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5 March, 2026
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Lessons in Cat­e­go­ry Cre­ation: In Con­ver­sa­tion with Bob­by Aza­mi­an, CEO Tar­sus Phar­ma­ceu­ti­cals
top stories
1. New FDA bonuses for faster reviews meant to help address ‘critical workforce challenges’
2. Roche-partnered Zealand Pharma posts positive Phase 2 data for amylin obesity drug
3. Helus Pharma's stock slides after psychedelic drug data face questions over dosing
4. Kura says its menin inhibitor is preferred treatment for a 'handful' of payers
5. The $100 genome, both a scientific milestone and marketing tool, is here
6. FDA approves J&J's multiple myeloma combo as second-line treatment
7. Eli Lilly's new program aims to boost employer coverage of GLP-1s
8. FDA puts PepGen’s Phase 2 muscle disease trial on partial hold
9. Merck KGaA drops two cancer trials on assets from SpringWorks deal
10. Tenaya wins support from Alnylam in cardio disease pact
11.
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Multimillion-dollar gene therapies weren’t supposed to face competition. China has other plans
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Alexis Kramer
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Three drugs have now been approved under the FDA’s controversial voucher program that’s meant to significantly speed reviews. The latest approval, for Johnson & Johnson’s multiple myeloma combo treatment, came 55 days after J&J filed its application. To date, one voucher recipient (Disc Medicine) has been rejected.

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Alexis Kramer
Editor, Endpoints News
1
by Max Bayer

A new bonus pi­lot pro­gram meant to re­ward fast-work­ing FDA re­view­ers will be fund­ed in part by mon­ey from in­dus­try user fees, the first de­tails on how Com­mis­sion­er Mar­ty Makary plans to fi­nance the in­cen­tive, sources and gov­ern­ment spokes­peo­ple told End­points News.

Get­ting drug ap­pli­ca­tions re­viewed on time is one of the FDA’s most close­ly-watched met­rics. Sources fa­mil­iar with the in­cen­tive pro­gram, speak­ing on the con­di­tion of anonymi­ty, said that the mon­ey from user fees is avail­able be­cause of ex­ist­ing staffing short­ages at the FDA af­ter job cuts last year. Drug de­vel­op­ers pay an­nu­al and ap­pli­ca­tion-re­lat­ed fees to the agency, which help pay for staff that re­view those prod­ucts.

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Adam Steensberg, Zealand Pharma CEO (Betty Laura Zapata/Bloomberg via Getty Images)
2
by Kyle LaHucik

Zealand Phar­ma is out with the Phase 2 da­ta for an amylin ana­log that spurred one of the in­dus­try’s largest-ever obe­si­ty drug deals last year.

The drug, called pe­tre­lin­tide, led to up to 10.7% mean body weight loss at week 42 as com­pared to 1.7% for place­bo in a Phase 2 study dubbed ZUPREME-1, Zealand said Thurs­day af­ter­noon. The tri­al in­clud­ed 493 peo­ple with obe­si­ty or over­weight at a mean BMI of 37 kg/m².

Pe­tre­lin­tide is one of the most watched next-gen­er­a­tion obe­si­ty drug can­di­dates in de­vel­op­ment. It’s the fo­cal point of a $1.65 bil­lion up­front deal — and up to $5.3 bil­lion in biobucks — with Roche for co-de­vel­op­ment and co-com­mer­cial­iza­tion.

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3
by Lei Lei Wu

Mid-stage da­ta from Helus Phar­ma’s psy­che­del­ic drug raised ques­tions about the dos­es the com­pa­ny picked for treat­ing anx­i­ety. Two dos­es — one 10 times high­er than the oth­er — led to vir­tu­al­ly the same ef­fi­ca­cy re­sults.

On Thurs­day, Helus said the Phase 2 da­ta showed its ex­per­i­men­tal psy­che­del­ic treat­ment led to a “clin­i­cal­ly mean­ing­ful im­prove­ment” in symp­toms of gen­er­al­ized anx­i­ety dis­or­der com­pared to base­line. But there was lit­tle dif­fer­ence in ef­fi­ca­cy be­tween the two dos­es be­ing test­ed, an in­di­ca­tion that a treat­ment may not be work­ing well or that the se­lect­ed dos­es may not be right.

Helus’ shares HELP fell 37% Thurs­day morn­ing fol­low­ing the da­ta re­lease.

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