On November 20, 2025 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on October 3, 2025 for FoundationOneCDx Cancer Genomic Profile to be used as a companion diagnostic for Augtyro (repotrectinib), an anti-cancer agent/tyrosine kinase inhibitor for NTRK fusion-positive solid-tumors. Bristol-Myers Squibb K.K. obtained a partial change approval for the manufacturing and marketing authorization of Augtyro in Japan.

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"We are pleased that FoundationOne CDx Cancer Genomic Profile was approved as a companion diagnostic for repotrectinib for identifying NTRK fusion-positive solid-tumors patients. We believe that being able to comprehensively identify with a single comprehensive genomic profiling test, rare genetic mutations that occur at low frequencies across cancer types, such as NTRK fusion genes, is useful for informing optimal treatment plans for patients. We will continue to contribute to the advancement of personalized healthcare based on each patient’s genetic mutation status by expanding companion diagnostics," said Dr. Osamu Okuda, Chugai’s President and CEO.

This approval enables the detection of NTRK1/2/3 fusion genes using the FoundationOne CDx Cancer Genomic Profile to guide the decision to use repotrectinib for NTRK fusion-positive solid-tumor patients. The efficacy and safety of repotrectinib for NTRK fusion-positive advanced or recurrent solid-tumors were evaluated in the international Phase I/II clinical study (TRIDENT-1) and overseas Phase I/II pediatric clinical study (CARE). Bristol Myers Squibb K.K. obtained approval from the MHLW on November 20, 2025.

As a oncology leading company, Chugai is committed to realizing advanced personalized healthcare in oncology and contributing to patients through the expansion of Comprehensive Genomic Profiling.

Approval information The underlined and bolded part has been newly added.

Intended uses or indications

The product is used for comprehensive genomic profiling of tumor tissues in patients with solid cancers.
The product is used for detecting gene mutations and other alterations to support the assessment of drug indications listed in the table below.
Alterations Cancer type Relevant drugs
Activated EGFR alterations Non-small cell lung cancer (NSCLC) afatinib dimaleate, erlotinib hydrochloride, gefitinib, osimertinib mesylate, dacomitinib hydrate
EGFR exon 20 T790M alterations osimertinib mesylate
ALK fusion genes alectinib hydrochloride, crizotinib, ceritinib, brigatinib
ROS1 fusion genes entrectinib
MET exon 14 skipping alterations capmatinib hydrochloride hydrate
BRAF V600E and V600K alterations Malignant melanoma dabrafenib mesylate, trametinib dimethyl sulfoxide, vemurafenib, encorafenib, binimetinib
ERBB2 copy number alterations (HER2 gene amplification positive) Breast cancer trastuzumab (genetical recombination)
AKT1 alterations capivasertib
PIK3CA alterations
PTEN alterations
KRAS/NRAS wild-type Colorectal cancer cetuximab (genetical recombination), panitumumab (genetical recombination)
Microsatellite instability high nivolumab (genetical recombination)
Microsatellite instability high Solid tumors pembrolizumab (genetical recombination)
Tumor mutational burden high pembrolizumab (genetical recombination)
NTRK1/2/3 fusion genes entrectinib, larotrectinib sulfate, repotrectinib
RET fusion genes selpercatinib
BRCA1/2 alterations Ovarian cancer olaparib
BRCA1/2 alterations Prostate cancer olaparib, talazoparib tosilate
FGFR2 fusion genes Biliary tract cancer pemigatinib
About FoundationOne CDx Cancer Genomic Profile
Developed by Foundation Medicine Inc., FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device for the detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. The program is available as a companion diagnostic for multiple molecular-targeted drugs approved in Japan.

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

(Press release, Chugai, NOV 20, 2025, View Source [SID1234660845])

On November 20, 2025 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) and Nippon Shinyaku Co., Ltd. (TOKYO: 4516) reported that the electronic package insert for the anti-cancer agent/humanized anti-CD20 monoclonal antibody Gazyva Intravenous Infusion 1000 mg [generic name: obinutuzumab (genetical recombination)] has been revised to allow combination therapy with the anti-cancer agent/BCL-2 inhibitor Venclexta Tablets 10 mg, 50 mg, and 100 mg [generic name: venetoclax] for previously untreated CD20-positive chronic lymphocytic leukemia (including small lymphocytic lymphoma).

