On February 23, 2026 Bristol Myers Squibb (NYSE: BMY) reported positive top-line results from the ongoing, ex-US, Phase 2 registrational study (NCT05664737) evaluating Reblozyl (luspatercept-aamt) versus placebo for anemia in adults with Alpha (α)-Thalassemia.

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The non‑transfusion‑dependent (NTD) and transfusion‑dependent (TD) cohorts of the study met their respective primary endpoints, with Reblozyl demonstrating a statistically significant and clinically meaningful increase in hemoglobin levels in NTD patients with α‑thalassemia, and a statistically significant and clinically meaningful decrease in red blood cell (RBC) transfusion burden in TD patients with α‑thalassemia. The study also met all key secondary endpoints. Safety findings were consistent with the known profile of Reblozyl in thalassemia.

"These positive data further support the potential of Reblozyl for patients around the world," said Cristian Massacesi, Executive Vice President, Chief Medical Officer and Head of Development, Bristol Myers Squibb. "This is the first and only registrational Phase 2 trial specifically designed to address the needs of patients, especially in China, with alpha-Thalassemia, a lifelong disease with limited treatment options and the potential for serious long‑term complications."

The data will be presented at an upcoming medical congress and will be discussed with the Center for Drug Evaluation in China.

About the Study (NCT05664737)

The Phase 2 trial is evaluating the efficacy and safety of luspatercept plus best supportive care versus placebo for anemia in adults and adolescents with α-thalassemia, including both red blood cell (RBC) transfusion-dependent (TD) and non-transfusion-dependent (NTD) cohorts. The primary endpoint of the NTD cohort measures an increase from baseline of ≥ 1 grams (g)/deciliter (dL) in mean hemoglobin (Hb) values over the continuous 12-week interval from Week 13 to Week 24 in the absence of RBC transfusion. The primary endpoint of the TD cohort measures ≥ 50% reduction from baseline in RBC transfusion burden with a reduction of at least 2 units during any continuous 12 weeks during Week 13-48 compared to 12-week interval immediately prior to date of first dose. The adolescent NTD and TD cohorts are ongoing.

About Reblozyl

Reblozyl, a first-in-class therapeutic option, promotes late-stage red blood cell maturation in animal models. Reblozyl is being developed and commercialized through a global collaboration with Merck as of November 2021. Reblozyl is indicated in the U.S. for the treatment of:

anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions, and
anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions.
anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndrome with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).
Reblozyl is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia. In the U.S., Reblozyl is not indicated for use in patients with non-transfusion-dependent beta thalassemia.

Important Safety Information

WARNINGS AND PRECAUTIONS

Thrombosis/Thromboembolism

In adult patients with beta thalassemia, thromboembolic events (TEE) were reported in 8/223 (3.6%) of REBLOZYL-treated patients. TEEs included deep vein thrombosis, pulmonary embolus, portal vein thrombosis, and ischemic stroke. All patients with TEE were splenectomized and had at least 1 other risk factor for developing TEE, such as a history of thrombocytosis or concomitant use of hormone-replacement therapy. The occurrence of TEE was not correlated with elevated hemoglobin levels. Patients with known risk factors for thromboembolism (splenectomy or concomitant use of hormone replacement therapy) may be at further increased risk of thromboembolic conditions. Consider thromboprophylaxis in patients at increased risk of TEE. Monitor patients for signs and symptoms of thromboembolic events and institute treatment promptly.

Hypertension

Hypertension was reported in 11.4% (63/554) of REBLOZYL-treated patients. Across clinical studies, the incidence of Grade 3 to 4 hypertension ranged from 2% to 9.6%. In patients with beta thalassemia with normal baseline blood pressure, 13 (6.2%) patients developed systolic blood pressure (SBP) ≥130 mm Hg and 33 (16.6%) patients developed diastolic blood pressure (DBP) ≥80 mm Hg. In ESA-refractory or -intolerant adult patients with MDS with normal baseline blood pressure, 26 (30%) patients developed SBP ≥130 mm Hg and 23 (16%) patients developed DBP ≥80 mm Hg. In ESA-naïve adult patients with MDS with normal baseline blood pressure, 23 (36%) patients developed SBP ≥140 mm Hg and 11 (6%) patients developed DBP ≥80 mm Hg. Monitor blood pressure prior to each administration. Manage new or exacerbations of preexisting hypertension using anti-hypertensive agents.

