FDA Com­mis­sion­er Mar­ty Makary of­fered a soft­er ver­sion of the FDA's view of Covid-19 vac­cines than emerged in a re­cent in­ter­nal memo, say­ing that the agency was­n't plan­ning to add its most se­vere warn­ing to the shots, and sug­gest­ing that pre­vi­ous risks might have di­min­ished over time.

Makary's com­ments, made to Bloomberg TV in an in­ter­view Mon­day, were a sig­nif­i­cant con­trast to an in­ter­nal email sent late last month from the FDA’s chief of vac­cines and bi­o­log­ics Vinay Prasad, in which Prasad claimed with cer­tain­ty that the shots had caused at least 10 chil­dren's deaths.

Myth­ic Ther­a­peu­tics has end­ed op­er­a­tions, ter­mi­nat­ing its sole clin­i­cal tri­al af­ter fail­ing to raise enough mon­ey to move for­ward, End­points News has learned.

The Boston-area biotech "pur­sued var­i­ous cap­i­tal so­lu­tions dur­ing 2025 to fund its con­tin­ued op­er­a­tions and de­spite the promise of MYTX-011 such ef­forts were not suc­cess­ful," CEO George Eli­ades said in an emailed state­ment to End­points on Tues­day. Myth­ic is "in the process of wind­ing down and sell­ing as­sets, and sev­er­al are still avail­able."

Myth­ic cit­ed a "busi­ness de­ci­sion" for aban­don­ing work on MYTX-011, ac­cord­ing to an up­date post­ed to the US fed­er­al clin­i­cal tri­als data­base Tues­day. The biotech was test­ing the an­ti­body-drug con­ju­gate in a Phase 1 in the US, Aus­tralia, Eu­rope, South Ko­rea and Tai­wan.

Verge Ge­nomic­s' sole clin­i­cal-stage drug has failed, and the Cal­i­for­nia biotech will shift to a part­ner­ship mod­el for its AI-dri­ven dis­cov­ery plat­form, End­points News has learned.

The biotech's VRG50635 did not meet the bar for ef­fi­ca­cy in a Phase 1b in pa­tients with amy­otroph­ic lat­er­al scle­ro­sis, Verge CEO Al­ice Zhang said in an emailed state­ment on Tues­day. She said the biotech will pub­lish the full study re­sults in the first half of next year.

The tri­al was com­plet­ed "as de­signed," Zhang said, but it was ter­mi­nat­ed, ac­cord­ing to an up­date post­ed to the US fed­er­al tri­als data­base on Mon­day.

With that, the decade-old biotech will "fo­cus sole­ly" on its AI plat­form that us­es a "pro­pri­etary mul­ti-modal mol­e­c­u­lar and clin­i­cal dataset de­rived di­rect­ly from pa­tient tis­sue," Zhang said. She said there's been in­creased de­mand for its datasets and that the shift will help part­ners "im­prove pipeline suc­cess rates."

In its sec­ond deal this week, Sanofi is spend­ing $80 mil­lion up­front to li­cense an Alzheimer’s drug can­di­date de­vel­oped by the South Ko­re­an biotech ADEL.

The French drug­mak­er will get glob­al rights to ADEL-Y01, a mon­o­clon­al an­ti­body de­signed to stop the buildup and spread of a tox­ic form of tau pro­tein, which plays a key role in Alzheimer’s pathol­o­gy. The pact could be worth up to $1.04 bil­lion when fac­tor­ing in mile­stones. ADEL is al­so el­i­gi­ble for tiered roy­al­ties rang­ing up to the dou­ble dig­its.

ADEL has been ad­vanc­ing ADEL-Y01 with an­oth­er South Ko­re­an biotech called Os­cotec, which will be el­i­gi­ble for 47% of all the pro­ceeds from the pact, ac­cord­ing to Os­cotec’s press re­lease in Ko­re­an. The drug is cur­rent­ly in first-in-hu­man de­vel­op­ment in the US. ADEL shared Phase 1a re­sults at the Clin­i­cal Tri­als on Alzheimer’s Dis­ease an­nu­al con­gress ear­li­er this month.