Court bat­tles over Medicare drug price ne­go­ti­a­tions are com­ing to a head.

Two drug­mak­ers are up against dead­lines next month to ap­peal their In­fla­tion Re­duc­tion Act chal­lenges to the US Supreme Court. Weeks af­ter that, the first set of ne­go­ti­at­ed prices un­der the law is slat­ed to take ef­fect. 

Le­gal ex­perts say it’s un­like­ly the Supreme Court will step in be­fore new prices take ef­fect on Jan. 1 for block­buster drugs like As­traZeneca’s Farx­i­ga and Bris­tol My­ers Squibb’s Eliquis. But some low­er court cas­es have yet to be re­solved, and a high court de­ci­sion af­ter the fact could still change how the ne­go­ti­at­ed prices are im­ple­ment­ed.

No­var­tis has se­cured FDA ap­proval for a new ver­sion of its one-time gene ther­a­py for spinal mus­cu­lar at­ro­phy (SMA) that it says could ben­e­fit a much broad­er swathe of pa­tients.

The Swiss drug­mak­er said the agency green­lit Itvis­ma for SMA pa­tients aged two years and old­er with a con­firmed mu­ta­tion in their SMN1 gene. No­var­tis told End­points News that Itvis­ma will car­ry a $2.59 mil­lion price tag to re­flect its “trans­for­ma­tive val­ue.”

Itvis­ma is “iden­ti­cal” to No­var­tis’ old­er SMA gene ther­a­py Zol­gens­ma, ex­cept for a dif­fer­ent con­cen­tra­tion and method of de­liv­ery, ac­cord­ing to an FDA re­lease. Zol­gens­ma is ap­proved for in­fants with SMA un­der the age of two with bial­lel­ic mu­ta­tions in the SMN1 gene.

It took 14 calls be­tween chief ex­ec­u­tives, four months of ne­go­ti­a­tions and four hiked pro­pos­als for No­var­tis and Avid­i­ty Bio­sciences to come to their $12 bil­lion agree­ment in Oc­to­ber, ac­cord­ing to a Mon­day fi­nan­cial fil­ing with the back­ground of 2025's sec­ond-largest bio­phar­ma ac­qui­si­tion.

The doc­u­ment shows the pow­er that a sell­er can have when it's in pos­ses­sion of an as­set that a big­ger com­pa­ny wants. Dur­ing the deal process, Avid­i­ty’s ad­vi­sors reached out to sev­en po­ten­tial coun­ter­par­ties to gauge their in­ter­est in a deal, but none of the com­pa­nies moved for­ward, ac­cord­ing to the fil­ing.

But while No­var­tis was the on­ly bid­der in the process, it had to raise its of­fer from $52 per share in Ju­ly up to $72 per share to close the deal on Oct. 26.

No­var­tis plans to re­or­ga­nize two Swiss fa­cil­i­ties, which it says could re­sult in 550 lay­offs as it dis­con­tin­ues some man­u­fac­tur­ing at its site in Stein.

The com­pa­ny in­tends to dis­con­tin­ue tablet and cap­sule man­u­fac­tur­ing and pack­ag­ing at the fa­cil­i­ty by the end of 2027, it said Tues­day in a re­lease. The po­ten­tial job cuts could oc­cur by the end of 2027, but that could change de­pend­ing on a con­sul­ta­tion process, No­var­tis said.

The Stein fac­to­ry will con­tin­ue to fo­cus on cell and gene ther­a­py man­u­fac­tur­ing, with No­var­tis plan­ning to in­vest $26 mil­lion at the site to boost ster­ile dosage form ca­pac­i­ty.

Mean­while, the drug­mak­er is al­so plan­ning to in­vest $80 mil­lion at its Schweiz­er­halle fa­cil­i­ty to ex­pand small in­ter­fer­ing RNA pro­duc­tion for its car­dio­vas­cu­lar, re­nal and meta­bol­ic ther­a­pies. The Schweiz­er­halle ex­pan­sion will cre­ate 80 new jobs.

No­vo Nordisk’s amylin com­bi­na­tion shot amy­cretin al­lowed pa­tients with di­a­betes to lose up to 14.5% of their body weight in just over eight months. Pa­tients in the same mid-stage tri­al who were giv­en a pill form of the drug lost up to 10.1% of their weight at the same time point.

No­vo said Tues­day that these weight-loss fig­ures are sta­tis­ti­cal­ly sig­nif­i­cant com­pared with in­ject­ed and oral place­bos, which yield­ed weight loss of 2.6% and 2.5%, re­spec­tive­ly.

The phar­ma com­pa­ny is plan­ning to start an “ex­ten­sive” Phase 3 pro­gram for amy­cretin in “mul­ti­ple in­di­ca­tions” next year. The drug could one day gen­er­ate con­sid­er­able sales for No­vo, with 2032 sales fore­casts in ex­cess of $4 bil­lion, ac­cord­ing to Eval­u­ate Phar­ma.