A fed­er­al judge has re­ject­ed some of Mod­er­na’s de­fens­es in the vac­cine mak­er's long-run­ning patent dis­pute with Ar­bu­tus.

The Tues­day de­ci­sion marks an in­cre­men­tal win for Ar­bu­tus, which claims that Mod­er­na’s Covid-19 vac­cine us­es its patent­ed lipid nanopar­ti­cle (LNP) tech­nol­o­gy. Mod­er­na as­sert­ed de­fens­es to try to in­val­i­date the patents, but Dis­trict Judge Joshua Wol­son sided with Ar­bu­tus on some of the claims.

“Not every de­fense presents a tri­able is­sue,” he said in a sum­ma­ry judg­ment rul­ing.

A Mod­er­na spokesper­son did­n't im­me­di­ate­ly re­spond to a re­quest for com­ment.

Wol­son said that be­cause Mod­er­na has al­ready mount­ed some of its de­fens­es in pro­ceed­ings be­fore the US Patent and Trade­mark Of­fice’s re­view board, “it can­not do so again in this case.” He al­so said that Mod­er­na lacked ev­i­dence to sup­port its claim that Ar­bu­tus’ in­ven­tion was de­rived from an­oth­er per­son.

Oc­u­lar Ther­a­peu­tix’ in­ves­ti­ga­tion­al drug could be­come the pre­ferred ther­a­py for wet age-re­lat­ed mac­u­lar de­gen­er­a­tion af­ter da­ta re­leased Tues­day showed sta­tis­ti­cal su­pe­ri­or­i­ty to Re­gen­eron and Bay­er’s cur­rent best­seller Eylea.

How­ev­er, the da­ta from the tri­al ap­pear to have dis­ap­point­ed, and the com­pa­ny’s stock OCUL was down about 22% at mar­ket open.

If Oc­u­lar's drug, known as Ax­paxli or OTX-TKI, is ap­proved by the FDA, pay­ers should be will­ing to fund use of the drug with­out the need for pa­tients to take and fail on Eylea or one of its cheap biosim­i­lars first, the com­pa­ny con­tends.

“This is the first drug ever to have the po­ten­tial to get a su­pe­ri­or­i­ty la­bel ver­sus an an­ti-VEGF. That is re­mark­able. That is his­toric,” Oc­u­lar CEO Pravin Dugel told End­points News.

The re­jec­tion of Disc Med­i­cine’s rare dis­ease treat­ment marks the first neg­a­tive out­come of the FDA's con­tro­ver­sial vouch­er pro­gram and sug­gests drugs that are se­lect­ed won't be guar­an­teed an ap­proval.

Dis­c's bitop­er­tin was an ear­ly test case of the Com­mis­sion­er's Na­tion­al Pri­or­i­ty Vouch­er (CN­PV) pro­gram, a pi­lot that aims to sig­nif­i­cant­ly short­en the typ­i­cal 10- to 12-month re­view times. The FDA said in a com­plete re­sponse let­ter from Fri­day that it had ques­tions about the bio­mark­er in­tend­ed to be used for ac­cel­er­at­ed ap­proval.

An­a­lysts viewed the re­jec­tion as a sur­prise, par­tic­u­lar­ly since Disc was one of the first com­pa­nies to get the vouch­er.

Boehringer In­gel­heim stopped de­vel­op­ment of an in­haled cys­tic fi­bro­sis gene ther­a­py that was in ear­ly-stage clin­i­cal tri­als.

The Ger­man phar­ma com­pa­ny told End­points News that it de­cid­ed to ter­mi­nate a study of the gene ther­a­py and stop work on the ex­per­i­men­tal treat­ment, known as BI 3720931, “as the clin­i­cal da­ta does not sup­port fur­ther in­ves­ti­ga­tion.”

Boehringer stopped the study af­ter en­rolling just five pa­tients, ac­cord­ing to a fed­er­al clin­i­cal tri­als data­base.

The tri­al start­ed last year as part of a col­lab­o­ra­tion be­tween Boehringer, the UK Res­pi­ra­to­ry Gene Ther­a­py Con­sor­tium, and Ox­ford Bio­med­ica. The study was ex­pect­ed to en­roll 36 pa­tients with cys­tic fi­bro­sis who are not el­i­gi­ble for CFTR mod­u­la­tor treat­ments, which are the go-to ther­a­pies for the dis­ease but don’t work for rough­ly 15% of them.

The sec­ond piv­otal tri­al of Com­pass Path­ways’ psilo­cy­bin for­mu­la­tion for treat­ment-re­sis­tant de­pres­sion has suc­ceed­ed, the com­pa­ny said Tues­day, a re­sult that could help the drug gain ap­proval next year.

The first ap­proval tri­al of the pill, which is known as COMP360, hit its pri­ma­ry end­point in June, al­though by a mar­gin slim­mer than Com­pass had hoped. At that point the com­pa­ny near­ly halved in val­ue.

This new study has re­versed Com­pass’ for­tunes to some ex­tent: Its shares CMPS rose more than 35% in mid­morn­ing trad­ing.

The study, called COMP006, had an un­usu­al de­sign. Un­like the first piv­otal tri­al, which com­pared COMP360 with place­bo, the sec­ond pit­ted dif­fer­ent dos­es against each oth­er. Rough­ly half the pa­tients in the tri­al took two 25 mg dos­es of the drug three weeks apart. A quar­ter of the tri­al’s sub­jects re­ceived two dos­es of 10 mg, and an­oth­er quar­ter two dos­es of 1 mg.