Spring­Works stalled in pre-launch mode for brand com­mu­ni­ca­tions af­ter FDA de­ci­sion de­lay

Spring­Works Ther­a­peu­tics was cruis­ing along with its pre-launch mar­ket­ing plans for its rare desmoid tu­mor drug can­di­date nirogace­s­tat. Its FDA de­ci­sion date was set for Au­gust, and it launched a place­hold­er web­site and Face­book page for nirogace­s­tat un­der its con­di­tion­al­ly ap­proved name Og­siveo.

Then in ear­ly June, the bio­phar­ma an­nounced the FDA’s de­ci­sion had been pushed back three months, to Nov. 27. The reg­u­la­tor told Spring­Works it need­ed more time to re­view sev­er­al re­spons­es it had re­quest­ed, con­sti­tut­ing what the FDA con­sid­ered a ma­jor amend­ment and a time­line change. Spring­Works, a 2017 Pfiz­er spin­out, had been grant­ed a pri­or­i­ty re­view for nirogace­s­tat in Feb­ru­ary.

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