On September 16, 2026 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on June 17, 2026 for FoundationOneCDx Cancer Genomic Profile to be used as a companion diagnostic for Ojemda Tablets 100 mg and Ojemda Dry Syrup 300 mg (generic name: tovorafenib), an anti-cancer agent/BRAF inhibitor, which IPSEN Co., Ltd. obtained a regulatory approval in Japan, for BRAF V600 alterations and BRAF fusion gene-positive glioma.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This approval enables the detection of BRAF V600 alterations and BRAF fusion genes using the FoundationOne CDx Cancer Genomic Profile to guide the decision to use tovorafenib for BRAF V600 alterations and BRAF fusion gene-positive glioma. The efficacy and safety of tovorafenib for relapsed or progressive low-grade glioma with BRAF V600 alterations or BRAF fusion gene-positive were evaluated in an overseas Phase II clinical study (FIREFLY-1 study). IPSEN Co., Ltd. obtained a regulatory approval from the MHLW on September 16, 2026.

FoundationOne CDx Cancer Genomic Profile has continuously expanded its companion diagnostic capabilities, enabling a single comprehensive genomic profiling test to support treatment decisions for multiple medicines. With the addition of a new companion diagnostic for glioma, the test now has companion diagnostic capabilities covering 9 cancer types including solid tumors. This is expected to further enhance its clinical utility.

As a leading company in oncology, Chugai is committed to realizing more advanced personalized healthcare in the oncology field and contributing to patients through the wider adoption 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, erlotinib, gefitinib, osimertinib
EGFR exon 20 T790M alterations osimertinib
ALK fusion genes alectinib, crizotinib, ceritinib, brigatinib
ROS1 fusion genes entrectinib
MET exon 14 skipping alterations capmatinib
BRAF V600E and V600K alterations Malignant melanoma dabrafenib, trametinib, vemurafenib, encorafenib, binimetinib
BRAF V600 alterations and BRAF fusion genes Glioma tovorafenib
ERBB2 copy number alterations (HER2 gene amplification positive) Breast cancer trastuzumab
AKT1 alterations capivasertib
PIK3CA alterations
PTEN alterations
KRAS/NRAS wild-type Colorectal cancer cetuximab, panitumumab
Microsatellite instability high nivolumab
Microsatellite instability high Solid tumors pembrolizumab
Tumor mutational burden high pembrolizumab
NTRK1/2/3 fusion genes entrectinib, larotrectinib, repotrectinib
RET fusion genes selpercatinib
ALK fusion genes alectinib
BRCA1/2 alterations Ovarian cancer olaparib
BRCA1/2 alterations Prostate cancer olaparib
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.

(Press release, Chugai, SEP 16, 2026, View Source;category= [SID1234670874])

On September 15, 2026 Legend Biotech Corporation (NASDAQ: LEGN) ("Legend Biotech" or the "Company"), a global leader in cell therapy, reported that its Board of Directors has appointed Ingrid Zhang as Chief Executive Officer, effective September 15, 2026. Ingrid Zhang succeeds Alan Bash, who has served as Interim Chief Executive Officer since July 2026 and will resume his role as President, CARVYKTI.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Ingrid Zhang is an accomplished global biopharmaceutical executive with deep experience leading commercial organizations, driving business growth, and advancing innovative medicines. Most recently, she served as Chief Commercial Officer for Novartis International. During her tenure at Novartis, she also led the company’s China business and innovative medicines organization. Earlier in her career, she held leadership positions at AstraZeneca, Pfizer, and McKinsey & Company, bringing a combination of global commercial expertise, operational leadership, and strategic insight to Legend Biotech.

"It is a privilege to join Legend Biotech at an important moment in the Company’s growth," said Ingrid Zhang, Chief Executive Officer of Legend Biotech. "Legend Biotech has established itself as a global leader in cell therapy through its commitment to scientific innovation, operational excellence, and transforming outcomes for patients. I look forward to working with the talented team at Legend to build on this strong foundation, advance our pipeline, expand our impact, and execute on our long-term growth strategy."

"Following a comprehensive search process, the Board concluded that Ingrid is the right leader to guide Legend Biotech through its next phase of growth," said Frank Zhang, EMBA, Ph.D., Chairman of the Board of Legend Biotech. "As a highly respected industry executive, Ingrid brings strategic vision, operational discipline, and experience leading complex global businesses. The Board is confident she is well-positioned to advance our mission of transforming patient care through cell therapy. We thank Alan Bash for his strong leadership as Interim CEO and are delighted to welcome Ingrid to Legend Biotech."

"Throughout this transition, our team has continued to execute against our strategic priorities with focus across the business," said Alan Bash, President, CARVYKTI. "The commitment and expertise of colleagues around the world have positioned Legend Biotech for its next chapter. The leadership team and I look forward to partnering closely with Ingrid as we continue executing our strategy and delivering meaningful impact for patients."

(Press release, Legend Biotech, SEP 15, 2026, View Source [SID1234670892])

On September 15, 2026 Juniper Biosciences reported two previously undisclosed radiopharmaceutical programs: JBS-002, a Ga-68 based cold kit for prostate cancer imaging, and JBS-004, a fluorine-18 labeled diagnostic imaging agent for Alzheimer’s disease. Both assets have been advanced privately through development and are disclosed today at the registrational stage, with registration batch manufacturing scheduled for the fourth quarter of 2026 in support of planned submissions to the U.S. Food and Drug Administration (FDA) in 2027.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company is disclosing both assets now that they stand at the threshold of regulatory submission, revealing a deep late-stage diagnostic portfolio — two registrational programs addressing large, established imaging markets.

