On May 22, 2026 Inocras, a bioinformatics-led company harnessing the power of whole-genome data and proprietary analytics to deliver curated insights, reported that new real-world evidence evaluating whole-genome sequencing-based homologous recombination deficiency phenotyping has been accepted for online publication at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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The abstract, titled "Whole-genome HRD phenotyping as a predictor of PARP inhibitor benefit in first-line maintenance high-grade serous ovarian cancer," reports findings from a collaborative study between Inocras and the Severance Hospital gynecologic oncology team, one of Inocras’s major clinical partners in Korea.

Using matched tumor-normal whole-genome sequencing through CancerVision, investigators evaluated 84 patients with high-grade serous ovarian cancer who received PARP inhibitor maintenance therapy in either the first-line or second-line maintenance setting. The study assessed whether WGS-based HRD indicators, or CancerVision’s WGS-HRD, correlated with clinical outcomes following PARP inhibitor therapy.

Patients classified as WGS-HRD-positive had a longer median progression-free survival than those classified as WGS-HRD-negative, with an overall mPFS of 27.5 months versus 12.0 months. The association was most pronounced in the first-line maintenance setting, where WGS-HRD positive patients had an mPFS of 44.2 months versus 10.0 months. In the second-line maintenance setting, no significant difference in survival was observed based on HRD status, suggesting the predictive value of WGS-HRD may be strongest in earlier treatment settings.

The study also found that 21.4% of patients were WGS-HRD positive despite lacking BRCA mutations, underscoring the potential of WGS-HRD to identify patients who may not be captured by BRCA testing alone. Compared with the conventional scarHRD method, WGS-HRD demonstrated higher predictive value in clinical prognosis and PARP inhibitor responsiveness. The study adds to Inocras’ growing body of evidence supporting CancerVision as a comprehensive whole-genome sequencing platform for precision oncology.

"These findings provide important real-world evidence that whole-genome HRD scoring can advance how we identify ovarian cancer patients most likely to benefit from PARP inhibitor maintenance therapy," said Jehee Suh, CEO of Inocras. "CancerVision is a comprehensive WGS-based clinical analysis platform, and these data highlight its potential to enhance clinical decision-making."

"The first-line maintenance findings are particularly encouraging because they suggest that WGS-based HRD assessment may refine current BRCA- and genomic-scar–based approaches for identifying patients most likely to derive durable benefit from PARP inhibitor maintenance therapy," said Joonoh Lim, Physician Scientist at Inocras, who led the study in collaboration with Severance Hospital. "These findings add to the growing evidence base for whole-genome HRD assessment, and we look forward to prospective validation."

Abstract Details

Title: Whole-genome HRD phenotyping as a predictor of PARP inhibitor benefit in first-line maintenance high-grade serous ovarian cancer.
Format: Online publication / Online-only abstract
Abstract Number: e17608
Publication Date/Time: May 21 at 05:00 PM ET
Authors: Joonoh Lim, MD, PhD, Inocras Inc., San Diego, CA
Session/Category: Gynecologic Cancer

(Press release, Inocras, MAY 22, 2026, View Source [SID1234666021])

On May 22, 2026 Formosa Pharmaceuticals, Inc. reported that its abstract highlighting the differentiated binding profile and preclinical efficacy of TSY-310, a novel bispecific antibody-drug conjugate (ADC), has been selected for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held May 29 – June 2, 2026, in Chicago, Illinois. TSY-310 simultaneously targets EGFR and ROR1, two receptors frequently co-expressed in prevalent solid tumors. By leveraging a unique bispecific modality, TSY-310 optimizes target engagement and intracellular delivery, facilitating a potent bystander effect to address the challenges of tumor heterogeneity.

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Details

Title: TSY-310, A Novel Bispecific EGFR x ROR1 ADC, Exhibits Potent Antitumor Activity in Heterogeneous Breast Tumors Through Enhanced Internalization and Bystander Cytotoxicity
Session: Developmental Therapeutics: Molecularly Targeted Agents and Tumor Biology
Date & Time: May 30, 2026, 1:30 pm – 4:30 pm CT
Abstract Number: 3086
Poster Number: 223
Presenter: Dr. Kuo-Ming Yu, Ph.D., Director, CMC and Production

Highlights

Superior Selectivity: Bispecific binding, enhancing internalization specifically in tumor cells co-expressing EGFR and ROR1.
Enhanced Payload Delivery: Evidence of efficient lysosomal trafficking and the subsequent release of the cytotoxic payload.
Bystander Efficacy: Eradication of neighboring antigen-negative tumor cells, a critical factor in treating complex, heterogeneous tumor environments.

