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Boehringer Ingelheim’s lung disease candidate data underwhelm some analysts Read in browser
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top stories
1. Why Regeneron is buying 23andMe
2. Stelara biosimilars look to gain traction, helped by recent lessons from Humira
3. Boehringer Ingelheim’s late-stage data for lung disease candidate underwhelm some analysts
4. Updated: FDA approves Novavax's Covid vaccine after six-week delay, but for a smaller population
5. Regeneron plans to buy 23andMe for $256M
6. Intellia's CRISPR therapy likely causes 'permanent' gene knockdown in ATTR amyloidosis
7. Apnimed posts first set of Phase 3 sleep apnea results, aims for approval filing in 2026
8. David Liu, Sam Sternberg unveil new way to insert big genes in human cells
more stories
 
Alexis Kramer
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HHS chief Robert F. Kennedy Jr. will face his third congressional budget hearing tomorrow after spending nearly an entire day testifying last week. He likely won’t offer more detail about his planned HHS reorganization with a court order still in place. But we’ll be watching to see what he says about staffing cuts and his next move on the vaccine front.

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Alexis Kramer
Editor, Endpoints News
George Yancopoulos, Regeneron CSO (Brendan McDermid/Reuters/Alamy)
1
by Andrew Dunn

Re­gen­eron is dou­bling down on its ge­net­ics re­search am­bi­tions by agree­ing to buy most of 23andMe’s busi­ness out of bank­rupt­cy.

Re­gen­eron is best known for de­vel­op­ing block­buster drugs like Dupix­ent and Eylea rather than sell­ing sali­va-test kits. The Tar­ry­town, NY-based biotech has min­i­mal ex­pe­ri­ence, or pre­vi­ous­ly stat­ed in­ter­est, in the world of di­rect-to-con­sumer health­care. The agree­ment in­cludes Re­gen­eron car­ry­ing on all con­sumer genome ser­vices un­in­ter­rupt­ed, ac­cord­ing to the press re­lease.

Re­gen­eron’s ex­ec­u­tives weren’t avail­able for an in­ter­view on the deal — at least for now, as the deal makes its way through the court’s process­es. It still needs to be fi­nal­ized in bank­rupt­cy court, but Re­gen­eron ex­pects to close the $256 mil­lion ac­qui­si­tion in the third quar­ter.

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2
by Zachary Brennan

Ab­b­Vie's de­fense of its megablock­buster Hu­mi­ra may go down in the his­to­ry books as the poster child for block­ing biosim­i­lar com­pe­ti­tion, but the launch of six Ste­lara biosim­i­lars this year shows how com­peti­tors have learned from that ex­pe­ri­ence.

Since launch­ing ear­li­er this year, the six Ste­lara biosim­i­lars on the mar­ket are al­ready gain­ing trac­tion against the John­son & John­son bi­o­log­ic, which is used to treat a va­ri­ety of au­toim­mune dis­eases and last year sold more than $10 bil­lion.

Cig­na's pri­vate-la­bel dis­trib­u­tor Qual­lent and Op­tum's pri­vate-la­bel dis­trib­u­tor Nu­vaila are both ready to go with Ste­lara biosim­i­lar deals made ear­li­er this year, and CVS' sub­sidiary Cor­davis, which cracked Ab­b­Vie's hold on Hu­mi­ra, could po­ten­tial­ly fol­low suit, al­though the com­pa­ny did­n't re­spond to a re­quest for com­ment.

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The Endpoints 100: What impact has Trump 2.0 had on biotech? And what comes next?
Biopharma’s elite are weighing in on Trump’s FDA overhaul and tariff impacts in our latest Endpoints 100 survey. Get the unfiltered analysis as John Carroll and industry leaders dissect what’s keeping executives up at night — and where they’re placing their bets despite the turbulence. Sign up today.
3
by Ayisha Sharma

Boehringer In­gel­heim claimed two Phase 3 wins for its PDE4 in­hibitor in fi­brot­ic lung dis­eases, but some Wall Street an­a­lysts said the can­di­date’s “mod­est” ef­fi­ca­cy and lim­it­ed com­bi­na­tion po­ten­tial could ham­per its re­al-world use in one of the in­di­ca­tions.

Da­ta pre­sent­ed on neran­domi­last for the treat­ment of id­io­path­ic pul­monary fi­bro­sis showed sta­tis­ti­cal­ly sig­nif­i­cant re­sults in two dif­fer­ent dos­ing reg­i­mens. The 18 mg dose of the drug achieved an av­er­age 68.8 ml dif­fer­ence from place­bo in a lung func­tion test called forced vi­tal ca­pac­i­ty at 52 weeks, while the 9 mg dose at­tained a 44.9 ml dif­fer­ence.

The Ger­man drug­mak­er on Sun­day shared the da­ta from its FI­BRONEER-IPF study of neran­domi­last at the Amer­i­can Tho­racic So­ci­ety meet­ing in San Fran­cis­co. The com­pa­ny first re­vealed the tri­al met its pri­ma­ry end­point in Sep­tem­ber 2024. It has al­ready filed for FDA ap­proval in IPF.

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4
by Max Bayer

Af­ter more than a month of wait­ing and ne­go­ti­a­tions with US reg­u­la­tors, No­vavax has gained FDA ap­proval for its Covid shot.

But it’s for a tighter pop­u­la­tion than the com­pa­ny had asked for, and sig­nals how much hard­er it may be for vac­cine mak­ers to sat­is­fy the agency un­der Com­mis­sion­er Mar­ty Makary and HHS Sec­re­tary Robert F. Kennedy Jr.

The shot was ap­proved for adults 65 and old­er and for peo­ple aged 12 to 64 who have at least one health con­di­tion that puts them at in­creased risk of se­vere ill­ness from Covid. No­vavax played down the tight­ened pop­u­la­tion, say­ing in a state­ment Sun­day that peo­ple at high­er risk are more like­ly to seek out vac­ci­na­tion.

The FDA's ac­tion al­so trig­gers a $175 mil­lion mile­stone pay­ment from Sanofi.

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5
by Kyle LaHu