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NANOBIOTIX Announces Updates to JNJ-1900 (NBTXR3) Clinical Program Following Transfer of Ongoing Phase 3 Head and Neck Cancer Trial Sponsorship and Operational Control

On October 24, 2025 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer and other major diseases, reported updates to the JNJ-1900 (NBTXR3) clinical development program.

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Nanobiotix has completed the transfer of NANORAY-312 sponsorship, initiated in 3Q2024, in the majority of regions along with the transfer of full operational control of the Phase 3 clinical trial to Johnson & Johnson ("J&J"). Following the transfer and Nanobiotix analysis of the latest information, Nanobiotix estimates that NANORAY-312 interim data will be analyzed and reported, after both the requisite number of events have been observed and the last patient has been recruited, in 1H2027.

Future guidance related to NANORAY-312 and other JNJ-1900 (NBTXR3)-related J&J-sponsored studies will be communicated by J&J. Nanobiotix will continue to provide JNJ-1900 (NBTXR3) clinical development updates and guidance related to Nanobiotix-sponsored studies as well as studies sponsored by The University of Texas MD Anderson Cancer Center.

About JNJ-1900 (NBTXR3)

JNJ-1900 (NBTXR3) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas through a successful randomized Phase 2/3 study in 2018. The product candidate’s mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that JNJ-1900 (NBTXR3) could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

Radiotherapy-activated JNJ-1900 (NBTXR3) is being evaluated across multiple solid tumor indications as a single agent or combination therapy. The program is led by NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of JNJ-1900 (NBTXR3) activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating JNJ-1900 (NBTXR3) across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a Johnson & Johnson company.

(Press release, Nanobiotix, OCT 24, 2025, View Source [SID1234656978])

Mural Oncology Announces that Mural Shareholders Approve the Proposed Acquisition by XRA 5 Corp., a Wholly Owned Subsidiary of XOMA Royalty

On October 24, 2025 Mural Oncology plc (Nasdaq: MURA) ("Mural") reported that its shareholders have voted to approve the previously announced proposed acquisition of Mural by XRA 5 Corp. ("Sub"), a wholly owned subsidiary of XOMA Royalty Corporation (Nasdaq: XOMA) ("XOMA Royalty"). As described in more detail below, a majority in number of the shareholders of record present and voting, either in person or by proxy and more than 99 percent of the votes cast at both a scheme meeting of shareholders (the "Scheme Meeting") and an extraordinary general meeting of shareholders (the "EGM"), both held on October 24, 2025 in Dublin, Ireland, were in favour of the transaction, representing in respect of the Scheme Meeting, approximately 58 percent of the shares outstanding and eligible to be voted at the Scheme Meeting and in respect of the EGM, approximately 61 percent of the shares outstanding and eligible to be voted at the EGM.

Under the terms of the transaction agreement among XOMA Royalty, Sub and Mural announced on August 20, 2025 (the "Transaction Agreement"), Sub has agreed to acquire the entire issued and to be issued share capital of Mural (the "Acquisition"). Under the terms of the Acquisition and subject to certain conditions, following closing, each Mural shareholder (i) would receive a base cash price of $2.035 per share (the "Base Price Per Share"), which has been calculated on the basis of Mural having approximately $36.2 million in Closing Net Cash on the Closing Net Cash Date (each as defined in the Transaction Agreement) (the "Estimated Closing Net Cash") and (ii) may receive an additional cash amount per share of up to $0.205 (the "Additional Price Per Share"), which would be calculated on the basis of the amount by which Mural’s Closing Net Cash on the Closing Net Cash Date exceeds the Estimated Closing Net Cash. The Base Price Per Share would be payable to Mural shareholders on closing of the Acquisition regardless of the actual quantum of Mural’s Closing Net Cash on the Closing Net Cash Date.

The Acquisition, excluding any amount that may be payable in respect of the Additional Price Per Share, values the entire issued and to be issued share capital of Mural at approximately $36.2 million.

The Acquisition is expected to close in the fourth quarter of 2025, subject to customary closing conditions and the sanction of the scheme of arrangement by the High Court of Ireland.

