The FDA said Fri­day it has is­sued new fast-track vouch­ers to three psy­che­del­ic com­pa­nies, and its se­lec­tions have come as a “sur­prise” to Wall Street.

In an un­usu­al move, the agency didn’t name the spon­sors or their pro­grams in its an­nounce­ment, but said the Com­mis­sion­er’s Na­tion­al Pri­or­i­ty Vouch­ers are go­ing to­ward com­pa­nies that are ad­vanc­ing psilo­cy­bin for treat­ment-re­sis­tant de­pres­sion, methy­lone for post-trau­mat­ic stress dis­or­der and psilo­cy­bin for ma­jor de­pres­sive dis­or­der.

Com­pass Path­ways con­firmed it was one of the re­cip­i­ents in a press re­lease is­sued hours lat­er. A source fa­mil­iar with the an­nounce­ment told End­points News that the oth­er two re­cip­i­ents are Tran­scend Ther­a­peu­tics and the Usona In­sti­tute. Tran­scend de­clined to com­ment, and Usona did not im­me­di­ate­ly re­spond to a re­quest for com­ment.

No­var­tis has with­drawn its EU ap­pli­ca­tion for Plu­vic­to's ex­pan­sion in­to ear­li­er prostate can­cer treat­ment, de­spite US and UK ap­proval for the same in­di­ca­tion.

The Swiss drug­mak­er failed to gain fa­vor with the Eu­ro­pean reg­u­la­tors for the ra­di­oli­gand ther­a­py’s la­bel ex­pan­sion, de­spite win­ning over the FDA last month, tripling the num­ber of pa­tients who can re­ceive the ther­a­py. The UK’s Med­i­cines and Health­care prod­ucts Reg­u­la­to­ry Agency ap­proved Plu­vic­to’s la­bel ex­pan­sion in that ear­li­er set­ting in Feb­ru­ary.

No­var­tis had ap­plied for Plu­vic­to to be ex­tend­ed as a treat­ment for adults with prostate-spe­cif­ic mem­brane anti­gen (PS­MA)-pos­i­tive, metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer (mCR­PC) who have no, or mild symp­toms, af­ter the dis­ease pro­gressed de­spite us­ing a hor­mone-block­ing drug and when chemother­a­py is not an op­tion.

MA­HA’s sway over HHS could face a fresh test now that Pres­i­dent Trump has a new pick for CDC di­rec­tor: Er­i­ca Schwartz, a for­mer deputy sur­geon gen­er­al.

The po­si­tion has been emp­ty since Au­gust, when Su­san Monarez was oust­ed af­ter clash­es with HHS Sec­re­tary Robert F. Kennedy Jr. Like Monarez, Schwartz is a more tra­di­tion­al pub­lic health choice, with a track record of sup­port­ing vac­ci­na­tion. But a cru­cial ques­tion will be just how much in­de­pen­dence she has from Kennedy's in­flu­ence and agen­da on im­mu­niza­tion.

To­day on Post-Hoc Live at 11 a.m. ET, we’ve got a crossover episode! We'll be joined by Why Should I Trust You? host Brin­da Ad­hikari, whose show takes a look at the MA­HA move­ment and chang­ing trust in pub­lic health. Ad­hikari will be chat­ting with me and End­points’ MA­HA ex­pert Max Bay­er to talk about how Schwartz could sta­bi­lize a tur­bu­lent CDC and what the pick says about MA­HA's stand­ing in Trump­world.

Sanofi’s tole­bru­ti­nib is on track to get an ap­proval in Eu­rope for a type of mul­ti­ple scle­ro­sis even af­ter re­ceiv­ing a com­plete re­sponse let­ter from the FDA in De­cem­ber.

On Fri­day, the Eu­ro­pean Med­i­cines Agency’s hu­man med­i­cines com­mit­tee rec­om­mend­ed ap­proval of the BTK in­hibitor for sec­ondary pro­gres­sive mul­ti­ple scle­ro­sis (SPMS) with­out re­laps­es in the past two years. The de­ci­sion was based in part on da­ta from the Phase 3 HER­CULES tri­al, which showed tole­bru­ti­nib de­layed time to on­set of six-month con­firmed dis­abil­i­ty pro­gres­sion by 31% ver­sus place­bo.

The FDA re­ject­ed tole­bru­ti­nib for non-re­laps­ing SPMS in De­cem­ber 2025. In Jan­u­ary, the agency pub­lished a CRL, which de­tailed four rea­sons for the de­ci­sion, in­clud­ing a se­ri­ous risk of se­vere drug-in­duced liv­er in­jury (DILI) and un­cer­tain­ties about ben­e­fits in spe­cif­ic pa­tient sub­groups. At that time, Sanofi de­scribed the re­jec­tion as “un­ex­pect­ed” and said the FDA had raised con­cerns too late for the com­pa­ny to make changes.

Dai­ichi Sankyo has pushed back the re­port­ing of its an­nu­al re­sults, say­ing it needs more time to fi­nal­ize the n