with these candidates in the second half of this year. We believe the addition of these product candidates will nearly double the addressable U.S. patient population in our heme program."

"During the Tandem Meetings of ASTCT and CIBMTR, we highlighted the relationship between donor chimerism and long-term outcomes in patients following HCT," added Chrystal U. Louis, M.D., Chief Medical Officer. "Specifically, patients that achieved complete donor chimerism by month two after transplant using a high-sensitivity assay have a significantly lower probability of relapse (HR=4.6, p=0.02) compared to those who did not achieve complete donor chimerism. We look forward to sharing early chimerism data from Cohort C and formally initiating our pivotal study for TSC-101."

The Phase 1 ALLOHA study is evaluating TSC-101 in A*02:01-positive patients with heme malignancies undergoing allogeneic hematopoietic cell transplantation (allo-HCT). TScan plans to share safety and early chimerism data from Cohort C in the second quarter of 2026. The Company also plans to launch a pivotal trial for TSC-101 in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) in the second quarter of 2026.

The U.S. FDA clearance of INDs for TSC-102-A01 and TSC-102-A03 continues the momentum in TScan’s heme program by expanding HLA coverage to include patients who are HLA-A*01:01-positive or HLA-A*03:01-positive, respectively. These TCR-T therapy candidates target CD45, a protein broadly expressed in heme cells but absent in non-heme tissues.

TScan plans to initiate a Phase 1 trial for both TSC-102-A01 and TSC-102-A03 in the second half of 2026. Products will be manufactured using the commercial-ready process and will enroll patients with various hematologic malignancies undergoing allo-HCT using either reduced intensity conditioning or myeloablative conditioning. The multi-center Phase 1 trial is designed to assess safety and initial efficacy of these TCR-T therapy candidates.

(Press release, TScan Therapeutics, FEB 26, 2026, View Source [SID1234663107])

On February 26, 2026 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported its attendance and presentations at upcoming investor conferences.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Molecular Partners will also issue its full-year 2025 financial report, along with its Annual Report, on March 12, 2026.

Details of the events:

TD Cowen 46th Annual Health Care Conference
Boston, MA, March 2-4, 2026
Molecular Partners CEO Patrick Amstutz will take part in a fireside chat on Monday, March 2 at 2.30-3.00 pm ET (8.30-9.00 pm CET).

Leerink Partners Global Healthcare Conference 2026
Miami, FL, March 9-11 March, 2026
Molecular Partners CEO Patrick Amstutz will take part in a fireside chat on Monday, March 9 at 4.20-4.50 pm EDT (9.20-9.50 pm CET).

Full Year 2025 Financial Results Announcement
Thursday, March 12, 2026 at 4.00 pm EDT (9.00 pm CET).

Both fireside chats will be made available on the Company’s website under the investor section.

(Press release, Molecular Partners, FEB 26, 2026, View Source [SID1234663010])

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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])