Not investment advice.May have position in names mentioned.Opinions expressed strictly my own,not representative of my employer.Factcheck urself.RT≠endorsement
This is the only account that could be a subscription and I'd gladly pay for it.
(and I'm not just saying that because he's the only one on biotwitter who actually nailed BBIO)
$APLS safety issue now have me looked back in the past cases of similar situation - esp. w/ the KEY valuation driver for the company .. going back, way back - it would be Tysabri in early 2005 - think it was 4-5 mos after the FDA approval then boom - the PML cases - the impact
Contrarian opinion: FDA is just doing its job. It's the companies that are at fault- ACAD FGEN CCXI AXSM RETA etc all presented a much rosier picture to investors than was actually the case. It's not the FDAs fault that investors were gullible enough to believe contorted truths
Sizing up some 2Q biotech events and consistent theme emerging among many of them is the likelihood of spin/deliberate obfuscation/sleight of hand/bait and switch/general smoke and mirror confusion. So to avoid a $FGEN esque repeat, laying out some of the more obvious candidates-
Great thread. Biotech is inherently uncertain, but investing is all about risk reward and $CABA at 200m ish EV offers a 15-20x payout if the story does pan out. Clean safety key in q4 update and will be a win. ANY hints of activity at these v low doses and this becomes a rocket
Can't recall a time when biotech sellside as a collective was as abject as it is currently. Almost no value adds. Apart from a very, very select few (they know who they are) the rest are just incompetent passengers cruising on the gravy train
$CLDX 95% CR at EAACI. Clean safety. Crushes Xolair on all counts. KOLs are hyped as can be gleaned from Maurer's comments below (he's THE authority on all things urticaria)
With sentiment in biotech turning, some takeaways from the CNST acq last week-
1. Hem-onc assets remain hot
2. No. of strategic acquirers > usual suspects
3. Readthru to cheap hem-onc cos
4. Skittish tape = more time to buy even AFTER +++ data, for folks looking to put $$ to work
Thanks for the great responses. Takeaways-
- low $ stocks dominate. 90% of the names were under $10
-twitter loves ocul. By far the most frequent name
-Alz recency bias- folks searching for the next big winner- names like anvs inmb clnn mentioned
-runup names- srra cbio ctic xfor
If we just look at the tougher-to-treat DLBCL patients rather than indolent lymphomas, $FATE 516 and 596 efficacy looks quite markedly ordinary compared to CAR-T. At least based on the evidence presented today. That's without even talking about the subpar DOR.
Anybody know what they’re planning to name the next bs “variants” that will inevitably pop up? Just so I can mute those and the ensuing fear mongering pre-emptively.
Enough of this nonsense. Get a life.
$GOSS weak. Consistent insider selling over past 2 weeks. Big under the radar binary approaching with NVS fevipiprant Ph3 having DIRECT readthrough to GOSS lead drug w/ same MoA. Analogous to how ANAB cut by 45% since REGN IL33 miss. Will put out some thoughts on that tomorrow--
ArgenX hits across endpoints.
From topline, did better than expectations of 20-30% delta vs pbo and 20% soliris delta (h/t Guggenheim preview below)
Redosed patients had similar responses as first cycle (positive for durability)
$ARGX $IMVT $MNTA
Lesson for new biotech investors- never short a shiny PoC platform story off of a commercial thesis that'll take several years to play out, by which time this initial thesis will almost inevitably be irrelevant. Especially when there are clear comps valued much higher $NTLA
Bottomline $STRO- could very well end up being best in class (see apples to apples table from Truist below). Potential for 20%+cORR in heavily pretreated plus unselected population. Ph1 study.
See $MRSN playbook when move earlier lines of tx- MRSN $1.3 billion EV vs STRO 450M.
Thanks for the kind words on $IFRX.
Big credit actually goes to
@BiotechPort
for laying the groundwork for the thesis here. Absolute gun analysis. He’s new to Twitter but a must follow.
On to the next one. Can tweetstorm some more ideas here if anyone cares!
$ARGX announces fail in PV
BP under review given comparable biology
Illustrative note from Cowen 2024 best ideas list gives perspective on sellside model % of Vyvgart peak sales from these indications (~30%+)
$PIRS Whoa.. Late breaker for PIRS "inhaled dupi" at ERS- title notes"robust FeNO reduction"
fwiw Dupi EU label update includes FeNO-
$PIRS market cap ~$250m
$FATE solid tumor data looks like a complete bust, made worse by the fact that it's in a combo setting with PD-1 and IL-2. No wonder we haven't seen a proper press release from the company highlighting this.
