The White House threw its weight be­hind ef­forts to help US biotech com­pete with Chi­na, us­ing the ad­min­is­tra­tion's bud­get pro­pos­al to out­line FDA pol­i­cy changes to speed up tri­als, cut costs for com­pa­nies that do ex­per­i­men­tal work in the US and ex­pe­dite reg­u­la­to­ry re­views.

One of the re­forms is a new clin­i­cal tri­al path­way that re­flects the quick­er process­es oth­er coun­tries have. The ex­pe­dit­ed path­way would be for some Phase 1 tri­als where there’s enough ex­ist­ing pre­clin­i­cal da­ta to sat­is­fy reg­u­la­tors. The FDA specif­i­cal­ly ex­pects the path­way to help “small­er biotech­nol­o­gy firms,” say­ing that the US’ ex­ist­ing IND process has fu­eled growth in Chi­na and Aus­tralia.

“The goal of this new path­way is to ac­cel­er­ate the drug de­vel­op­ment time­line and en­cour­age US biotech­nol­o­gy in­vest­ment – in line with the Pres­i­dent’s ac­tions to on­shore the phar­ma­ceu­ti­cal in­dus­try,” ac­cord­ing to the bud­get re­quest.

Am­gen said that an in­jectable ver­sion of its eye drug Te­pez­za suc­ceed­ed in a Phase 3 study for thy­roid eye dis­ease, set­ting up a show­down with Virid­i­an Ther­a­peu­tics, which last week al­so post­ed Phase 3 re­sults on an in­jectable treat­ment.

In a Phase 3 tri­al for pa­tients with mod­er­ate-to-se­vere dis­ease, in­jectable Te­pez­za sub­stan­tial­ly cut prop­to­sis, or bulging of the eye, in 77% of pa­tients com­pared to 19.6% with place­bo at 24 weeks.

That’s about a 57 per­cent­age-point im­prove­ment over place­bo, com­pared to the 36 per­cent­age-point im­prove­ment that Virid­i­an re­port­ed last week.

Am­gen is try­ing to keep its place atop the thy­roid eye dis­ease mar­ket in the face of up­com­ing com­pe­ti­tion. Te­pez­za is cur­rent­ly the on­ly ap­proved treat­ment for thy­roid eye dis­ease, but is de­liv­ered by IV in­fu­sion.

Take­da’s on­go­ing re­struc­tur­ing has hit an­oth­er De­nali pro­gram as an eight-year-old part­ner­ship comes to an end be­tween the two com­pa­nies.

Take­da re­turned the full rights to a De­nali drug called DNL593 ahead of a Phase 1/2 read­out. The pro­gram is de­signed to treat fron­totem­po­ral de­men­tia caused by mu­ta­tions in the gran­ulin gene, one of the most com­mon ge­net­ic caus­es of the dis­ease.

The de­ci­sion was “not re­lat­ed” to any of the pro­gram’s ef­fi­ca­cy or safe­ty da­ta, ac­cord­ing to a De­nali press re­lease. De­nali has led DNL593’s de­vel­op­ment so far and is aim­ing to re­port da­ta by the end of 2026.

Take­da and De­nali orig­i­nal­ly signed their col­lab­o­ra­tion in 2018 to work on three pro­grams in neu­rode­gen­er­a­tive dis­eases. Take­da orig­i­nal­ly paid $150 mil­lion up­front and promised more than $1 bil­lion in to­tal mile­stones. For DNL593, De­nali could have earned up to $315 mil­lion in biobucks, ac­cord­ing to SEC doc­u­ments.

Neu­ro­crine Bio­sciences is join­ing the M&A bo­nan­za with a $2.9 bil­lion takeover of prof­itable rare dis­ease drug­mak­er Soleno Ther­a­peu­tics.

Neu­ro­crine will pay $53 per share in cash, a 34% pre­mi­um to its last clos­ing price, the com­pa­nies said Mon­day morn­ing. The deal gives Neu­ro­crine ac­cess to Soleno's Vykat XR, ap­proved last year to squelch in­sa­tiable hunger in peo­ple with the rare ge­net­ic con­di­tion Prad­er-Willi syn­drome, which can lead to obe­si­ty and mus­cle im­pair­ments.

The move ex­tends a phar­ma buy­ing spree as drug­mak­ers look to shore up their near-term pipelines and fu­ture gaps. It adds to a 10-deal, $31.5 bil­lion March in which a few oth­er com­mer­cial-stage biotechs were al­so bought, in­clud­ing Apel­lis Phar­ma­ceu­ti­cals and Day One Bio­phar­ma­ceu­ti­cals.