Neu­ro­crine Bio­sciences’ In­grez­za has failed a late-stage tri­al in a type of cere­bral pal­sy, adding to a spate of clin­i­cal dis­ap­point­ments for the biotech in re­cent years.

Neu­ro­crine did not im­me­di­ate­ly re­spond to an End­points News query about whether it would con­tin­ue to de­vel­op the drug or not.

In­grez­za missed the pri­ma­ry and key sec­ondary end­points in a place­bo-con­trolled Phase 3 study called KINECT-DCP, ac­cord­ing to a Mon­day re­lease. The tri­al’s pri­ma­ry end­point looked at In­grez­za’s abil­i­ty to re­duce a type of in­vol­un­tary move­ment called chorea. KINECT-DCP en­rolled 86 chil­dren and adults with dys­k­i­net­ic cere­bral pal­sy (DCP) who have chor­eiform move­ments.

Neu­ro­crine did not share de­tailed re­sults, but said it will do so at a fu­ture med­ical meet­ing.

Plus, news about Bio­Marin and Cas­sa­va.

💊 Gilead opts in­to As­sem­bly Bio’s gen­i­tal her­pes pro­grams: As a re­sult, Gilead will pay As­sem­bly $35 mil­lion based on a 2023 deal. The de­ci­sion comes af­ter As­sem­bly re­port­ed Phase 1b da­ta on two ex­per­i­men­tal treat­ments for re­cur­rent gen­i­tal her­pes, ABI-1179 and ABI-5366, show­ing that each re­duced le­sions. Gilead called the da­ta “po­ten­tial­ly sup­port­ive of first new treat­ment for re­cur­rent gen­i­tal her­pes in 25 years.” — Lei Lei Wu

🫁 FDA ap­proves Boehringer In­gel­heim’s Jas­cayd for sec­ond lung in­di­ca­tion: The reg­u­la­tor cleared Jas­cayd to treat the pro­gres­sive lung scar­ring con­di­tion called pro­gres­sive pul­monary fi­bro­sis. The drug re­ceived its first ap­proval in Oc­to­ber for id­io­path­ic pul­monary fi­bro­sis, mark­ing the first new drug ap­proved for that dis­ease in over a decade. — Lei Lei Wu

A pa­tient in Pfiz­er’s tri­al of its he­mo­phil­ia drug Hym­pa­vzi died from a throm­bot­ic stroke, the drug­mak­er said Mon­day.

Pfiz­er said it had in­formed reg­u­la­tors and in­ves­ti­ga­tors of the death. In a state­ment emailed to End­points News, it said that it didn’t “an­tic­i­pate any im­pact to safe­ty” for pa­tients giv­en Hym­pa­vzi.

Pfiz­er said the pa­tient died af­ter ex­pe­ri­enc­ing a stroke orig­i­nat­ing in the ar­ter­ies that pro­vide blood to the brain and spine, fol­lowed by cere­bral he­m­or­rhage. Ac­cord­ing to a state­ment from the Eu­ro­pean Haemophil­ia Con­sor­tium, the per­son died on Dec. 14.

The con­sor­tium is a Eu­ro­pean pa­tient group for peo­ple with bleed­ing dis­or­ders. While it didn’t say how it knew the added in­for­ma­tion, pa­tient and physi­cian groups of­ten re­ceive in­for­ma­tion from drug­mak­ers when there is a safe­ty is­sue in a tri­al.