inovrmihd

@A_May_MD @Andre_AGTC @Dremontjones @threadreaderapp unroll

@Andre_AGTC @Dremontjones .

$ABVX I was challenged by Adam. Here is my response $ABVX peak rev per Stifel is 3.3B >Obe is approvable due to good efficacy and oral convenience >Potential ADCOM and warning in the label similar to JAKs >Launch slower due to highly competitive field but to progress well

@Biohazard3737 @meremrtl pointed out that on the cc, Dr. Rubin said he would use it on only 10-15% as a first line option. Cormobidities like psoriasis explain a few cases, but why wouldn’t he use it as a 1l for most cases given $abvx efficacy data? Thanks for sharing any thoughts.

@seedy19tron Seedy, do you have any thoughts on @meremrtl ‘s observation that Rubin cc answer that he would only use it on 10-15% of his patients as a first line treatment? Comorbidities like psoriasis explain a small number of patients, but why not 1l for most given $abvx efficacy numbers?

Here’s the smoking gun if you’re scratching your head over $abvx , after pooling in the evidence I’m comfortable to stay long. Sharing with you all so you can rest better. 2yr rat carc and 6 mo mouse data in Obe had no malignancy signal (verified by a number of buyside and sellside folk today). No signal in the Ph2b and protocol was the same as Ph3 to pick up malignancies. Pod bros are dumb which is why they perform so terribly let them convince each other of their dumb narrative but we don’t have to wait 12 months to know that the cumulative weight of evidence against drug caused malignancy is genuinely substantial. Happy for any onco folk to chime in but 44 weeks is shorter than the shortest documented cancer latency period for de novo carcinogenesis in any tumor type. A drug cannot initiate cancer that becomes clinically detectable within 10 mo unless it’s working through a mechanism qualitatively different from carcinogenesis as understood. Which typically only if it acts as a tumor promoter (accelerating growth of already established but subclinical tumors) rather than as a tumor initiator. Obe CANNOT and is not causing cancer but is there something in the mechanism that promotes pre existing sub clinical cancer? Well a clean rat + mouse carc package is the gold standard nonclinical evidence that a chronic use drug is not carcinogenic. Which is why there will be no black box! No signal here is amazing historically, drugs that clear 2 yr rat carc cleanly very rarely turn out to have human carcinogenicity that emerges in post marketing surveillance. Rodent carc studies have systematic mandated histopathology of every major organ system at termination plus interim deaths. They detect tumors at much lower thresholds than clinical AE reporting. I’m so done with Pod bros ducking dummies crying oh but MoA , miR 124 is one of the MOST extensively studied tumor suppressor microRNAs. Instead of going for beers and dinners for ideas do some research. That helps! Speaking on consensus (which they guys love and just follow what one says without any own work), there’s a unified stable scientific consensus across multiple labs and tumor types over 15+ years of research. The mechanistic prior for miR 124 enhancement is ANTI CANCER, not pro cancer. Oh but.. off target effects ABX464.. omg since ABX464 binds the cap binding complex which has functions beyond miR 124 induction.. find me ONE published evidence linking CBC modulation to carcinogenesis and jbtw a tumor promoting off target effect would have surfaced in the 2 yr rat carc. ABX464 is non genotoxic across the full ICH S2 panel! Per the Phase 2b OLE + Study 108 extension: •~217 patients on 50 mg for up to 96 weeks (Ph 2b OLE) •~130 patients de escalated to 25 mg for up to 5 additional years (Study 108) •Total cumulative exposure ~7 years •Monthly visits in Yr 1 quarterly in Yr 2 •Mandatory flexible sigmoidoscopy with rectal/sigmoidal biopsies at Week 48 and Week 96 •No malignancy signal . ZERO Even accounting for the imperfect surveillance for non colonic cancers (no scheduled mammography or PSA), the colonic surveillance was rigorous AND would have detected the dysplasia events that showed up in Ph 3. ZERO in ~800 pt yrs of active surveillance IS MEANINGFUL. More Context: Ph 3 50 mg arm: 3 non NMSC + 4 NMSC in ~165 PY •One sided Fisher’s/Poisson p = ~0.13 for non NMSC vs pbo •Mean cancer case age 62 vs trial mean ~42 •SIR vs SEER age standardized rates: combined SIR ~3-6 if you weight by the trial age distribution •BUT pbo and 25 mg arms ran below SEER baseline (SIR ~0-1), which is part of why the 50 mg arm looks elevated by direct comparison •Investigator deemed unrelated for all cases •2 of 4 NMSC dismissed as not/unlikely related •1 had prior NMSC history The only 2 arguments that are left are: The cynomolgus immunosuppression finding in the primate study… and the dose response pattern cotd below

@A_May_MD @Dok__Tok Adam, would you mind please addressing @unemon1’s point? mgmt confirmed on the call they have Part 2 open-label data (~250 pts on 50mg continuously) and are holding it for a future congress. If that data is clean, and $Abvx is looking to raise, why didn’t they release it?