"Our participation at ASCO (Free ASCO Whitepaper) is an acknowledgement of the program’s potential as a worthy contributor to the future oncology treatment landscape," said Erick Co, President & CEO of Formosa Pharmaceuticals. "We are eager to place TSY-310 in the toolbox of oncologists and patients who face the evolving challenges with traditional single-target therapies."

Full abstract and presentation details will be available through ASCO (Free ASCO Whitepaper) and corporate websites in accordance with the meeting’s policies.

About TSY-310: TSY-310 is a next-generation bispecific ADC targeting EGFR and ROR1. By achieving high-affinity target recognition through an efficient, simplified protein architecture, TSY-310 aims to provide a durable, "best-in-class" therapeutic option for patients with advanced solid tumors, including Non-Small Cell Lung Cancer (NSCLC).

(Press release, Formosa Pharmaceuticals, MAY 22, 2026, View Source [SID1234665926])

On May 22, 2026 Alligator Bioscience (Nasdaq Stockholm: ATORX) today comments on a recent update shared by Shanghai Henlius Biotech, Inc. regarding long-term follow-up observations from clinical studies of HLX22.

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According to Henlius’ communication, long-term follow-up over more than 39 months indicates that patients treated with HLX22 continue to demonstrate extended progression-free survival (PFS) at the current observation point. The update reflects ongoing follow-up and does not include new numerical efficacy data.

HLX22 is an innovative anti-HER2 monoclonal antibody that has been granted orphan drug designation in both the U.S. and EU for gastric cancer and is being developed by Henlius under a license from AbClon, Inc., following a discovery collaboration which grants Alligator the right to participate in potential future revenues.

"We view Henlius’ update on the long-term follow-up of HLX22 as further evidence of the continued clinical development of the program," said Søren Bregenholt, CEO of Alligator Bioscience. "Sustained follow-up across studies is an important part of building the overall understanding of a molecule’s profile, and we note Henlius’ ongoing efforts to advance HLX22 across multiple indications."
Under the terms of Alligator’s agreement with AbClon, Alligator is entitled to 35% of AbClon’s revenue from its sublicense to Henlius, including potential milestone payments and royalty revenues, which, if HLX22 is successfully developed and approved, could represent a meaningful long-term revenue opportunity for Alligator.

(Press release, Alligator Bioscience, MAY 22, 2026, View Source [SID1234666006])

On May 22, 2026 PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, reported five upcoming presentations at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress. The ASCO (Free ASCO Whitepaper) annual meeting will be held May 29-June 2 in Chicago, and the EHA (Free EHA Whitepaper)2026 Congress will be held June 11-14 in Stockholm, Sweden.

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PharmaEssentia will present new analyses from the Phase 3 SURPASS-ET study (NCT04285086) of ropeginterferon alfa-2b in patients with essential thrombocythemia (ET), including two-year outcomes comparing early versus delayed initiation (continuous treatment from baseline vs. initiation following prior anagrelide therapy) and post-hoc analyses of patients who transitioned from anagrelide. Ropeginterferon alfa-2b-njft is currently FDA-approved and marketed as BESREMi for the treatment of adults with polycythemia vera (PV). The use of ropeginterferon alfa-2b-njft for ET is currently still investigational, but it is currently under review by FDA with a PDUFA goal date of August 30, 2026.

Findings from SURPASS-ET demonstrate sustained hematologic control and progressive molecular improvement with longer interferon exposure, with deeper molecular responses and improved long-term disease control observed with earlier initiation. Patients who transitioned from anagrelide showed improved hematologic parameters over 12 weeks, supporting the feasibility of treatment transition. Importantly, estimated progression-free survival (PFS) at 24 months was 76.9% in patients who received ropeginterferon alfa-2b from baseline compared to 43.1% in those with delayed initiation. Together, these data support consideration of earlier ropeginterferon alfa-2b use in high-risk ET following hydroxyurea intolerance or resistance.

PharmaEssentia will also present an integrated analysis of the SURPASS-ET and Phase 2b EXCEED-ET (NCT05482971) trials. The analysis includes 182 patients across both studies and evaluates the consistency of clinical benefit across treatment lines, including treatment-naïve and previously treated populations, as well as across molecular subtypes and ethnicities. Results demonstrated clinically meaningful hematologic and molecular responses in both treatment-naïve and pretreated patients. Efficacy was consistent across driver mutation subtypes, and the presence of additional non-driver mutations did not adversely impact outcomes.

