The new ne­go­ti­at­ed prices for No­vo Nordisk’s GLP-1 drugs un­der the In­fla­tion Re­duc­tion Act have raised ques­tions about how they will im­pact the prices No­vo agreed to un­der its sep­a­rate “most fa­vored na­tion” deal with the White House.

On Wednes­day, a CMS spokesper­son told End­points News that the MFN prices "are ex­pect­ed to su­per­sede” the IRA prices for Medicare, in light of the terms and time­lines of both deals.

Un­der the IRA, CMS ne­go­ti­at­ed a $274 month­ly price for Ozem­pic, We­govy and Ry­bel­sus, which would take ef­fect in 2027 and be ap­plied dif­fer­ent­ly across dose forms and strengths. Un­der the MFN deal it reached ear­li­er this month, No­vo agreed to sell Ozem­pic and We­govy to Medicare for $245 per month start­ing in 2026, with a $50 co­pay for qual­i­fy­ing ben­e­fi­cia­ries.

Alk­er­mes wins.

On Wednes­day, Dan­ish drug­mak­er Lund­beck said it was giv­ing up on its ef­fort to try to steal Avadel from a $2.1 bil­lion deal with Alk­er­mes signed in Oc­to­ber. Its de­ci­sion to walk away comes af­ter it made a bid worth as much as $2.6 bil­lion, which Alk­er­mes then large­ly matched.

Lund­beck said it re­viewed the "lat­est process dy­nam­ics" and de­ter­mined that in­creas­ing its of­fer would not meet its "cri­te­ria for val­ue cre­ation." It said it re­mains in­ter­est­ed in sleep dis­or­ders and will con­tin­ue to hunt for po­ten­tial ac­qui­si­tion tar­gets.

A spokesper­son for Lund­beck de­clined to com­ment fur­ther. Avadel's share price AVDL fell near­ly 7% af­ter Lund­beck­'s an­nounce­ment ear­li­er Wednes­day.

No­vo Nordisk sub­mit­ted a high­er dose of its obe­si­ty drug We­govy for FDA ap­proval and is us­ing a re­cent­ly-won vouch­er to ex­pe­dite the re­view.

The com­pa­ny said Wednes­day that it sub­mit­ted a sup­ple­men­tal new drug ap­pli­ca­tion for the 7.2 mg dose of We­govy, al­most a year af­ter post­ing suc­cess­ful Phase 3 da­ta. It is us­ing a Com­mis­sion­er’s Na­tion­al Pri­or­i­ty Vouch­er, which is ex­pect­ed to short­en the re­view time to as lit­tle as one month fol­low­ing sub­mis­sion.

No­vo got the vouch­er ear­li­er this month as part of its deal with the gov­ern­ment to low­er the price of its GLP-1 med­i­cines.

The new We­govy dose is al­so un­der reg­u­la­to­ry re­view in the EU and oth­er coun­tries, No­vo said. A de­ci­sion in Eu­rope is ex­pect­ed in the first quar­ter of 2026.

The FDA has ex­tend­ed its re­view for As­cendis’ once-week­ly treat­ment for achon­dropla­sia, al­so known as dwarfism.

The de­ci­sion de­lay cen­ters around the tri­al pro­to­col for the treat­ment’s post-mar­ket­ing study, As­cendis said in a Tues­day press re­lease. The drug, called TransCon CNP, was ex­pect­ed to re­ceive ac­cel­er­at­ed ap­proval and con­firm the ben­e­fit in an ad­di­tion­al tri­al fol­low­ing the de­ci­sion. The post-mar­ket­ing study is the “lone item” that re­mains out­stand­ing in the re­view.

The de­ci­sion was pre­vi­ous­ly ex­pect­ed by Nov. 30. The new PDU­FA date is Feb. 28, 2026.

Most an­a­lysts don’t ex­pect the de­lay to ham­per chances of ap­proval. Some even spec­u­lat­ed that the FDA could be us­ing PDU­FA de­lays as a way to al­le­vi­ate the staffing short­ages from this year’s HHS re­or­ga­ni­za­tion un­der sec­re­tary Robert F. Kennedy Jr.

Ot­su­ka se­cured FDA ac­cel­er­at­ed ap­proval for its an­ti­body drug in a dis­ease that im­pacts the kid­neys’ abil­i­ty to fil­ter waste.

The Japan­ese drug­mak­er said late Tues­day the agency green­lit sibepren­limab for IgA nephropa­thy (IgAN). The de­ci­sion was based on da­ta from a Phase 3 tri­al called VI­SION­ARY in which sibepren­limab re­duced lev­els of pro­tein in the urine, al­so known as pro­tein­uria, by just over half ver­sus place­bo. Pro­tein­uria is a bio­mark­er of kid­ney func­tion.

Ot­su­ka ob­tained the rights to sibepren­limab dur­ing its $430 mil­lion ac­qui­si­tion of Vis­ter­ra in 2018. The drug will be mar­ket­ed as Voyx­act. Pric­ing in­for­ma­tion was­n't im­me­di­ate­ly avail­able.