Roche receives FDA approval for companion diagnostic tests to identify patients with HER2-positive metastatic gastroesophageal adenocarcinoma eligible for ZIIHERA

On August 26, 2026 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that it has received FDA approval for expanded use of its PATHWAY HER2 (4B5) and VENTANA HER2 Dual ISH DNA Probe Cocktail tests. These companion diagnostics are now approved to assess HER2-positive status in metastatic gastroesophageal adenocarcinoma (GEA) patients, including those with gastric, gastroesophageal junction, and esophageal adenocarcinoma. The approval enables clinicians to identify HER2-positive GEA patients who may be eligible for HER2-targeted treatment with Jazz Pharmaceuticals’ ZIIHERA (zanidatamab-hrii). Two ZIIHERA-containing regimens are now FDA approved for the first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive GEA.

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Gastroesophageal adenocarcinoma encompasses a group of related cancers originating in the gastrointestinal tract, including gastric and esophageal cancer. These closely-related, aggressive cancers are typically diagnosed late1,2 and are the fifth (gastric) and sixth (esophageal) leading causes of cancer deaths worldwide.3 Despite advances in diagnosis and treatment, the prognosis for these cancers remains poor, with limited therapeutic options available.4,5

"GEA can be a difficult diagnosis for patients to face, with most cases only being detected once the disease has progressed to an advanced stage," said Laura Apitz, Head of Pathology Lab at Roche Diagnostics. "By adding GEA to the approved indications for our widely-available HER2 assay, we expand the patient population eligible for targeted therapy and potentially improve patient outcomes."

This FDA approval broadens the population of patients eligible for HER2-targeted therapies to include those with HER2-positive GEA.6 Until now, no tests had been approved to determine HER2 status in esophageal cancer, meaning patients were unable to access targeted therapy. Already widely used and trusted in breast and gastric cancers, these tests are an important step forward in providing access to new treatment options for this hard-to-treat disease.

About the PATHWAY HER2 (4B5) test and VENTANA HER2 Dual ISH DNA Probe Cocktail

The PATHWAY HER2 (4B5) Rabbit Monoclonal Primary Antibody test and VENTANA HER2 Dual ISH DNA Probe Cocktail work together to assess HER2 status, delivering diagnostic precision and enabling timely therapeutic decisions for patients with HER2-positive cancers. Together, these tests provide labs and pathologists with reliable, actionable insights to support personalised treatment approaches.

The PATHWAY HER2 (4B5) test is the most widely adopted HER2-immunohistochemistry (IHC) primary antibody globally,7 achieving consistently high proficiency assessment scores,7 and demonstrating high concordance with HER2 FISH testing.8,9 Its design ensures accuracy and reproducibility, with integration into the fully automated VENTANA BenchMark slide staining platform to minimise variability and reduce manual steps across all IHC processes.

The VENTANA HER2 Dual ISH DNA Probe Cocktail enables the advanced detection of HER2 gene amplification. With its dual-colour technology, pathologists can easily compare HER2 status with H&E and other GI panel markers within the same case,10 ensuring consistent and confident diagnoses. The test also maintains high concordance with HER2 FISH testing,11 making it a reliable component of HER2 diagnostic workflows.

Together, the tests strengthen Roche’s comprehensive HER2 diagnostic portfolio. By delivering reliable and actionable results, they support diagnostic precision across multiple cancer types, expanding access to personalised treatment options and improving outcomes for patients facing HER2-positive cancers.

For more information about the portfolio, please visit the Roche Diagnostics Pathology Lab companion diagnostics page.

(Press release, Hoffmann-La Roche, AUG 26, 2026, View Source [SID1234670364])

Faron Pharmaceuticals Ltd: Half-year financial results 1 January – 30 June 2026

On August 26, 2026 Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, reported it has published its unaudited half-year financial results for the six months ended 30 June 2026, on 26 August 2026.

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Figures in parentheses refer to the corresponding period of previous year, unless otherwise indicated.

This half-year report is unaudited. The unaudited interim financial report incorporates the Company, Faron Pharmaceuticals Ltd only. Following the liquidation and closure of the Company’s subsidiaries during the reporting period, the Company no longer has subsidiaries and therefore does not prepare consolidated financial information. The comparative figures have been adjusted to include only the Company’s figures.

