On September 1, 2026 Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for cancer patients, reported that in a post hoc analysis of its Phase 3 CARES-310 study, camrelizumab, an anti-PD-1 antibody, plus rivoceranib, an oral TKI, demonstrated a clinically meaningful progression-free survival (PFS) benefit across all age subgroups when compared to sorafenib in patients with unresectable hepatocellular carcinoma (uHCC).

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The poster, titled "Younger Age and Clinical Outcomes in Patients with Unresectable Hepatocellular Carcinoma Treated with Camrelizumab + Rivoceranib vs Sorafenib (CARES-310)," will be on display throughout the International Liver Cancer Association 2026 Annual Conference, which runs Sept. 3-5 at Le Plaza Hotel in Brussels. Elevar is sponsoring the conference’s welcome reception on Sept. 3., from 6:15-7:30 p.m. (CET).

"We remain deeply committed to gaining FDA approval and helping patients confronted with hepatocellular carcinoma, because the scientific data demonstrates that the combination of camrelizumab and rivoceranib shows consistent potential to extend survival when compared to currently approved treatments," said Dong-Gun Kim, chief executive officer of Elevar. "This post-hoc analysis of CARES-310 further demonstrates the broad potential of the combination. We are excited to share it with our peers at the ILCA Annual Conference."

The post-hoc, exploratory analysis concluded that:

Camrelizumab plus rivoceranib improved median overall survival (mOS) versus sorafenib in patients aged <50 years (21.5 vs. 15.2 months; HR 0.7; 95% CI, 0.47-1.06; P=0.0445*) and ≥50 years (23.9 vs. 15.2 months; HR 0.6; 95% CI, 0.47-0.77; P<0.0001), with a numerically longer mOS also observed in patients <40 years (24.2 vs. 15.2 months; HR 0.82; 95% CI, 0.4-1.72; P=0.2982)^.
Camrelizumab plus rivoceranib also improved mPFS versus sorafenib across age subgroups, including patients <50 years (5.5 vs. 2.7 months; HR 0.53; 95% CI, 0.37–0.77; P=0.0004), ≥50 years (6.2 vs. 3.7 months; HR 0.56; 95% CI, 0.45–0.72; P<0.0001), and <40 years (5.5 vs. 2.2 months; HR 0.56; 95% CI, 0.29–1.12; P=0.0485)^.
Treatment-related adverse events (TRAEs) were similar across age subgroups. The most common (≥5%) grade 3-4 TRAE was hypertension for camrelizumab plus rivoceranib and palmar-plantar erythrodysesthesia syndrome for sorafenib, regardless of age.

*All P values are one sided.
^Median follow-up time is 22.1 months.

Lead poster author Arndt Vogel, M.D., Ph.D., scientist in the Division of Gastroenterology and Hepatology at Toronto General Hospital Research Institute, and a medical oncologist at the UHN-Princess Margaret Cancer Centre at the University of Toronto, will present the poster #P-106 during the conference Poster Tour, Friday, Sept. 4, 10:30-11 a.m.

"The analysis of camrelizumab plus rivoceranib by age subgroups provides further evidence that the combination has potential to improve outcomes across diverse healthcare settings," said Dr. Vogel. "It has also been investigated across early, intermediate, and advanced stages of HCC, both alone and in combination with locoregional therapies, and has consistently demonstrated clinically meaningful antitumor activity together with a manageable safety profile. These findings highlight the potential of this regimen to become an important component of multidisciplinary HCC management."

For more information about Elevar, visit Elevartx.com.

About Hepatocellular Carcinoma

Hepatocellular Carcinoma (HCC) is the most common type of liver cancer and most frequently develops in people with chronic underlying liver inflammation, which may be from viral and non-viral causes. HCC typically has a poor prognosis with limited treatment options and continues to be a diagnosis with an ongoing urgent medical need. More than 800,000 people worldwide are diagnosed with liver cancer each year and it is also a leading cause of cancer deaths, accounting for more than 700,000 annually, according to the American Cancer Society.

