CX Liu

$NVO added %BW loss for women in Ph3 REDEFINE-11 for Cagrisema as secondary. With higher BW loss in women being known effect across GLP-1 and amylin, this may be the first sex-stratified endpoint that I can recall. The study could achieve better BW loss by design. $LLY

As $ALNY disclosed, Ph3 TRITON-CM for Nucresiran in ATTR-CM pt # up 40% due to faster than expected enrollment (pre-specified protocol option). Trial timeline not impacted.

As disclosed by $SYRE, SKYLINE-UC Ph2 randomized Part B started enrolling in Apr, and readout in 2027.

$TAK Mezagitamab (CD38) Ph3 in IgAN dropped the 2nd cycle of treatment entirely. Now looks very similar to $BIIB Felzartamab in the finite dosing regimen.

Looks like $TAK follow-on orexin agonist TAK-360 Ph2 in both NT2 and IH pushed out a bit and will readout year end or next yr. $ALKS $LLY

$AZN broadened pt pool by adding stage III B/C to both Ph3 studies in 1L Sq and Nsq NSCLC for Rilvegostomig (PD1/TIGIT). Pt # up ~30%. Probably won't benefit hazard ratio much. More like slow recruitment issue or potential label expansion.

$NVS abelacimab (FXI) Ph3 in AF likely has lower event rate vs planned: timeline pushed out ~16mo ( still event driven though), pt # up ~30%, clarified on undertermined stroke.

As planned, $BHVN added PD-1 combo for BHV-1530 (FGFR3) Ph1 study. Dose opt for monotx focus on urothelial. All-comer only for urothelial/NSCLC/HNSCC, not other tumor types.

$AMGN seems broadening MariTide Ph3 MARITIME-HF population: drop NT-proBNP and other confirmatory in inclusion, remove LVEF≤40% history in exclusion. Now very different population vs $LLY or $NVO. Also added nephropathy in secondary, maybe no dedicated FLOW-like study anymore?

$BHVN pushed out Ph2/3 RISE-3 for Opakalim (BHV-7000) in epilepsy ~5mo, so data likely 4Q26. Meanwhile 50mg dose was dropped from primary endpoint. Also dropped seizure-free and early-onset endpoint from secondary, lowered threshold of %seizure reduction from 75% to 50% for 50mg

$NVO Ph3 RENEW-1 study for Cagri monotx in obesity added lots of secondary on liver/pancreatic fat, thigh muscle/fat (likely MRI level). So far $LLY Eloralintide showed DXA data, and no detail from $Roche/Zealand Petrelintide yet. Good to see more muscle data from amylins.

For Ph2/3 BRUNELLO study of EYE103 (EyeBio) in DME, $MRK shortened secondary BCVA from 104wk to 52wk. Reasonable as Yr 2 is not Q4W dosing any more (switch to PTI). Study to wrap up soon, and this could make analysis cleaner.

There will be NO interim on outocmes in $NVO FGF21 (Efruxifermin) Ph3 F2/3 study. They also removed progression to cirrhosis from the composite, likely to reduce biopsy work and focus on other events. Overall regulatory path looks a bit cleaner.

$Roche Enicepatide (CT-388) Ph2 T2D completed, with nuance that actual pt # is 24% higher than planned. They shortened the trial from 48wk to 36wk last yr. Maybe T2D signal is more noised, or there is more dropout? Anyway Ph3 T2D (Enith2) already started. $LLY $NVO

Oh wow, did not realize $PFE just missed it back then, with the fact that PFS was dropped and a bit more alpha reallocated to OS. But at least they confirmed no IB6 response.

Quick enrollment in southern hemisphere for $MRK CD388 Ph3 ANCHOR study, now completion pushed out ~5mo. Notably, Stratum B subgroup is explicitly added to secondary, where the differentiation vs vaccines are more clear I guess.

@ar929348 Ha, that’s it then😄

@cxliu06 It’s in early July, hedge funds 😂😂

$TEVA IL15 (TEV-53408) Ph1 in vitiligo pushed out ~4mo. This program already got funding support from $RPRX through Phase 3 potentially, after they saw some emerging Ph1 data. It should've been de-risked.

$Roche Ph3 Krascendo 1 for Divarasib H2H vs established G12C in NSCLC completed. As guided, should see data soon (WCLC/ESMO). Field is moving fast, this 2L win is wonderful but may not be enough, still facing 1L and other next gen RAS competition.

$Roche Brainshuttle AD study for Trontinemab to wrap up much earlier. Guess they are all set for Ph3 now. $BIIB $LLY