Extramedullary Hematopoietic (EMH) Masses

In adult patients with transfusion-dependent beta thalassemia, EMH masses were observed in 3.2% of REBLOZYL-treated patients, with spinal cord compression symptoms due to EMH masses occurring in 1.9% of patients (BELIEVE and REBLOZYL long-term follow-up study).

In a study of adult patients with non-transfusion-dependent beta thalassemia, a higher incidence of EMH masses was observed in 6.3% of REBLOZYL-treated patients vs. 2% of placebo-treated patients in the double-blind phase of the study, with spinal cord compression due to EMH masses occurring in 1 patient with a prior history of EMH. REBLOZYL is not indicated for use in patients with non-transfusion-dependent beta thalassemia.

Possible risk factors for the development of EMH masses in patients with beta thalassemia include history of EMH masses, splenectomy, splenomegaly, hepatomegaly, or low baseline hemoglobin (<8.5 g/dL). Signs and symptoms may vary depending on the anatomical location. Monitor patients with beta thalassemia at initiation and during treatment for symptoms and signs or complications resulting from the EMH masses and treat according to clinical guidelines. Discontinue treatment with REBLOZYL in case of serious complications due to EMH masses. Avoid use of REBLOZYL in patients requiring treatment to control the growth of EMH masses.

Embryo-Fetal Toxicity

REBLOZYL may cause fetal harm when administered to a pregnant woman. REBLOZYL caused increased post-implantation loss, decreased litter size, and an increased incidence of skeletal variations in pregnant rat and rabbit studies. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 3 months after the final dose.

ADVERSE REACTIONS

Beta-Thalassemia

Serious adverse reactions occurred in 3.6% of patients on REBLOZYL. Serious adverse reactions occurring in 1% of patients included cerebrovascular accident and deep vein thrombosis. A fatal adverse reaction occurred in 1 patient treated with REBLOZYL who died due to an unconfirmed case of acute myeloid leukemia (AML).

Most common adverse reactions (at least 10% for REBLOZYL and 1% more than placebo) were headache (26% vs 24%), bone pain (20% vs 8%), arthralgia (19% vs 12%), fatigue (14% vs 13%), cough (14% vs 11%), abdominal pain (14% vs 12%), diarrhea (12% vs 10%) and dizziness (11% vs 5%).

ESA-naïve adult patients with Myelodysplastic Syndromes

Grade ≥3 (≥2%) adverse reactions included hypertension and dyspnea. The most common (≥10%) all-grade adverse reactions included diarrhea, fatigue, hypertension, peripheral edema, nausea, and dyspnea.

ESA-refractory or -intolerant adult patients with Myelodysplastic Syndromes

Grade ≥3 (≥2%) adverse reactions included fatigue, hypertension, syncope and musculoskeletal pain. A fatal adverse reaction occurred in 5 (2.1%) patients. The most common (≥10%) adverse reactions included fatigue, musculoskeletal pain, dizziness, diarrhea, nausea, hypersensitivity reactions, hypertension, headache, upper respiratory tract infection, bronchitis, and urinary tract infection.

LACTATION

It is not known whether REBLOZYL is excreted into human milk or absorbed systemically after ingestion by a nursing infant. REBLOZYL was detected in milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Because many drugs are excreted in human milk, and because of the unknown effects of REBLOZYL in infants, a decision should be made whether to discontinue nursing or to discontinue treatment. Because of the potential for serious adverse reactions in the breastfed child, breastfeeding is not recommended during treatment and for 3 months after the last dose.

DRUG ABUSE POTENTIAL

Abuse: Abuse of REBLOZYL may be seen in athletes for the effects on erythropoiesis. Misuse of drugs that increase erythropoiesis, such as REBLOZYL, by healthy persons may lead to polycythemia, which may be associated with life-threatening cardiovascular complications.

Please see accompanying U.S. Full Prescribing Information for REBLOZYL.

(Press release, Bristol-Myers Squibb, FEB 23, 2026, View Source;Thalassemia/default.aspx [SID1234662846])

On February 23, 2026 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that management will participate in the following March investor conferences:

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TD Cowen 46th Annual Health Care Conference
Date:
Fireside chat:
Place:
Webcast Link:
Monday, March 2, 2026
2:30 p.m. ET
Boston Marriott Copley Place, Boston, Mass.
Here

Jefferies Biotech on the Beach Summit
Date:
Place: Tuesday, March 10, 2026
1 Hotel South Beach, Miami Beach, Fla.

