Novartis Wins EU Nod for Cosentyx in Polymyalgia Rheumatica — but Four Pipeline Misses in a Month Keep the Pressure On
Published on 09/20/2026 at 06:43 | Editorial boerse-global.de
European regulators have handed Novartis a long-awaited win, even as the Swiss drugmaker's research engine sputters on multiple other fronts. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion on Friday for Cosentyx (secukinumab) in polymyalgia rheumatica. Should the European Commission follow through, the drug would become the first approved IL-17A inhibitor for that indication anywhere in Europe. A final decision from Brussels is now pending.
The timing matters. Just two days earlier, Novartis had pulled the plug on an experimental ALS candidate after its Phase 2 trial missed its objectives — the company's fourth clinical setback in under a month.
A Month of Setbacks, in Sequence
The run of disappointments stretches back to late August, when Novartis paused eight studies of an experimental cell therapy targeting autoimmune and neurological diseases following the deaths of three patients. Days later, on September 4, pelacarsen failed to significantly reduce cardiovascular events such as heart attacks or strokes versus placebo in the Phase 3 Lp(a)HORIZON trial, despite successfully lowering Lp(a) levels. Roughly two weeks ago came the next blow: Del-desiran missed its primary endpoint in the Phase 3 HARBOR study in myotonic dystrophy type 1 — a failure that triggered the steepest single-day share price drop in the company's history. Then on Wednesday, the axe fell on VHB937 (lifonebart), which missed both primary and secondary endpoints in the Phase 2 ASTRALS study in ALS.
The Del-desiran miss cuts deepest strategically. The compound sat at the heart of Novartis's multibillion-dollar acquisition of Avidity, and while the company continues to explore development paths within its antibody-oligonucleotide conjugate platform, the setback has cast a shadow over the deal logic.
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Shareholders Turn Up the Heat
That string of failures has not gone unnoticed among the ownership base. According to Reuters, a major shareholder has demanded personnel consequences and changes to the board following the recent trial disappointments. Confidence in CEO Vas Narasimhan is eroding, with eight shareholders surveyed by the news agency voicing pointed criticism of management's acquisition strategy — above all the Avidity purchase, for which Novartis shelled out USD 12 billion.
Sell-side analysts have turned more cautious too. Berenberg cut its price target on the stock from CHF 120 to CHF 105 on Wednesday. UBS, as reported in the media, confirmed its "Neutral" rating on Thursday, and Deutsche Bank kept its "Neutral" stance on Friday.
Where the Stock Stands
Novartis shares closed Friday's session at EUR 122.44. That leaves the stock down 10% over the past 30 days and roughly 15% below its 52-week high of EUR 144.30.
Management Clings to Its Growth Story
Despite the pipeline turmoil, Novartis is sticking to its long-term targets. The company reiterated its forecast of growing net sales by 5% to 6% annually through 2030. In the second quarter of 2026, the business leaned heavily on established medicines, with momentum from Kisqali, Kesimpta, Scemblix and Pluvicto helping to confirm the full-year 2026 guidance. Whether those workhorses alone can permanently fill the gaps left by the failed development programs is the question investors will be wrestling with in the quarters ahead.
For now, the CHMP's backing for Cosentyx shifts attention back to the existing portfolio and its label expansions — a welcome distraction while the market awaits the European Commission's final word.
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