$RXDX
What should be the objective bar forclinical remission for a non-oral therapy in a biosimilar TNF-alpha world
To start off, 10-15% delta is sellside bullshit. Look at these 2021 comments from CEO ("obviously no need for another 12% delta") and CMO "not here for 12-15%")-
$ACRS the obvious one. Names like $CLDX $GOSS in play as well. Also makes upside more pronounced for a platform name like $CABA if data deliver. If $FBRX works now, would go bonkers given this backdrop…
Game over for TIGIT?
Roche TIGIT SKYSCRAPER-1 fails on PFS in first line PD-L1-high NSCLC. OS immature but commentary reads pretty bleak $RCUS $ITOS $GILD
$KALV the bigger thesis for what is only a $650M EV at pre market levels-
Readthru to Prophylactic is the endgame. Ability to demo CLEAN efficacy AND safety w/ acute suggests have chemistry/PK/PD nailed down- BIG
Acquisitive space w/ Shire/Tak
Comps valued higher(see $PHVS)
$CRTX the spin is irrelevant. When you have Hy's law cases there's no path forward. There's a reason the FDA put this on partial clinical hold. End of story
Stock will do what it will do, but this $KRYS Vyjuvek launch is objectively one of the most underwhelming ones I’ve seen, for a disease clearly as severe as DEB is
Only 284 *start forms*, ~18 weeks since approval. 121 in q2 and so 163 in q3 by my math . Comp to likes of RETA
$SRPT blaming the -102 fail on imbalance between arms. Not sure how they can say that considering they've repeatedly touted how well balanced the study is. See below quotes from Evercore and Baird conferences on EXACTLY this issue
SNY R&D head John Reed tipped his hand last week citing interest in “oral immunology options with interesting MoA”. $KDMN acquired a mere week later!
Fwiw also notes interest in oncology/onc platforms and gene editing. Place your bets!
99% of the nitpicking around the $ALNY data is just dumb. It's as clean a win as you can expect in a trial of this duration in this indication (see tafamidis data for reference) and population. I get the inclination to be skeptical but credit where it's due
Alternative headline: “Woodcock confident in integrity of Aducanumab approval, offers to have third party dissect interactions between FDA and Biogen to definitively quell any public concerns”
It’s a good question. Probably have to think about strategic value here given it LOOKS like a viable + competitive drug even accounting for small n. DERM got taken out for $1B so even if $ASLN doubles to ~15 it’s at a 50% discount to a recent comp with ostensibly “similar” data
Digging into the $BMEA data. On first pass I agree with the general view coming out of ADA that the data are quite remarkable, with the durability of a short course of therapy and off-treatment effect pretty much unheard of for the commercial diabetes drugs, which of course are…
Biotech Companies using the word “approval” in the PR header for anything other than an actual FDA NDA/BLA/product approval are just trying to game the algos. Might work in the ultra short term, but add it to the list of real red flags. Reflects on mgnt character.
If you’re hanging on to $WVE in the hope they show something in the pipeline, consider the fact that the stereochemistry is apparently SO pure that it couldn’t even get the nominal increase in dystrophin that srpt and prosensa were able to generate.
$WVE cash ~ $6/sh
$WVE Open market selling by founder Gregory Verdine (non 10b5-1 selling like the other WVE transactions)
As far as I can tell, the only open market purchase since WVE has been public has been...Ra Capital
Given the propensity for biotechs to spin data lately, *this* management team's history and deep into the "end of summer" timeline, prob best to assume a $TGTX spin as base case and prepare for it. (1/n)
Anything less than a stat sig diff on ORR should be considered a fail
$EDIT down 10% off this. Critical update tomorrow. While PR headline will very likely claim "positive" or "encouraging" or some variation of the same, data need to be pristine and match $PRQR (see below from GS). Going higher dose or longer duration not going to help.True binary!