Results of Scheme Meeting and Extraordinary General Meeting

As described above, on October 24, 2025, Mural held the Scheme Meeting and EGM in Dublin, Ireland, in each case relating to the Acquisition. Both meetings were held to seek shareholder approval of the Acquisition, which will be effected by means of a "scheme of arrangement" under Chapter 1 of Part 9 of the Irish Companies Act of 2014, in accordance with Irish law. Mural shareholders approved the proposal at the Scheme Meeting and each of the proposals at the EGM that were required to approve and implement the scheme of arrangement.

There were 17,324,771 ordinary shares of Mural outstanding as of 10.00 p.m. (Irish local time) on September 18, 2025, the voting record time for the Scheme Meeting and the EGM. A quorum was present at each of the Scheme Meeting and the EGM. Because the votes required to approve the proposals at the Scheme Meeting and the EGM are based on votes properly cast at the applicable meeting, and because abstentions are not considered votes properly cast, abstentions and broker non-votes along with failures to vote have no effect on such proposals.

Mural will be filing a Current Report on Form 8-K with the U.S. Securities and Exchange Commission setting forth the final results of voting on each of the proposals submitted to a vote of Mural’s shareholders at the Scheme Meeting and the EGM. The final results of voting on each of the proposals submitted to a vote of Mural’s shareholders at the Scheme Meeting and the EGM are as follows.

Scheme Meeting

At the Scheme Meeting, the Mural shareholders voted on the proposal described below.

1. That the scheme of arrangement in its original form or with or subject to any modification(s), addition(s) or condition(s) approved or imposed by the Irish High Court be agreed to:

Mural shareholders approved Proposal 1 with the following voting results including the percentage of votes cast for and against the proposal:

For Against Abstain Broker Non-Votes
10,103,706 99.20%
81,149 0.79%
52,031 -

In addition, of the 9 shareholders of record voting on the proposal, 8 shareholders of record or 88.89% of those voting, voted in favour of the proposal and 1 shareholder of record or 11.11% of those voting, voted against the proposal.

The Mural shares voted in favour of and against Proposal 1 represented 58.31% and 0.46%, respectively, of the 17,324,771 Mural shares outstanding as of the voting record time and entitled to vote at the Scheme Meeting.

The votes cast in favour of Proposal 1 represented a majority in number of the shareholders of record present and voting, either in person or by proxy, and at least 75% of the value of the shares voted at the meeting, either in person or by proxy.

EGM

At the EGM, Mural shareholders voted on the proposals described below.

1. To approve the scheme of arrangement in its original form or with or subject to any modification(s), addition(s) or condition(s) approved or imposed by the Irish High Court and authorize the directors of Mural to take all such actions as they consider necessary or appropriate for carrying the scheme of arrangement into effect:

Mural shareholders approved Proposal 1 at the EGM with the following voting results including the percentage of votes cast for and against the proposal:

For Against Abstain Broker Non-Votes
10,607,228 99.16% 89,435 0.83% 13,056 -

2. To approve the amendment to the articles of association of Mural so that any ordinary shares of Mural that are issued on or after the voting record time to persons other than Sub and/or its nominees will either be subject to the terms of the scheme or be immediately and automatically acquired by Sub and/or its nominee(s) for the scheme consideration:

Mural shareholders approved Proposal 2 at the EGM with the following voting results including the percentage of votes cast for and against the proposal:

For Against Abstain Broker Non-Votes
10,647,967 99.54% 48,436 0.45% 13,316

(Press release, Mural Oncology, OCT 24, 2025, View Source [SID1234656977])

Kura Oncology Receives $30 Million Development Milestone Payment in Ziftomenib AML Program with Kyowa Kirin

On October 24, 2025 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported receipt of a $30 million milestone payment under its collaboration agreement with Kyowa Kirin in connection with the dosing of the first patient in the KOMET-017 Phase 3 registrational trials of ziftomenib, a once-daily, investigational oral menin inhibitor. Kura and Kyowa Kirin announced the launch of the KOMET-017 trials on September 29, 2025.

KOMET-017 (NCT07007312) comprises two independent, global, randomized double-blind, placebo-controlled Phase 3 trials to evaluate ziftomenib in combination with both intensive and non-intensive chemotherapy regimens in patients with newly diagnosed NPM1-mutated (NPM1-m) or KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML). Kura believes KOMET-017 is the only menin inhibitor program actively pursuing registrational trials across both intensive and non-intensive chemotherapy settings.

