For all in­tents and pur­pos­es, Amy­lyx is now a GLP-1 biotech.

The com­pa­ny's now-with­drawn ALS drug, brand­ed as Re­lyvrio and co­de­named AMX0035, failed a Phase 2b study for a sep­a­rate rare neu­ro­log­i­cal dis­ease called pro­gres­sive supranu­clear pal­sy, or PSP. The drug missed all of its pri­ma­ry and sec­ondary end­points in the tri­al, it an­nounced Wednes­day morn­ing.

As a re­sult, Amy­lyx will dis­con­tin­ue the Phase 2b tri­al and scrap plans for a Phase 3 in PSP.

It’s an­oth­er black mark for AMX0035, al­beit on a small­er scale than its ALS with­draw­al.

Amy­lyx had for years built its en­tire busi­ness around AMX0035 in ALS, hop­ing it could break through in a uni­ver­sal­ly fa­tal dis­ease that on­ly has mod­est­ly ef­fec­tive treat­ments. The drug demon­strat­ed a sta­tis­ti­cal­ly sig­nif­i­cant ben­e­fit in Phase 2 and re­ceived FDA ap­proval off those da­ta, but the ben­e­fit was not con­firmed when a Phase 3 study failed last year. Amy­lyx sub­se­quent­ly with­drew the drug from the mar­ket.

A new re­search foun­da­tion backed with funds from the es­tate of Paul Allen, the de­ceased co-founder of Mi­crosoft, will dole out at least $500 mil­lion to re­search in life sci­ences, the en­vi­ron­ment and ar­ti­fi­cial in­tel­li­gence over the next four years.

The Seat­tle-based Fund for Sci­ence and Tech­nol­o­gy (FF­ST) was qui­et­ly es­tab­lished in 2022 but made its first big splash on Wednes­day. The foun­da­tion’s re­mit is in­ten­tion­al­ly broad and will sup­port cu­rios­i­ty-dri­ven re­search and “blue sky” ideas, CEO Lyn­da Stu­art told End­points News.

“We're a bunch of sci­en­tists our­selves, and we are go­ing to fund sci­en­tists,” she said. “We're re­al­ly will­ing to take big bets and long bets on re­al­ly tough prob­lems.”

In­di­v­ior said it is ex­e­cut­ing the first phase of a mul­ti­year re­struc­tur­ing plan to “max­i­mize the po­ten­tial” of its busi­ness, start­ing with lay­offs and re­al es­tate con­sol­i­da­tion.

The Vir­ginia-based biotech did not dis­close the num­ber of em­ploy­ees it plans to lay off. But the work­force cuts are ex­pect­ed to in­cur sev­er­ance-re­lat­ed charges of $16 mil­lion to $19 mil­lion, ac­cord­ing to an SEC fil­ing shared Tues­day. In­di­v­ior had 1,094 em­ploy­ees at the end of 2024, an an­nu­al re­port states.

The com­pa­ny al­so plans to back out of cer­tain re­al es­tate projects, which could in­cur fees of $15 mil­lion to $22 mil­lion. It al­so ex­pects to in­cur con­sult­ing, le­gal and tax plan­ning ex­pens­es of ap­prox­i­mate­ly $8 mil­lion to $9 mil­lion.

In to­tal, these ear­ly moves mean the com­pa­ny will have to spend be­tween $39 mil­lion to $50 mil­lion for the over­haul in the third and fourth quar­ters of this year.

Plus, news about Nykode, Th­er­na Bio­sciences, Fo­s­un, Sita­la Bio, Cat­a­lyst Phar­ma­ceu­ti­cals and Lupin:

🔎 Lil­ly’s Verzenio im­proves sur­vival in ear­ly breast can­cer: In the sev­en-year analy­sis of the monar­chE tri­al, two years of treat­ment with Verzenio on top of en­docrine ther­a­py as an ad­ju­vant ther­a­py im­proved sur­vival com­pared to en­docrine ther­a­py alone. The mas­sive study en­rolled over 5,000 pa­tients with HR+, HER2-, node-pos­i­tive ear­ly breast can­cer at high risk of re­cur­rence. Lil­ly kept de­tails un­der wraps, say­ing the da­ta will be shared at a fu­ture med­ical meet­ing. Verzenio was first ap­proved in this in­di­ca­tion in 2021 with an ex­pand­ed la­bel in 2023. — Lei Lei Wu