Yea if want to blame anything for biotech underperformance YTD look no further than the flood of supply and issuances. Too many IPOs that are too early to deserve being public cos, illiquid once they come public, and bankers keep shoving these down the market on every 3% xbi pop
XBI vs. SPY
I'd wager the three biggest factors driving this underperformance are:
1) too many overvalued early stage IPOs
2) too little M&A
3) not enough positive data which may be a bit of stretch considering CRSPR news but a lot of that was priced into these names already
Catching up to $FULC - very very interesting. If this really can achieve gene therapy-like HbF levels in sickle cell patients with a simple oral drug then it’s obviously extremely cheap. Good start with today’s data. Will be listening to the call. Note from MS below-
$FULC Reported positive interim results from ongoing Phase 1 trial in healthy adult volunteers with FTX-6058 for sickle cell disease demonstrating proof of mechanism and proof of biology
Thread breaking down $IGMS presentation and data integrity issues. While sellside and management will try to distract investors on the basis of just two last minute metabolic activity responses,in reality IGM-2323 finds itself between a rock and a hard place at a VERY early stage
I was wrong. The 50mg, 100mg BID and 200mg all have HbA1c reductions of 0.4-0.5%. This calls into question the 100mg data, and likely means the drug isn’t doing anything
Digging into the $BMEA data. On first pass I agree with the general view coming out of ADA that the data are quite remarkable, with the durability of a short course of therapy and off-treatment effect pretty much unheard of for the commercial diabetes drugs, which of course are…
$XFOR Very early data (as of Jan 22, 2021). Of 4 patients at 3 months, all responded with median decrease of 51% (major response). So, at least 2 (50%) had a major response. For comparison, ibrutinib shows 38% and 28% major response rate at 6 months. More mature data at EHA
$IGMS
#ASH2020
IGM-2323
-1 unconfirmed PR in 16 patients,that too in DLBCL where only CRs matter, AND new lesion showed up
-Gr2 CRS already, resorting to step dosing
-Forced to use steroids as well
-No responses in FL (even at 100mg) which is easiest to treat
cash per share $7
4% in AML, 0% in MDS.
That's right.
FOUR percent. ZERO percent.
For a supposed biomarker-defined, targeted drug.
That's 1 responder, in 48 evaluable patients.
Cash per share at end of 2017 is ~2.3/sh, or ~80% downside from Friday close.
Thanks for coming
$SYRS
OTOH, if $11B IS the price for a PoC PAH asset (~20% rebrozyl/75% sota XLRN), then $GOSS- at $700m EV, readouts in PAH AND UC in the next ~6 mths, + outstanding mgnt that's executed well since asthma misstep- can easily run 150-200%+ INTO the data, much better investment case
A favorite target of short sellers are often biotechs too - thin liquidity and high risk. How many drugs haven't come to market because of predatory tactics and market manipulation?
$NVS announces LUSTER trials fail, despite apparent pooling. Discontinuing fevipiprant development entirely.
$GOSS cash ~$2/sh by 2H2020.
Lead drug same class as the ~11 DP2s that have failed. Bull thesis was it will work in a more severe population.
Well, that just went bust
FWIW $ACAD PR on sNDA deficiencies matches that $TCDA received before a CRL ie "FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time"
Great buying opp*
*ignore $8B mcap that almost entirely hinges on
a controlled gene tx ph2
that now NEEDS to show functional benefit
2 wks ago had to be upsized for adequate power
is 18 mths out
in the meantime stock is vulnerable to downside over- rxns on even mild AE reports
So days before their big Ph3 readout $MDGL has, out of nowhere, decided to update the trial page to now include F1 patients as well in the primary and seconday endpoint analyses
if it's right and doesn't make money then it's wrong. But it's definitely another example of how abysmal supposed "big pharma due diligence" usually is. empirically would expect higher success rates from acquisitions but the reality is there's no difference, and much worse ROI
“Chalk up a pyrrhic victory for the Principia Biopharma short sellers. After arguing [its] pipeline was worthless, short sellers saw Sanofi snap up the biotech… in a $3.7 billion deal. Now, rilzabrutinib… flunked its first major clinical test.” We were right in the end on $PRNB
Detailed $ALLK EGID data presented at UEG. If you're long this thinking this will work in ph3 and/or hoping for takeout, def worth taking a closer look.
For context, *THIS* is what a representative PRO time curve for EoE looks like
$KZR 94.1% ORR at week 29, 35% CRR. Comfortably beats Jefferies bull case scenario below.
Stock got up as high as $18 during a biotech bear market, with much less data. Now back at 7...
Couple quick $RETA points-
- How do bulls justify the "bardoxolone MoA is panacea for all indications" stance given CTD-PAH (used to be lead indication) complete fail despite trial being upsized?
- What's the floor for the stock (cash is $24/sh btw) if the FDA asks for 2 yr data
There are quite a few. Look at a name like $CABA for instance. $200mm EV currently. If it works it’s at least a 10x. I know “if it works” is the most obvious caveat in biotech but the difference now is you’re getting paid 7-10x to take that risk rather than 1-2x a few months ago
If they do dose lower (and assuming it’s not the FDA that’s asking them to do that), then the safety aspect of the short thesis gets much less credible. Impressive therapeutic window so far