Novartis announced on June 30, 2026, that the European Commission (EC) has approved Itvisma (onasemnogene abeparvovec) for the treatment of children two years and older, teens, and adults living with 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the survival motor neuron 1 (SMN1) gene. The approval marks Itvisma as the first and only gene replacement therapy currently approved for this broad SMA population in the European Union. This development expands access to a one-time treatment option designed to replace the faulty SMN1 gene, addressing the genetic root cause of the disease.

Itvisma is uniquely designed to address the genetic root cause of SMA with a one-time fixed dose that does not need to be adjusted for age or body weight. By replacing the SMN1 gene, Itvisma aims to improve motor function, offering a distinct option from ongoing dosing approaches associated with other available therapies. The approval enables Novartis to offer gene replacement therapy options across different stages of SMA in Europe, from newborns to adults, alongside its existing therapy Zolgensma.

The regulatory approval is based on data from the registrational STEER study, as well as supportive Phase IIIb STRENGTH and Phase I/II STRONG studies. In the STEER study, Itvisma demonstrated a statistically significant 2.39-point improvement in the Hammersmith Functional Motor Scale (HFMSE), with effects sustained over 52 weeks of follow-up. The STEER and STRENGTH studies also indicated clinically meaningful benefits for both treatment-naïve and pre-treated patients.

"This approval marks a major milestone for people living with SMA," said Patrick Horber, MD, President, International, Novartis. "With Itvisma, we are going further to expand access to a one-time gene replacement therapy for older children, teens and adults – potentially addressing long-standing unmet needs for patients."

Spinal muscular atrophy is a rare, genetic neuromuscular disease caused by a mutated or missing SMN1 gene, leading to progressive muscle weakness. The most common side effects associated with Itvisma include upper respiratory tract infection, pyrexia, vomiting, headache, and increased hepatic enzymes. Novartis holds exclusive, worldwide licenses for the intrathecal delivery of AAV9 gene replacement therapy for the treatment of all types of SMA.

Public shareholders tendered zero equity shares in the dematerialized form and 182 shares in physical form in the open offer for Novartis India Limited initiated by a consortium of acquirers including WaveRise Investments Limited, ChrysCapital Fund X, and Two Infinity Partners. The offer aimed to acquire up to 64,19,608 fully paid-up equity shares of face value INR 5 each, representing 26% of the voting share capital of the target company. The minimal participation indicates that shareholders largely chose not to sell their holdings at the offer price.

Axis Capital Limited, the manager to the open offer, disclosed to BSE Limited that no shares were tendered in the Open Offer Escrow Demat Account with Ventura Securities Limited as of June 24, 2026. The dematerialized shares were to be credited to the "MIPL NOVARTIS INDIA LIMITED OPEN OFFER ESCROW DEMAT ACCOUNT". However, 182 equity shares were tendered in physical form with the Registrar to the Open Offer, constituting 0.00% of the offer size.

The acquirers, acting in concert with Persons Acting in Concert (PACs) ChrysCapital X, LLC and OceanEdge Investments Limited, had issued a Letter of Offer dated June 1, 2026. The offer was governed by the SEBI (Substantial Acquisition of Shares and Takeovers) Regulations. The table below summarizes the key details of the open offer and the tendering status.

The manager clarified that the shares tendered by public shareholders are subject to validation and verification of submitted documents. The number of shares "validly tendered" and ultimately accepted by the acquirers may differ from the initial tendering figures. The acceptance of shares will be strictly in accordance with the SEBI (SAST) Regulations and the terms outlined in the Letter of Offer.