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Pluvicto Subgroup analyses from the Phase III PSMAddition study

(lutetium Lu177 vipivotide tetraxetan) of Pluvicto plus standard of care (SoC) (ARPI + ADT)

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in patients with PSMA+ metastatic hormone-sensitive

prostate cancer (mHSPC)(1) demonstrated consistent

improvement in radiographic progression-free survival

(rPFS) versus SoC alone, regardless of disease volume

or presentation (de novo or recurrent). The benefit

was comparable with the previously reported primary

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endpoint showing a 28% reduction in the risk of progression

or death, with a consistent safety profile. Data were

presented at ASCO.

Further PSMAddition data showed Pluvicto plus SoC

achieved a higher frequency and depth of PSA response

versus SoC alone in PSMA+ mHSPC, with a 58% reduction

in the risk of PSA progression. Data were presented

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at AUA.

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Cosentyx In the Phase III REPLENISH study, Cosentyx demonstrated

(secukinumab) statistically significant sustained remission versus

placebo at Week 52 in patients with polymyalgia rheumatica

(PMR), doubling remission rates, while also reducing

cumulative glucocorticoid exposure, with a safety

profile consistent with Cosentyx. Data were published

at the New England Journal of Medicine and presented

at EULAR. Data have been submitted for health authority

review in the US, EU and Japan.

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VAY736 In the Phase III NEPTUNUS-1 and -2 studies in adult

(ianalumab) patients with Sjögren's Disease, ianalumab demonstrated

consistent improvement across most ESSDAI domains,

including key lymphadenopathy, PNS, muscular and pulmonary

domains. In the NEPTUNUS extension study, deepening

control of disease activity was observed, with continued

reductions in ESSDAI at Week 108 and a favorable safety

profile. Data were presented at EULAR. Data have been

submitted for health authority review in the US, EU

and Japan.

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Vanrafia Final 30-month results from the Phase III ALIGN study

(atrasentan) showed Vanrafia achieved a clinically meaningful slowing

of kidney function decline in adults with IgAN together

with sustained proteinuria reductions. The benefits

were consistent across kidney function measures and

in patient groups receiving SGLT2 inhibitors. The

safety profile was consistent with prior studies.

Results were published in The Lancet and presented

at ERA.

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DWH213 The biomarker cohort of the FORTITUDE Phase I/II study

(del-brax) of del-brax in patients with facioscapulohumeral muscular

dystrophy (FSHD) met its primary and key secondary

endpoints, with reductions in KHDC1L (cDUX) and creatine

kinase biomarker levels, indicating both strong target

engagement and reduction in muscle damage. The safety

profile was consistent with previous findings.

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Scemblix Week 144 data from the pivotal Phase III ASC4FIRST

(asciminib) study of Scemblix in adults with newly diagnosed Ph+

CML-CP demonstrated superior major molecular response

(MMR) compared with all SoC tyrosine kinase inhibitors

(TKIs), including a 15.2% higher MMR rate versus 2G

TKIs. Scemblix showed fewer grade >=3 AEs and less

than half the discontinuation rate due to AEs. Data

were presented at ASCO.

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Kisqali The NATALEE six-year follow up study showed clinically

(ribociclib) meaningful overall survival (OS) in the broadest at

risk early breast cancer (eBC) population. Data will

be presented at an upcoming medical congress.

In the largest CDK4/6i biomarker analysis in HR+/HER2-

eBC, NATALEE showed Kisqali plus non-steroidal aromatase

inhibitor (NSAI) demonstrated consistent invasive

disease-free survival (iDFS) benefit versus NSAI alone

across all PAM50 intrinsic subtypes, with greater

benefit trends in patients with higher genomic risk

or proliferation signature scores, including high-risk

node-negative (N0) disease. Data were presented at

ASCO.

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HTT227 In the 24-month interim analysis of the Phase II PIVOT-HD

(Votoplam) long-term extension study, votoplam 10 mg dose demonstrated

sustained mHTT lowering in early stage Huntington's

disease (HD) patients with a favorable safety profile.

The Phase III INVEST-HD study is actively enrolling.

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FUB523 Long-term data from the Phase I/II study of zigakibart

(zigakibart) showed durable reductions in disease-relevant biomarkers,

including Gd-IgA1 and IgA through Week 124, alongside

clinically meaningful reductions in proteinuria and

stabilization of eGFR, with no new safety signals.

Data were presented at ERA.

Zigakibart is currently being evaluated in the Phase

III BEYOND study in adults with IgAN, with readout

anticipated in H1 2027.

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YTB323 Preliminary data from the Phase II AUTOGRAPH studies

(rap-cel) of rap-cel showed early, clinically meaningful improvements

in patients with severe, refractory idiopathic inflammatory

myopathies (IIM) and diffuse cutaneous systemic sclerosis

(dcSSc), alongside rapid and deep B-cell depletion,

with a manageable safety profile.

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(225) Ac-PSMA-617 Phase I data from the AcTION study of the actinium-based

RLT Ac225--PSMA--617 showed antitumor activity, with

PSA declines and radiographic responses in patients

with PSMA+ metastatic castration--resistant prostate

cancer(2). The safety profile was manageable. Data

were presented at ASCO.

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