FDA sends No­vaVax back to the clin­ic; Stoke Ther­a­peu­tics sets terms for up­sized $101M IPO

→ A be­lea­guered No­vaVax has run in­to a ma­jor hur­dle on its RSV vac­cine’s quest to mar­ket. The FDA is ask­ing the com­pa­ny to con­duct a whole new Phase III tri­al to con­firm that ResVax can pro­tect in­fants from “med­ical­ly sig­nif­i­cant RSV dis­ease” if their moth­ers were vac­ci­nat­ed. While it’s sort­ing out the sit­u­a­tion in the US and Eu­rope, No­vaVax said it will con­tin­ue work­ing with its back­ers at the Bill & Melin­da Gates Foun­da­tion to in­tro­duce the vac­cine in low to mid­dle in­come coun­tries.

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