TSE

Renesas Commences Tender Offer for All Outstanding Shares and ADSs of Sequans

Retrieved on: 
Monday, September 11, 2023
ADS, American depositary receipt, Electronics, NYSE, TSE, Security (finance), Renesas Electronics

Shareholders to Receive U.S. $0.7575 per Ordinary Share and U.S. $3.03 per ADS in cash

Key Points: 
  • Tokyo, Japan and Paris, France--(Newsfile Corp. - September 11, 2023) - Renesas Electronics Corporation (TSE: 6723) ("Renesas") and Sequans Communications S.A. (NYSE: SQNS) ("Sequans") today announced that Renesas has commenced the previously-announced tender offer to acquire all of the outstanding ordinary shares of Sequans for $0.7575 per ordinary share and American Depositary Shares ("ADSs") of Sequans for $3.03 per ADS (each ADS representing four ordinary shares) in cash, without interest and less any applicable withholding taxes.
  • The tender offer is being made pursuant to the memorandum of understanding between Renesas and Sequans dated August 4, 2023, as amended.
  • As previously announced on August 16, 2023, the Sequans Board of Directors determined that the Renesas offer is consistent with and will further the business objectives and goals of Sequans, and is in the best interests of Sequans, its employees, and its shareholders, and recommends that all holders of ordinary shares and ADSs accept Renesas' offer and tender their outstanding shares and/or ADSs to Renesas.
  • The closing of the tender offer is subject to the valid tender of ordinary shares and ADSs of Sequans representing - together with ordinary shares and ADSs of Sequans beneficially owned by Renesas, if any - at least 90% of the fully diluted ordinary shares and ADSs, as well as confirmation of tax treatment from relevant authorities, regulatory approvals and other customary closing conditions.

NEC selected by AMED for design of a universal vaccine that is effective against influenza virus strains

Retrieved on: 
Thursday, September 14, 2023
NEC, Vaccine, Kōchi University, AMED, Japan Agency for Medical Research and Development, Health care, Cancer, System, Global health, Research, ICT, Pandemic, Patient, School, AI, Virus, Medical research, TSE, Pharmaceutical industry, Development

During this research project, NEC will utilize cutting-edge AI technologies in order to identify immunogenic regions that are effective against a wide range of influenza virus strains and to design a universal vaccine.

Key Points: 
  • During this research project, NEC will utilize cutting-edge AI technologies in order to identify immunogenic regions that are effective against a wide range of influenza virus strains and to design a universal vaccine.
  • Research on universal vaccines that are broadly protective against mutating viruses are being conducted around the world in preparation for future pandemics.
  • However, it is likely to take a considerable amount of time for universal vaccines to be put to practical use.
  • "We are pleased that our proposal has been selected by SCARDA for the development of universal vaccine design technology through industry-government-academia collaboration.

Sosei Heptares’ partner Neurocrine Biosciences Initiates Phase 1 Clinical Study Evaluating Effects of NBI-1117570 in Healthy Adults

Retrieved on: 
Tuesday, September 12, 2023
Cognition, M4, Psychosis, Neurocrine Biosciences, Schizophrenia, Pharmacokinetics, Trial of the century, Therapy, Safety, M1, TSE, Pharmaceutical industry, Neurocrine

NBI-1117570 is an investigational, oral, muscarinic M1/M4 selective dual agonist that may have the potential to treat neurological and neuropsychiatric conditions and was developed utilising Sosei Heptares' structure-based drug design platform.

Key Points: 
  • NBI-1117570 is an investigational, oral, muscarinic M1/M4 selective dual agonist that may have the potential to treat neurological and neuropsychiatric conditions and was developed utilising Sosei Heptares' structure-based drug design platform.
  • “Initiation of this Phase 1 study represents an important step forward for NBI-1117570, a potentially first-in-class, orally active, selective investigational dual M1/M4 agonist,” said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences.
  • NBI-1117570 is the second candidate to advance into clinical trials from the portfolio of selective muscarinic receptor agonists discovered and licensed by Sosei Heptares to Neurocrine in 2021.
  • Sosei Heptares will announce the receipt of any milestone payments in accordance with TSE reporting requirements.

Patritumab Deruxtecan Demonstrated Clinically Meaningful and Durable Responses in Patients with EGFR-Mutated Metastatic Non-Small Cell Lung Cancer in HERTHENA-Lung01 Phase 2 Trial

Retrieved on: 
Sunday, September 10, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Neutropenia, Brain, Central nervous system, PRS, HER3, Liver disease, American Journal of Clinical Oncology, TSE, DOR, DCR, Trastuzumab deruxtecan, Lung cancer, ILD, TKI, NSCLC, Treatment of lung cancer, History, Immunotherapy, CNS, PFS, Associate, Patritumab, ORR, Radiation, Journal, HIV disease progression rates, MD, EGFR, Patient, Leukopenia, Daiichi Sankyo, Anemia, Hypokalemia, DXD, Weakness, Memorial Sloan Kettering Cancer Center, ADC, CRS, Diagnosis, Neoplasm, R, Thrombocytopenia, SD, Conference, PR, Fatigue, Medical imaging, Fine chemical, Pharmaceutical industry

Results from the HERTHENA-Lung01 phase 2 trial showed that patritumab deruxtecan (HER3-DXd) demonstrated clinically meaningful and durable responses in patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) following disease progression with an EGFR TKI and platinum-based chemotherapy.

