Zydus Lifesciences announced that Sentyln Therapeutics has received FDA acceptance for the resubmission of its New Drug Application (NDA) for CUTX-101, intended to treat Menkes disease in pediatric patients. The FDA has assigned January 14, 2026 as the new PDUFA Target Action Date for the resubmission.

Regulatory Timeline and Acceptance Details

The FDA accepted the resubmission as a Class I response, marking a significant milestone in the approval process for CUTX-101. Sentyln resubmitted its revised NDA on November 14, 2025 after receiving a complete response letter (CRL) from the FDA on September 30, 2025.

Complete Response Letter Analysis

The CRL cited observations regarding the manufacturing sites cGMP compliance but did not identify any other approvability concerns. Importantly, the FDA found no 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.

CUTX-101 Clinical Efficacy Data

CUTX-101 is an investigational copper histidinate candidate that showed statistically significant improvement in overall survival for Menkes disease subjects. The clinical trial results demonstrated an early 80.00% reduction in the risk of death compared to untreated historical controls.

Market Significance and Disease Impact

If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease, a rare X-linked recessive pediatric genetic disease. The condition impacts an estimated 1 in 34,810 to as high as 1 in 8,664 live male births and is characterized by distinctive clinical features including sparse and depigmented hair, connective tissue problems, and severe neurological symptoms.

This FDA acceptance brings the potential first treatment for Menkes disease closer to approval, offering hope for patients and families affected by this rare condition.

Zydus life science has announced the completion of its postal ballot voting process for a special resolution, with results declared on December 12, 2025. The pharmaceutical company submitted detailed voting results to both BSE Limited and National Stock Exchange of India Limited, fulfilling its regulatory obligations under the SEBI Listing Regulations.

Postal Ballot Process Details

The company facilitated remote e-voting through Central Depository Services (India) Limited platform for its shareholders. The voting process was structured with specific timelines to ensure maximum participation from eligible shareholders.

Voting Results by Category

The postal ballot results show participation across different shareholder categories, with detailed breakdowns of votes polled and voting patterns. The promoter and promoter group category recorded significant participation in the voting process.

Regulatory Compliance

The company has fulfilled its obligations under Regulation 44(3) of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. The detailed voting results have been submitted along with the Scrutinizer's Report on remote e-voting to ensure transparency and compliance.

The voting results and related documents are being uploaded on the company's official website for public access. This postal ballot process was conducted without a physical Annual General Meeting, as indicated by the "Not Applicable" status for AGM-related parameters in the official documentation.

Corporate Communication

Dhaval N. Soni, Company Secretary and Compliance Officer (Membership No. FCS7063), signed the official communication to the stock exchanges. The company maintains its registered office at Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), near Vaishnodevi Circle, S.G. Highway, Ahmedabad-382481, Gujarat.