$IOVA seems to have disclosed g5 AEs (i.e., deaths) to the sellside based on this after-market WF note. How was this not disclosed in the initial press release or 21-page slide deck?
Just how many deaths is WF insinuating $IOVA has had? 🤣
How much does this bullish WF coverage of the stock mean when they show they clearly don't even know what a G5 AE is in the very first paragraph?
$IOVA lung study has been ongoing 5.5 yrs. Somehow only 69 pts disclosed.
Are they hiding data? I don’t think so.
Rather: no doc wants to enroll pts in this study.
Enrollment rate is 0.0058 pts/site/mo.
In simple English: each site is enrolling 1 patient every 5-6 yrs.
$IOVA is this a joke?
22% cORR doesn’t even beat doce/ramu 23% cORR. Let alone all the emerging lung 2L+ tx.
Immature mDOR ~1yr.
PFS not disclosed but surely well below SOC.
No safety slide? For a program that was previously on clinical hold?
I have respectfully disagreed with Adam on many of his prior takes (nktr, mrna, zura) but he is correct here.
Listen, we all *want* $IOVA to help lung cancer patients, but these updated data are just bad. Very bad. You could tell as soon as there was no mDOR in the press release (the last PR *did* disclose mDOR - why are they hiding it now?). The slides confirm that the new responses are VERY short. Not good at all.
Sure, the ORR went down a little bit, but only by 1%. It is the lack of any durability in the new cut of patients that is the huge problem. The first cut had 4 patients still responding >1 year out - several of them 2-3 years out! Not bad back then - but this new cut has no responders even *close* to that degree of durability.
So far, of these new patients, it looks like 1 might have made it past 1 year but has already progressed since then. There are WAY more early progressors in this new cut by my read of the data. Of the new confirmed responses, only 2 appear to be ongoing at ~4 and ~6 months. 4 other responders appear to have all progressed in the ~4-8 month range. VERY poor durability. This looks like 2x as many relapsers in that 4-8 month range compared to the first dataset *with* fewer responders in the new cut overall...
There were also 0 new CRs in the new cut. CR rate now <3%.
The reason this new trend of very short durability is especially alarming for $IOVA is that this new cut of data uses the less intense LD chemo regimen that the FDA made them use following a death and trial hold earlier on in this study.
It looks like the less intense LD they are having to use is leading to markedly worse durability. If you look at mDOR of *just* the new, reduced intensity LD, mDOR is looking like, what? Maybe 6-8ish months? And the overall population certainly looks like it will be <1 year mDOR...the initial datacut was >2 years! Huge drop off looks likely.
Again, bummer. We obviously want lung cancer patients to do well. But facts are facts and to me this just doesn't look encouraging relative to what $IOVA had presented before. I know the cult trolls will be after me for pointing out the crash in durability, but whatever. Your cult leader biotechscammer is saying these are the best data ever, like he has done nonstop for 5 years straight. Let's see what reality has to say about that, and how that might inform who these cultists listen to someday.
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$IOVA for those asking me if this could trade like $MRNA, I’d say the biggest difference is: the $MRNA data are objectively impressive (valuation arguments aside), the $IOVA data are objectively bad.
$IOVA is this a joke?
22% cORR doesn’t even beat doce/ramu 23% cORR. Let alone all the emerging lung 2L+ tx.
Immature mDOR ~1yr.
PFS not disclosed but surely well below SOC.
No safety slide? For a program that was previously on clinical hold?
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$DFTX $CMPS WF doc panel particularly negative. Expect uptake 90-95% below Spravato.
Issues highlighted: staffing requirements, bathroom needs
The debate isn’t demand. It’s a question of bed space, nursing staff, etc. needed for 8hr $DFTX sessions. Spravato (~2hrs) isn’t the right comp bc it doesn’t have that constraint. xitter.gq/ravarora1/status/20803…
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$MRK TLA1 ph2 just put up 27% pbo-adj HiSCR75.
$MLTX ph2 20-29% pbo-adj HiSCR75 which regressed in ph3.
$ABBV IL1a/b ph2 21-28% pbo-adj HiSCR75, ph3 data imminent.
$ZURA bar is mid-20s% pbo-adj HiSCR75.
$AVTX 17% delta confounded by high pbo.
448 days since my last pitch ($ABVX), it’s now finally time for my next one: $ZURA (Zura Bio).
Like with the $NKTR and $ABVX pitches before this, I will post a general outline of my research on $ZURA as a thread here. However, for those looking to really get into the weeds, there is a Google Doc link to the full length pitch attached below.
Let’s dig in.
docs.google.com/document/d/1…
$KOD all the buzz at #AAO26, near-universal praise.
Less discussed: Roche 52wk SANDCAT data worsened over time. Recall this study failed to hit its 16wk primary endpoint. Odds of approval now lower.
Possible $KOD has MESI all to itself pending ph3 results.
$KOD Baker meanwhile bought another ~$160mn of stock this week at an avg price of ~$80/share. I suppose they too are bullish into MESI.
$KOD Baker meanwhile bought another ~$160mn of stock this week at an avg price of ~$80/share. I suppose they too are bullish into MESI.
LD retweeted
Is $VKTX going to disclose that the chief commercial officer left the company?
LD retweeted
By the way, Vabysmo had only 45% of patients getting to 16w interval in the first year vs. 54% patients with 24w interval for Zenkuda. A very clear and significant difference in my view.
And this is with much less strict retreatment criteria than $KOD.
$KOD
With 54% of patients every 24m treatment and clean safety, this drug, in my view, is the best option for wAMD as of now. Take in account that they also used a far more stringent re-treatment criteria than anyone of the other agents currently on the market.
Clean safety with almost no inflammation and no cataract (which was a concern before this read out).
The whole IL-6 wAMD and MESi (Macular edema) story on top all of that.
Financing will not be an issue at all with those results and Bakers as a lead.
With no really interesting assets out there in ophthalmology and the hunger for acquisitions in this space, how is this not a clean take out in few months?
There's a new version of this post
I think you are pretty smart but saying stuff like this hurts your credibility.
$ABVX is more effective vs Rinvoq in every way? Really?
Obe induction pbo-adj CR: 5-21%
Rinvoq induction pbo-adj CR: 22-29%
At worst $ABVX is a *more effective* Rinvoq without the need for lab monitoring and with a far superior safety label (even if it does get 1 black box bullet point).
It’s objectively better than Rinvoq in every way even in the *worst* case scenario, and the JAKis do several billion in IBD already (peaks will be higher).
That’s why I really really don’t understand the $ABVX price action…even if you *do* think the cancer risk leads to a black box….it’s *severely* oversold at these prices…the drug replaces JAK inhibitors…
For those keeping score at home, don’t think this is accurate fwiw.
Based on ph2b OLM supplement:
- 1 case of colon dysplasia
- 1 case of cervical dysplasia
- 1 case of malignant meningioma
@A_May_MD
