FORTITUDE Data Support Accelerated Filing; Model Updated

研报英文原文证据摘录

FORTITUDE Data Support Accelerated Filing; Model Updated

Pharmaceuticals/Major

Novartis

TD SECURITIES (USA) LLC ESTIMATE CHANGES

June 11, 2026

Price: $148.12 | CHF119.04 (06/10/2026) FORTITUDE Data Support Accelerated Filing;

Price Target: $180.00 | CHF138.00 Model Updated

HOLD (2)

ESG SCORE: 59/100

Steve Scala, R.Ph., CFA THE TD COWEN INSIGHT

617 946 3923

FORTITUDE Cohort C trial of del-brax in FSHD met primary and secondary endpoints. NVS

stephen.scala@tdsecurities.com

will engage with regulators on this data, which may support accelerated approval. We model

Michael Nedelcovych, Ph.D. $1.5B in del brax sales in 2032. Separately, our NVS model was updated. Revenue was raised

617 946 3744 in most years during 2025-32 but EPS was lowered 1pp to +5% CAGR during this time.

michael.nedelcovych@tdsecurities.com

Chris LoBianco The News – Novartis announced today that the biomarker cohort of the Phase I/II FORTITUDE

617 946 3734 trial of delpacibart braxlosiran (del-brax) in FSHD met the primary and key secondary

chris.lobianco@tdsecurities.com endpoints. The results are from Cohort C, which assessed the impact of del-brax 2 mg/ kg

Paul Kuhn, Ph.D. Q6W for 12 months in 51 patients with a primary endpoint of change in KHDC1L plasma

646 562 1328 concentration (referred to as cDUX by Avidity), a DUX-4 regulated circulating biomarker. The

paul.kuhn@tdsecurities.com key secondary endpoint was change from baseline in the levels of creatine kinase, a marker

of muscle damage. The PR does not disclose any numerical efficacy numbers, but notes that

Key Data

the data "replicate the target engagement and downstream muscle protection seen with del-

Symbol NYSE: NVS | SWX: NOVN.S

brax in earlier dose escalation cohorts". In the previously presented Cohort A/B data, del-brax