"These findings represent an important step forward in understanding the potential use of interferon-based approaches in essential thrombocythemia," said Ruben Mesa, M.D., co-principal investigator, presenting author, and President of Advocate Health Cancer National Service Line. "Together, these data continue to build on the growing body of evidence supporting the use of ropeginterferon alfa-2b in ET and reinforce its potential role as a meaningful treatment option for patients."

In addition, PharmaEssentia will present real-world data evaluating the association between neutrophil-to-lymphocyte ratio (NLR) and thrombotic risk in 11,809 U.S. veterans with PV. An online-only abstract will also report findings from a meta-analysis evaluating dosing strategies for ropeginterferon alfa-2b in PV, suggesting that a higher initial dose with accelerated titration (HIDAT) may lead to improved early hematologic and molecular response rates compared to lower-dose currently approved regimens.

ASCO
Poster Presentations

Title: Integrated Analysis of the Ropeginterferon alfa-2b Clinical Program in Essential Thrombocythemia to Demonstrate Molecular and Hematologic Responses with Safety Profile Across Treatment Lines, Ethnicities, and Driver Mutation Types
Abstract Number: 6576
Poster: 369
Presenter: Ruben Mesa, M.D.
Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Date: June 1st
Time: 9-12 pm CDT

Title: Association of neutrophil‑to‑lymphocyte ratio and thrombotic events in US Veterans with Polycythemia vera
Abstract Number: 6578
Poster: 371
Presenter: Ying Wang, PhD
Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Date: June 1st
Time: 9-12 pm CDT

Published Abstract

Title: Effect of Higher Initial Dose and Accelerated Titration of Ropeginterferon Alfa-2b on Early Hematologic and Molecular Responses in Polycythemia Vera: A Meta-Analysis
Abstract Number: e18592

EHA
Oral Presentation
Title: Early versus Delayed Initiation of Ropeginterferon Alfa-2b in High-Risk Essential Thrombocythaemia: Two-Year Results from the Phase 3 SURPASS-ET Study
Abstract Number: S219
Presenter: Harry Gill, M.D.
Session: Myeloproliferative neoplasms – Clinical
Date: June 13th
Time: 5:15 – 6:30 pm CEST

Poster Presentations

Title: Ropeginterferon alfa-2b Demonstrates Molecular and Hematologic Responses with a Favorable Safety Profile in Essential Thrombocythemia
Abstract Number: PS1986
Presenter: Harry Gill, M.D.
Session: Myeloproliferative neoplasms – Clinical
Date: June 13th
Time: 6:45 – 7:45 pm CEST

Title: Hematologic Control and Improved Safety Following Switch from Anagrelide to Ropeginterferon Alfa-2b in Patients with Essential Thrombocythemia: 12-Week Pre-/Post-Switch Analysis from the SURPASS-ET study
Abstract Number: PF912
Presenter: Lucia Masarova, M.D.
Session: Myeloproliferative neoplasms – Clinical
Date: June 12th
Time: 6:45 – 7:45 pm CEST

(Press release, PharmaEssentia, MAY 22, 2026, View Source [SID1234666022])

On May 21, 2026 GENFIT (Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, reported its cash position as of March 31, 2026 and revenues for the first three months of 20261 and provides a corporate update.

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Cash Position & Revenues
Cash position

As of March 31, 2026, the Company’s cash and cash equivalents amounted to €136.1 million compared with €129.5 million as of March 31, 2025, and €101.1 million as of December 31, 2025. In 2026, cash utilization is mainly the result of our research and development efforts (notably NTZ/G1090N, SRT-015, CLM-022, and VS-02 HE in Acute on-Chronic Liver Failure), as well as GNS561 in Cholangiocarcinoma (CCA). Cash utilization is offset by two items received in the first quarter of 2026 – the €17.0 million (US$20.0 million) first commercial milestone recognized at the end of 2025 and collected in early 2026 under the Ipsen Agreement, and the €30.0 million second installment of the Royalty Financing agreement. 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 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

Revenue2 for the first three months of 2026 amounted to €9.6 million compared to €2.8 million for the same period in 2025. Revenue for the first three months of both periods was attributable to royalties from sales of Iqirvo3 (elafibranor) from Ipsen.