January – June 2026 in brief

27 January 2026 – Faron announced a significant expansion to the scope of clinical trials involving bexmarilimab by supporting the investigator-initiated trial (IIT) BEXAR, building evidence on the role of the Clever-1 pathway in solid tumors. The BEXAR trial evaluates Faron’s lead asset, bexmarilimab, in combination with standard-of-care (SoC) doxorubicin for patients with metastatic soft-tissue sarcoma.
9 February 2026 – Faron announced that it is planning a rights issue of approximately EUR 40 million to strengthen its capital structure and to drive its lead asset bexmarilimab to key value-creating milestones and convened an Extraordinary General Meeting to approve the related authorization to the Board of Directors.
19 February 2026 – Faron announced the Phase 2 BEAM IIT, led by the Nordic AML Group, evaluating bexmarilimab in combination with azacitidine to prevent relapse in measurable residual disease (MRD)-positive acute myeloid leukemia (AML) after allogeneic stem cell transplantation.
2 March 2026 – Faron and City of Hope (US) announced the development of a Phase 2 IIT of bexmarilimab in combination with an oral hypomethylating agent (HMA) in relapsed/refractory (r/r) myelodysplastic syndrome (MDS).
26 March 2026 – Faron appointed Mr. Heikki Jouttijärvi as Chief Technical Officer (CTO) to strengthen late-stage development, manufacturing and supply chain activities.
9 April 2026 – Faron published the final results of its rights issue, raising gross proceeds of approximately EUR 40.1 million.
16 April 2026 – Faron announced a collaboration with Parexel, a global clinical research organization, to support the randomized Phase 2b BEXERA trial (FP2CLI012) in frontline, treatment-naïve higher-risk (HR) MDS, planned to start in the second half of 2026.
4 May 2026 – The Annual General Meeting (AGM) adopted the 2025 financial statements, re-elected the auditor, approved a new stock option plan and elected Dr. George Stanley Golumbeski as a new member of the Board of Directors.
15 June 2026 – Faron announced the matured BEXMAB data presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress confirming durable efficacy and bone marrow reprogramming in HR-MDS. Median duration of complete remission (CR) in treatment-naïve HR-MDS patients extended to 16.1 months with bexmarilimab + azacitidine.
R&D expenses were EUR 7.6 (7.1) million.
Operating loss for the reporting period was EUR -11.1 (-11.8) million.
Loss per share was EUR 0.06 (0.18).
On 30 June 2026, cash and cash equivalents were EUR 32.0 (13.5) million.
Net assets were EUR 11.6 (-16.7) million.
Significant events after the reporting period

1 July 2026 – The Company’ Board has confirmed the grant of a total of 2,173,000 options over ordinary shares in the Company under the Company’s Share Option Plan 2026.
13 July 2026 – Faron provided an update on its portfolio of Investigator-Initiated Trials (IITs) evaluating bexmarilimab, its wholly owned anti-Clever-1 immunotherapy, in multiple oncology indications. The update covers five IITs in solid tumors and hematological malignancies, reflecting both advances and adjustments across the program.
27 July 2026 – Faron announced that it has conducted its first overall survival (OS) data cut from treatment-naïve higher-risk myelodysplastic syndrome (HR-MDS) patients enrolled in the BEXMAB trial. At this time, after a median follow-up of 14.9 months, the only subgroup to have hit the median is the biallelic TP53 mutated population. This subgroup, historically associated with very poor outcomes, achieved a median OS of 8.8 months, which is in line with historical data and reassuring given the complex cytogenetics within the BEXMAB biallelic patient population.
3 August 2026 – Faron approved the exercise of 3,657,321 special rights entitling to 3,657,321 shares in the Company, for an aggregate subscription price of EUR 1,578,499.74 in connection with the scheduled amortisation payment of the First and Second Tranche Bonds.
Key figures, IFRS

EUR ’000 unless otherwise indicated 1-6/2026
(Unaudited) 1-6/2025
(Unaudited) 1-12/2025
(Audited)
Other operating income – – 1,308
Research and development expenses (7,592) (7,095) (12,628)
General and administrative expenses (3,510) (4,736) (7,570)
Operative loss for the reporting period (11,103) (11,831) (18,890)
Loss per share EUR (0.06) (0.18) (0.24)
Number of shares at end of period 202,881,315 111,954,597 114,420,465
Average number of shares 152,771,955 107,403,444 111,718,219
Cash and cash equivalents 31,977 13,509 12,308
Equity 11,558 (16,714) (18,984)
Balance sheet total 35,811 16,828 17,826
Outlook for 2026

Due to the nature of Faron Pharmaceuticals’ business, the Company does not provide a short-term outlook.

CEO Statement

"The first half of 2026 was a demanding period for Faron, which we successfully navigated with determination and hard work. We began the year with two main themes: advancing bexmarilimab’s development in HR-MDS and demonstrating that our lead asset is also suitable in other indications, especially in solid tumors. I am proud to say that we made decisive progress on both of these fronts during the first half and are very enthusiastic about the future.