JBS-002: A Ga-68 based Kit for Precision Prostate Cancer Imaging

Prostate-specific membrane antigen (PSMA) is a transmembrane protein expressed at low levels in normal prostate tissue but dramatically overexpressed on the surface of prostate cancer cells, including in metastatic and hormone-resistant disease. JBS-002 is an investigational PET imaging agent that binds directly to PSMA-expressing lesions and renders them visible on a whole-body scan. PSMA PET imaging is now established in clinical practice for staging men with high-risk disease before definitive treatment and for localizing the site of recurrence in patients with rising PSA after surgery or radiation, findings that frequently change the intended course of therapy.

PSMA PET has become standard of care, and the U.S. market is now estimated at approximately $1.8 billion annually. Growth continues on two fronts: expanding NCCN-guideline use across the disease course, and the rapid adoption of PSMA-targeted radioligand therapy, which depends on PSMA imaging to select and monitor patients.

JBS-004: An F-18 Diagnostic Imaging Agent for Alzheimer’s Disease

JBS-004 is an investigational fluorine-18 labeled PET imaging agent designed to provide a non-invasive visual assessment of Alzheimer’s disease pathology in adult patients being evaluated for cognitive impairment. Historically, a definitive determination of Alzheimer’s pathology could be made only at autopsy, leaving clinicians to diagnose by exclusion. Molecular imaging changes that calculus by making the underlying pathology directly observable in living patients, supporting earlier diagnostic certainty, reducing misdiagnosis in a population where symptoms overlap with numerous other conditions, and identifying which patients are appropriate candidates for the new generation of disease-modifying Alzheimer’s therapies—treatments that require confirmation of pathology before they can be prescribed.

The commercial context for this imaging has changed fundamentally in recent years. The arrival of therapies converted Alzheimer’s PET from a research tool into a required gateway to treatment. Scan volumes have grown sharply against a small field of approved agents.

An Expanding Late-Stage Portfolio

With JBS-002 and JBS-004 both entering registration batch manufacturing in the fourth quarter of 2026, Juniper Biosciences has two late-stage diagnostic assets advancing in parallel toward FDA submission in 2027, alongside JBS-003, the Company’s previously disclosed Phase III program in HPV-positive oropharyngeal cancer. Three programs now sit in registrational or Phase III development across prostate cancer, Alzheimer’s disease, and head and neck cancer—a portfolio built by a team with deep operating experience in radiochemistry and complex manufacturing.

"Reaching registration batch manufacturing on two programs in the same quarter is a defining moment for a company of our size," said Alex Agnoletto, Chief Executive Officer of Juniper Biosciences. "JBS-002 and JBS-004 serve different physicians and different diseases, but they reflect the same conviction: better decisions require better information. Together with JBS-003, they give us three programs in registrational or Phase III development and a clear path to becoming a commercial-stage company in the near future"

Commercialization

Juniper Biosciences intends to commercialize JBS-002 and JBS-004 in the United States if the programs receive marketing approval from the FDA. The Company is advancing both agents through registration with the objective of transitioning from a development-stage organization to a commercial-stage one, and preparatory work to support a potential launch of each program is proceeding in parallel with the regulatory work described above.

JBS-002 and JBS-004 are investigational agents. Neither has been approved by the FDA or any other regulatory authority, and the safety and effectiveness of neither agent has been established. Any commercial launch is contingent on FDA approval, and neither the outcome nor the timing of the regulatory review process can be assured.

(Press release, Juniper Biosciences, SEP 15, 2026, View Source [SID1234670891])

On September 15, 2026 Biodexa Pharmaceuticals PLC, (Nasdaq: BDRX) ("Biodexa" or the "Company"), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, reported that it has entered into a warrant exercise agreement with an existing accredited investor to exercise certain outstanding warrants to purchase an aggregate of 2,204,218 American Depositary Shares ("ADSs") of the Company (the "Existing Warrants") at an exercise price of $1.05 for gross cash proceeds of approximately $2.3 million, before deducting financial advisor fees and other transaction expenses. The ADSs issuable upon the exercise of the existing warrants have been registered pursuant to an effective registration statement on Form F-1, as amended (File No. 333-297473).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In consideration for the immediate exercise of the Existing Warrants for cash, the exercising holder will receive new unregistered warrants to purchase an aggregate of up to 4,408,436 ADSs (the "New Warrants"). The New Warrants will have an exercise price of $1.05, will be immediately exercisable upon issuance, and will have a term of exercise of five (5) years. The closing of the warrant inducement transaction is expected to occur on or about September 15, 2026, subject to satisfaction of customary closing conditions.

Maxim Group LLC acted as warrant inducement agent and financial advisor in connection with the transaction.

The New Warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act") and, along with the ADSs issuable upon their exercise, have not been registered under the Securities Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements. The New Warrants were offered only to accredited investors. The Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission covering the resale of the ADSs issuable upon exercise of the New Warrants.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Biodexa Pharmaceuticals, SEP 15, 2026, View Source [SID1234670890])

On September 15, 2026 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including metastatic colorectal cancer (mCRC) and triple-negative breast cancer (TNBC), reported that Robert E. Hoffman, Chief Financial Officer, will present live at the Life Sciences Investor Forum hosted by VirtualInvestorConferences.com on September 17th, 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

DATE: Thursday, September 17, 2026

TIME: 12:30 PM PT / 3:30 PM ET

REGISTER HERE

The event will be conducted as a live, interactive online forum, offering investors and industry professionals within the life sciences community the opportunity to submit questions to management in real time. A replay of the webcast will be available following the conclusion of the conference.

It is recommended that online investors pre-register and run the online system check to expedite participation and receive event updates.

(Press release, CytoDyn, SEP 15, 2026, View Source [SID1234670889])