About Rivoceranib

Rivoceranib, an oral small-molecule tyrosine kinase inhibitor (TKI), is a highly selective inhibitor of vascular endothelial growth factor receptors (VEGFRs), a primary pathway for tumor angiogenesis. VEGFR inhibition is a clinically validated target to limit tumor growth and disease progression. Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy in various solid tumor indications. Several clinical studies were completed in patients with uHCC (in combination with camrelizumab), gastric cancer (as a monotherapy and in combination with paclitaxel), adenoid cystic carcinoma (as a monotherapy) and colorectal cancer (in combination with Lonsurf). Rivoceranib, under the name apatinib (Aitan), was the first TKI approved in gastric cancer in China (October 2014). It was also approved in China in combination with camrelizumab as a first-line treatment for unresectable or metastatic HCC (January 2023). The drug has been studied in more than 6,000 patients worldwide and was well tolerated in clinical trials with a comparable safety profile to other TKIs and VEGF inhibitors. Orphan drug designations have been granted for gastric cancer (U.S., EU and South Korea), adenoid cystic carcinoma (U.S.) and uHCC (U.S. and EU). Elevar Therapeutics, Inc. holds the global rights (excluding China) to rivoceranib and has partnered for its development and marketing with HLB-LS in South Korea. Hengrui Pharma, is the license-holder of rivoceranib in the Chinese -territory. As previously disclosed, in July, Elevar received a Complete Response Letter from the FDA regarding its NDA for rivoceranib in combination with camrelizumab due to deficiencies identified during an inspection of the manufacturing site. Elevar is working closely with Hengrui to address the identified issues and prepare for resubmission of the application.

About Camrelizumab

Camrelizumab (SHR-1210) is a humanized monoclonal antibody that binds to the programmed death-1 (PD-1) receptor. Blockade of the PD-1/PD-L1 signaling pathway is a therapeutic strategy showing success in a wide variety of solid and hematological cancers. Camrelizumab is developed by Hengrui Pharma and has been studied in more than 5,000 patients. Currently, 50 clinical trials are underway in a broad range of tumors (including liver cancer, lung cancer, gastric cancer and breast cancer, etc.) and treatment settings. Camrelizumab, under the brand name AiRuiKa, is currently approved for eight indications in China, including monotherapy for the treatment of HCC (second-line), in combination with rivoceranib as a treatment for HCC (first-line), relapsed/refractory classic Hodgkin’s lymphoma (third-line), esophageal squamous cell carcinoma (second-line) and nasopharyngeal carcinoma (third-line or further) and in combination with chemotherapy for the treatment of non-small cell lung cancer (non-squamous and squamous), esophageal squamous cell carcinoma and nasopharyngeal carcinoma in the first-line setting. The U.S. Food and Drug Administration granted Orphan Drug Designation to camrelizumab for advanced HCC in April 2021 and by the EMA in August 2024. In October 2023, Elevar licensed camrelizumab for commercialization from Hengrui Pharma worldwide excluding Greater China and Korea.

(Press release, Elevar Therapeutics, SEP 1, 2026, View Source [SID1234670516])

On September 1, 2026 Juniper Biosciences reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to JBS-003 (18F-fluoromisonidazole, or FMISO), the first-in-class hypoxia tracer in the U.S., for the identification of tumor hypoxia to guide de-escalated radiation therapy in patients with HPV-positive Oropharyngeal Carcinoma (OPC). JBS-003, licensed from Memorial Sloan Kettering Cancer Center (MSK), is the cornerstone of a new precision oncology paradigm designed to spare patients from the devastating side effects of high-dose radiation therapy. As a leader in molecular imaging, MSK pioneered the use of hypoxia tracers to overcome the limitations of traditional imaging.

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FDA Recognition of a Substantial Improvement Over the Current Standard of Care

Breakthrough Therapy Designation is reserved for programs intended to address a serious condition where preliminary clinical evidence indicates the potential for substantial improvement over available therapy on a clinically significant endpoint. The designation for JBS-003 was supported by the body of clinical evidence generated to date for FMISO-guided radiation de-escalation, spanning the foundational investigator-led hypoxia imaging experience at MSK and the ongoing clinical program now advancing under Juniper’s leadership. The designation provides for intensive FDA guidance on an efficient development program, organizational commitment involving senior agency leadership, and eligibility for rolling and priority review.

