4568 (4568) News
Follow 4568 (4568) news in one place: company catalysts, earnings, analyst actions and wider market developments. Review 24 public stories across 14 publication days to understand how the story developed. Public news appears after a 15-minute delay; LiveCast subscribers can follow new headlines and hear important updates without this additional delay.
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EU Approves Enhertu as Adjuvant Treatment for Early HER2-Positive Breast Cancer
The EU approved Enhertu (trastuzumab deruxtecan) as adjuvant monotherapy for adults with resected HER2-positive early breast cancer and residual invasive disease after neoadjuvant treatment.
REGULATION | Oct 27, 2026, 07:36 AM UTC
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SC Upholds HC Order, Clarifies Scope of Fortis Forensic Audit
Indu Bhan New Delhi: Upholding the August 31 Delhi HC order that directed a forensic audit of banks and financial institutions in the Daiichi Sankyo arbitration case, the Supreme Court on Tuesday clarified that the foren
NEWS | Sep 30, 2026, 04:17 AM UTC
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SC questions Daiichi's stand on forensic audit of banks in Fortis dispute
New Delhi, Sept. 29 -- The Supreme Court on Tuesday questioned Daiichi Sankyo's stand on the need for a forensic audit of banks in its dispute with former Fortis promoters Malvinder Mohan Singh and Shivinder Mohan Singh,
NEWS | Sep 29, 2026, 03:27 PM UTC
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Weekly Recap: U.S. BLA withdrawn for I—DxD and Phase 3s continue
Daiichi Sankyo Company, Limited (TSE:4568) withdrew its U.S. BLA for ifinatamab deruxtecan after FDA said current Phase 2/supporting data don’t justify accelerated approval, yet the company and partners press on with Pha
REGULATION | Sep 28, 2026, 10:01 PM UTC
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India's top court allows forensic audit in Fortis-IHH Healthcare unit case
Malaysia's IHH Healthcare MYX:IHH said on Monday that India's top court has disposed of Fortis Healthcare's NSE:FORTIS petition challenging a court-ordered forensic audit concerning a decade-long dispute, allowing the au
NEWS | Sep 28, 2026, 11:43 AM UTC
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SC upholds forensic audit of Fortis in ex-promoters’ Daiichi dispute
The Supreme Court on Friday declined to interfere with the Delhi High Court’s direction for a forensic audit of Fortis Healthcare Limited in proceedings linked to Daiichi Sankyo’s attempt to enforce its arbitral award ag
NEWS | Sep 26, 2026, 05:13 AM UTC
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Merck, Daiichi Sankyo Withdraw Application for Accelerated Approval of Lung Cancer Treatment
By Elias SchisgallMerck & Co. and Daiichi Sankyo have withdrawn their application seeking accelerated approval for a small cell lung cancer treatment, saying the data they had submitted to the Food and Drug Administratio
NEWS | Sep 25, 2026, 09:03 PM UTC
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Merck, Daiichi Sankyo withdraw US application for lung cancer therapy
Merck NYSE:MRK and Daiichi Sankyo TSE:4568 have voluntarily withdrawn their US application seeking accelerated approval for their experimental lung cancer therapy, the companies said on Friday.The decision followed discu
NEWS | Sep 25, 2026, 08:43 PM UTC
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Merck, Daiichi Sankyo withdraw US application for lung cancer drug
Merck NYSE:MRK and Daiichi Sankyo TSE:4568 have voluntarily withdrawn their US application seeking accelerated approval for their experimental lung cancer therapy, the drugmakers said on Friday.
NEWS | Sep 25, 2026, 08:37 PM UTC
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Daiichi Sankyo Company, Limited Withdraws U.S. BLA for I-DXd in ES-SCLC
Daiichi Sankyo voluntarily withdrew the U.S. accelerated approval BLA for ifinatamab deruxtecan in previously treated ES-SCLC after FDA said current data, including from phase 2 IDeate-Lung01, do not support approval. En
REGULATION | Sep 25, 2026, 08:30 PM UTC
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Ifinatamab Deruxtecan Biologics License Application for Certain Patients with Previously Treated Extensive-Stage Small Cell Lung Cancer Voluntarily Withdrawn
The Biologics License Application (BLA) seeking accelerated approval in the U.S. for Daiichi Sankyo (TSE: 4568) and Merck’s (NYSE: MRK), known as MSD outside of the United States and Canada, ifinatamab deruxtecan (I-DXd)
NEWS | Sep 25, 2026, 08:30 PM UTC
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Malaysia's IHH's unit appeals dismissal of Daiichi Sankyo damages claim
Malaysia's IHH Healthcare MYX:IHH said on Thursday a unit has appealed a Tokyo court's dismissal of its damages claim against Daiichi Sankyo TSE:4568 over its acquisition of a stake in India's Fortis Healthcare NSE:FORTI
MNA | Sep 24, 2026, 10:25 AM UTC
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AstraZeneca’s Enhertu approved for NHS use in England
AstraZeneca and Daiichi Sankyo said their breast cancer treatment Enhertu has been approved for use in England’s state-run healthcare system, expanding access to a drug available in Scotland since 2023.