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This revision of the electronic package insert is based on the results of clinical studies evaluating the efficacy and safety of combination therapy with venetoclax and obinutuzumab for previously untreated chronic lymphocytic leukemia (including small lymphocytic lymphoma). These include a Japanese Phase II clinical study (M20-353) conducted by AbbVie GK and a global Phase III clinical study (CLL14/BO25323) conducted by Roche in cooperation with AbbVie Inc. and the German CLL Study Group from the University of Cologne.

Approval Information *Excerpt of relevant sections; underlined portions indicate changes

Before Revision After Revision
7. Precautions Concerning Dosage and Administration

7.1-7.2 (Omitted)

7.3-7.5 (Omitted)

7.6 Initiate administration of this product after 28 days of acalabrutinib treatment.

7.7-7.8 (Omitted) 7. Precautions Concerning Dosage and Administration

7.1-7.2 (Omitted)

7.3-7.5 (Omitted)

7.6 When used in combination with acalabrutinib, initiate administration of this product after 28 days of acalabrutinib treatment.
7.7-7.8 (Omitted)
7.9 For dosage and administration when used in combination with venetoclax, refer to the electronic package insert for venetoclax.
About the Japanese Phase II Clinical Study (M20-353)1
M20-353 study is an uncontrolled, open-label Japanese Phase II clinical study to evaluate the efficacy and safety of venetoclax in combination with obinutuzumab and venetoclax in combination with ibrutinib in Japanese patients with treatment-naïve chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The primary endpoint was the rate of complete response (CR) and complete response with incomplete bone marrow recovery (CRi) as assessed by an Independent Review Committee (IRC).

About the Global Phase III Clinical Study (CLL14 Study, BO25323)2
CLL14 Study (BO25323) is a multicenter, randomized, open-label global Phase III clinical study comparing venetoclax in combination with obinutuzumab versus obinutuzumab in combination with chlorambucil (not approved in Japan) in patients with treatment-naïve CLL. The primary endpoint was progression-free survival (PFS) as assessed by investigators.

About Gazyva (obinutuzumab)3
Gazyva is a glycoengineered type II anti-CD20 monoclonal antibody designed to bind to CD20, a protein expressed on certain B cells, but not on stem cells or plasma cells. Gazyva is designed to attack and destroy targeted B cells both directly and together with the body’s immune system. Chugai and Nippon Shinyaku jointly develop and market the product in Japan.

About Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)
In CLL, blood stem cells in the bone marrow become excessive abnormal lymphocytes and these abnormal cells have difficulty fighting infections. As the number of abnormal cells grows there is less room for healthy white blood cells, red blood cells, and platelets4. This could result in anemia, infection, and bleeding. SLL is the same type of cancer as CLL. When lymphocytes are not located in the peripheral blood or bone marrow, the disease is called SLL5. CLL/SLL is a rare type of lymphoma accounting for less than one case in 100,000 population annually in Japan.

(Press release, Chugai, NOV 20, 2025, View Source [SID1234660844])

On November 20, 2025 Chemomab Therapeutics Ltd. (Nasdaq: CMMB), (Chemomab), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, reported financial and operating results for the third quarter ended September 30, 2025, and provided a corporate update.

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"In the third quarter of 2025 we focused on advancing preparations for the nebokitug Phase 3 trial in patients with primary sclerosing cholangitis (PSC), continuing our very productive discussions with the FDA and EMA," said Adi Mor, PhD, co-founder, Chief Executive Officer and Chief Scientific Officer of Chemomab. "I am delighted to report that we have support from both agencies that a single Phase 3 registration trial would be sufficient for approval. In addition, both have agreed that a composite of clinically relevant events can be used for the study endpoint. In view of the general alignment of the two regulatory agencies and the advanced status of the Phase 3 design, we expect to launch the trial as soon as feasible."

