Zydus Lifesciences will hold a meeting of the Board of Directors of the Company on 5 February 2025.Powered by Capital Market - Live News

Sentynl Therapeutics, Inc. (Sentynl), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences (Zydus Group), and Fortress Biotech, Inc. (Nasdaq: FBIO) (Fortress) announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and Priority review Sentynl`s New Drug Application (NDA) for CUTX-101, the product candidate for the treatment of Menkes disease. Menkes disease is a rare X-linked recessive pediatric disease caused by gene mutations of the copper transporter ATP7A. Recent estimates suggest a prevalence of 1 in 34,810 to as high as 1 in 8,664 live male births. Sentynl`s NDA is supported by positive topline clinical efficacy results for CUTX-101, demonstrating statistically significant improvement in overall survival for Menkes disease subjects who received early treatment with CUTX-101, with a nearly 80% reduction in the risk of death compared to an untreated historical control cohort. Median overall survival was 177.1 months for CUTX-101 early treatment cohort compared to 16.1 months for the untreated historical control cohort.�The NDA acceptance of CUTX-101 marks an important step towards our vision to transform lives and meaningfully impact patients, caregivers, and the rare disease community at large,� said Punit Patel, President and CEO, Zydus Americas. �We remain committed to providing access to path-breaking discoveries that can address unmet needs globally, as evident in the potential impact of CUTX-101 on Menkes disease patients and their families.� �Menkes disease presents a difficult journey for patients and their caregivers, as ATP7A mutations impact the transport of copper to a range of organs and systems, such as the lungs, brain and heart. With no known cure or current FDA-approved treatments, death typically occurs between 2 to 3 years of age,� said Matt Heck, President & Chief Executive Officer of Sentynl. �We are eager for the FDA to review our application for CUTX-101, which has the potential to be the first FDA-approved therapy for this devastating condition.�Powered by Capital Market - Live News

Zydus Lifesciences has appointed Vikram Shukla as a President-Parenteral Operations and designated as the Senior Management Personnel. Powered by Capital Market - Live News

In September 2024, Zydus Lifesciences intimated about execution of Business Transfer Agreement (BTA) to purchase the API business of Sterling Biotech (SBL), subject to certain conditions precedent and closing date adjustments as provided in the BTA, with effect from such date, and in such manner and on the terms and conditions as mentioned in the BTA. This transaction was expected to be completed by 31 December 2024. Now, SBL is still in the process of completing certain conditions precedents of the BTA and is expected to take some more time to complete the same. In view of the same, and as per the terms and conditions of the BTA, the Company and SBL have mutually decided to extend the date of closing upto 31 March 2025.The Company and SBL have today, i.e. 27 December 2024, executed a letter to extend the date of completion as above. In view of the same, the transaction is expected to be completed on or before 31 March 2025. Powered by Capital Market - Live News

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Lidocaine and Prilocaine Cream USP, 2.5%/2.5% (USRLD: EMLA� Cream, 2.5%/2.5%). Lidocaine and Prilocaine Cream USP is indicated as a topical anaesthetic for use on normal intact skin for local analgesia and genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anaesthesia. Lidocaine and Prilocaine cream will be produced at the Group`s topical manufacturing site at Changodar, Ahmedabad. Lidocaine and Prilocaine cream had annual sales of USD 22.05 mn in the United States (IQVIA MAT October 2024). The group now has 412 approvals and has so far filed over 473* ANDAs since the commencement of the filing process in FY 2003-04. Powered by Capital Market - Live News