Barclays 28th Annual Global Healthcare Conference
Date:
Fireside chat:
Place:
Webcast Link: Wednesday, March 11, 2026
2:00 p.m. ET
Loews Miami Beach, Miami Beach, Fla.
Here

Investors interested in arranging a meeting with the Company’s management during these conferences should contact the respective conference coordinators.

A live audio webcast of the TD Cowen and Barclays Conference presentations can also be accessed on the Events & Presentations section of the Supernus Pharmaceuticals website at www.supernus.com. Archived replays of these webcasts will be available for 60 days on the Company’s website following the conference.

(Press release, Supernus, FEB 23, 2026, View Source [SID1234662862])

On February 23, 2026 Flatiron Health reported its presence at the American Society of Genitourinary Cancers Symposium happening from February 26-28, 2026, in San Francisco, California. Flatiron’s real-world data and research capabilities are featured across multiple presentations, including 6 research acceptances spanning genitourinary cancers.

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A cornerstone of Flatiron’s presence at ASCO (Free ASCO Whitepaper) GU 2026 is the global prostate cancer and bladder cancer Panoramic datasets, which draw from over 420,000 relevant longitudinal patient records in Flatiron’s network. These prostate datasets specifically unlock high-quality, source-level unstructured and structured EHR data across Germany, the UK, and the US. Built on a common data model across all regions, these datasets enable unprecedented interoperability—allowing researchers to seamlessly analyze patient outcomes and treatment patterns across markets to inform global evidence strategies.

"Recent advancements have fundamentally transformed treatment options for genitourinary cancers, but our research reveals a critical gap: too many patients—particularly those with platinum-ineligibility, non-BRCA mutations, or comorbidities—are not benefiting from these breakthroughs," said Emily Castellanos, MD, MPH, Senior Medical Director and Head of Research Oncology at Flatiron Health. "Our ASCO (Free ASCO Whitepaper) GU research, spanning disease states, biomarker status, and treatment types, illuminates how to translate innovation into practice. By capturing this real-world complexity at scale through our Panoramic Database, we’re generating the evidence needed to guide clinicians in a rapidly evolving treatment landscape—enabling them to deliver personalized medicine to any patient that is in front of them."

Research highlights include:

A study demonstrating the need for broader genetic testing and more equitable access to PARP inhibitors for all patients with DNA repair mutations, not just BRCAm carriers, to improve outcomes in advanced prostate cancer
A study suggesting that selected cisplatin-ineligible patients with muscle-invasive bladder cancer may benefit from chemotherapy despite medical limitations
A study revealing a critical need for more effective therapy options following Lu177, a treatment recently approved for metastatic castration-resistant prostate cancer
Join Flatiron Health at booth #26 Follow Flatiron Health on X and LinkedIn for more updates from #ASCOGU26.

Abstracts and Poster Presentations
Beyond BRCA: Real-world outcomes with poly(ADP-ribose) polymerase inhibitors among patients with metastatic castration-resistant prostate cancer and homologous recombination repair mutations
Eunice A. Hankinson, Brendan T. Kerr, Patrick Ward, Khilna Patel, Samantha Reiss, Aaron Dolor, Michael Curry, Emily Castellanos
Abstract Number: 89
Poster Board Number: B22
Session Title: Poster Session A: Prostate Cancer
Date and Time: February 26, 2026, 11:30 AM-12:45 PM; 5:45 PM-6:45 PM (PST)

Persistent gaps in BRCA mutation testing among mCRPC patients: Insights from US cancer practices (2018–2024)
Rana R. McKay, Weiyan Li, James Roose, Brendan T. Kerr, Smriti Karwa, Chinelo Orji, Nina Yeh, Theresa Cain, Jean H.E. Yong, Kumar Mukherjee
Author Affiliations: University of California San Diego, AstraZeneca, Merck & Co, Flatiron Health
Abstract Number: 102
Poster Board Number: C9
Session Title: Poster Session A: Prostate Cancer
Date and Time: February 26, 2026, 11:30 AM-12:45 PM; 5:45 PM-6:45 PM (PST)

Treatment Patterns and Survival Outcomes Among Lutetium 177 – Experienced Patients with Metastatic Castration-Resistant Prostate Cancer
Ben Tran, Tanya Dorff, Madeline Richey, Eunice Hankinson, Patrick Olsen, Smriti Karwa, Jason Sharpe, Megan Braunlin, Christopher Kim
Author Affiliations: Peter Mac, City of Hope, Amgen, Flatiron Health
Abstract Number: 69
Poster Board Number: B2
Session Title: Poster Session A: Prostate Cancer
Date and Time: February 26, 2026, 11:30 AM-12:45 PM; 5:45 PM-6:45 PM (PST)

