Novartis’ Cosentyx gets positive CHMP opinion for polymyalgia rheumatica

Novartis (NVS) faces pressure from a major shareholder after several clinical trial setbacks, including failures in studies for del-desiran, pelacarsen, and rap-cel. However, the company reported positive Phase III results for remibrutinib and a positive CHMP opinion for Cosentyx. Novartis reaffirmed its 2026 guidance, expecting low single-digit net sales growth and a decline in core operating income. The stock closed at $140.37, down 0.39%.

Gilead Sciences expanded licensing for investigational once-yearly lenacapavir for HIV prevention, aiming to streamline future approval and distribution. WHO updated malaria guidelines to include Coartem® Baby, an antimalarial for newborns developed by Novartis and partners, now approved in 11 countries.

The European Medicines Agency's CHMP recommended 12 new medicines for approval, including Novo Nordisk's (NVO) Frehemgo for haemophilia A and AstraZeneca's (AZN) Etcamah for cancer. Novo Nordisk also gained approval for its oral Wegovy obesity treatment. Novartis (NVS) received approval for Vijoice, a rare disorder treatment.

Novartis announced a positive CHMP opinion for Cosentyx (secukinumab) in treating polymyalgia rheumatica (PMR). The recommendation is based on trial data showing Cosentyx doubled sustained remission rates and reduced steroid use. If approved, Cosentyx would be the first IL-17A inhibitor for PMR in Europe. The European Commission is expected to decide within two months.

Novartis (NOVN: VX) will acquire Sironax's brain delivery platform for $125 million, per an agreement. Sironax retains rights to develop, manufacture, and commercialize selected assets using the platform. The deal follows an option and asset purchase agreement announced in July 2025.

Novartis discontinued VHB937, a TREM2 antibody for ALS, after a Phase 2 trial missed its primary endpoint. The trial tested the drug in 251 early-stage ALS patients. Novartis did not release numerical data, with detailed findings expected in December. The setback follows recent failures in Novartis' pipeline, including pelacarsen and del-desiran. ALS drug development has seen many failures, with no current treatments stopping or reversing the disease.