Sage Ther­a­peu­tics has sued Bio­gen in Delaware court, one week af­ter re­ceiv­ing a $469 mil­lion buy­out of­fer from the larg­er neu­ro­science phar­ma com­pa­ny.

The full law­suit was sealed, and the court said the case was con­fi­den­tial af­ter be­ing con­tact­ed by End­points News. But a sep­a­rate court fil­ing from Sage states that it is “seek­ing pre­lim­i­nary in­junc­tive re­lief to en­force a stand­still agree­ment and a tri­al on a pa­per record on an ex­pe­dit­ed ba­sis.”

Bio­gen de­clined to com­ment on on­go­ing lit­i­ga­tion. A spokesper­son for Sage said that “any dis­cus­sions be­tween Bio­gen and Sage re­gard­ing an ac­qui­si­tion of Sage should be con­duct­ed in pri­vate.” The spokesper­son added that the com­pa­ny is seek­ing a tem­po­rary re­strain­ing or­der “to pre­serve our rights and en­force the stand­still pro­vi­sion pre­vi­ous­ly agreed to with Bio­gen.”

CMS did­n't wait for Pres­i­dent-elect Don­ald Trump to take of­fice be­fore is­su­ing its sec­ond list of drugs to be ne­go­ti­at­ed un­der the In­fla­tion Re­duc­tion Act, even though the agency had un­til Feb. 1 to re­lease it.

CMS of­fi­cials on Fri­day ex­plained the de­ci­sion on a me­dia call, say­ing the ear­ly re­lease ahead of the statu­to­ry dead­line will pro­vide man­u­fac­tur­ers with more time to pre­pare their da­ta for the ne­go­ti­a­tions.

But once the Trump ad­min­is­tra­tion takes over next week, it could move in sev­er­al dif­fer­ent di­rec­tions to ei­ther sup­port or quash drug price ne­go­ti­a­tions in the fu­ture.

If the Trump ad­min­is­tra­tion were to make changes to the ne­go­ti­a­tions, a CMS of­fi­cial said Fri­day that "it would re­quire ad­di­tion­al guid­ance and po­ten­tial rule­mak­ing and po­ten­tial­ly new in­for­ma­tion." The in­com­ing ad­min­is­tra­tion has­n't said any­thing pub­lic yet on its di­rec­tion.

No­vo Nordisk’s block­buster GLP-1 prod­ucts Ozem­pic and We­govy are among the next 15 drugs sub­ject to the gov­ern­ment’s Medicare ne­go­ti­a­tion pro­gram un­der the In­fla­tion Re­duc­tion Act, fol­low­ing re­peat­ed calls from law­mak­ers to make the treat­ments more af­ford­able.

The list came weeks be­fore the gov­ern­men­t's dead­line, kick­ing off a new cy­cle that’s slat­ed to take place un­der the in­com­ing Trump ad­min­is­tra­tion. To­geth­er, the 15 drugs cost Medicare Part D about $41 bil­lion from No­vem­ber 2023 through Oc­to­ber 2024.

Com­bined with the first 10 drugs sub­ject to Medicare ne­go­ti­a­tions, the 25 drugs ac­count­ed for 36% of Medicare Part D spend­ing dur­ing the same pe­ri­od.

The FDA on Fri­day ap­proved datopotam­ab derux­te­can, an an­ti­body-drug con­ju­gate de­vel­oped by As­traZeneca and Dai­ichi Sankyo, for a sub­set of pa­tients with the most com­mon form of breast can­cer, de­spite mixed clin­i­cal tri­al out­comes.

Brand­ed as Da­troway, the TROP2-di­rect­ed an­ti­body-drug con­ju­gate was ap­proved for adults with un­re­sectable or metasta­t­ic HR-pos­i­tive/HER2-neg­a­tive breast can­cer af­ter chemother­a­py and hor­mone ther­a­py. The new­ly ap­proved treat­ment will com­pete with Gilead’s Trodelvy, a TROP2-di­rect­ed ADC that was ap­proved in a sim­i­lar set­ting in 2023.

Dai­ichi Sankyo told End­points News via email the list price for Da­troway in the US is $4,891.07 per 100 mg vial, which comes out to a month­ly list price of around $28,259.52 at the rec­om­mend­ed dose of 6 mg/kg once every three weeks.

Fol­low­ing the poor­er-than-hoped per­for­mance of Ca­griSe­ma last month, No­vo Nordisk need­ed an em­phat­ic clin­i­cal suc­cess with its high-dose ver­sion of We­govy. The obe­si­ty drug did not quite man­age one.

A tri­al as­sess­ing the high-dose form of the in­ject­ed GLP-1 met its pri­ma­ry end­point, the com­pa­ny said Fri­day — but the weight loss fell short of that seen in a tri­al of Eli Lil­ly’s ri­val prod­uct Zep­bound. No­vo’s shares NVO dipped 4% in ear­ly trade as in­vestors con­sid­ered the da­ta, as well as ques­tions around man­u­fac­tur­ing and pric­ing.

No­vo said that pa­tients giv­en high-dose We­govy for 72 weeks lost 20.7% of their body weight. Tri­al sub­jects giv­en the ap­proved We­govy dose lost 17.5%, and place­bo pa­tients saw a weight re­duc­tion of 2.4%. These fig­ures were based on a per-pro­to­col analy­sis, which elim­i­nates pa­tients who did not ad­here to treat­ment.

→ Spark co-founder Kathy High made a qui­et re­turn to eye dis­ease drug de­vel­op­ment, be­com­ing CEO of US-Swiss biotech RhyGaze “late last year,” the Philadel­phia Busi­ness Jour­nal re­port­ed this week. RhyGaze said in a Jan. 10 re­lease that GV led an $86 mil­lion Se­ries A raise, with ARCH Ven­ture Part­ners, F-Prime Cap­i­tal, Bio­Gen­er­a­tion Ven­tures and No­var­tis Ven­ture Fund all chip­ping in. The com­pa­ny al­so put to­geth­er an $11 mil­lion seed round last sum­mer.

The CEO will try to repli­cate the same suc­cess she had at Spark with Lux­tur­na, the first-ever gene ther­a­py to be ap­proved by the FDA. RhyGaze is de­vel­op­ing its own gene ther­a­py for reti­nal dis­eases that cause blind­ness. High left Spark in ear­ly 2020 af­ter it was ac­quired by Roche, and she then spent two years with AskBio as pres­i­dent of ther­a­peu­tics.