Real-world (rw) first-line (1L) treatment (tx) patterns and overall survival (rwOS) in patients (pts) with locally advanced/metastatic urothelial carcinoma (la/mUC) with frailty or comorbidities
Enrique Grande, Aristotelis Bamias, Ronald de Wit, Syed Hussain, Constance Thibault, Mairead Kearney, Jason Hoffman, Valerie Morris, Li Chen, James Roose, Eunice Hankinson, Leonardo Crama, Julie Telliez, Joaquim Bellmunt
Author Affiliations: Quironsalud Madrid, National & Kapodistrian University of Athens, Erasmus MC Cancer Institute, University of Sheffield, Université Paris Cité, Merck KGaA, EMD Serono, Roche, Dana-Farber Cancer Institute, Flatiron Health
Abstract Number: 666
Poster Board Number: C16
Session Title: Poster Session B: Prostate Cancer and Urothelial Carcinoma
Date and Time: February 27, 2026, 11:30 AM-12:45 PM; 4:45 PM-5:45 PM (PST)

Real-world neoadjuvant therapy utilization and outcomes in patients with muscle-invasive bladder cancer ineligible for cisplatin treatment
Khilna Patel, Danni Zhao, Eunice Hankinson, Prakirthi Yerram, Aashay Mahesh Mehta, Emily Castellanos
Abstract Number: 672
Poster Board Number: C22
Session Title: Poster Session B: Prostate Cancer and Urothelial Carcinoma
Date and Time: February 27, 2026, 11:30 AM-12:45 PM; 4:45 PM-5:45 PM (PST)

Opportunities for Precision Oncology: Real-world Patterns and Disparities in FGFR3 Testing Among US Patients with Locally Advanced/Metastatic Urothelial Cancer (LA/mUC)
Emily Nash Smyth, Madeline Richey, Khilna Patel, Alan Brnabic, Nada Boualam, Sarah Reid, Ronac Mamtani
Author Affiliations: Eli Lilly and Company, Abramson Cancer Center, Flatiron Health
Abstract Number: 682
Poster Board Number: D6
Session Title: Poster Session B: Prostate Cancer and Urothelial Carcinoma
Date and Time: February 27, 2026, 11:30 AM-12:45 PM; 4:45 PM-5:45 PM (PST)

(Press release, Flatiron Health, FEB 23, 2026, View Source [SID1234662879])

On February 22, 2026 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, reported that yet another participant with mCRPC in the Cohort Expansion Phase (Phase II) of the SECuRE trial achieved undetectable PSA and negative PSMA PET. The undetectable PSA was measured following the first cycle and the negative PSMA PET was reported following the second cycle of 67Cu-SAR-bisPSMA (8 GBq each cycle).

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The participant is a 76-year-old man who was initially diagnosed with prostate cancer 15 years ago. He had radical prostatectomy to treat the primary disease and radiotherapy for local recurrence, having progressed to metastatic disease in 2020. Previous systemic anti-cancer treatments included an androgen receptor pathway inhibitor (ARPI) and androgen deprivation therapy (ADT). In 2025, the disease progressed further, and he was enrolled into the Cohort Expansion Phase of the SECuRE study with a baseline PSA of 3.25 ng/mL. Seven weeks after his first cycle of 67Cu-SAR-bisPSMA, this participant achieved undetectable PSA levels. He proceeded to receive one more cycle of 67Cu-SAR-bisPSMA, and no disease was observed on PSMA PET following the second dose (Figure 1). This participant exhibited mild (Grade 1) related AEs, including altered taste, dry eyes, eye pain, fatigue and salivary gland soreness (all resolved except fatigue). No haematological or renal AEs were observed to date.

This new case represents the fifth participant to achieve undetectable disease by radiographic assessment following 67Cu-SAR-bisPSMA treatment in Clarity’s SAR-bisPSMA theranostic program (3 participants who received up to four cycles of 8 GBq, and 2 participants who received up to three cycles of 12 GBq)2,3,4.