Dr. Mor continued, "We are also encouraged that at the recent AASLD 2025 conference, the PSC community, including KOLs, global clinical centers and patient advocates, voiced their support for the nebokitug Phase 3 design, along with their interest in participating in the trial. With a clear regulatory pathway to approval in the US, international regulatory alignment on key aspects of the Phase 3 trial design and increasing market interest, we are seeing growing recognition of nebokitug’s potential to become the first disease-modifying therapy for this devastating condition. The limited number of ongoing PSC trials provides a unique opportunity to leverage our strong engagement with global PSC centers to advance our Phase 3 program rapidly and efficiently. In parallel, we are continuing discussions with potential strategic partners. We see this dual track as positioning Chemomab for maximum strength and flexibility as we work to launch the Phase 3 nebokitug trial as soon as the necessary financial resources are available."

Dr. Mor concluded, "This is an exciting time for Chemomab as we see more options for advancing nebokitug into a registrational trial that could enable us to be the first effective therapy in this large, unserved market, while providing hope to the tens of thousands of PSC patients seeking better options for managing their condition. We are continuing to lay the groundwork for rapidly launching the Phase 3 trial and look forward to reporting on our progress over the remainder of the year."

Third Quarter 2025 and Recent Highlights:

On November 6, 2025, Chemomab reported that data from the Phase 2 SPRING trial assessing nebokitug for the treatment of PSC was featured in three poster presentations at the American Association for the Study of Liver Disease (AASLD) The Liver Meeting 2025. All three were designated by conference organizers as "posters of distinction." Data presented from the SPRING trial open label extension (OLE) showed the continued and consistent positive effects of nebokitug on key inflammatory and fibrotic biomarkers when administered to patients with PSC for up to 48 weeks, confirming its good safety profile and further reinforcing its disease-modifying potential. Two additional posters presented new clinical data that provided additional insights into the macrophage-related mechanism of action of nebokitug, a first-in-class antibody that inhibits the soluble protein CCL24, a key driver of disease processes in fibro-inflammatory diseases such as PSC. These results further confirm that nebokitug may halt or slow disease progression and improve clinical outcomes — the primary objectives of the proposed nebokitug Phase 3 study in PSC.

On August 14, 2025, Chemomab reported that it would change the ratio of its American Depositary Shares ("ADSs") to its Class A ordinary shares (the "ADS Ratio"), from the then current ADS Ratio of one ADS to 20 Class A ordinary shares to a new ADS Ratio of one ADS to 80 Class A ordinary shares, effective on August 26, 2025. This ratio adjustment essentially served as a one-for-four reverse ADS split for Chemomab ADS holders.
Third Quarter 2025 Financial Highlights

Cash Position: Cash, cash equivalents and short-term bank deposits were $10.2 million as of September 30, 2025, compared to $9.5 million as of June 30, 2025 and $14.2 million as of December 31, 2024. This cash is expected to fund the company through the end of the fourth quarter of 2026.

Research and Development (R&D) Expenses: R&D expenses were approximately $1 million in the third quarter of 2025, compared to $2.8 million in the third quarter of 2024. The decrease in R&D expenses in the third quarter of 2025 compared to the third quarter of 2024 primarily resulted from the end of activities related to the nebokitug Phase 2 SPRING trial.

General and Administrative (G&A) Expenses: G&A expenses were approximately $0.9 million for the third quarter of 2025, generally equivalent to approximately $0.9 million in G&A expenses for the third quarter of 2024.

Net Loss: Net loss was $1.7 million, or a net loss of less than one-half of one cent per basic and diluted ordinary share for the third quarter of 2025, compared to a net loss of $3.5 million, or a net loss of approximately $0.01 per basic and diluted ordinary share, for the third quarter of 2024. The weighted average number of ordinary shares outstanding, basic and diluted, was 494,338,497 million (equal to approximately 6,179,231 million ADSs) for the third quarter of 2025.