(Press release, Kura Oncology, OCT 24, 2025, View Source [SID1234656976])

Chugai Announces 2025 3rd Quarter Results

On October 24, 2025 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its financial results for the third quarter of fiscal year 2025.

Chugai reported increased revenue and operating profit year-on-year for the third quarter (Core-basis).

Regarding revenue, domestic sales increased by 3.6%. In the oncology field, sales increased by 0.2%. While our mainstay product Avastin was affected by NHI drug price revisions and generics, this was offset by steady growth of new products Phesgo, Lunsumio, and our mainstay product Polivy. In the specialty field, sales increased by 7.7%, driven by steady performance of mainstay products Vabysmo, Hemlibra, and Enspryng, along with successful market penetration of the new product PiaSky. Overseas sales increased by 7.7%, driven by a substantial increase in exports of Actemra to Roche. Other revenue decreased by 0.9%, despite the increase in income related to Hemlibra, mainly due to a decrease in one-time income.

Cost to sales ratio increased by 0.6 percentage points year-on-year to 33.1%, mainly due to changes in the product mix. Research and development expenses increased by 0.7% due to investments into drug discovery and early development, and increases associated with the progress of development projects, while selling, general and administrative expenses decreased by 4.3% mainly driven by various expenses. Other operating income (expense) resulted in income of ¥0.4 billion. As a result, Core operating profit was ¥450.5 billion (+5.6%) with a Core operating profit margin (to revenue) of 49.4%.

Chugai made good progress in both in-house products and products in-licensed from Roche.

For in-house products, PiaSky was launched in Taiwan as the first subcutaneous formulation for paroxysmal nocturnal hemoglobinuria. Enspryng has obtained results from Phase III clinical trials for thyroid eye disease, and will be discussed with health authorities. For Chugai originated project, Orforglipron, an oral GLP-1 receptor agonist out-licensed to Eli Lilly, met primary endpoints in multiple Phase III clinical trials for obesity and type 2 diabetes.

For products in-licensed from Roche, Tecentriq has obtained approval for an expanded indication for relapsed or refractory extranodal NK/T-cell lymphoma, nasal type. Avastin has been filed for an expanded indication for neurofibromatosis type II. Glofitamab has initiated Phase II clinical trials in Japan for both relapsed or refractory diffuse large B-cell lymphoma and relapsed or refractory mantle cell lymphoma. Additionally, afimkibart has initiated Phase III clinical trial for Crohn’s disease, and divarasib initiated Phase Ib/II clinical trial for non-small cell lung cancer (first-line treatment). Furthermore, Chugai has in-licensed CT-388, a long-acting GLP-1/GIP receptor agonist, from Roche.

[2025 third quarter results]

Billion JPY 2025
Jan – Sep 2024
Jan – Sep % change
Core results
Revenue 911.6 868.5 +5.0%
　Sales 794.6 750.3 +5.9%
　Other revenue 117.1 118.2 -0.9%
Operating profit 450.5 426.6 +5.6%
Net income 320.0 301.3 +6.2%
IFRS results
Revenue 911.6 868.5 +5.0%
Operating profit 429.8 418.6 +2.7%
Net income 305.6 295.8 +3.3%
[Sales breakdown]

Billion JPY 2025
Jan – Sep 2024
Jan – Sep % change
Sales 794.6 750.3 +5.9%
Domestic sales 343.7 331.7 +3.6%
　Oncology 180.7 180.3 +0.2%
　Specialty 163.0 151.3 +7.7%
Overseas sales 450.9 418.7 +7.7%
[Oncology field (Domestic) Top5-selling medicines]

Billion JPY 2025
Jan – Sep 2024
Jan – Sep % change
Tecentriq 46.0 47.4 -3.0%
Polivy 27.0 24.5 +10.2%
Phesgo 24.5 15.0 +63.3%
Alecensa 24.3 22.4 +8.5%
Avastin 19.6 25.6 -23.4%
[Specialty field (Domestic) Top5-selling medicines]

Billion JPY 2025
Jan – Sep 2024
Jan – Sep % change
Hemlibra 44.7 41.5 +7.7%
Actemra 36.7 34.8 +5.5%
Enspryng 20.9 17.8 +17.4%
Vabysmo 18.5 14.7 +25.9%
Evrysdi 12.0 11.3 +6.2%
[Progress in R&D activities from Jul 25th, 2025 to Oct 24th, 2025]

About Core results

Chugai discloses its results on a Core basis from 2013 in conjunction with its decision to apply IFRS. Core results are the results after adjusting Non-Core items to IFRS results. Chugai’s recognition of non-recurring items may differ from that of Roche due to the difference in the scale of operations, the scope of business and other factors. Core results are used by Chugai as an internal performance indicator, for explaining the underlying business performance both internally and externally, and as the basis for payment-by-results such as a return to shareholders.

