ITM to Announce Phase 3 COMPETE Trial Post-Hoc Subgroup Analysis in Pancreatic Neuroendocrine Tumors and Host Satellite Symposium at ENETS 2026

On February 25, 2026 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, reported that it will provide further exploratory and post-hoc subgroup analysis data focusing on Pancreatic Neuroendocrine Tumors from its Phase 3 COMPETE trial in an oral presentation at the 23nd Annual European Neuroendocrine Tumor Society (ENETS) Conference, held from March 4 – March 6, 2026 in Kraków, Poland. The company will also host a conference booth (#6) and an interactive symposium on March 5, 2026, bringing together leading experts in radiopharmaceutical oncology to share their perspectives on key challenges and emerging clinical approaches for the treatment of neuroendocrine tumors (NETs).

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!

Oral Presentation Details
Title: 177Lu-edotreotide for the Treatment of Pancreatic Neuroendocrine Tumours: A Subgroup Analysis from the COMPETE Study
Presentation ID: D54
Session: Clinical science | Session 2B: Abstract session
Date and Time: Thursday, March 5, 11:50–11:57 AM (CET)
Location: Theatre Hall S2, ICE Kraków Congress Centre
Presenter: Prof. Dr. Thomas Walter, Medical Oncologist, Lyon, France

Satellite Symposium Details
Title: Vote and Learn: Radiopharmaceutical Therapy in NETs
Date and Time: Thursday, March 5, 07:45–08:45 AM (CET)
Location: Theatre Hall S2, ICE Kraków Congress Centre
Presenters: Dr. Francesca Spada, Medical Oncologist, Milano, Italy; Prof. Christophe Deroose, Nuclear Medicine Physician, Leuven, Belgium; Prof. Simron Singh, Medical Oncologist, Toronto, Canada

About the COMPETE Trial
The COMPETE trial (NCT03049189) evaluated 177Lu-edotreotide (ITM-11), a proprietary, synthetic, targeted radiotherapeutic investigational agent compared to everolimus, a targeted molecular therapy, in patients with inoperable, progressive Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This trial met its primary endpoint, with 177Lu-edotreotide demonstrating clinically and statistically significant improvement in progression-free survival (PFS) compared to everolimus. 177Lu-edotreotide is an investigational product pending review by the U.S. Food and Drug Administration (FDA) and is not approved by any regulatory authority for the safety and/or efficacy of any intended use. It is also being evaluated in COMPOSE, a Phase 3 study in patients with well-differentiated, aggressive Grade 2 or Grade 3, somatostatin receptor (SSTR)-positive GEP-NET tumors.

(Press release, ITM Isotopen Technologien Munchen, FEB 25, 2026, View Source [SID1234663021])

Financial report for the half year ended 31 December 2025

On February 25, 2026 Imugene reported financial report for the half year ended December 2025.

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!

(Press release, Imugene, FEB 25, 2026, View Source [SID1234669283])

Alkermes plc Reports Financial Results for the Fourth Quarter and Year Ended Dec. 31, 2025 and Provides Financial Expectations for 2026

On February 25, 2026 Alkermes plc (Nasdaq: ALKS) reported financial results for the quarter and year ended Dec. 31, 2025 and provided financial expectations for 2026. To view the detailed fourth quarter and full year 2025 earnings press release and presentation please visit the company’s investor relations website at View Source

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!

Alkermes will host a conference call and webcast presentation at 8:00 a.m. EST (1:00 p.m. GMT) today, to discuss these financial results and expectations and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes’ website at View Source The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call may be accessed by visiting Alkermes’ website.

(Press release, Alkermes, FEB 25, 2026, View Source [SID1234662983])

Xencor Reports Fourth Quarter and Full Year 2025 Financial Results

On February 25, 2026 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and autoimmune diseases, reported financial results for the fourth quarter and full year ended December 31, 2025.

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!

"Xencor’s lead oncology drug candidate is XmAb819, a novel first-in-class T-cell engager that could offer a much-needed new therapeutic modality for patients with advanced clear cell renal cell carcinoma (ccRCC). Excitement from the clinical community on our initial data from the dose-escalation study presented during ENA 2025 supports achieving our goal of presenting dose-expansion data during a medical meeting in the second half of 2026 and our plans to initiate a pivotal study during 2027," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "Building on the early success in ccRCC, we recently opened additional dose expansion cohorts in other tumor types that have high ENPP3 expression: colorectal cancer, non-small cell lung cancer and papillary renal cell carcinoma."