Successful rights issue supports Faron’s lead position in HR-MDS

In April, we completed one of Finland’s largest biotechnology financing rounds ever with our EUR 40.1 million rights issue. We are very pleased with the results of the rights issue, which reflect the strong commitment and trust of both our existing shareholders and new cornerstone investors. The raised funds provide a decisive foundation for our next chapter and our most important value driver: the upcoming randomized Phase 2b BEXERA trial in frontline HR-MDS.

Preparations for the BEXERA trial are well underway, and we expect the trial to begin as planned in the second half of 2026. The trial is expected to enrol 90 participants across up to 35 sites in the United States (US), Europe and the United Kingdom (UK). The objective of the trial is to select the recommended Phase 3 dose and demonstrate the efficacy and safety of combining bexmarilimab with SoC azacitidine in a frontline randomized, placebo-controlled setting to support future registrational filings. In April, we entered into an agreement with Parexel, a leading global clinical research organization, to support the trial. The collaboration is focused on ensuring disciplined trial execution, timely delivery and operational efficiency as the program progresses.

Bexmarilimab continues to stand out as one of the most innovative and advanced development programmes in HR-MDS. In June, we presented matured data from the BEXMAB Phase 1/2 study at the EHA (Free EHA Whitepaper) 2026 Congress, further reinforcing the clinical and biological potential of bexmarilimab to induce haematopoiesis, activate T cells and overcome treatment resistance in the bone marrow microenvironment. In our view, bexmarilimab remains at the forefront of innovation in MDS, representing a novel mechanism with the potential to transform treatment outcomes. While the field is attracting increasing interest from both existing players and new entrants, most competing approaches are built on previously failed treatment methods, such as BCL-2 and CD47 inhibitors. We have adapted our trial design based on clinical learnings, including redefining the approval endpoint to CR, and are now seeing others in the field beginning to follow a similar path. With our strengthened balance sheet, we are well positioned to advance the program, generate further clinical evidence and maintain strategic flexibility while continuing partnering discussions.

Investigator-initiated trials provide evidence in solid tumors

While our primary focus remains in HR-MDS, we continue to demonstrate bexmarilimab’s potential in solid tumors through a growing number of IITs. Last year, two articles were published in the Journal for ImmunoTherapy of Cancer, highlighting the significance of Clever-1 in solid tumors and deepening our understanding of bexmarilimab’s mode of action in the tumor microenvironment. These results contribute to the design of future trials.

IITs require minimal financial investment from Faron and are designed to evaluate bexmarilimab’s potential in overcoming treatment resistance in diseases such as lung cancer, melanoma and sarcoma. In January, we announced support for the BLAZE and BEXAR IITs, which significantly expands the range of clinical settings in which bexmarilimab is being investigated. The BEXAR trial evaluates bexmarilimab in combination with SoC doxorubicin for patients with metastatic soft-tissue sarcoma, while the BLAZE trial aims to overcome resistance to anti-PD-1 therapy in checkpoint-refractory melanoma and non-small cell lung cancer.

In addition to solid tumors, we are expanding our efforts in malignant haematology. While the BEXMAB trial primarily focuses on HR MDS, it also includes patients with AML. Insights gained from these patients have helped shape our AML development strategy and supported plans for a dedicated Phase 2 trial in AML, targeting biologically defined patient population with a differentiated competitive position. In February, we announced the Phase 2 BEAM IIT, led by the Nordic AML Group, evaluating bexmarilimab in combination with azacitidine to prevent relapse in measurable residual disease (MRD)-positive AML after allogeneic stem cell transplantation. This setting is supported by a strong biological rationale and represents a distinct opportunity within the AML treatment landscape. We are excited to advance these trials and generate further clinical evidence of bexmarilimab’s potential to overcome treatment resistance in new indications.

(Press release, Faron Pharmaceuticals, AUG 26, 2026, View Source [SID1234670363])

BioInvent International AB: Interim report January – June 2026

On August 26, 2026 BioInvent International AB reported Interim report January – June 2026.

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"During the second quarter, both of our lead programs generated clinical data that further strengthened their competitive positioning. BI-1808 (anti-TNFR2) reported new results in two distinct indications, recurrent ovarian cancer and cutaneous T-cell lymphoma (CTCL), each a setting where patients have few effective options after standard treatment fails. BI-1206 (anti-FcγRIIB) reported triplet combination data in relapsed/refractory non-Hodgkin’s lymphoma (NHL) that compares favorably with recently approved regimens. We presented these results at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) and discussed them directly with the clinical community through two KOL events." – Martin Welschof, CEO of BioInvent.