Redefining the Standard of Care: From 70 Gray to 30 Gray Radiation

In the current standard of care for HPV-positive OPC, patients are subjected to a "one-size-fits-all" aggressive radiation regimen regardless of their individual tumor biology, often resulting in severe, permanent morbidity—including the risk of jawbone removal (osteoradionecrosis), significant weight loss requiring feeding tubes, and long-term quality-of-life impairment. JBS-003 utilizes precision molecular imaging to identify tumor hypoxia, a known marker of radioresistance. By mapping these oxygen-starved regions, clinicians can, for the first time, accurately risk-stratify patients. Research indicates that approximately 80% of these patients have non-hypoxic tumors and may safely undergo a greater than 50% reduction in radiation, de-escalating from the standard 70 Gray to 30 Gray absorbed dose of ionizing radiation.

Accelerating the Precision Radiopharmaceutical Platform

JBS-003 is a vital component of Juniper Biosciences’ expanding multi-indication precision platform. The Breakthrough Therapy Designation reinforces the value of the Company’s partnership with MSK and its commitment to building a high-value pipeline that addresses the most complex challenges in nuclear medicine. Juniper Biosciences will work closely with the FDA to define the most efficient path to registration for JBS-003.

"This designation is a powerful validation of what precision imaging can do for these patients. Using F-MISO PET imaging, we can visualize the specific hypoxic signatures of a tumor to maintain aggressive control where it’s needed, while safely reducing radiation doses for patients with well-oxygenated tissue. The FDA has now recognized that this approach may represent a substantial improvement over the current standard of care. We are very excited to see future patients benefit from it." said Alex Agnoletto, CEO.

About the JBS-003 Phase 3 Clinical Trial (NCT06563479)

The ongoing Phase 3 trial is a randomized, double-blind study evaluating FMISO-selected de-escalated radiation therapy. Patients in the personalized arm receive a FMISO scan at week two; those with non-hypoxic scans are eligible for a reduced 30 Gray radiation dose, while those with positive scans continue with the standard 70 Gray regimen. The trial is expected to reach primary completion in early 2028. "We are excited that the FDA has granted Breakthrough Therapy designation, and we look forward to completing this Phase 3 trial and generating the pivotal evidence needed to support potential FDA approval," says Nancy Y. Lee, MD, FASTRO, Radiation Oncologist and Service Chief for Head & Neck Oncology, and Proton Therapy, at MSK.

(Press release, Juniper Biosciences, SEP 1, 2026, View Source [SID1234670515])

On September 1, 2026 BridgeBio Oncology Therapeutics, Inc. ("BBOT") (Nasdaq: BBOT), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, reported that members of its leadership team will participate in upcoming investor conferences.

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Details of the company’s participation are as follows:

Cantor Global Healthcare Conference 2026
Wednesday, September 9, 2026, at 9:45 a.m. ET
Citi’s 2026 Biopharma Back to School Conference
Thursday, September 10, 2026, at 3:00 p.m. ET
Morgan Stanley 24th Annual Global Healthcare Conference
Tuesday, September 15, 2026, at 1:50 p.m. ET
Live webcasts of the presentations will be accessible on the "Events" page of the BBOT website at View Source Replays of the webcasts will be available for at least 90 days following the event.

(Press release, BridgeBio Oncology Therapeutics, SEP 1, 2026, View Source [SID1234670514])

On September 1, 2026 Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") reported completion of patient enrollment in the Phase 3 BiPASS study of its commercial PSMA-PET1 imaging agents, Illuccix (kit for the preparation of gallium Ga68 gozetotide injection) and Gozellix (kit for the preparation of gallium Ga68 gozetotide injection) for prostate cancer imaging in the pre-biopsy setting. Telix has also aligned with the United States (U.S.) Food and Drug Administration (FDA) on a New Drug Application (NDA) pathway for BiPASS that, if approved, would support reimbursement as a new product and broaden patient access.