"In 2026, we plan to present additional key clinical data and progress updates as we also advance XmAb541 and our ongoing B-cell depleting autoimmune programs, respectively. Our TL1A pipeline in inflammatory bowel disease continues to advance, as well. We are making great progress with enrollment in our Phase 2b XENITH-UC study of XmAb942 and are excited to begin the first-in-human study of XmAb412, our novel TL1A x IL23p19 bispecific antibody in the second half of 2026. We are proud of our execution across an evolved clinical pipeline and of the Xencor team’s focus on designing proteins to deliver novel medicines for patients."

Wholly Owned Pipeline Overview

XmAb819 (ENPP3 x CD3), a first-in-class, tumor-targeted T-cell engaging XmAb 2+1 bispecific antibody in development for patients with advanced clear cell renal cell carcinoma (ccRCC). The dose-expansion portion of the ongoing Phase 1 study is enrolling patients and dose-optimization continues. Tumor expansion cohorts in colorectal cancer (CRC), non-small cell lung cancer (NSCLC) and papillary renal cell carcinoma (pRCC) are now open to enrollment. Xencor plans to present new clinical data to support a recommended Phase 3 dose in 2H26 and initiate a pivotal study of XmAb819 in ccRCC during 2027.

XmAb541 (CLDN6 x CD3), a first-in-class, tumor-targeted T-cell engaging XmAb 2+1 bispecific antibody in Phase 1 clinical development for patients with advanced gynecologic and germ cell tumors. Xencor plans to present new clinical data to support a recommended Phase 3 dose in 2H26 and evaluate plans for a pivotal study of XmAb541 during 2027.
XmAb942 (Xtend anti-TL1A), a potential best-in-class, high-potency, extended half-life antibody in development for patients with inflammatory bowel disease. Xencor is conducting the global XENITH-UC Study, a Phase 2b study of XmAb942 in ulcerative colitis (UC). XENITH-UC is a randomized, double-blind, placebo-controlled trial in patients with moderate-to-severe UC, whose disease has progressed after at least one conventional or advanced therapy. Xencor is on-track to present final results from the Phase 1 study of XmAb942 in healthy volunteers in a poster titled "XmAb942, a Potential Best-in-class, Long-acting Anti-TL1A Antibody for the Treatment of Inflammatory Bowel Disease: Phase 1 Final Results" at Digestive Disease Week (DDW), being held May 2-5, 2026 in Chicago and online, and to provide an update on progress achieved in the XENITH-UC study around year-end 2026.

XmAb412 (TL1A x IL23p19), a bispecific antibody for dual targeting of important inflammatory pathways in autoimmune and inflammatory disease, while avoiding the complexities of dosing and formulary access for two separate TL1A and IL23 targeted drugs. Xencor is on track to present the preclinical characterization of XmAb412 in a poster titled "Discovery and Characterization of XmAb412: A Novel, High-Affinity, Anti-TL1A x Anti-IL23 Native-like Bispecific Antibody With Extended Half-life for the Treatment of Inflammatory Bowel Disease" at DDW in May 2026 and to initiate a first-in-human study of XmAb412 in 2H26.
Plamotamab (CD20 x CD3), a clinical-stage, B-cell depleting bispecific T-cell engager in Phase 1 development for patients with rheumatoid arthritis (RA), who have progressed through prior standard-of-care treatment. Xencor plans to provide an update on progress achieved in the Phase 1b study of plamotamab in RA in 2H26.
XmAb657 (CD19 x CD3), a clinical-stage, potent, extended half-life B-cell depleting bispecific T-cell engager in Phase 1 development for patients with idiopathic inflammatory myopathies (IIM). Xencor plans to provide an update on progress achieved in the Phase 1 study of XmAb657 in 2H26.

XmAb808 (B7-H3 x CD28), a bispecific antibody designed to provide conditional co-stimulation of T cells when also bound to tumor cells. Xencor plans to present a poster characterizing preclinical combinations of XmAb808 with multiple CD3 T cell engaging bispecific antibodies at a medical meeting in 1H26.
Xtend U.S. Patent Term Extension: In December 2025, Xencor announced the issuance of U.S. Patent 12,492,253, which covers Xencor’s Xtend Fc domain for extending the half-life of antibodies targeting C5, with a term that extends into December 2028. Xencor anticipates receiving low-single digit royalties on net sales of Ultomiris (ravulizumab-cwvz), an anti-C5 antibody engineered with a licensed Xtend Fc domain, into December 2028 in the United States. Ultomiris is a drug being developed and commercialized by Alexion Pharmaceuticals, Inc., and is a registered trademark of Alexion. Xencor previously secured regulatory extensions of exclusivity in several EU countries, Japan and Australia. Based upon consensus sales forecasts, Xencor estimates recognizing potential royalty revenue in excess of the caps under its royalty agreement with OMERS in the range of $100 million to $120 million in aggregate for the extended patent term through 2028.