EVENTS IN THE SECOND QUARTER

BioInvent revealed solid data for the BI-1808 and KEYTRUDA (pembrolizumab) combination (ASCO 2026):
24% confirmed ORR (including complete response) in heavily pretreated patients (n=25) with advanced ovarian cancer who received BI-1808 and KEYTRUDA — multiplying by three the historical KEYTRUDA single agent activity of 8% in KEYNOTE-100 (2019) (R)
BI-1808 showcased strong activity and immune activation data as single agent and in combination with KEYTRUDA in advanced CTCL (EHA 2026)
BI-1206 triplet combination with rituximab and acalabrutinib achieved 83% response rate in refractory NHL with improved safety vs. standard of care (EHA 2026)
Two successful KOL events showcasing the positive ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) data for BI-1808 and BI-1206
EVENTS AFTER THE END OF THE PERIOD

BI-1808 received FDA Fast Track Designation for the treatment of ovarian cancer
BioInvent’s BI-1808 abstract from Modest to Meaningful in platinum-resistant ovarian cancer accepted for poster presentation at ESMO (Free ESMO Whitepaper) 2026
BioInvent published two scientific papers in peer-reviewed journals. One in Cancer Research: "Ligand-Blocking and Agonist Antibodies Targeting TNFR2 Employ Distinct Modes of Action to Induce Antitumor Immunity" and one in JECCR: Tailored FcγR Blockade with BI-1206 and BI-1607 Enhances Cancer Antibody Therapies and Overcomes Resistance in Preclinical Models
(R)= Regulatory event

FINANCIAL INFORMATION
Second quarter 2026

Net sales SEK 12.8 (198.1) million.
Profit/loss after tax SEK -122.9 (38.8) million.
Profit/loss after tax per share before and after dilution SEK -1.87 (0.59)
Cash flow from operating activities SEK -112.0 (66.8) million.
January – June 2026

Net sales SEK 26.2 (220.2) million.
Profit/loss after tax SEK -242.1 (-77.8) million.
Profit/loss after tax per share before and after dilution SEK -3.68 (-1.18)
Cash flow from operating activities SEK -244.8 (-53.2) million.
Liquid funds and current investments as of June 30, 2026: SEK 340.8 (797.5) million.
The complete interim report is available for download below and on the company’s website under Financial reports.

(Press release, BioInvent, AUG 26, 2026, https://www.bioinvent.com/en/press/bioinvent-international-ab-interim-report-january-june-2026-2477090 [SID1234670361])

West to Participate in Upcoming Investor Conferences

On August 26, 2026 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported that it will present at the following upcoming investor conferences:

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Wells Fargo Annual Healthcare Conference on Thursday, September 10, 2026 at 8:45 a.m. EDT in Everett, MA
Morgan Stanley Annual Global Healthcare Conference on Monday, September 14, 2026 at 8:30 a.m. EDT in New York, NY
The live webcasts for these events can be accessed in the Investors section of the Company’s website. A replay of each webcast will also be available on the Company’s website for approximately 90 days after each respective event.

(Press release, West Pharmaceutical Services, AUG 26, 2026, View Source [SID1234670357])

Vertex to Participate in Upcoming September Investor Conferences

On August 26, 2026 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported management participation in four upcoming investor conferences.

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Susie Lisa, Senior Vice President of Investor Relations and Manisha Pai, Executive Director of Investor Relations, will participate in a fireside chat at the Wells Fargo 21st Annual Healthcare Conference on Wednesday, September 9, 2026, at 4:30 p.m. EDT.
Susie Lisa and Manisha Pai will also participate in a fireside chat at the 2026 Cantor Global Healthcare Conference on Thursday, September 10, 2026, at 2:10 p.m. EDT.
Reshma Kewalramani, M.D., CEO and President, will participate in a fireside chat at the Morgan Stanley 24th Annual Global Healthcare Conference on Monday, September 14, 2026, at 7:00 a.m. EDT.
Susie Lisa and Miroslava Minkova, Executive Director of Investor Relations, will participate in a fireside chat at the Bank of America Global Healthcare Conference London on Wednesday, September 23, 2026, at 10:05 a.m. GMT/5:05 a.m. EDT.

A live webcast of management’s remarks will be available through the Vertex website, www.vrtx.com, in the "Investors" section under the "News and Events" page. A replay of the conference webcast will be archived on the company’s website.

(Press release, Vertex Pharmaceuticals, AUG 26, 2026, View Source [SID1234670356])