Liquidity and Capital Resources: Chemomab believes its existing liquidity resources as of September 30th, 2025 will enable it to fund its operations through the end of the fourth quarter of 2026.

Number of Issued and Outstanding Shares:. As of September 30, 2025, the company had 492,409,320 Ordinary shares issued and outstanding (equal to 6,155,117 ADSs), compared to 377,132,220 Ordinary shares issued and outstanding (equal to 4,714,153 ADSs) as of December 31, 2024.

(Press release, Chemomab, NOV 20, 2025, View Source [SID1234660843])

On November 20, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported that its subsidiary, BriaPro Therapeutics Corp. ("BriaPro"), has initiated a research collaboration with Receptor.AI, an AI-driven drug discovery company, to design anti-cancer isoform-selective kinase inhibitors for multiple cancer indications.

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The collaboration will integrate AI-driven molecular design expertise and BriaPro’s proprietary technology to expand BriaPro’s small-molecule pipeline and accelerate the development of selective kinase inhibitors that may enhance immune-mediated tumor targeting and improve cancer patient outcomes.

"This partnership marks an important step in BriaCell’s strategic expansion beyond cell-based immunotherapy into small-molecule discovery, reinforcing its mission to deliver differentiated and complementary approaches to cancer treatment," stated Dr. William V. Williams, President and CEO of BriaCell and BriaPro.

"Kinase selectivity, down to the isoform level, remains one of the hardest optimization problems in oncology," said Dr. Alan Nafiev, CEO and Founder of Receptor.AI. "This collaboration is about bringing disciplined, AI-first molecular design and rigorous ADMET constraints to BriaCell’s oncology programs, enhancing precision and translational confidence from the earliest stages of discovery."

Receptor.AI has developed a multiplatform ecosystem for AI-enabled drug discovery, integrating small-molecule, peptide, and induced-proximity technologies into a unified framework that accelerates therapeutic innovation across modalities. Within the collaboration, Receptor.AI will harness its small-molecule discovery platform to drive target assessment, hit identification, and lead optimization, with a particular focus on achieving precise isoform selectivity among closely related kinases.

(Press release, BriaCell Therapeutics, NOV 20, 2025, View Source [SID1234660842])

On November 20, 2025 Alexion and AstraZeneca reported that its Rare Disease Koselugo (selumetinib), an oral, selective MEK inhibitor, has been approved in the US for the treatment of adult patients with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).

The approval by the US Food and Drug Administration (FDA) was based on positive results from KOMET, the largest and only placebo-controlled global Phase III trial in this patient population. Data were presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and published in The Lancet.

NF1 is a rare, progressive, genetic condition usually diagnosed in early childhood, but often progressing into adulthood, that can impact every organ system. Up to 50% of people living with NF1 may develop a type of non-malignant tumour called PN that may affect the brain, spinal cord and nerves.4,5 PN may appear later in a person’s life and can grow and become large, leading to pain, disfigurement and muscle weakness, among other debilitating symptoms.

Prof. Pierre Wolkenstein, MD, PhD, Head of the Department of Dermatology at Henri Mondor Hospital, APHP, Paris East University (UPEC), and Investigator of the KOMET trial, said: "The KOMET Phase III trial, which builds on the established clinical profile of Koselugo and its real-world use in paediatric patients, underscores its potential to address the substantial and oftentimes progressive clinical burdens associated with PN in adulthood. This approval reaffirms the role of Koselugo as a strong option for the treatment of adult and paediatric patients with NF1 PN."

Marc Dunoyer, Chief Executive Officer, Alexion, said: "This expanded approval of Koselugo in adults with NF1 PN, together with the recently approved granule formulation for young children aged one year and older, enables much-needed continuity of care and supports patients across the disease journey in the US. As the first approved therapy in NF1 PN, backed by more than a decade of clinical evidence, Koselugo has transformed the treatment standard for this rare disease."

