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11 July, 2025
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Un­cov­er­ing the Po­ten­tial of Tar­get­ing the CD38 Path­way for Im­mune-Me­di­at­ed Dis­eases
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1. As researchers come together for HIV conference, few biotechs can stay the course
2. FDA hands Capricor a CRL for its Duchenne cell therapy  
3. Will Antag's bet on GIP blockade in obesity pay off?
4. UK clears Bayer's hot flash treatment, marking first approval worldwide
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Manufacturing layoffs at Pacira; Oak Hill Bio’s Phase 1 Angelman data
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Sally Susman waves goodbye to Pfizer; Xaira's new president and COO
7. Century Therapeutics lays off half of its staff, CFO departs as it narrows priorities
8. Varda raises $187M to advance drug manufacturing in space
9. Jazz taps current COO Renée Galá to replace CEO and co-founder Bruce Cozadd
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Reynald Castaneda
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Kyle LaHucik will be attending this year’s IAS conference on HIV science, and before he flew to Rwanda, he scoped out the biotechs that are working on tackling the challenging virus. Kyle found that there are not many of these companies — and the likely reasons behind it. Read more below.

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Reynald Castaneda
Deputy Editor, Endpoints News
Credit: Shutterstock
1
by Kyle LaHucik

A key del­e­ga­tion of HIV re­searchers, pub­lic health ex­perts and drug de­vel­op­ers will come to­geth­er next week in Rwan­da for the bi­en­ni­al In­ter­na­tion­al AIDS So­ci­ety con­fer­ence on HIV sci­ence.

But as 3,000 of the field’s lead­ers gath­er in Ki­gali to dis­cuss the lat­est ad­vance­ments, in­clud­ing a twice-year­ly pre­ven­tion shot, there’s a scarci­ty of new biotech com­pa­nies to car­ry for­ward R&D.

The ones that al­ready ex­ist are strug­gling to gath­er funds. Much of the de­vel­op­ment is in the hands of three long­stand­ing com­pa­nies: Gilead Sci­ences, GSK’s Vi­iV Health­care and Mer­ck. Each of the com­pa­nies will be pre­sent­ing re­search at the con­fab.

In­dus­try in­sid­ers who spoke with End­points News point to a con­flu­ence of fac­tors be­hind the pauci­ty of star­tups, in­clud­ing fi­nanc­ing bar­ri­ers, avail­abil­i­ty of ap­proved prod­ucts, US gov­ern­ment fund­ing cuts and a small scope of ex­it op­por­tu­ni­ties.

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2
by Anna Brown

Capri­cor Ther­a­peu­tics said on Fri­day it re­ceived a Com­plete Re­sponse Let­ter from the FDA for its lead cell ther­a­py for Duchenne mus­cu­lar dy­s­tro­phy (DMD), cit­ing the agency was not sat­is­fied with its clin­i­cal da­ta and cer­tain man­u­fac­tur­ing com­mit­ments.

The agency cit­ed a lack of clin­i­cal da­ta show­ing the ef­fec­tive­ness of the cell ther­a­py, named de­ramio­cel, and has re­quest­ed fur­ther in­for­ma­tion, ac­cord­ing to a re­lease. Capri­cor’s BLA was sup­port­ed by da­ta from its Phase 2 tri­al called HOPE-2, which in­ves­ti­gat­ed the cell ther­a­py in 20 pa­tients with DMD. Those mid-stage da­ta showed clin­i­cal­ly mean­ing­ful preser­va­tion of heart func­tion over four years com­pared to a place­bo.

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3
by Elizabeth Cairns

An­tag Ther­a­peu­tics is tak­ing an un­usu­al, al­though not un­known, ap­proach to obe­si­ty.

Where drugs like Eli Lil­ly’s Zep­bound and oth­er com­pounds from Roche and Viking Ther­a­peu­tics have mech­a­nisms part­ly based on GIP ag­o­nism, An­tag is pur­su­ing GIP block­ade.

Com­pa­nies, in­clud­ing Pfiz­er and He­licore Bio­phar­ma, are al­so look­ing at this ap­proach, but the clear prece­dent is Am­gen’s Mar­i­Tide, which com­bines GLP-1 ag­o­nism with GIP an­tag­o­nism. This drug has prompt­ed side ef­fect wor­ries, and Am­gen in­tends to use low­er dos­es in its Phase 3 tri­als than in ear­li­er stud­ies.

So, what makes An­tag think the GIP block­ade will work? And if it does, why do sev­er­al drugs achieve weight loss by do­ing the op­po­site?

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Manufacturing Day 2025
What are the new rules for biopharma manufacturing? The Trump administration’s tariff policies have thrown the world economic order off its axis, and manufacturing is squarely in the middle of the upheaval. Join us as we break down what’s really happening behind the scenes — get your spot.