Key Points: 
  • Results from the HERTHENA-Lung01 phase 2 trial showed that patritumab deruxtecan (HER3-DXd) demonstrated clinically meaningful and durable responses in patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) following disease progression with an EGFR TKI and platinum-based chemotherapy.
  • Patritumab deruxtecan is a specifically engineered potential first-in-class HER3 directed antibody drug conjugate (ADC) designed using Daiichi Sankyo’s (TSE: 4568) proprietary DXd ADC technology.
  • One complete response (CR), 66 partial responses (PRs) and 99 cases of stable disease (SD) were seen.
  • As of the snapshot data cutoff of May 18, 2023, the median trial duration was 18.9 (14.9-27.5) months, and 13 patients were continuing to receive patritumab deruxtecan.

Trinseo Announces Completion of Transaction to Refinance $660 million 2024 Term Loan and $385 million of 2025 Senior Notes

Retrieved on: 
Friday, September 8, 2023
Automotive Manufacturing, Manufacturing, Textiles, Packaging, Chemicals, Plastics, Oaktree Capital Management, Centerview Partners, Note, Partnership, Angelo Gordon, Debt-to-GDP ratio, PMMA, Ropes & Gray, NYSE, Apollo Global Management, TSE, Bank, Trinseo

Proceeds will be used to refinance the entirety of the Company’s outstanding 2024 term loan and $385 million of its existing $500 million 2025 Senior Notes.

Key Points: 
  • Proceeds will be used to refinance the entirety of the Company’s outstanding 2024 term loan and $385 million of its existing $500 million 2025 Senior Notes.
  • The financing process was very competitive, a testament to investors’ strong belief in the long-term outlook for the business.
  • We welcome the support and partnership from leading investors Oaktree, Angelo Gordon and Apollo.”
    Bozich continued, “I want to thank our employees, customers and suppliers for their partnerships in managing through the current challenging demand environment.
  • Paul Hastings LLP acted as legal counsel to Oaktree, Angelo Gordon, and Apollo.

Datopotamab Deruxtecan Plus Durvalumab Showed Promising Clinical Activity in the First-Line Advanced Non-Small Cell Lung Cancer Setting in TROPION-Lung04 Phase 1b Trial

Retrieved on: 
Sunday, September 10, 2023
Research, Clinical Trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, PRS, DCR, International Association, Lung cancer, ILD, NSCLC, Carboplatin, Lung, AstraZeneca, Alvin J. Siteman Cancer Center, HIV disease progression rates, MD, Patient, EGFR, DXD, Daiichi Sankyo, Anemia, Washington University School of Medicine, ADC, Spacecraft, Thrombocytopenia, ORR, Conference, TSE, Disease, ALK, Pharmaceutical industry, Fine chemical, Durvalumab

These data were presented today during a late-breaking oral presentation ( OA05.06 ) at the IASLC 2023 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC23).

Key Points: 
  • These data were presented today during a late-breaking oral presentation ( OA05.06 ) at the IASLC 2023 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC23).
  • Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN).
  • Response rates were higher in patients receiving datopotamab deruxtecan plus durvalumab and carboplatin (triplet; n=13) which demonstrated an ORR of 76.9% (95% CI: 46.2-95.0), including 10 PRs and a DCR of 92.3% (95% CI: 64.0-99.8).
  • “The TROPION-Lung04 results offer preliminary evidence for the efficacy of datopotamab deruxtecan in combination with durvalumab and chemotherapy in first-line advanced non-small cell lung cancer with no new safety signals.

Ifinatamab Deruxtecan Continues to Demonstrate Durable Responses in Patients with Advanced Small Cell Lung Cancer in Early Trial

Retrieved on: 
Sunday, September 10, 2023
Pharmaceutical, Health, Oncology, Clinical Trials, Learning, Carcinoma, Brain, PRS, TSE, DOR, COVID-19, Survival, Cancer, International Association, Lung cancer, ILD, Pneumonitis, Neoplasm, Appetite, Immunotherapy, PFS, SCLC, Vomiting, HIV disease progression rates, MD, Patient, DXD, Daiichi Sankyo, Anemia, Irinotecan, Nausea, ADC, Conference, ORR, Pneumonia, Fatigue, Taxane, Sarah Cannon Research Institute, Medical imaging, Pharmaceutical industry

Updated results from a subgroup analysis of a phase 1/2 trial showed that ifinatamab deruxtecan (I-DXd) continues to demonstrate durable responses in patients with heavily pretreated advanced small cell lung cancer (SCLC).