Trademarks used or mentioned in this release are protected by law.

(Press release, Chugai, OCT 24, 2025, View Source [SID1234656975])

Arvinas Presents Preclinical Data for ARV-806 Demonstrating Robust and Differentiated Activity in Models of KRAS G12D-mutated Cancer at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

On October 24, 2025 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported preclinical data for ARV-806, a PROTAC KRAS G12D degrader, at the 2025 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in Boston, Massachusetts. The ARV-806 data presented show a differentiated profile based on degradation potency, antiproliferative activity, and induction of cancer cell death. ARV-806 is designed to target both the ON and OFF forms of KRAS G12D, which is the most common mutation of the KRAS protein. ARV-806 has the potential to address high unmet need in solid tumors, such as pancreatic, colorectal and non-small cell lung cancer.

"These data suggest the potential of targeted protein degradation to overcome historical limitations in addressing undruggable KRAS mutations," said Angela Cacace, Ph.D., Chief Scientific Officer of Arvinas. "ARV-806’s ability to eliminate both ON and OFF forms of KRAS G12D, combined with its potency and durability shown in preclinical models, supports our confidence in its clinical potential to deliver meaningful benefit for patients with KRAS G12D-mutated cancers."

Key highlights from the presentation include:

In vitro, ARV-806 degraded KRAS G12D with picomolar potency across pancreatic, colorectal, and lung cancer cell lines but did not induce degradation of wild-type and other mutant RAS isoforms.
ARV-806 is differentiated from other KRAS G12D targeting agents in development and has potential to be a best-in-class therapy for KRAS G12D mutated cancers due to:
Catalytic activity, which allows it to overcome upregulation, a common mechanism of resistance to inhibitor treatment
Compared with clinical-stage KRAS G12D ON and OFF inhibitors and another clinical-stage G12D degrader, ARV-806 demonstrated:
>25-fold greater potency in reducing cancer cell proliferation,
>40-fold higher potency in degrading KRAS G12D protein (versus the comparable clinical-stage G12D degrader), and
>10-fold lower concentrations required to induce pro-apoptotic BIM expression.
Following a single intravenous dose in a colorectal tumor xenograft model, ARV-806 degraded >90% of KRAS G12D for seven days, with parallel suppression of c-MYC (a key driver of cancer cell proliferation) and induction of BIM (Bcl-2-interacting mediator of cell death, a pro-apoptotic factor) for ≥5 days.
ARV-806 demonstrated robust efficacy responses at low doses in tumor models including: ≥30% tumor volume reductions in pancreatic and colorectal cell line-derived xenograft (CDX) models and a patient-derived xenograft (PDX) model of lung cancer.

These data demonstrate sustained pharmacodynamic activity consistent with long-lasting target degradation, which we believe supports intermittent clinical dosing. Arvinas is currently evaluating ARV-806 in a Phase 1 clinical trial in patients with KRAS G12D–mutated advanced solid tumors (NCT07023731).

Also shown in the poster, orally bioavailable pan-KRAS degraders have been identified that potently degrade multiple variants of KRAS and spare other RAS isoforms. A tool pan-KRAS PROTAC demonstrated robust single-agent activity and superior combination efficacy with immune checkpoint blockade compared with a pan-RAS ON inhibitor (7 complete responses compared with 2 complete responses).

About ARV-806
ARV‑806 is a novel, investigational PROTAC degrader designed to selectively target and degrade mutant Kirsten rat sarcoma (KRAS) G12D which is the most common mutation of the KRAS protein. Therefore, ARV-806 has the potential to address high unmet need in solid tumors, such as pancreatic, colorectal and lung cancer. ARV‑806 is currently being evaluated in a Phase 1 clinical trial in patients with advanced solid tumors harboring KRAS G12D mutations.

(Press release, Arvinas, OCT 24, 2025, View Source [SID1234656974])