Update on previously reported participant with no detectable disease following 67Cu-SAR-bisPSMA treatment
Follow-up on the previously reported participant from the Cohort Expansion Phase (no detectable disease and absence of prior bone metastasis following three cycles of 8 GBq 67Cu-SAR-bisPSMA treatment)2, demonstrated that his PSA remains undetectable, with no disease identified on his latest PET conducted 1 month after the administration of the fourth cycle (Feb 2026; Figure 2). Following the first three cycles of 67Cu-SAR-bisPSMA, the participant exhibited mild (Grade 1) related AEs, most of which were gastrointestinal events, with no haematological or renal AEs2. Notably, no new safety signals have been observed during and since the administration of the fourth cycle to date.The interim data from this Phase II continues to confirm the favourable safety profile and promising efficacy seen in previous cohorts of SECuRE3 and supports the continuation of the trial with the aim to progress to a registrational Phase III study.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "The momentum of data we are generating with our lead SAR-bisPSMA product in both theranostic and diagnostic trials is strong, with excellent results to date on all fronts. We are beyond excited to see yet another patient achieve undetectable disease following their 67Cu-SAR-bisPSMA treatments. What is particularly outstanding is that this new patient presented with undetectable PSA just 7 weeks after his first 8 GBq cycle, with a negative PSMA PET being reported after the second cycle. This result is particularly impressive given this participant has been battling prostate cancer for 15 years and is now free of any detectable disease based on PSA and PET assessments with only mild (Grade 1) AEs.

"While this outcome is extraordinary, we now know this is not just luck or coincidence. Despite the number of participants in the SECuRE trial being relatively small, this is now the fifth time we have seen a patient present with undetectable disease following their 67Cu-SAR-bisPSMA treatments2,3,4, and study recruitment is still ongoing. We are also excited to see that the previous participant in the Cohort Expansion Phase of the SECuRE trial to achieve undetectable disease observed by anatomical and molecular imaging2 continues to show undetectable disease during his last follow up in February 2026, following the fourth 67Cu-SAR-bisPSMA cycle. This is especially encouraging as this participant had bone metastasis at study entry and now continues to report excellent quality of life after his treatment with 67Cu-SAR-bisPSMA."

"Our methodical commitment to science and the highest standard of clinical development underpins our achievements to date. Combining the optimised bivalent "bis" structure with the benefits offered by the copper isotope pairing, enabled by the proprietary sarcophagine (SAR) chelating technology, is key to the benefits we are seeing from the SAR-bisPSMA products. The most recent data released from the Co-PSMA study clearly establishes that 64Cu-SAR-bisPSMA considerably outperforms its competitors in detecting prostate cancer recurrence and sheds light on the importance of the improved lesion detection, where the diagnostic benefits translate into enhanced patient management5. Our registrational diagnostic AMPLIFY6 and CLARIFY7 trials with 64Cu-SAR-bisPSMA are also nearing the end of recruitment, getting us closer to commercialisation. We now look forward to progressing the SECuRE trial recruitment and have already initiated the planning for a registrational Phase III trial, as we hope to see more people benefit from our unique theranostic product. Having three Fast Track Designations (FTDs) for SAR-bisPSMA gives us confidence to persevere harder than ever, and positive interactions with the US Food and Drug Administration (FDA) confirm that we are on the right track. Our team is motivated and driven to progress SAR-bisPSMA to the market through the entirety of the prostate cancer journey, from first detection to late-stage metastatic disease. As we continue to generate exceptional data, we believe SAR-bisPSMA is well positioned to fully exploit the current treatment and diagnostic challenges in radiopharmaceuticals and improve treatment outcomes for patients with cancer."

About the SECuRE trial
The SECuRE trial (NCT04868604)1 is a Phase I/IIa theranostic trial for identification and treatment of participants with PSMA-expressing mCRPC using 64Cu/67Cu-SAR-bisPSMA. 64Cu-SAR-bisPSMA is used to visualise PSMA-expressing lesions and select candidates for subsequent 67Cu-SAR-bisPSMA therapy. The trial is a multi-centre, single arm study, planning to enroll approximately 54 participants in the US. The overall aim of the trial is to determine the safety and efficacy of 67Cu-SAR-bisPSMA for the treatment of prostate cancer.

The SECuRE trial consists of the Dose Escalation (Phase I) and Cohort Expansion (Phase II) Phases. Based on the data from the Dose Escalation Phase, which demonstrated a favourable safety profile and efficacy of 67Cu-SAR-bisPSMA, the SECuRE trial progressed to the Cohort Expansion at an 8 GBq dose level as per the Safety Review Committee (SRC) recommendation (up to 6 cycles per patient in total)3.

