Novartis announced that the biomarker cohort of the FORTITUDE Phase I/II study of del-brax met its primary and key secondary endpoints, demonstrating reductions in KHDC1L and creatine kinase biomarker levels. These reductions indicate strong target engagement and a reduction in muscle damage in patients with facioscapulohumeral muscular dystrophy (FSHD). The therapy shows potential to become the first disease-modifying treatment for FSHD, a rare, irreversible neuromuscular disease affecting approximately 45,000 to 87,000 people in the US and EU.

The FORTITUDE Phase I/II study is a randomized, double-blind, placebo-controlled clinical trial evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and exploratory efficacy of del-brax. The trial includes three dose cohorts. Cohorts A and B assessed del-brax 2 mg/kg or 4 mg/kg versus placebo, while Cohort C, the biomarker cohort, evaluated del-brax 2 mg/kg every 6 weeks versus placebo for 12 months in 51 FSHD patients aged 16-70. The primary endpoint was the change in plasma concentration of KHDC1L, a DUX4-regulated circulating biomarker, and the key secondary endpoint was the change in creatine kinase levels.

Clinical Development Status

Based on the results from the initial cohorts, the del-brax 2 mg/kg dose every 6 weeks was selected for Cohort C and the ongoing Phase III study. Novartis is currently enrolling patients for FORTITUDE-3, a randomized, double-blind, placebo-controlled Phase III study evaluating the efficacy and safety of del-brax in 200 patients with FSHD aged 16-70 years. The primary endpoint for the Phase III study is quantitative muscle testing (QMT) in the US and the 10-meter walk/run test (10MWRT) in Europe.

Del-brax is an investigational antibody oligonucleotide conjugate (AOC) designed to address the root cause of FSHD by suppressing the aberrant expression of DUX4. It combines the tissue specificity of monoclonal antibodies with the precision of oligonucleotides to deliver siRNA to muscle cells. The therapy has received FDA Orphan Drug and Fast Track designations, as well as EMA Orphan Drug designation.

Del-brax is one of three potential first-in-class, late-stage, disease-modifying AOC therapies added to the Novartis neuroscience pipeline through the acquisition of Avidity Biosciences completed in February 2026. The other therapies include delpacibart-etedesiran (del-desiran) in Phase III development for myotonic dystrophy type 1 (DM1) and delpacibart-zotadirsen (del-zota) in Phase II development for Duchenne muscular dystrophy (DMD).

Novartis India Limited has announced the appointment of Ms. Gowree Gokhale (DIN: 09351661) as a Non-Executive and Independent Director for a term of five years. The resolution was passed through a postal ballot conducted via remote e-voting, concluding on May 16, 2026.

Voting Results Summary

The special resolution received overwhelming approval from shareholders. A total of 17,547,644 votes were polled, with 99.97% cast in favour of the appointment. The detailed voting pattern across various shareholder categories is outlined below.

Postal Ballot Process

The postal ballot notice was initially dispatched on April 16, 2026. A corrigendum was subsequently issued on May 15, 2026, to correct the classification of the resolution from an "Ordinary Resolution" to a "Special Resolution." Remote e-voting was conducted from April 17, 2026, to May 16, 2026, on the platform provided by NSDL.

Scrutinizer's Report

S. N. Ananthasubramanian & Co., Company Secretaries, were appointed as the scrutinizer for the postal ballot. In their report dated May 18, 2026, they confirmed that the resolution was passed with the requisite majority. The results have been submitted to BSE Limited and are available on the company's website.