Financial Guidance: Based on current operating plans, Xencor expects to end 2026 with between $400 million and $430 million in cash, cash equivalents and marketable debt securities, and to have sufficient cash resources to fund research and development programs and operations through 2028.

Financial Results for the Fourth Quarter and Full Year Ended December 31, 2025

Cash, cash equivalents, and marketable debt securities totaled $610.8 million as of December 31, 2025 compared to $706.7 million as of December 31, 2024.

Total revenue for the fourth quarter ended December 31, 2025 was $28.2 million compared to $52.8 million for the same period in 2024. Revenue for the full year ended December 31, 2025 was $125.6 million compared to $110.5 million for the same period in 2024. The increase in revenue in 2025 compared to 2024 was primarily driven by revenue recognition associated with Alexion and Incyte license agreements.

Research and development (R&D) expenses for the fourth quarter ended December 31, 2025 were $64.8 million compared to $51.1 million for the same period in 2024. R&D expenses for the full year ended December 31, 2025 were $239.4 million compared to $227.7 million for the same period in 2024. Increased R&D expenses in 2025 compared to 2024 were primarily driven by higher external and internal costs associated with pipeline programs, partially offset by lower stock-based compensation expense.

General and administrative (G&A) expenses for the fourth quarter ended December 31, 2025 were $17.0 million compared to $14.9 million for the same period in 2024. G&A expenses for the full year ended December 31, 2025 were $63.6 million compared to $61.2 million for the same period in 2024. G&A expenses in 2025 compared to 2024 remained relatively consistent.

Other income, net for the fourth quarter ended December 31, 2025 was $49.4 million compared to other expense, net of $31.4 million for the same period in 2024. Other income, net for the full year ended December 31, 2025 was $87.9 million compared to other expense, net of $56.5 million in the same period in 2024. Other income, net, in 2025 compared to other expense, net, in 2024 was primarily driven by a combination of realized and unrealized gains from marketable equity securities.

Net loss attributable to Xencor for the fourth quarter ended December 31, 2025 was $6.7 million or $(0.09) on a fully diluted per share basis compared to net loss of $45.6 million or $(0.62) on a fully diluted per share basis, for the same period in 2024. For the full year ended December 31, 2025 net loss attributable to Xencor was $91.9 million or $(1.24) on a fully diluted per share basis compared to net loss of $232.6 million or $(3.58) on a fully diluted per share basis, for the same period in 2024.

About Digestive Disease Week

Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers, and academics in the fields of gastroenterology, hepatology, endoscopy, and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting.

Digestive Disease Week is a registered trademark of DDW, LLC.

(Press release, Xencor, FEB 25, 2026, View Source [SID1234663001])

InnoCare Announces Key Developments of Critical Clinical Studies

On February 25, 2026 InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported key clinical development progress, including the completion of patient enrollment of multiple Phase III registrational trials.

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!

The Company completed patient enrollment of a Phase III registrational clinical trial of BCL2 inhibitor mesutoclax (ICP-248) in combination with BTK inhibitor orelabrutinib for treatment-naïve chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients.

Mesutoclax is a novel, highly selective oral BCL2 inhibitor. BCL2 is an important regulatory protein in the apoptosis pathway, and its abnormal expression is associated with the development of various hematologic malignancies. Mesutoclax exerts anti-tumor activity by selectively inhibiting BCL2 and restoring the normal apoptosis process in cancer cells. The fixed-duration treatment of mesutoclax in combination with orelabrutinib will provide deeper remission for treatment-naïve CLL/SLL patients without drug-resistant mutations, bringing hope of clinical cure to treatment-naïve CLL/SLL patients.

In addition, InnoCare also accelerated the clinical development of two novel TYK2 inhibitors. The company has completed patient enrollment in the Phase III registrational trial of soficitinib (ICP-332) for the moderate to severe atopic dermatitis (AD) and in the Phase III registrational trial of ICP-488 for the treatment of psoriasis recently.

These important milestones mark a crucial step forward in addressing the huge unmet needs in AD with soficitinib and in psoriasis with ICP-488.

Meanwhile, InnoCare has also completed patient enrollment in the Phase II clinical trial of soficitinib for the treatment of vitiligo.

Soficitinib is a potent and selective TYK2 inhibitor that is being developed for the treatment of various T-cell related autoimmune disorders. The current indications under development are strategically positioned within the vast dermatology market, including AD, vitiligo, prurigo nodularis, CSU, and psoriasis.

ICP-488 is an oral, potent, and selective TYK2 allosteric inhibitor. By binding to the JH2 domain, ICP-488 blocks the signal transduction pathways of IL-23, IL-12, type 1 IFN, and other inflammatory cytokines, thereby inhibiting the pathological processes of autoimmune and inflammatory diseases.

(Press release, InnoCare Pharma, FEB 25, 2026, View Source [SID1234663022])