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(Press release, AstraZeneca, NOV 20, 2025, View Source [SID1234660839])

Annette Bakker, PhD, Chief Executive Officer, Children’s Tumor Foundation, said: "We celebrate this FDA approval of Koselugo for adults with NF1 plexiform neurofibromas-a major step forward for NF patients everywhere. Koselugo has already changed what is possible for children with NF1, and now adults will benefit from that same progress. It is proof that NF research is delivering real results and opening the door to even more treatment options. This milestone shows what can be achieved when scientists, clinicians, industry and the NF community work together with one focus: getting effective treatments to patients faster."

In the primary analysis of the KOMET Phase III trial, Koselugo showed a statistically significant and clinically meaningful overall response rate (ORR) of 20% (n=14/71, 95% confidence interval [CI]: 11, 31) compared to 5% with placebo (n=4/74, 95% CI: 2, 13; p=0.011) by cycle 16, with 86% of patients on Koselugo having an observed duration of response (DOR) of at least 6 months. After 12 cycles, patients on placebo were switched to Koselugo and patients on Koselugo remained on treatment for an additional 12 cycles.1

The safety of Koselugo in the KOMET Phase III trial was consistent with its known profile and established use in paediatric patients.2

Koselugo has been recently approved in the EU, Japan and other countries for the treatment of adult patients with NF1 who have symptomatic, inoperable PN based on data from the KOMET Phase III trial, and additional regulatory reviews are ongoing. In the US, Koselugo granules have recently been approved for paediatric patients one year of age and older with NF1 PN.

Notes

NF1
NF1 is a rare, progressive, genetic condition that is caused by a spontaneous or inherited mutation in the NF1 gene.3,4 NF1 is associated with a variety of symptoms, including soft lumps on and under the skin (cutaneous neurofibromas) and, in up to 50% of patients, tumours called plexiform neurofibromas (PN) may develop on the nerve sheaths.4,5 These PN can cause clinical issues such as disfigurement, motor dysfunction, pain, airway dysfunction, visual impairment and bladder or bowel dysfunction.4,5

KOMET
KOMET is a global Phase III randomised, double-blind, placebo-controlled, multicentre trial designed to evaluate the efficacy and safety of Koselugo in adults with NF1 who have symptomatic, inoperable PN. The trial enrolled 145 adults from 13 countries across North America, South America, Europe, Asia and Australia, with participants’ baseline characteristics, including gender and distribution of PN, reflective of the global adult NF1 patient population. Patients were enrolled and randomised to receive Koselugo or placebo (1:1) for 12 28-day cycles. Participants were required to have diagnosis of NF1, at least one symptomatic, inoperable PN measurable by volumetric MRI analysis, chronic PN pain score documented during screening, adequate organ and marrow function and stable chronic PN pain medication use at enrolment.2,6

The primary endpoint is confirmed overall response rate (ORR) by cycle 16 as assessed by ICR. ORR is defined as the percentage of patients with confirmed complete response (disappearance of PNs) or partial response (at least 20% reduction in tumour volume). Secondary endpoints include improved PN-related pain and health-related quality of life (HRQoL) at cycle 12.2,6

After 12 cycles, patients on placebo were switched to Koselugo and patients on Koselugo remained on treatment for an additional 12 cycles. Patients who had the opportunity to complete 24 cycles of treatment have the option to participate in a long-term extension period and continue to receive Koselugo.2,6

Koselugo
Koselugo (selumetinib) is a kinase inhibitor that blocks specific enzymes (MEK1 and MEK2), which are involved in stimulating cells to grow. In NF1, these enzymes are overactive, causing tumour cells to grow in an unregulated way creating so-called plexiform neurofibromas (PN). By blocking these enzymes, Koselugo slows down the growth of tumour cells and, therefore, the PN growth.

Koselugo is approved in the US, EU, Japan, China and other countries for the treatment of certain paediatric patients with NF1 who have symptomatic, inoperable PN.

Koselugo is approved in the US, EU, Japan and other countries for the treatment of adult patients with NF1 who have symptomatic, inoperable PN, and additional regulatory reviews are ongoing.

Koselugo has been granted Orphan Drug Designation in the US, EU, Japan and other countries for the treatment of NF1.