On July 20, 2026 Halozyme Therapeutics, Inc. (Nasdaq: HALO) ("Halozyme" or the "Company") reported that it has entered into a global collaboration and license agreement with Incyte (Nasdaq: INCY) to evaluate additional subcutaneous formulations of INCA033989, a first-in-class mutant calreticulin (mutCALR)-targeted monoclonal antibody, in patients with mutCALR-expressing myeloproliferative neoplasms (MPNs), utilizing Halozyme’s proprietary ENHANZE drug delivery technology. The collaboration will focus on the potential for ENHANZE to strengthen the subcutaneous formulation currently in development for INCA033989, with the goal of enabling more convenient delivery and dosing regimens that may improve the treatment experience.

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Under the terms of the agreement, Halozyme will receive an upfront payment from Incyte and is eligible to receive additional payments upon achievement of agreed upon milestones. In addition, Halozyme is eligible to receive royalties on net sales of commercialized medicines using ENHANZE. Under the collaboration, Incyte also has the option to nominate up to two additional targets for use with ENHANZE.

"This collaboration with Incyte underscores the continued momentum and broad applicability of our ENHANZE technology across high-value therapeutic areas," said Dr. Helen Torley, President and Chief Executive Officer of Halozyme. "Incyte brings a strong portfolio and deep expertise in hematology, and we look forward to working together to enable the development of more convenient subcutaneous treatment options for patients. This agreement builds on Halozyme’s established track record of successful collaborations with leading biopharmaceutical companies and further diversifies our portfolio of partnered programs across multiple therapeutic areas."

(Press release, Halozyme, JUL 20, 2026, View Source [SID1234669321])

On July 20, 2026 Syntara Limited (ASX: SNT), a clinical-stage drug development company, reported completion of the first dose-escalation cohort in the Phase 1b component of the AZALOX clinical trial evaluating amsulostat, in combination with the hypomethylating agent 5-Azacitidine (5-AZA) in patients with high-risk Myelodysplastic Neoplasms (MDS) and Chronic Myelomonocytic Leukaemia (CMML).Following review of the safety data from the first cohort, the independent Drug Safety Monitoring Board (DSMB) has approved escalation to the final Phase 1b dose cohort, in which patients will receive amsulostat at 200 mg twice daily in combination with 5-AZA.The initial cohort evaluated amsulostat at 150 mg twice daily in combination with 5-AZA. No dose-limiting toxicities were observed and no new adverse events attributable to amsulostat were reported.

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The Phase 1b component of AZALOX is intended to establish the safety profile and recommended Phase 2 dose of amsulostat in combination with 5-AZA. Subject to completion of the 200 mg cohort and review of the associated safety data, the study is expected to progress to a Phase 2 component designed to evaluate the safety and efficacy of the selected dose in approximately 30 patients.

Preliminary results from the completed Phase 1b dose-escalation component are expected during Q4 CY26.

All 10 participating clinical sites in Germany have now been initiated and are open for recruitment. Sites are actively pre-screened potential participants while awaiting the DSMB review, with patients already pre-registered for the 200 mg cohort.

Syntara Chief Executive Officer Gary Phillips said:

"Completion of the first AZALOX cohort without any dose-limiting toxicities and clearance to progress to the 200 mg dose represents an important step forward for the amsulostat program.

"With 10 German centres now open and patients already pre-registered for the final dose cohort, the study is well positioned to generate preliminary Phase 1b data during the fourth quarter of 2026.

"High-risk MDS represents a significant potential indication expansion and commercial opportunity for amsulostat beyond the FDA-supported development pathway in myelofibrosis. Together with the Australian MESSAGE study in lowerrisk disease, AZALOX provides the opportunity to evaluate amsulostat across distinct MDS populations and build a broader clinical data package around the asset."

AZALOX is being conducted through the German MDS Study Group under the sponsorship of Heidelberg University, in collaboration with the Coordination Centre for Clinical Studies Heidelberg. The study is financially supported by German Cancer Aid.

The study was initiated following encouraging preclinical research indicating that the combination of amsulostat and a hypomethylating agent may reactivate red blood cell and platelet production. The ongoing clinical study is assessing whether this approach may reduce patients’ dependence on blood transfusions and lower the risk of disease progression to acute myeloid leukaemia.

Progress in AZALOX represents an important potential indication expansion for amsulostat beyond myelofibrosis, providing Syntara with the opportunity to establish a broader clinical and commercial profile for the asset across haematological cancers characterised by dysfunction of extracellular matrix and blood cell production.