Cohort 2 of the Dose Escalation phase of the trial, where participants were dosed with 8 GBq of 67Cu-SAR-bisPSMA, demonstrated a very low rate of related AEs while all three participants achieved PSA declines of 80% or more (PSA80)3. The Dose Escalation Phase also showed high PSA response rates of the mCRPC in the pre-chemotherapy setting with a favourable safety profile: 92% of pre-chemotherapy participants (12/13) demonstrated PSA drops greater than 35%, 61.5% (8/13) of participants achieved PSA reductions greater than 50%, and 46.2% (6/13) of participants achieved PSA reductions of 80% or more3. These results supported the progress of the trial to its Cohort Expansion Phase using 8 GBq multi-dose in participants who had not received chemotherapy in the mCRPC setting.

Recruitment is currently ongoing into the Cohort Expansion Phase which will include 24 participants. A subset of participants will be treated with the combination of 8 GBq of 67Cu-SAR-bisPSMA with enzalutamide (ARPI), in line with the positive results from the Enza-p trial8 and previous discussions with and advice from key global medical experts in the field of prostate cancer.

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary SAR technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death in men worldwide9. Prostate cancer is the second-leading cause of cancer death in American men. The American Cancer Institute estimates there will be about 333,830 new cases of prostate cancer in the US in 2026 and around 36,320 deaths from the disease.

(Press release, Clarity Pharmaceuticals, FEB 22, 2026, View Source [SID1234662832])

On February 22, 2026 CStone Pharmaceuticals ("CStone," HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of therapies for oncology, autoimmune/inflammation, and other key disease areas, reported that the UK MHRA has granted a new indication for sugemalimab as a monotherapy for adult patients with unresectable stage III NSCLC with PD-L1 expression on ≥1% of tumour cells and no sensitising EGFR mutations, or ALK, ROS1 genomic aberrations and whose disease has not progressed following platinum-based chemoradiotherapy (CRT).

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Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, stated, "Since its initial EU approval in July 2024, sugemalimab has become one of only two PD-(L)1 antibodies approved for stage III NSCLC in Europe, providing a comprehensive treatment option spanning both locally advanced, unresectable stage III and metastatic stage IV NSCLC. Its commercial footprint has now expanded to over 60 countries and regions globally, with market access applications approved or under regulatory review in more than ten countries. Furthermore, sugemalimab has been included in multiple national reimbursement systems—an affirmation of its recognized clinical value and pharmacoeconomic benefit."

Dr. Qingmei Shi, Chief Medical Officer of CStone, added, "The MHRA’s approval of sugemalimab for Stage III NSCLC represents another significant endorsement from a major international regulatory agency and will further unlock its global commercial potential. We are proud of CStone’s clinical development and regulatory affairs teams for their’ effective execution, invaluable experience in global registration, and ability to navigate mature regulatory frameworks in Europe and the UK. Sugemalimab in combination with chemotherapy treating stage IV NSCLC has received the highest-level recommendation [I, A] in the first-line setting for both squamous and non-squamous NSCLC in the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Non-Oncogene-Addicted Metastatic NSCLC Living Guideline. We look forward to the potential inclusion of this newly approved stage III NSCLC indication in this authoritative guideline in the near future. CStone will continue to advance regulatory filings for sugemalimab in additional indications, including gastric cancer (GC) and esophageal squamous cell carcinoma (ESCC)."

About Sugemalimab

The anti-PD-L1 monoclonal antibody sugemalimab was developed by CStone using OmniRat transgenic animal platform, which allows creation of fully human antibodies in one step. Sugemalimab is a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody, which may reduce the risk of immunogenicity and toxicity for patients, a unique advantage over similar drugs.

The EC and MHRA have approved sugemalimab for two indications:

In combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations; and
Monotherapy for adult patients with unresectable stage III NSCLC with PD-L1 expression on ≥1% of tumour cells and no sensitising EGFR mutations, or ALK, ROS1 genomic aberrations and whose disease has not progressed following platinum-based CRT.
The National Medical Products Administration (NMPA) of China has approved sugemalimab for five indications:

In combination with chemotherapy as first-line treatment of patients with metastatic squamous and non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations and metastatic squamous NSCLC;
For the treatment of patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent or sequential platinum-based CRT;
For the treatment of patients with relapsed or refractory extranodal NK/T-cell lymphoma;
In combination with fluorouracil and platinum-based chemotherapy as first-line treatment of patients with unresectable locally advanced, recurrent or metastatic ESCC; and
In combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatment for unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma with a PD-L1 expression CPS ≥5.

(Press release, CStone Pharmaceauticals, FEB 22, 2026, View Source [SID1234662833])