Novartis clears key EU hurdle for Scemblix, shares in focus for oncology growth

By Julia Schmitt, Sector & Peer Group desk. Reviewed prior to publication on 2026-06-26, 20:27.

Novartis AG (CH0012005267) has received a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP) to extend the label of its cancer drug Scemblix to include pediatric patients with chronic myeloid leukemia. The Swiss group, which is listed on SIX in Zurich and competes directly with Roche in oncology, reported the regulatory milestone in a fresh investor communication.

CHMP backs Scemblix pediatric use

According to a Novartis investor update published this week, the CHMP recommends expanding Scemblix (asciminib) for the treatment of Philadelphia chromosome positive chronic myeloid leukemia in pediatric patients who have received at least one prior tyrosine kinase inhibitor. The Novartis media releases page details the CHMP opinion and positions the drug as a next-generation option in difficult-to-treat CML.

The recommendation is a key step toward full European Commission approval, which typically follows CHMP opinions within several months, and would broaden Scemblix's addressable patient base beyond adults. In its statement, Novartis highlights that the pediatric data are derived from a dedicated trial evaluating asciminib's safety and efficacy in children with chronic myeloid leukemia who had limited options under current standards of care.

Oncology portfolio and peer comparison

Novartis continues to tilt its portfolio toward innovative oncology and immunology treatments following the spin-off of its generic unit Sandoz in 2023, sharpening its focus against peers such as Roche and AstraZeneca. Coverage on Novartis by the Financial Times underscores that oncology remains a central driver of revenue growth, with drugs like Kisqali, Pluvicto and Scemblix forming a core of its strategy.

Analysts at several major houses, including UBS and Deutsche Bank, have repeatedly emphasized that regulatory progress in hematology and solid tumor indications is critical for Novartis's medium-term earnings trajectory. Although individual price target changes were not disclosed in today's sources, consensus data earlier in June showed the stock trading at a discount to the European pharma peer group, reflecting a cautious stance on execution risk but also potential upside if pivotal launches and label expansions deliver.

The product behind the stock

Scemblix (asciminib) is a targeted therapy for chronic myeloid leukemia that works by selectively inhibiting the ABL myristoyl pocket, offering an alternative mechanism versus earlier tyrosine kinase inhibitors. Novartis positions the drug as a next-generation option for patients who have not responded sufficiently to prior therapies, and now aims to extend this promise to pediatric patients via the new CHMP-backed indication.

Where the stock trades today

Novartis AG shares trade on SIX Swiss Exchange in Zurich; the latest available quote from major market data providers shows the stock around the mid-90s Swiss francs level in recent sessions, reflecting a large-cap healthcare valuation in the SMI index.

This article was produced with AI assistance and editorially reviewed. Price and company figures without guarantee; prices and dates may change at short notice. No investment advice, no buy or sell recommendation. Stock-market transactions carry risks up to and including total loss.