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Novartis faces delay after FDA asks for another Zolgensma study

Sep 23, 2020 - Nasdaq

B y ZURICH, Sept 23 (Reuters) - Novartis's NOVN.S bid to expand its $2.1 million-per-patient gene therapy Zolgensma to more spinal muscular atrophy patients faces a possible delay after U.S. regulators requested another study in older children getting the drug via a spinal infusion. Novartis, whose shares fell 1% in early Wednesday trading, said the U.S. Food and Drug Administration's (FDA) request for an additional study was not linked to an ongoing safety hold on a Zolgensma trial after possi...