Mys­tery biotech Em­maus grabs ground­break­ing FDA pan­el back­ing for sick­le cell drug — af­ter qui­et­ly scrap­ping $225M deal

A lit­tle-known biotech out of Tor­rance, CA is one big step clos­er to win­ning the first new drug ap­proval for sick­le cell dis­ease in close to 20 years. And it has achieved pre­cious lit­tle at­ten­tion for its years-long clin­i­cal odyssey with the drug — or the $225 mil­lion deal it just qui­et­ly scut­tled days ago.

Em­maus Life Sci­ences won an FDA pan­el vote fa­vor­ing an ap­proval by 10-3, set­ting it on a course for an odds-on ap­proval by the PDU­FA date of Ju­ly 7. The break­through win comes just days af­ter Em­maus filed doc­u­ments with the SEC say­ing that it had called off a move to sell a ma­jor­i­ty in­ter­est in the com­pa­ny to Generex for $10 mil­lion in cash plus $215 mil­lion in stock.

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