@Dok__Tok Would be a different story if this were psoriasis. GIs frequently/unanimously write for JAKs with far worse labels than this. Even the “worst case” of a black box you’ve got a multi billion dollar drug here.

$LLY Zepbound has a boxed warning for MTC/MEN2 — yet one of the largest blockbusters ever, for losing lbs ..vs simple lifestyle change Wall St losing its $hit over few isolated CA signals with $ABVX Obe with unprecedented efficacy in UC - a debilitating disease is peak insanity.

@unemon1 @Rajinvests @threadreaderap unroll

@Rajinvests Noooo!!!! ABTECT - Maintenance had 1116 patients enrolled ... in yesterday PR they only disclosed data on 580 patients (the induction responders) .... we have 250 patients of part 2 that were on 50mg ... why not disclose their data and relieve the cancer concerns?

$ABVX .. they have the data! Why waiting A conference in October? releasing clean Part 2 safety data (especially on the ~250 patients on 50 mg) would likely help alleviate market concerns substantially Yet, they are sitting on the data? have we to assume 50mg cancer incidence?

@financebully @Tirzepjunkie @threadreaderapp unroll

@Tirzepjunkie you're conflating a massive 12 month pooled exposure dataset across all indications with a standalone maintenance trial. even worse, $abvx maint study is 44 weeks vs $abbv maint study is 52 weeks. rinvoqhcp.com/gastroenterolo…

still own $abvx but this is exactly why $jnj would never acquire an asset with an unknown moa for chronic i&i indications - always potential surprises over the longterm. icotyde and even $abbv rinvoq still looking good.

@seedy19tron @Jonny_fun_guy @threadreaderapp unroll

you don’t need 25 mg approved as an induction dose at all… Look at the labels for tofa , upa, mirikizumab Induction and maintenance dosing are separately characterized and separately labeled. induce on 50 mg for 8 weeks step down to 25 mg for chronic maintenance The split label structure is how Obe almost certainly gets approved and that structure is exactly the one designed for situations like this.

$abvx **in depth note** post readout write up following review and chatting to some of the smartest minds. Okay let’s start with BEST in disease efficacy. Non contentious point.. Obe is the most effective oral in UC. 40% delta at Week 44 against a clean low pbo beats Rinvoq’s mMayo rescored 30% delta, in a MORE refractory pop that included JAK failures. It’s above everyone’s bull case and edges out upa 30mg. Pbo numbers vindicating the rapid washout thesis and the steroid taper design I spoke about in the preview. Every key secondary cleared at both doses endoscopic improvement Δ51% endoscopic remission Δ38% HEMI Δ47% CS free remission Δ38% sustained remission Δ49–53%. There is NO efficacy debate. 0 So let’s address the 7 cancer cases on 50 mg vs 1 on 25 mg and 1 on pbo, in a 44 week trial. None individually stat sig (3 vs 0 non NMSC is Fisher’s p~0.12) ALL investigator deemed unrelated two of the four 50 mg NMSC cases dismissed as not/unlikely related one had prior NMSC history mean age of NMSC cases was 62 vs 42 for the trial $abvx are right that you cannot conclude causation from these numbers. Although the FDA does not need to. The signal exists and I’m not contesting that and at 50 mg it lines up exactly with the safety pattern that drove the JAK class boxed warning. That is precisely why $abvx MC wiped roughly $7B+ AH. Sotyktu data is a decent comp, especially for low dose. Low dose obe looks safer than that and Sotyktu only got a warning. My theory is that the 25 mg vs 50 mg story is now the investment case to focus on. The 25 mg arm produced 50.8% remission with 0 non NMSC malignancies and an NMSC rate identical to pbo WHILST delivering essentially the same efficacy as 50 mg (51.3%). Ph 2b showed a flat dose response. $abvx showed 68% remission at Week 144 after de escalation from 50 to 25. Now Ph 3 shows the safety divergence between the two doses without an efficacy divergence. This everyone agrees on. Logically as much as I want to push the narrative for both doses the dose selection argument writes itself.. there is no clinical reason to prefer the higher dose and there is ‘potential’ safety reason not to. But you can use the higher dose as negotiation leverage for a clean label on the lower dose. So I see why Marc on call said he’s gonna go for both. (More on this below) So what are the odds? (Considering I’ve been right almost consistently since ph2B on $abvx here’s my view) •Best case - Both doses approved no boxed warning perhaps a malignancy/NMSC monitoring statement ~30%): obe lands as a clean oral above the JAKs. Peak UC ~$5B. •base case - Both doses approved boxed warning on 50 mg only 25 mg clean or with a softer warning (~40%)… the most likely actual outcome given FDA’s pattern of dose dependent labeling. $abvx effectively launches 25 mg uses 50 mg as rescue or Label Leverage (very important point). Still $3-4B in sales territory Rinvoq label as the realistic comp. •bear case 1 - Class level boxed warning regardless of dose (~20%) .. FYI FDA has done this to whole MOA classes before (S1P cardiac, JAK ORAL Surveillance read across). Cuts deeply into the differentiation thesis. ~$2B floor which then means this trades roughly around where it is now. (I can elaborate on this further but EV , 4x peak sales and at least $1B risk adjusted valuation for Crohn’s) •bear case 2 - Approval delayed pending more long term safety (10%) less likely with these efficacy numbers but a CRL on safety with a 6 to 12 mo delay is not 0. 70% imho chance that this is a $4B ish drug in UC alone. @a_may_md correctly points out the ph2b for greater safety PY data , one question I’ll ask mgmt is how rigorously Phase 2b/OLE screened for malignancy. $abvx has 7 years and 120 to200 pts on drug with no reported cancers. If that surveillance was protocol mandated centrally adjudicated and routine that’s a strong rebuttal to the ph 3 imbalance and gives FDA the basis to call it noise.

