I think we are now in the range where the $ABVX Part 2 dataset could be released after hours any day, providing an even larger safety dataset than the original Part 1 did.
Given the large sample size, OBVIOUSLY more cases of non-nonmelanoma skin cancers are EXPECTED. Exactly how many cases would be "in range" depends on the final patient-year (PY) sample size *and* on which arms (25mg vs 50mg) the cases occur in.
Ultimately what matters here is that the non-NMSC rate falls near/within the expected rate when including all of the P2 and P3 patient years.
As I and others have calculated, that currently rests well-within range at ~0.6/100PY, which INCLUDES an extra case of prostate cancer that the FDA would absolutely not care about at all (given that it happened early in during induction - essentially impossible to have been drug related, zero doubt that it was pre-existing) and totally excludes *all* of the hundreds of squeaky clean 25mg PYs. The calculations I have run so far are very conservative, and still completely confirm Obefazimod's safety without cance risk.
Basically, unless the Part 2 data show new cases of cancer occurring wildly above expected background rates, we can already disprove the cancer risk scare with existing data.
Why is the stock not responding to these facts? Who knows. I do suspect that some of the people who panic sold on the Part 1 data before taking a moment to run some basic calculations are hoping that the EXPECTED new cancer cases that we WILL see in Part 2 will spook the market a 2nd time, allowing them to buy back in lower.
Hopefully the market knows better this time around, and can see that (again, assuming Part 2 cancer rates don't *wildly* exceed background rates), cancer occurring in a clinical trial at the EXPECTED BACKGROUND RATE is absolutely meaningless. This is something so basic I am shocked that I am having to talk about it at all, but here we are. Speaking the OBVIOUS and watching the market ignore it.
If nothing else, getting this catalyst out of the way can "remove the overhang" of remaining safety data, even though, again - the existing data already disprove the notion of a cancer problem to begin with.
Once this is (hopefully) cleared up, what are we looking at for the $ABVX stock price? Consistently, sellside models had efficacy bull case scenarios at well over $175, including some even over $210 (ehem, Jefferies). This flock of lemmings all lowered their price targets on "safety concerns" despite efficacy *EXCEEDING* every single firm's bull case scenario. Of course this is sellside reacting to the stock price moving, not actually trying to read the data and see whether a safety signal existed or not.
So, once there's no made up safety narrative to obfuscate with, we are back to $ABVX having otherworldly best-in-disease efficacy with squeaky clean safety in a once-daily pill with a unique MoA that has ZERO near-term me-too competition (unheard of in modern pharma).
Why couldn't the stock go back to the $175-$185 range that the sellside firms predicted and which the stock briefly traded to before spooked panic sellers started dumping the stock on a "cancer signal" narrative that they could've debunked in 30 minutes?
I see no rational/logical reason why the stock can't go back to those levels. If the signal isn't real, it isn't real. "But it really crashed for a couple weeks when people thought it was real" is not a reasonable argument to explain why the stock would remain undervalued after the risk has been debunked.
Obviously I can't know exactly where the stock goes on Part 2, but my prediction is that $ABVX will be able to definitively prove the "cancer signal" narrative is nonsense, the stock will trade up significantly, and the company will run an offering at much higher prices - which they originally expected to do on Part 1.
With no black box warning, I have this as a $4-5B/year drug in UC, and a $4-$5B in Crohn's should it hit there as well. Very rough M&A valuation math from my perspective would be:
➡️UC $4.5B peak x 3.5x multiple = $15.75B
➡️CD $4.5B peak x 1.5x multiple =$6.75B
↪️$22.5B peak w/ ~91M sOS = $247/share
That's rough math obviously, and the big lever would be success/failure in CD moving that 1.5x multiple. Obviously if $ABVX waits long enough for Crohn's to read out and it hits...the numbers rise significantly.
Once Part 2 data are released, all of the big P3 data are in. We can combine with the P2 safety data and (hopefully...IMO likely) be completely confident that no black box warning is impending (although a black box warning seems to be what the stock is pricing in today...).
In my mind, M&A before or around JPM '27 then becomes extremely likely, and I would be disappointed by any price tag that does not exceed $225.
Hopefully the market can wake up and see the value here once the "cancer signal overhang" is removed, and this time next week we are trading much higher after a big successful secondary offering! At that point, I would finally say we would be entering the likely M&A window for $ABVX after spending the last year saying "not yet!".
$ABVX
Basic regulatory process to keep in mind:
Per compliance requirements for reporting unexpected events (not listed in IRB), Investigators would have reported unblinded Malignancies to Abivax within 24 hrs of finding and then Abivax (or their contractors) reporting to FDA within 15 days and then FDA deciding whether it’s drug related. Then Abivax submitting aggregate reports with stats of all events combined and FDA checking against background rate. Independent DSMB doing the same. Nothing (I.e. clinical hold or protocol amendment) came out during 7 year trial is reassuring. JAK malignancy was added to blackbox with other significant AEs of multiple organs after sufficient class wide post-market surveillance data (9 years after Xeljanz approval in 2012) of multiple JAKs and thorough investigation that its drug attributed. Linkage with Obe isn’t established nor there is sign it might be established in future based on its pharmacology.
It is also common sense that if FDA will start issuing black box for having refractory & severe patients in trials for having non drug related events, no one will ever enroll these high risk patients to their trials and most vulnerable who needs this the most will be left out. That’s not how regulatory system works. Not in US FDA not anywhere else in the world!
* My views only. No financial advice
@BiotechObserver@BenWil46805 Based on what I've heard these days, most institutions are laser focusing on safety signals in part 2. Ofc, safety is critical, but ultimately it's a risk reward compared to the current options e.g. Jaks.