As CEO bounces back from Covid-19, Apel­lis says FDA meet­ing clears path to file for an OK on Soliris ri­val

Af­ter hold­ing up the com­pa­ny more than 4 months af­ter re­port­ing pos­i­tive head-to-head da­ta against the block­buster drug Soliris, Apel­lis $APLS says it’s cleared things up with the FDA and is ready to file for an ap­proval with their ri­val PNH drug pegc­eta­coplan.

The Waltham, MA-based biotech — whose CEO, Cedric Fran­cois, has re­cov­ered from a bout with Covid-19 — put out the word Thurs­day morn­ing that ex­ecs had a “suc­cess­ful out­come of the pre-NDA meet­ing” with the agency and they’re ready to press ahead with their fil­ing in the sec­ond half of this year.

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