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BiPASS (Biopsy of the Prostate Avoidance Stratification Study2) is the first registrational study of 68Ga-PSMA-PET imaging in the pre-biopsy setting. The study aims to evaluate whether the combination of MRI3 and PSMA-PET/CT4 with Telix’s proprietary 68Ga-PSMA-PET agents can further improve diagnostic accuracy, reduce unnecessary biopsies, or improve targeting of biopsy compared with current standard practice. A total of 350 patients were enrolled in the U.S. and Australia in this prospective, open-label Phase 3 trial.

Globally, more than three million prostate biopsies are performed each year5, yet up to 75% are found to be negative6. Patient compliance remains a significant clinical challenge with approximately one in four patients declining a physician recommendation to undergo biopsy7. Biopsy is often stressful and painful, may lead to complications, and delivers no real diagnostic benefit for many patients8.

BiPASS builds on the clinical foundation established by the landmark PRIMARY9 and PRIMARY210 studies, which demonstrated that combining 68Ga-PSMA-PET imaging with MRI can significantly improve the detection of clinically significant prostate cancer while reducing unnecessary biopsies by almost 50 percent. If BiPASS meets its primary objectives, the data, alongside evidence from PRIMARY and PRIMARY2, have the potential to shift 68Ga-PSMA-PET beyond its current use in initial staging and secondary re-staging at disease recurrence and establish precision imaging as a critical step in initial diagnosis. Earlier and more accurate identification of clinically significant disease could improve patient selection and treatment decisions, reduce unnecessary biopsies, and potentially decrease the long-term patient burden and healthcare cost of prostate cancer recurrence. Successful implementation of BiPASS could broaden access to 68Ga-PSMA-PET imaging across a substantially larger patient population.

Professor Louise Emmett, Director of Theranostics and Nuclear Medicine, St Vincent’s Hospital and BiPASS Investigator, said, "Completing patient enrollment in BiPASS is an important milestone for men with suspected prostate cancer, particularly those with equivocal MRI findings. The PRIMARY and PRIMARY2 studies demonstrated that 68Ga-PSMA-PET, when used alongside MRI, can safely halve the number of biopsies required without missing clinically significant prostate cancer. BiPASS now has the potential to fundamentally change the current standard of care, streamlining the diagnostic pathway, accelerating treatment decision-making and helping to ensure that men receive the most appropriate therapy earlier in their treatment journey."

Dr. Brian Mazzarella, Vice President of Research for Urology America and BiPASS Investigator added, "PSMA-PET imaging with tracers such as Illuccix and Gozellix has already changed how we stage and manage prostate cancer. By combining the functional information from PSMA-PET with the detailed anatomic information provided by MRI, we have an unprecedented opportunity to improve the detection of clinically significant prostate cancer and guide more informed diagnostic decisions. For patients, this approach has the potential to reduce unnecessary procedures, lower procedural risk, ease anxiety, and ultimately enable more precise, individualized treatment decision-making."

Dr. David N. Cade, Telix Group Chief Medical Officer, commented, "Recruitment of BiPASS was completed rapidly, reflecting strong enthusiasm from clinicians and patients for a more accurate, non-invasive approach to diagnosis. We believe BiPASS may represent a transformative event in the management of prostate cancer, alongside the compelling data from the PRIMARY studies. Instead of asking how best to stage prostate cancer, clinicians may increasingly use advanced imaging to determine which men need to undergo biopsy in the first place. Telix is uniquely positioned to define and lead this patient-first approach that, if approved, would represent a new clinical application with a reimbursement pathway that facilitates much broader patient access to gallium-based PSMA-PET."

About Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection)

Illuccix, after radiolabeling with 68Ga, is indicated for PET scanning of PSMA positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy, those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level, and for selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products.

IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS

Risk for Misinterpretation
Image interpretation errors can occur with Illuccix PET. A negative image does not rule out the presence of prostate cancer, and a positive image does not confirm the presence of prostate cancer. Gallium Ga 68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget’s disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Imaging Prior to Initial Definitive or Suspected Recurrence Therapy
The performance of Illuccix for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of Illuccix for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score.

Radiation Risks
Gallium Ga 68 gozetotide contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration.