@RodDMartin @threadreaderunroll

7/ Sweden proved socialism fails. Democrats are selling the exact model Sweden rejected: wealth taxes, hostility to school choice, endless spending, and punishment of success. The real Sweden chose capitalism, fiscal discipline, and freedom — and thrived. America should learn the same lesson before it’s too late. Full essay on my site — link in bio. Do you agree the “Sweden model” is a myth? Drop your thoughts below. 🔥

🧵Democrats still cite Sweden as proof socialism works. They’re lying. The real Sweden survived by rejecting socialism — abolishing wealth taxes, protecting capital, expanding school choice, and becoming one of the world’s great startup nations. Here’s the story they hope you never hear. 🧵

@biotech_jack @unemon1 @threadreaderapp unroll

@unemon1 By consolidating the process on Friday evening, all the material facts were made public in a single regulatory move. The company has laid itself completely bare, legally speaking, in order to ensure full compliance ahead of the upcoming transaction weekend.

$ABVX ... no need to put out those updates in the quarterly! ... Make $ABVX look a bit more de-risked ... ... makes u think if it was so that the Buyer could have a plausible excuse in the eye of its own investors ... for pulling the trigger ahead of real June data!

@biotech_jack @smithy05261244 @unemon1 @threadunrollapp

@biotech_jack Why is it genius to release this data now?

Safety data: Some patients were treated with obefazimod for up to 7 years. No new safety signals were observed. This means that the risk of serious systemic side effects (such as those associated with competing JAK inhibitors) is statistically minimised in the long term. $ABVX

$ABVX The fact that Abivax is presenting new interim data from the open-label extension study (Phase 2a/2b) for ulcerative colitis (UC) alongside its quarterly results is a stroke of strategic genius. 1/

@Vmaxpax Thanks.

@inovrmihd ampx has an advantage but how many one way attritable drones need that premium? phase 2 of drone dominance gauntlet today dropped and they're testing for long range one way drones with price cap of $4500. look around, there's other battery cos servicing the drone industry

Worth a read if you're in Amprius $ampx I've exited and have commented when researched in 2024-25 their phantom Colorado plant + it seemed production was actually in China spooked me. AVAV Switchblade a client tipped me. Have found other drone battery plays since

@Vmaxpax Sorry to be a pest, but are you saying you don’t believe the batteries made by $ampx have a clear advantage in energy density for drone applications? I get the other objections. I am just interested in your “found other plays” comment.

@inovrmihd I'm saying when I researched this co in 2024 I entered bc AVAV was using them but I found it suspicious/curious US footprint was only RnD, Colorado phantom, real manufacturing China. THey later announced Korea but apparently need to peel back layers. Yes, I found other plays

@origoinvest @threadreaderapp unroll

I am keeping a very close eye on Honeywell $HON In particular the spin-off of its aerospace & defence division which pattern matches $GE in many ways They are the dominant player in avionics / APUs for commercial aircraft and in addition are a key supplier in the space and satellite launch economy which we've been covering $HON share price has been flat over the past year, spin-off is slated for H2'26

@MrMojoRisinX Would you please elaborate on what your thought process was at the time you were trading this? When and why did you reach the conclusion this wasn’t going to happen?

