Novartis: Del-Brax in FSHD positive biomarker data; Awaiting view on fileability

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Novartis: Del-Brax in FSHD positive biomarker data; Awaiting view on fileability

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Novartis

Del-Brax in FSHD positive biomarker data;

Awaiting view on fileability

Maintain Rating: BUY | PO: 140.00 CHF | Price: 119.04 CHF

Del-brax PI/II biomarker data in FSHD matches earlier data 11 June 2026

Novartis has headlined Del-brax PI/II biomarker data in FSHD which is positive, though Equity

key remains whether regulators will accept biomarker data for filing/approval ahead of

Sachin Jain, CFA >>

full PIII due in FY28. Novartis has consistently communicated biomarker filing as upside Research Analyst

and filing in FY28 as base case. Importantly, the press release confirms this data is MLI (UK) s.jain@bofa.com

consistent with prior, noting “biomarker cohort data importantly replicate the target

Charlie Haywood >>

engagement and downstream muscle protection seen with del-brax in earlier dose- Research Analyst

escalation cohorts,” with prior data summarised below and KOL feedback suggesting MLIcharlie.haywood@bofa.com(UK)

sufficient for approval. We model c$2bn peak sales (c$1bn risk-adj., in-line cons), but

Keilah Carbonel-Deere >>

addressable market potentially mid-sd bn, with a patient population of c45-87k. Buy. Research Analyst

MLI (UK)

Del-brax; $2bn opp. Accelerated approval vs PIII in FY28 keilah.carbonel-deere@bofa.com

FSHD is a rare, hereditary disorder, causing progressive muscle weakness and loss. It Alexander Moore >> Research Analyst

does not reduce life expectancy, but c20% of patients become wheelchair bound, where MLI (UK)

there are currently no approved disease-modifying therapies. Del-brax is being trialled in: alexander.moore2@bofa.com

(1) PIII FORTITUDE-3 for global confirmatory approval (functional data and regulatory