1、7T2se3r0Ot6kwoPa7T2se3r0Ot6kwoPaDistributed on:22/07/2025 16:10:05 GMTDistributed on:22/07/2025 16:10:05 GMT22 July 2025Deutsche BankResearch Rating Sell Europe Switzerland Pharmaceuticals Pharmaceuticals Company Roche Date Company Update FENTREPID?Or more sunk cost.Takes on P2 fenebrutinib papers(+

2、SAN).Summary takesAs noted in our take on astegolimabs P3 miss yesterday morning(ROG:Tough weekend:STARGLO fallout hangs on SKYGLO?Plus astegolimab takes.(21/07/25),Roches remaining duo(fenebrutinib,giredestrant)of key P3 2025 read-outs have received renewed significance in light of the first item f

3、alling by the wayside.It thus caught our eye to note that the P2 data for fenebrutinib was published last week in this months issue of Lancet Neurology with an accompanying editorial and we briefly comment.The summary is that most investors view the fenebrutinib P3 in RMS(FENHANCE1/2)as destined to

4、fail in light of disappointments for MRKs evobrutinib and SANs tolebrutinib,with the debate on PPMS(FENTREPID)more equivocal.Neither the evidence to date nor our read of the papers here would lead us to draw any different conclusions and we think“mere”noninferiority in both the RMS and PPMS studies

5、is likely,leaving uncertain regulatory/commercial prospects and more questions on Roches ability to organically navigate the end-decade patent cliff.Key detailsnWe remind that P2 FENOPTA was modestly sized study(n=109)that showed the number of new T1 Gd+lesions at weeks 4/8/12 were 0.077 vs 0.245 fo

6、r pbo(69%relative reduction),with the wk12 data itself showing a 90%reduction,whilst during the OLE through week 48 the unadjusted annualised relapse rate(ARR)was 0.04.On safety,the most common adverse events that were more frequent for fenebrutinib were hepatic enzyme elevations(6%vs 0)nAs the pape