Was able to take $19 beaners out of $FWRD over the course of the fake strategic alternatives process (long and short and via trade structuring), which turned out to be a fraud and likely to be investigated but nothing will come of it is my initial take. My trade bundle that I had on, mind you not put on as a single trade structure re all at once, was the following going into this deal break: Long stock (15^) Short in the money calls (collected 30% of the underlying) Calendar spreads 1x3 (short 1 unit higher strike and long 3 units lower strike) Delta was 180% short The original trade structure was long common (light delta) vs a risk of loss put, and over time traded against this mainly from short side.

@_inpractise @threadreaderapp unroll

On why GE sponsored the rise of CPP: "Because GE did not like the duopoly and was smart enough to realize there wouldn't be enough capacity for the LEAP. They had a very aggressive plan, which we all saw. Even with CPP, there wasn't enough capacity for this giant ramp on LEAP. They didn't think PCC and Howmet would have the capacity, and they were right. Even with CPP on board, there still wasn't enough capacity. With every LEAP A and B, they were behind, and engines were not being delivered on time. Prior to Covid, they were six months late. Nobody was meeting the ramp-up scale that GE wanted before Covid, even with CPP in the mix"

A former Howmet Aerospace Director on how the CEO renegotiated LTA with OEMs $HWM : "His view was that capacity was something we could take advantage of, especially in the pre-Covid era when there wasn't enough capacity in the market. I'm specifically referring to aerospace and airfoils, where I have expertise and responsibility. He insisted that we demand a premium from customers. When renegotiating long-term agreements, prices went up with every customer. Previously, customers felt they had the upper hand, expecting suppliers to come up with cost reduction initiatives, leading to price decreases over the long term. Plant flipped that script, insisting that prices go up because we have to allocate capacity for them, and to lock in that capacity, they would pay a premium price. This approach has continued to drive margin improvement. Plant has been there for six years, and every contract negotiation has been approached this way"

@BlackScholesMan @sarcastic_hedgi @threadreaderapp unroll

@sarcastic_hedgi lol trying to give me more reasons to buy more Sunday?

$079550 (KRX) - LIG Defense & Aerospace. Now that U.S. investors can directly access the Korean market I am super excited to share this idea! The patriot complex has a global competitor that delivers on time. A thread 🧵

@pennycheck Thanks for this $ampx note. Do you still see a lot of upside at these levels? If you assume $28.8 million ebitda 20 months out, that is still an 87x multiple. Could you please elaborate on what you are seeing to underwrite at a 2.5 billion market cap?Thanks in advance.

Notes from the note: $AMPX Maintain Buy, raise PT to $22 ⁃ Key takeaways include guiding 2026 baseline revenue above the Street, reaching certain NDAAcompliance targets ahead of schedule, and providing Insight into the longer-term opportunity. ⁃ The baseline outlook for 2026 included revenue of >$125M and EBITDA of >$4M compared to BRiley's/Street estimates for revenue and EBITDA of $126.8M/$122.1M and $2.2M/($1.8M), respectively. ⁃ BRiley is leaving revenue estimates unchanged but raising its 2026/2027 EBITDA estimates to from $2.2M/$27.0M to $5.0M/$28.8M. ⁃ BRiley's price target rises from $16 to $22 on the heightened visibility, reflecting 12.5x its 2027E revenue. ⁃ BRiley's target multiple remains below certain next-gen Battery peers despite Amprius' earlier sales ramp and profitability. ⁃ The company has made meaningful progress on driving NDAA-compliant cell production, qualifying all 11 components for current cell designs ahead of its ~Q326 target timeframe . ⁃ This is significant for U.S. Defense opportunities and, notably, is largely supplemental to current revenue. ⁃ In Q4/2025, 90%/84% of Amprius' revenue was international. ⁃ Longer-term, Amprius set a 2030 target of $600M+ of revenue capacity, with >30% gross margins and >20% EBITDA margins. ⁃ The company is enthusiastic about its Unmanned Aerial Vehicle (UAV) leadership in addition to growing opportunities across satellites/space, Light Electric vehicles (LEV), Robotics, and eVTOLs. ⁃ R2K +1.7%) and rose 52.2% over just the past week (R2K -4.1%), BRiley believes this is a multi-year opportunity driven by strong macro tailwinds and meaningful technology leadership

@BlackScholesMan You’ve been ambivalent about $ampx in the past (at least in the posts I can see). If you don’t mind disclosing, do you have a stronger opinion on it currently? Thanks for any response.

$PKE putting in a new ATH on a quite day.