II. Corporate update and program highlights

The Company confirms previous timelines across all growth platforms.

Ipsen’s Iqirvo (elafibranor) in Primary Biliary Cholangitis (PBC) 4

The strong commercial sales trajectory reported by our partner Ipsen in the first quarter of 2026 is explained by accelerated sales growth in the US driven by a higher number of patients, and strong launches across European countries. Iqirvo’s net sales for the first quarter of 2026 amounted to €78.8m. Full-year 2025 sales amounted to US$208 million, triggering the first US$20 million commercial milestone payment to GENFIT one year ahead of schedule. This momentum also allowed GENFIT to activate, in January 2026, an additional €30 million tranche under GENFIT’s Royalty Financing agreement with HCRx, enhancing financial flexibility without shareholder dilution.

Next steps: On July 30, 2026, Ipsen will publish its sales results for the first semester of 2026. Ipsen confirmed ELSPIRE Phase 3 study readout by end of 2026.

Non-invasive diagnostic technology in Metabolic dysfunction‑Associated SteatoHepatitis (MASH)

The MASH therapeutics market accelerated in 2025, with near blockbuster performance (~US$1 billion in sales) achieved by the first approved drug therapy in its first year of commercialization, increasing the need for large scale, non-invasive diagnostic, further reinforced by the entry of an additional major pharmaceutical company in August. Against this backdrop, U.S. Medicare and Medicaid have taken an initial step by establishing a pricing framework for NASHnext. NASHnext is a diagnostic test developed and commercialized by Labcorp as a Laboratory Developed Test (LDT) under license from GENFIT. It leverages GENFIT’s proprietary non-invasive diagnostic technology to identify patients at risk of progressive MASH and support treatment decision-making. This represents an important progress toward potential reimbursement and broader payer adoption, supported by Labcorp’s US commercial infrastructure.

Next steps: A commercial launch by Labcorp is expected in the coming weeks, with initial access to NASHnext enabled through Labcorp’s on-demand test menu, marking the start of a phased expansion beyond the current clinical trial setting. This rollout is already accelerating, notably in anticipation of upcoming reimbursement. GENFIT plans to host an analyst event to present recent publications demonstrating the clinical utility of its non-invasive (NIS) technology, outline its strategy in MASH diagnostics — including its In Vitro Diagnostics (IVD) approach — and provide a detailed overview of the MASH diagnostics market potential.

Clinical development of GNS561 in Cholangiocarcinoma (CCA)

Following encouraging preliminary data from the ongoing Phase 1b study evaluating investigational drug GNS561 with a MEK inhibitor (MEKi) in KRAS mutated CCA, the Phase 1b dose escalation is progressing as planned.

Next steps: Phase 1b safety data from initial cohorts expected in mid 2026, as planned. Additional data anticipated in the second half of 2026, following study expansion into additional cohorts supported by encouraging preliminary signals.

Clinical development of G1090N/NTZ in Acute-on-Chronic Liver Failure (ACLF)

Positive Phase 1 data reported in early 2026 confirmed the favorable safety profile of G1090N/nitazoxanide (NTZ) and demonstrated multi‑modal biological activity, supporting its continued clinical development across the ACLF disease continuum. In March 2026, NTZ was granted Orphan Drug Designation for the treatment of ACLF.

Next steps: Initiation of a proof‑of‑concept study with nitazoxanide targeted for the second half of 2026, with data expected in 2027.

Ipsen’s elafibranor lifecycle: important potential in PSC (Primary Sclerosing Cholangitis)4

In early 2026, Ipsen announced the initiation of the Phase 3 ELASCOPE study in PSC. The PSC market opportunity is estimated to be comparable in size to the second‑line PBC market. Subject to successful development and regulatory approval of elafibranor in this indication, GENFIT would be eligible to receive additional milestone payments as well as incremental double‑digit royalties.

Next steps: Phase 3 readout, based on clinical outcomes rather than a surrogate endpoint, is expected around 2031.

Preclinical programs

A pipeline update on ongoing research programs is planned for the third quarter of 2026, covering assets across the ACLF continuum (SRT‑015, CLM‑022, VS‑02‑HE and EViv) as well as Urea Cycle Disorders (UCD) with VS‑01‑HAC.

(Press release, Genfit, MAY 21, 2026, https://ir.genfit.com/news-releases/news-release-details/genfit-reports-first-quarter-2026-financial-information-and [SID1234665927])