In parallel with AZALOX, the Australasian Leukaemia & Lymphoma Group (ALLG) is leading the Australian MDS05/D3 MESSAGE study evaluating amsulostat in combination with the oral hypomethylating agent ASTX727 in patients with transfusion-dependent low and intermediate-risk MDS. The MESSAGE study remains in recruitment for its initial dose-escalation cohort, with Syntara anticipating preliminary results during the first half of calendar 2027. The study is intended to complement AZALOX by evaluating amsulostat in a distinct MDS patient population and treatment setting.

(Press release, Syntara, JUL 20, 2026, View Source [SID1234669303])

On July 20, 2026 Biohaven Ltd. (NYSE: BHVN) ("Biohaven"), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, reported that new data on BHV-1530, its FGFR3-directed antibody-drug conjugate (ADC) using a novel topoisomerase I (TopoIx) payload, will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026, to be held October 23-27 in Madrid, Spain.

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The new Phase 1 data planned for ESMO (Free ESMO Whitepaper) will provide a clinically meaningful update to the early Phase 1 data initially disclosed at Biohaven’s R&D Day on May 27, 2026. The new data will include signals of clinical activity demonstrated in the ongoing Phase 1, open-label, dose-escalation study of BHV-1530 in patients with advanced solid tumors. The data from May 27 2026, showed early signs of antitumor activity in patients with both FGFR3-altered and wild-type overexpressing tumors, and across multiple tumor types. This included a heavily pretreated patient with FGFR3-TACC3 fusion–positive metastatic urothelial cancer who had progressed on four prior lines of therapy, including Padcev (a nectin-4-directed ADC), pembrolizumab, and two FGFR-targeting small molecules. This patient has tolerated BHV-1530 with no FGFR-related toxicity. The data has shown a favorable safety profile, with no dose-limiting toxicities and no FGFR inhibitor–class toxicities, such as hyperphosphatemia, nail disorders, stomatitis, or retinopathy, that commonly constrain dosing and duration of approved FGFR tyrosine kinase inhibitors.

Clinical Supply Agreement with Regeneron for BHV-1530 and Cemiplimab

Biohaven has entered into a clinical supply agreement with Regeneron Pharmaceuticals, Inc. to evaluate the combination of BHV-1530 and cemiplimab (Libtayo) in patients with solid tumors based upon the emerging monotherapy clinical data and preclinical data demonstrating synergistic activity between BHV-1530 and immune therapy. BHV-1530’s TopoIx payload has been demonstrated to generate immunogenic cell death and stimulate an antitumor immune response, providing a compelling mechanistic rationale for combination with checkpoint inhibition.

This agreement builds upon the existing clinical supply agreement between Biohaven and Regeneron for BHV-1510, a next-generation TROP2-directed ADC, further deepening the collaborative relationship between the two companies across Biohaven’s oncology pipeline. Of note, early clinical data from the BHV-1510 program demonstrate a signal consistent with this thesis, as responses have been observed in multiple patients with prior anti–PD-(L)1 therapy.

About BHV-1530

BHV-1530 is an antibody-drug conjugate directed against FGFR3, a validated but underexploited target in urothelial cancer and other FGFR3-driven cancers, and is a first in clinic FGFR3-directed ADC incorporating Biohaven’s proprietary TopoIx payload. Unlike approved FGFR tyrosine kinase inhibitors, which are restricted to genomically selected patients and constrained by class-related toxicities, BHV-1530 is designed to target FGFR3 independent of requiring pathway inhibition, with the potential to address both FGFR3-altered and wild-type overexpressing tumors. BHV-1530 is being studied in an ongoing Phase 1 dose-escalation trial in unselected patients with advanced urothelial cancer, head and neck squamous cell carcinoma, and non-small cell lung cancer who have failed standard-of-care therapy, as well as other tumor types harboring FGFR3 genomic alterations. Biohaven plans to initiate combination cohorts evaluating BHV-1530 with anti-PD-1 therapy, including the recently announced combination with cemiplimab (Libtayo), in the second half of 2026.

(Press release, Biohaven Pharmaceutical, JUL 20, 2026, View Source [SID1234669323])

On July 20, 2026 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, and Hemispherian AS, a clinical-stage oncology company developing novel small molecule therapeutics, reported that an abstract featuring pre-clinical data demonstrating strong synergy between GLIX1 and various PARP inhibitors in HR-proficient ovarian cancer cell lines has been accepted as an e-Poster at the 2026 European Society for Medical Oncology Annual Congress (ESMO 2026), taking place October 23rd to October 27th in Madrid, Spain.

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Presentation Details:

Title: GLIX1, a TET2 Activator Targeting the DNA Damage Response, Synergizes with PARP Inhibitors in Ovarian Cancer Cell Lines

Presentation #: 1435eP

Presentation type: e-Poster

Location: e-Poster Area, Hall 25

About GLIX1

GLIX1 is a first-in-class, orally administered, brain penetrating, small molecule activator of the Ten-Eleven Translocation 2 (TET2) pathway that is commonly inhibited in cancer. Activating the novel TET2 pathway by GLIX1 overwhelms the DNA repair capacity of cancer cells, resulting in apoptotic cancer cell death.