Key Points: 
  • Updated results from a subgroup analysis of a phase 1/2 trial showed that ifinatamab deruxtecan (I-DXd) continues to demonstrate durable responses in patients with heavily pretreated advanced small cell lung cancer (SCLC).
  • Ifinatamab deruxtecan is a specifically engineered potential first-in-class B7-H3 directed antibody drug conjugate (ADC) designed using Daiichi Sankyo’s (TSE: 4568) proprietary DXd ADC technology.
  • “With limited effective treatment options beyond traditional chemotherapy and immunotherapy, small cell lung cancer can be difficult to treat,” said Melissa Johnson, MD, Director, Lung Cancer Research, Sarah Cannon Research Institute.
  • The median duration of follow up was 11.7 months (95% CI: 4.63-12.88) and two patients remain on treatment with ifinatamab deruxtecan.

DS-3939 Enters Clinical Development in Patients Across Several Types of Advanced Solid Cancers

Retrieved on: 
Thursday, September 7, 2023
Pharmaceutical, Health, Oncology, Clinical Trials, Pancreatic cancer, ADC, Cancer, Biliary tract, Breast, MD, Patient, DXD, Daiichi Sankyo, TSE, Medical imaging, Fine chemical

Daiichi Sankyo (TSE: 4568) announced today that the first patient has been dosed in a first-in-human phase 1/2 trial evaluating DS-3939 in patients with several types of advanced solid tumors including non-small cell lung, breast, urothelial, ovarian, biliary tract, and pancreatic cancer.

Key Points: 
  • Daiichi Sankyo (TSE: 4568) announced today that the first patient has been dosed in a first-in-human phase 1/2 trial evaluating DS-3939 in patients with several types of advanced solid tumors including non-small cell lung, breast, urothelial, ovarian, biliary tract, and pancreatic cancer.
  • DS-3939 is a specifically engineered potential first-in-class tumor-associated mucin-1 (TA-MUC1) directed antibody drug conjugate (ADC) designed using Daiichi Sankyo’s proprietary DXd ADC technology.
  • TA-MUC1 is a tumor-specific transmembrane glycoprotein and is overexpressed in most human epithelial cancers, making it a promising target for cancer therapy.1,2 Currently, there are no TA-MUC1 directed therapies approved for any type of cancer.
  • “With DS-3939, we are pairing our unique DXd antibody drug conjugate technology with a TA-MUC1 antibody in order to evaluate this novel treatment strategy for patients with several types of advanced cancer,” said Mark Rutstein, MD, Global Head, Oncology Clinical Development, Daiichi Sankyo.

Blue Ocean Technologies & Tokyo Stock Exchange Close Strategic Investment Agreement Focused on Expanding Trading Hours for Japanese Investors

Retrieved on: 
Wednesday, September 13, 2023
Partnership, Blue Ocean Strategy, Tokyo Stock Exchange, BOT, TSE, Video game

NEW YORK & TOKYO, Sept. 13, 2023 /PRNewswire/ -- Blue Ocean Technologies , LLC (BOT), a unique capital markets fintech leader in global afterhours trading, and the Tokyo Stock Exchange (TSE) announced today the completion of their strategic partnership agreement and TSE's five percent investment in BOT.

Key Points: 
  • NEW YORK & TOKYO, Sept. 13, 2023 /PRNewswire/ -- Blue Ocean Technologies , LLC (BOT), a unique capital markets fintech leader in global afterhours trading, and the Tokyo Stock Exchange (TSE) announced today the completion of their strategic partnership agreement and TSE's five percent investment in BOT.
  • The deal is focused on expanding access for global investors in Japan and enabling TSE customers to trade US equities on the Blue Ocean ATS during Japanese business day-time hours.
  • Brian Hyndman, President and CEO of Blue Ocean Technologies and Blue Ocean ATS, commented, "We are happy to complete this strategic transaction with the Tokyo Stock Exchange.
  • Blue Ocean Technologies is approximately 35% owned by Urbana Corporation, a Canadian, publicly traded investment company.

European Medicines Agency Validates Type II Variation for Astellas' XTANDI® (enzalutamide) for Treatment of Non-Metastatic Hormone-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence

Retrieved on: 
Wednesday, September 13, 2023
Senior, Astellas Pharma, Type 2, Food, European Medicines Agency, MFS, Cancer, BCR, Leuprorelin, Type, EMA, Patient, Risk, FDA, Recurrence, Death, Regulation of tobacco by the U.S. Food and Drug Administration, Safety, MPH, PSA, Disease, Metastasis, TSE, Prostate cancer, Medical imaging, Pharmaceutical industry, MD

TOKYO, Sept. 12, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the European Medicines Agency (EMA) has validated its Type II variation for XTANDI® (enzalutamide) for the treatment of patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as non-metastatic castration-sensitive prostate cancer or nmCSPC) with high-risk biochemical recurrence (BCR) who are unsuitable for salvage-radiotherapy.

Key Points: 
  • These patients, particularly those with rapidly rising PSA levels, need new therapeutic approaches.
  • Detailed results from the trial were presented as a plenary session during the 2023 American Urological Association Annual Meeting on April 29.
  • The overall safety profile was consistent with the known safety profile of each of the medicines.
  • Astellas has already reflected the impact from this acceptance in its financial forecast of the current fiscal year ending March 31, 2024.