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Ve­ra out­lines full Phase 3 win for kid­ney drug Read in browser
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Drew Armstrong
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The White House's announcement of its deal for weight loss drugs with Lilly and Novo will happen any minute, with the president expected to announce significant cuts to the cash price for the products. Our reporter Max Bayer is at the White House and we'll alert as soon as we have more.

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Drew Armstrong
Executive Editor, Endpoints News
@ArmstrongDrew
Maziar Mike Doustdar, Novo Nordisk CEO (Ritzau Scanpix/Sipa USA/Sipa via AP Images)
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by Drew Armstrong

No­vo Nordisk has once again upped its bid for Met­sera, ac­cord­ing to sources fa­mil­iar with the mat­ter, in an ef­fort to beat out a raised Pfiz­er of­fer that was de­liv­ered late Wednes­day.

The ex­act de­tails of the new of­fers weren't im­me­di­ate­ly clear. The peo­ple who de­scribed them spoke on con­di­tion of anonymi­ty.

Met­sera shares MT­SR were up about 13% on Thurs­day as in­vestors bet the bid­ding war would dri­ve up the fi­nal price. The com­pa­nies ei­ther did­n't im­me­di­ate­ly re­spond to ques­tions or did­n't have a com­ment.

Pfiz­er and No­vo have been trad­ing blows in court, in Wash­ing­ton and around the bid­ding ta­ble, as they seek to win what both are treat­ing as a cru­cial prize in the mar­ket for an­ti-obe­si­ty and weight loss treat­ments. On Mon­day, Pfiz­er raised its bid to as much as $8.1 bil­lion. Then, on Tues­day, No­vo hiked its pro­pos­al to as much as $10 bil­lion — a to­tal that Pfiz­er then matched.

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by Max Gelman

Ve­ra Ther­a­peu­tics built its case for a rare kid­ney dis­ease drug Thurs­day morn­ing, re­veal­ing a fuller Phase 3 dataset af­ter toplin­ing the re­sults ear­li­er this year.

If the com­pa­ny can con­vince the FDA — Ve­ra plans to file for ac­cel­er­at­ed ap­proval be­fore 2025 ends — it will se­cure its first prod­uct ap­proval and tran­si­tion to a com­mer­cial biotech. But Ve­ra is al­so ex­pect­ed to face a crowd­ed mar­ket should its drug, called at­aci­cept, get ap­proved. Ex­ec­u­tives hope Thurs­day’s da­ta can help set its can­di­date apart.

One po­ten­tial com­peti­tor is Ot­suka's ex­per­i­men­tal drug, which has an FDA de­ci­sion date of Nov. 28, in the same set­ting of IgA nephropa­thy (IgAN). A read­out from Ot­su­ka’s drug in June caused Ve­ra’s stock VE­RA to fall 30% at the time, as in­vestors com­pared the two pro­grams.

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by Max Bayer

John­son & John­son’s Caply­ta has won FDA ap­proval as a new ad­junc­tive treat­ment for pa­tients with ma­jor de­pres­sive dis­or­der, bol­ster­ing the ac­qui­si­tion that gave the large phar­ma con­trol of the drug.

The new ap­proval is Caply­ta’s first for­ay in­to the de­pres­sion mar­ket af­ter its orig­i­nal ap­proval as an an­tipsy­chot­ic for schiz­o­phre­nia, and for de­pres­sive symp­toms as­so­ci­at­ed with bipo­lar I and II. The de­ci­sion was based on two Phase 3 stud­ies that found that a once-dai­ly oral dose of Caply­ta, when tacked on­to an an­ti­de­pres­sant, spurred a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in de­pres­sion symp­toms.

Caply­ta was the foun­da­tion of J&J’s $14.6 bil­lion ac­qui­si­tion of In­tra-Cel­lu­lar Ther­a­pies ear­li­er this year, which fol­lowed Phase 3 read­outs in ma­jor de­pres­sive dis­or­der in 2024. J&J is look­ing to win a slice of the de­pres­sion mar­ket, specif­i­cal­ly the more than half of pa­tients whose first-line treat­ments don't help enough be­cause of weak ef­fi­ca­cy or side ef­fects.

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News Briefing: Quick hits from the biopharma web
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by ENDPOINTS

Plus, news about Cul­li­nan, 4DMT, Ax­some, As­traZeneca, Noe­ma, Uro­Gen Phar­ma, Halozyme and Ben­itec:

↩️ Dyne de­lays my­oton­ic dy­s­tro­phy plans again: Dyne said it now ex­pects to sub­mit an ap­pli­ca­tion for FDA ap­proval of its my­oton­ic dy­s­tro­phy type 1 drug, called DYNE-101, in the third quar­ter of 2027. Ear­li­er this year, the com­pa­ny changed the pri­ma­ry end­point of its study, de­lay­ing its fil­ing to late 2026. — Lei Lei Wu

🤝 Dy­navax and Vaxart make a deal: Dy­navax said it has an ex­clu­sive li­cense to Vaxart’s oral Covid-19 vac­cine that is cur­rent­ly in a Phase 2b tri­al. Vaxart will re­ceive a $25 mil­lion up­front fee; Dy­navax will al­so have a $5 mil­lion eq­ui­ty in­vest­ment in Vaxart. There’s al­so an ad­di­tion­al $50 mil­lion for Vaxart af­ter the