About Ovarian Cancer

Ovarian cancer is the deadliest gynecologic malignancy in the United States, with an estimated approximately 21,000 new cases and 12,450 deaths projected in 2026. Standard first-line treatment consists of cytoreductive surgery and platinum-based chemotherapy, with PARP inhibitors used as maintenance therapy in selected patients, particularly those with BRCA-mutated or homologous recombination (HR)-deficient disease. However, PARP inhibitors are markedly less effective in patients with HR-proficient tumors, which account for approximately 50% of high-grade serous ovarian cancers and are associated with primary platinum resistance and shorter survival. This leaves a substantial and currently underserved patient population in need of new treatment strategies capable of extending the benefits of PARP inhibitors.

(Press release, BioLineRx, JUL 20, 2026, View Source [SID1234669324])

On July 18, 2026 MediLink Therapeutics (Suzhou) Co., Ltd. reported that the New Drug Application (NDA) for its independently developed B7-H3-targeting antibody-drug conjugate (ADC) Tam-Peli (research code: YL201) has been accepted for review by the National Medical Products Administration (NMPA). The submission is for the treatment of adult patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who have previously failed PD-(L)1 inhibitors and at least two lines of chemotherapy. The application is based on the prespecified interim analysis results from a randomized, controlled, multicenter Phase III study, YL201-CN-301-01 (TAISHAN-301), comparing YL201 versus investigator’s choice of chemotherapy in this patient population.

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Dr. Xue Tongtong, CEO of MediLink , commented: "The formal acceptance of YL201’s NDA by the CDE marks a significant milestone for MediLink as we transition from clinical development toward commercialization. It is also an important testament to our team’s innovation and execution capabilities. We fully recognize that patients in the later-line NPC setting have extremely limited treatment options and face a huge unmet medical need. We are fully committed to cooperating with the regulatory review process and striving to bring this internationally competitive innovative therapy to Chinese patients as soon as possible."

Current Status of Advanced Nasopharyngeal Carcinoma Treatment

Nasopharyngeal carcinoma (NPC) is a malignant tumor arising from the epithelial lining of the nasopharynx, primarily associated with Epstein–Barr virus (EBV) infection, genetic predisposition, and environmental factors. NPC exhibits significant racial and geographic disparities. Among the three major racial groups worldwide, Asian populations have the highest incidence, followed by Black populations, while NPC is extremely rare in Caucasians. According to World Health Organization (WHO) data published in 2022, China bears a heavy disease burden of NPC: approximately half of global new cases (51,000 out of 120,000) and over one-third of global deaths (28,000 out of 73,000) occur in China, placing the country’s morbidity and mortality burden among the highest worldwide [1][2].

About Tam-Peli

Tam-Peli (YL201) is an ADC targeting B7-H3, developed using MediLink ‘s proprietary TMALIN (Tumor Microenvironment-Activable Linker-payload) platform, which features a tumor-cleavable camptothecin-based linker-payload technology. In January 2026, Yilong Biomedical entered into an exclusive licensing agreement with Roche for the YL201 program, granting Roche exclusive global development, manufacturing, and commercialization rights outside mainland China, Hong Kong SAR, and Macau SAR. The two parties will jointly accelerate global R&D and regulatory filings, advancing development and commercialization across multiple solid tumor indications. Under the agreement, MediLink received an upfront payment and near-term milestones totaling $570 million, and is eligible for additional development, regulatory, and commercial milestone payments, as well as tiered royalties on net overseas sales.

On May 23, 2026, MediLink announced that in the Phase III trial for recurrent/metastatic NPC (TAISHAN-301), an Independent Data Monitoring Committee (IDMC) confirmed that the prespecified interim analysis had met the co-primary endpoint of objective response rate (ORR) assessed by blinded independent central review (BICR). This is the first positive Phase III result globally for a B7-H3 ADC.

Currently, YL201 is being evaluated in global clinical studies across multiple advanced solid tumor types. In China, YL201 has initiated three separate Phase III registrational trials for NPC, small cell lung cancer (SCLC), and esophageal squamous cell carcinoma (ESCC). Previously, YL201 has received five Breakthrough Therapy Designations from the NMPA’s Center for Drug Evaluation (CDE) for indications including SCLC, NPC, ESCC, and pancreatic cancer, as well as a Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for SCLC. In addition, YL201 has been granted three Orphan Drug Designations by the FDA for SCLC, NPC, and ESCC.

(Press release, Suzhou Medilink Therapeutics, JUL 18, 2026, View Source [SID1234669368])