EQUITY | Sep 17, 2026, 11:31 AM UTC
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AstraZeneca-Daiichi breast-cancer drug Enhertu approved for routine use in England
NICE approved Enhertu for routine use in England after changing its recommendation following the U.S.-U.K. pharmaceutical-pricing deal.
REGULATION | Sep 17, 2026, 06:08 AM UTC
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Enhertu Shows Six-Month PFS Gain In HER2-Mutant Lung Cancer
AstraZeneca and Daiichi Sankyo’s Enhertu reduced disease progression risk by 37% compared with pembrolizumab plus chemotherapy in a Phase III trialAstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) demonst
NEWS | Sep 15, 2026, 08:33 AM UTC
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Weekly Recap: Enhertu first—line HER2—mutant NSCLC and NTK suit dismissed
Daiichi Sankyo Company, Limited (TSE:4568) reported DESTINY-Lung04 showed Enhertu significantly improved PFS (14.3 months; HR 0.63), ORR (70% vs 44.5%) and PFS2, though ILD and grade≥3 AEs were notable, while a Tokyo cou
NEWS | Sep 14, 2026, 10:14 PM UTC
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Enhertu® Demonstrated a Median Progression-Free Survival of 14.3 Months as First-Line Therapy in Patients with HER2 Mutant Advanced Non-Small Cell Lung Cancer in DESTINY-Lung04 Phase 3 Trial
Positive results from the DESTINY-Lung04 phase 3 trial showed Enhertu® (trastuzumab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus glo
NEWS | Sep 14, 2026, 01:45 AM UTC
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IHH unit’s Tokyo damage claims dismissed over Daiichi Sankyo Fortis deal
IHH Healthcare said a Tokyo court dismissed its unit NTK’s damage claims against Daiichi Sankyo linked to IHH’s 2018 acquisition of a stake in Fortis Healthcare. NTK had filed the claims in October.
REGULATION | Sep 10, 2026, 11:39 AM UTC
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IHH Healthcare unit loses Tokyo court damage claims over Fortis stake
IHH Healthcare said a Tokyo court dismissed its unit Northern TK Venture’s damage claims against Daiichi Sankyo over the acquisition of a stake in India’s Fortis Healthcare. The court also ordered Northern TK Venture to
REGULATION | Sep 10, 2026, 11:01 AM UTC
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Daiichi Sankyo receives favorable judgment in NTK damage claim
EQUITY | Sep 10, 2026, 08:05 AM UTC
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AstraZeneca and Daiichi Sankyo win new EU approval for breast cancer drug
AstraZeneca and Daiichi Sankyo received a new EU approval for a breast cancer drug.
EQUITY | Sep 01, 2026, 07:02 AM UTC
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EU approves Enhertu plus pertuzumab for HER2+ metastatic breast cancer
The EU has approved Enhertu plus pertuzumab as a new first-line regimen for patients with HER2-positive metastatic breast cancer.
EQUITY | Sep 01, 2026, 06:30 AM UTC
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New Daiichi Sankyo Data Underscore the Effect of Bempedoic Acid in the Real-World Management of Dyslipidemia and Cardiovascular risk
New Daiichi Sankyo Data Underscore the Effect of Bempedoic Acid in the Real-World Management of Dyslipidemia and Cardiovascular risk
EQUITY | Aug 28, 2026, 08:00 AM UTC
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DS1025 enters clinical development for advanced solid tumors
DS1025 is entering clinical development for patients with advanced solid tumors as a CD25-directed ADC.
EQUITY | Aug 27, 2026, 11:00 AM UTC