Did Sum­mit Ther­a­peu­tics set ex­pec­ta­tions too high?

Ex­cite­ment has been build­ing over its can­cer drug ivonescimab over the last two years as the com­pa­ny, in­vestors and clin­i­cians all won­dered if it could pose a ma­jor chal­lenge to Mer­ck’s best-sell­ing im­munother­a­py Keytru­da.

But af­ter yet an­oth­er mixed read­out Sun­day from its close­ly-watched Phase 3 tri­al, Sum­mit was busy de­fend­ing it­self on Mon­day, as Wall Street an­a­lysts pep­pered ex­ec­u­tives with un­usu­al­ly point­ed and di­rect ques­tions. Many of those ques­tions dealt with Sum­mit's plans, which seemed yet to be de­ter­mined.

The stock SMMT lost al­most a quar­ter of its near­ly $20 bil­lion mar­ket val­ue.

Sun­day's da­ta in­clud­ed a new post-hoc analy­sis show­ing that, af­ter sev­er­al months of ad­di­tion­al da­ta from West­ern pa­tients, the tri­al fi­nal­ly hit sta­tis­ti­cal sig­nif­i­cance on over­all sur­vival af­ter fail­ing that test ear­li­er this year.

The suc­cess sto­ry of ba­by KJ’s cus­tomized CRISPR ther­a­py and the prospects for oth­ers like it have the FDA ready­ing a new ap­proval path­way for those with ex­treme­ly lim­it­ed treat­ment op­tions.

The new path­way will be for nov­el ther­a­pies in­tend­ed for just one or a few pa­tients, the FDA’s Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search Di­rec­tor Vinay Prasad told a Duke-Mar­go­lis work­shop last week. The agency is plan­ning to out­line it in the New Eng­land Jour­nal of Med­i­cine, ac­cord­ing to Prasad, who de­scribed it as "the plau­si­ble mech­a­nism path­way."

The idea was first float­ed by FDA Com­mis­sion­er Mar­ty Makary in April, who de­scribed it at the time as a "con­di­tion­al ap­proval" path­way. Prasad said that “it will be a nov­el path­way for drug de­vel­op­ers who are pur­su­ing be­spoke ther­a­py. By that, I mean com­plete­ly in­di­vid­u­al­ized ther­a­py that ba­by A gets one treat­ment, B gets the next treat­ment, ba­by C gets a dif­fer­ent treat­ment.”

Pfiz­er says a new for­mu­la­tion of its Covid-19 vac­cine boost­ed an­ti­body lev­els by at least four-fold in adults ahead of the up­com­ing res­pi­ra­to­ry sea­son.

The bio­phar­ma and Comir­naty co-de­vel­op­er BioN­Tech re­leased new da­ta Mon­day on an up­dat­ed ver­sion of the shot, tar­get­ing the LP.8.1 vari­ant of the virus, in peo­ple 65 and old­er and at-risk peo­ple aged 18 to 64. The da­ta come from the open-la­bel por­tion of a Phase 3 study, and all par­tic­i­pants were at least six months re­moved from re­ceiv­ing a dose of last year’s vac­cine.

The study en­rolled 100 peo­ple, half of which were 65 and old­er and the oth­er half were younger adults. The an­ti­body lev­els were test­ed two weeks fol­low­ing vac­ci­na­tion, and Pfiz­er said the safe­ty pro­file was con­sis­tent and no new con­cerns arose. Da­ta were ac­crued in two months, af­ter the tri­al launched in ear­ly Ju­ly, ac­cord­ing to a US clin­i­cal tri­al data­base. Pa­tients were re­cruit­ed across six sites in the US, and the study is ex­pect­ed to fin­ish in Jan­u­ary 2026.