ADVERSE REACTIONS
The safety of gallium Ga 68 gozetotide was evaluated in 960 patients in the PSMA-PreRP and PSMA-BCR studies, each receiving one dose of gallium Ga 68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%.

In the VISION study, 1003 patients received one dose of gallium Ga 68 gozetotide intravenously with the amount of radioactivity 167.1 ± 23.1 MBq (4.52 ± 0.62 mCi). Adverse reactions occurring at ≥0.5% in patients with metastatic prostate cancer who received gallium Ga 68 gozetotide injection in the clinical study were fatigue (1.2%), nausea (0.8%), constipation (0.5%), and vomiting (0.5%).
Adverse reactions occurring at a rate of < 0.5% in the VISION study were diarrhea, dry mouth, injection site reactions, including injection site hematoma and injection site warmth and chills.

Injection site pain has been identified during post-approval use of ILLUCCIX.

DRUG INTERACTIONS
Androgen deprivation therapy and other therapies targeting the androgen pathway
Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga 68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga 68 gozetotide PET has not been established.

Please note that this information is not comprehensive.
Please see the Full Prescribing Information here.

About Gozellix (kit for the preparation of gallium Ga 68 gozetotide injection)

Gozellix, after radiolabeling with 68Ga, is indicated for PET scanning of PSMA positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy, and those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS

Risk for Misinterpretation
Image interpretation errors can occur with GOZELLIX PET. A negative image does not rule out the presence of prostate cancer, and a positive image does not confirm the presence of prostate cancer. Gallium Ga-68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget’s disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Imaging Prior to Initial Definitive or Suspected Recurrence Therapy
The performance of GOZELLIX for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of GOZELLIX for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score.

Radiation Risks
Gallium Ga-68 gozetotide contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration.

Hypersensitivity Reactions to Sulfites
Ascorbic Acid Stabilizer contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.

ADVERSE REACTIONS
The safety of gallium Ga-68 gozetotide was evaluated in 960 patients in the PSMA-PreRP and PSMABCR studies, each receiving one dose of gallium Ga-68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%.

DRUG INTERACTIONS
Androgen deprivation therapy and other therapies targeting the androgen pathway Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga-68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga-68 gozetotide PET has not been established.

(Press release, Telix Pharmaceuticals, SEP 1, 2026, View Source [SID1234670513])

On September 1, 2026 Styx Biotechnologies, Inc., a San Diego-based biotechnology company developing next-generation antibody-drug conjugates (ADCs) for solid tumors, reported a strategic agreement with ZoeNCure Therapeutics Pvt. Ltd. to accelerate selected Styx ADC programs toward first-in-human clinical studies.

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Under the agreement, Styx will receive an upfront payment and additional milestone-based payments tied to development progress. In exchange, ZoeNCure will provide development capital and leverage its specialized clinical infrastructure to execute early-phase clinical studies. Additional financial terms were not disclosed.

The collaboration provides Styx with a capital-efficient pathway for selected ADC assets while preserving opportunities for broader global clinical development and strategic partnering. The agreement supports coordinated preclinical, CMC, regulatory, and clinical activities, enabling Styx to advance key pipeline programs without assuming the full capital burden typically required for early clinical development.

"This agreement represents an important step in our strategy to advance our most promising ADC programs efficiently while preserving long-term value," said Ashutosh Tiwari, PhD, Chief Executive Officer of Styx Biotechnologies. "This collaboration creates a capital-efficient path to first-in-human development by allowing Styx to clinically de-risk selected programs while preserving our ability to pursue broader global development and partnering opportunities."

Styx is developing a pipeline of novel ADCs across multiple solid tumor indications, including liver, gastric and rare cancers. Its programs combine clinically relevant tumor biology with differentiated antibody, and dual-payload strategies designed to address therapeutic index, tumor heterogeneity, and treatment resistance. The collaboration allows Styx to advance these lead assets toward clinical validation while continuing to invest in its broader portfolio. The companies believe this approach can shorten development timelines, improve capital efficiency and establish a strong foundation for subsequent global clinical development.

(Press release, Styx Biotechnologies, SEP 1, 2026, View Source [SID1234670511])