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Regeneron heads to FDA with treatment for very rare bone disease Read in browser
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17 September, 2025
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1. The Fed cut interest rates by a quarter point. How much will it move the needle for biotech?
2. Regeneron heads to FDA with treatment for very rare bone disease
3. AGC Bio to sell two sites in Colorado, will lay off 278 workers in the process
4. In a first, FDA calls out Hims and other telehealth companies for GLP-1 advertising
5. Lilly's diabetes pill beats Novo's Rybelsus in head-to-head trial, company mulls fast-track filing
6. AstraZeneca's Fasenra once again falls short in COPD
7. Roivant tees up dermatomyositis drug filing on heels of Phase 3 success
8. Next-gen psoriasis drugs seek to challenge existing treatment options
9. Joe Jimenez's new biotech inks up to $1B biobuck deal for Mabwell's cardio siRNA
more stories
 
 
Alexis Kramer
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If you haven’t already, check out our live blog to see how former CDC director Susan Monarez and ex-chief medical officer Debra Houry fared before the Senate HELP committee earlier today. We had a team of reporters covering the fast-paced hearing.

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Alexis Kramer
Editor, Endpoints News
1
by Max Gelman

The Fed­er­al Re­serve on Wednes­day cut in­ter­est rates by a quar­ter of a per­cent­age point as ex­pect­ed, in a move that could breathe some life back in­to the bio­phar­ma in­dus­try.

Biotechs and their in­vestors have long called for low­er in­ter­est rates since the pan­dem­ic’s free-flow­ing fundrais­ing en­vi­ron­ment dried up a few years ago. It’s the biotech sec­tor's view that suc­cess is in­verse­ly cor­re­lat­ed with low or non-ex­is­tent in­ter­est rates, and once rates fall, com­pa­nies will have an eas­i­er time rais­ing mon­ey in the pub­lic mar­kets.

But the Fed’s bench­mark rate now sits at 4%, which is still high­er than the rates be­fore the Great Re­ces­sion start­ed in late 2007. The last time the Fed cut rates was in De­cem­ber, and there was a brief re­prieve, but then the mar­ket cooled down again. In­fla­tion, which prompt­ed the Fed’s rate in­creas­es in 2022 and 2023 and has eased in re­cent months, is al­so still high­er than it was be­fore the pan­dem­ic.

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2
by Lei Lei Wu

Re­gen­eron re­port­ed that its ex­per­i­men­tal treat­ment sub­stan­tial­ly re­duced harm­ful bone growths in peo­ple with a very rare dis­ease, and it’s plan­ning to ask the FDA for ap­proval.

In fi­brodys­pla­sia os­si­f­i­cans pro­gres­si­va, or FOP, bone growths re­place soft tis­sue such as mus­cles, ten­dons and lig­a­ments, which even­tu­al­ly makes mov­ing very chal­leng­ing or im­pos­si­ble. The drug, gare­tos­mab, is an an­ti­body against a pro­tein called ac­tivin A, which is crit­i­cal to those bone growths.

Re­gen­eron en­rolled 63 peo­ple with the ul­tra-rare dis­ease in its study, and di­vid­ed them in­to three groups. One group re­ceived a 3 mg/kg dose of gare­tos­mab, one group was giv­en a 10 mg/kg dose, and the last group re­ceived place­bo in the Phase 3 tri­al.

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3
by Anna Brown

In an ef­fort to cap­i­tal­ize on bio­phar­ma com­pa­nies look­ing to reshore man­u­fac­tur­ing to the US, AGC Bi­o­log­ics has put up a "for sale" sign on two of its fa­cil­i­ties in Col­orado. Al­so, the CD­MO will lay off 278 em­ploy­ees.

In what it calls a “struc­tured process,” a spokesper­son told End­points News that AGC Bio is look­ing to sell its mam­malian man­u­fac­tur­ing fa­cil­i­ty in Boul­der. It is al­so look­ing for buy­ers for its cell and gene ther­a­py site in Long­mont, which it al­ready par­tial­ly closed last year.

AGC Bio will lay off 267 em­ploy­ees from its site in Boul­der and the oth­er 11 staffers will be let go from its oth­er US fa­cil­i­ties. Ac­cord­ing to a Col­orado WARN no­tice, the head­count re­duc­tion will be made from Nov. 15 un­til the end of the year.

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2025'S BREAKOUT STARTUPS. WHO'S ON THE LIST? - Endpoints 11
Endpoints News returns to Boston’s State Room to announce the 2025 class of biotechs worth watching. Join the live unveiling and see the industry’s next chapter come into focus. Which biotechs will make the leap? Join us.
4
by Ngai Yeung

The FDA is­sued warn­ing let­ters to tele­health com­pa­nies for mak­ing "false or mis­lead­ing" claims about com­pound­ed GLP-1 obe­si­ty drugs.

The let­ters were part of a larg­er group of warn­ings post­ed on Tues­day that were sent to on­line phar­ma­cies, phar­ma­ceu­ti­cal gi­ants, tele­health star­tups and oth­er com­pa­nies as part of the Trump ad­min­is­tra­tion's clam­p­down on drug ad­ver­tis­ing.

Among the tele­health com­pa­nies that re­ceived let­ters were Hims & Hers and Rem­e­dy Meds, which bought fel­low dig­i­tal health plat­form Thir­ty Madi­son for $500 mil­lion. Both sell com­pound­ed ver­sions of pop­u­lar weight loss drugs. While these com­pound­ed drugs are not ap­proved by the FDA, they surged in pop­u­lar­i­ty over the past few years dur­ing the na­tion­wide short­age of GLP-1 drugs. Some tele­health com­pa­nies cap­i­tal­ized on the de­mand, build­ing en­tire busi­ness­es around the al­ter­na­tive ver­sions.