Zydus Lifesciences Ltd

Zydus Lifesciences will hold a meeting of the Board of Directors of the Company on 9 February 2026.Powered by Capital Market - Live

Zydus Lifesciences announced that the USFDA conducted an inspection at the group's Unit ' 2 manufacturing plant at Ankleshwar, Gujarat. The inspection was conducted from 19th to 23rd January, 2026 and concluded with 3 observations. There were no data integrity related observations. The Company will closely work with the USFDA to address the observations expeditiously.Powered by Capital Market - Live

Zydus Lifesciences has launched the world's first biosimilar of Nivolumab in India under the brand name Tishtha', reinforcing the company's growing capability in advanced biologics and Immuno-Oncology. Tishtha' will be available in 100 mg and 40 mg dosages priced at Rs 28,950 and Rs 13,950 respectively. The prices are approximately 1/4th of the reference drug. This will improve affordability and reduce the overall treatment burden for patients. The two strength portfolio enables oncologists to optimise dosing and minimise wastage - a key driver of treatment economics in immunotherapy. Powered by Capital Market - Live

The product is available in 100 mg and 40 mg strengths, priced at Rs 28,950 and Rs 13,950 respectively. The company said the prices are approximately one-fourth of the reference drug. According to the company, the lower pricing is expected to improve affordability and reduce the overall cost of immunotherapy, with potential benefits for more than 5 lakh patients. The availability of two dosage strengths is intended to help clinicians optimise dosing and minimise drug wastage, which is a key cost factor in immuno-oncology treatments. Zydus stated that Tishtha has been developed and manufactured in India, with an emphasis on ensuring consistent and long-term availability for patients who require therapy over multiple treatment cycles. The company highlighted affordability, consistency of supply, and reach as critical factors influencing access to modern cancer therapies. Zydus Lifesciences is a global life sciences company with operations across pharmaceuticals, consumer wellness, and medical technology. It posted a 38.12% YoY rise in consolidated net profit to Rs 1,258.6 crore in Q2 FY26, while revenue grew 18.07% to Rs 6,037.9 crore. Powered by Capital Market - Live

Sentynl Therapeutics Inc. (Sentynl), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences (Zydus Group), announced that the U.S. Food and Drug Administration has approved ZYCUBO' (copper histidinate) for the treatment of Menkes disease in pediatric patients. This is the first and only treatment approved for Menkes disease, a rare and fatal genetic condition, in the United States. ZYCUBO' is not indicated for the treatment of Occipital Horn Syndrome. Menkes disease is a rare X-linked recessive pediatric disease caused by mutations of the copper transporter ATP7A encoded by the ATP7A gene. Patients with Menkes disease are born with the inability to absorb dietary copper and subsequently have impaired copper transport across the blood-brain barrier, and, until now, there has been no approved treatment in the United States. ZYCUBO' is a subcutaneous injectable formulation of copper histidinate that restores copper homeostasis and maintains copper levels in patients with Menkes disease.Powered by Capital Market - Live

This marks the first and only FDA-approved therapy for this rare and fatal genetic disorder in the United States. ZYCUBO' is not indicated for Occipital Horn Syndrome. Menkes disease, an X-linked recessive pediatric condition caused by mutations in the ATP7A gene, prevents patients from absorbing dietary copper, resulting in impaired copper transport across the blood-brain barrier. Untreated patients typically do not survive beyond three years of age. ZYCUBO is a subcutaneous injectable formulation that restores copper homeostasis and maintains copper levels in patients. Clinical trials demonstrated a statistically significant improvement in overall survival, with the early treatment cohort showing median survival of 177.1 months compared to 17.6 months for untreated patients, representing a nearly 80% reduction in risk of death. Common adverse reactions (≥7% incidence) included pneumonia, viral infection, respiratory failure, seizure, bacterial infection, hemorrhage, hypotension, vomiting, tachycardia, pyrexia, volume depletion, fracture, dyspnea, elevated transaminases, diarrhea, fungal infection, anemia, and local administration reactions. Commenting on the approval, Dr. Sharvil P. Patel, MD, Zydus Lifesciences, said, 'This milestone marks a transformative moment for the Zydus Group and for families affected by Menkes disease. For the first time, patients have access to an approved therapy, offering hope where no options existed. We are proud to advance patient care and deliver innovative solutions to those who need them most.' Matt Heck, CEO of Sentynl, added, 'FDA's approval serves as compelling affirmation that a safe and effective therapy is now available for patients living with this devastating disease.' Dr. Stephen Kaler, clinical genetics specialist at Columbia University Medical Center, said, 'Beginning copper histidinate therapy in affected neonates has been shown to reduce symptoms and prolong life. Increased awareness and rapid testing are critical.' Sentynl, which acquired ZYCUBO' from Cyprium Therapeutics in 2023, advanced the drug through final FDA review, receiving Breakthrough Therapy, Fast Track, Rare Pediatric Disease, and Orphan Drug designations. Copper histidinate has also been granted Orphan Drug status by the European Medicines Agency. This approval is expected to bring new treatment options to the rare disease community, reinforcing Zydus Group's presence in the global pediatric therapeutics space. The Zydus Group, with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global life-sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs over 27000 people worldwide and is driven by its mission to unlock new possibilities in life sciences through quality healthcare solutions that impact lives. Zydus Lifesciences reported a 38.12% jump in consolidated net profit to Rs 1,258.60 crore in Q2 FY26, compared with Rs 911.2 crore posted in Q2 FY25. Revenue from operations increased 18.07% year on year (YoY) to Rs 6,037.9 crore in Q2 FY26. Shares of Zydus Lifesciences shed 0.15% to Rs 895 on the BSE. Powered by Capital Market - Live

