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Pharmaceuticals, Mid Cap

 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.

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Denosumab is a monoclonal antibody with several indications related to bone health, primarily used in the treatment of osteoporosis and in preventing skeletal complications in cancer patients. The launch of Zyrifa will help treat patients with bone metastases resulting from breast, prostate, lung, myeloma, kidney, thyroid, head and neck, and other solid tumours. Bone metastasis occurs when cancer spreads to the bones or other organs, indicating an advanced stage of disease. Zyrifa is priced at an MRP of Rs 12,495.

Bone metastases are a serious complication across multiple cancers, significantly affecting patient quality of life. Patients may experience pain, fractures, spinal cord compression, reduced mobility and loss of independence, often diminishing dignity and increasing mortality risk. The condition most commonly affects the axial skeleton?the spine, pelvis and ribs?leading to severe complications.

Population-scale studies indicate that bone involvement affects 50?70% of patients with advanced breast or prostate cancer, while 15?40% of those with lung, kidney, thyroid and melanoma also develop skeletal metastases over time.

Zydus Lifesciences has been launching a wide range of biosimilars to treat various cancers ranging from breast cancer to prostate cancer, various other solid tumours and blood cancer. The company has also partnered with diagnostic companies.

Dr Sharvil P. Patel, Managing Director, Zydus Lifesciences, said, ?With Denosumab 120 mg SC, we aim to bring access, affordability of medication in cancer patients needing critical care. This will help patients to retain mobility and support them in their fight against cancer.?

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.

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Zydus Lifesciences has launched 'Zyrifa', a Denosumab biosimilar. Denosumab is a monoclonal antibody with several indications related to bone health, primarily in the treatment of osteoporosis and the prevention of skeletal complications in cancer patients. This will provide access and treat patients with bone metastases due to breast, prostate, lung, myeloma, kidney, thyroid, head & neck, and other solid tumours. Metastases, is when the cancer spreads to the bones and other organs in the body indicating an advanced stage of cancer. 'Zyrifa' is priced at MRP of Rs 12,495.

Speaking on this launch, Dr. Sharvil P. Patel, Managing Director, Zydus Lifesciences, said ?With Denosumab 120 mg SC, we aim to bring access, affordability of medication in cancer patients needing critical care. This will help patients to retain mobility, and support them in their fight against cancer?

Zydus Lifesciences Limited has been launching a wide range of biosimilars to treat various cancers ranging from breast cancer to prostate cancer, various other solid tumours and blood cancer. The company has also partnered with diagnostic companies.

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Zydus Lifesciences has received the Establishment Inspection Report (EIR) from the USFDA for a GMP follow-up inspection conducted at its injectable facility located at Jarod, Vadodara from 25 August to 05 September 2025 and classifying the facility as Voluntary Action Indicated (VAI). This inspection was conducted following the Warning Letter issued on 29 August 2024 by the USFDA.

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