Zydus Lifesciences Ltd is up for a fifth straight session today. The stock is quoting at Rs 924.45, up 0.27% on the day as on 12:44 IST on the NSE. The benchmark NIFTY is down around 0.33% on the day, quoting at 26163.7. The Sensex is at 85033.17, down 0.48%. Zydus Lifesciences Ltd has slipped around 0.02% in last one month. Meanwhile, Nifty Pharma index of which Zydus Lifesciences Ltd is a constituent, has slipped around 1.38% in last one month and is currently quoting at 22743.4, up 0.92% on the day. The volume in the stock stood at 1.4 lakh shares today, compared to the daily average of 5.58 lakh shares in last one month. The benchmark January futures contract for the stock is quoting at Rs 931.45, up 0.62% on the day. Zydus Lifesciences Ltd is down 7.63% in last one year as compared to a 10.36% jump in NIFTY and a 1.19% jump in the Nifty Pharma index.The PE of the stock is 19.22 based on TTM earnings ending September 25.Powered by Capital Market - Live

Bioeq AG (Bioeq), a Swiss biopharmaceutical company, and Zydus Lifesciences (Zydus), an innovation-led life-sciences company with an international presence, today announced that its wholly owned subsidiary, Zydus Lifesciences Global FZE, United Arab Emirates has entered into a strategic partnership with Bioeq, for the licensing, supply and commercialization of Bioeq`s Vascular Endothelial Growth Factor (VEGF) inhibitor NUFYMCO', an interchangeable biosimilar of Lucentis' (Ranibizumab) for the U.S. market. The Biologics License Application (BLA) for NUFYMCO' has been approved by U.S. Food and Drug Administration (USFDA) on December 18, 2025. This transaction marks an expansion of Zydus' U.S. biosimilar business, following its recent partnership with Formycon AG for a biosimilar of Keytruda' (Pembrolizumab). Under the terms of this agreement, Bioeq will be responsible for the development, manufacturing, registration and supply of the finished product, while Zydus will be responsible for the commercialisation of NUFYMCO' in the U.S. market.  Powered by Capital Market - Live

Zydus Lifesciences has signed an agreement with Myriad Genetics, a leader in molecular diagnostic testing and precision medicine company. Pursuant to the Agreement, Zydus will be introducing MyRisk' Hereditary Cancer Test, MyChoice' HRD Plus, Homologous Recombination Deficiency (HRD) Test and Prolaris' Prostate Cancer Prognostic Test to patients, clinicians, and healthcare systems across India. With the increasing incidence of cancers globally, the MyRisk' Test can help people safeguard their health and take precautionary steps and lifestyle changes that can minimise the risk of cancer. In patients suffering from prostate and ovarian cancers, the Prolaris' Test and MyChoice' HRD Plus Test, respectively, can help patients understand the disease progression and inform the right treatment path. As part of this agreement, Zydus will exclusively market, create awareness, access and engage clinicians on three of Myriad Genetics' broadly validated diagnostic platforms, MyRisk' Hereditary Cancer Test, MyChoice' HRD Plus Test for ovarian cancer, and Prolaris' a gene expression Prostate Cancer Prognostic Test. These tests have been widely adopted in the North America, Europe, and major global cancer centres, and will now empower Indian oncologists with cutting-edge genomic decision-support tools.  Powered by Capital Market - Live

 Sentynl Therapeutics, Inc. (Sentynl), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences (Zydus Group), today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of its New Drug Application (NDA) for copper histidinate (CUTX-101), intended to treat Menkes disease in pediatric patients. The resubmission has been accepted as a Class I response and as a result, the Company has received January 14, 2026 as the new PDUFA date. 'We appreciate the Agency's partnership and commitment to expeditiously reviewing our NDA resubmission,' said Matt Heck, CEO, Sentynl. 'The acceptance of the application brings us one step closer to a milestone for patients and families who are living with Menkes disease. Sentynl resubmitted its revised NDA on 14 November 2025 after receiving a complete response letter (CRL) from the FDA on 30 September 2025, which cited observations regarding the manufacturing site's cGMP compliance. The CRL did not cite any other approvability concerns, nor did it identify any deficiencies in CUTX-101's efficacy and safety data, which demonstrate improvement in overall survival for Menkes disease subjects who received early treatment with the therapy. Powered by Capital Market - Live