@spontonic It is main reason drug is first line therapy,... not second,..third,....! $BDTX!
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Miljenko Zuanic
7K posts
$BDTX Has anyone seen or heard any commentary on inhibition of de novo brain mets? TIA, if so.
Spontonic@spontonic
@KMIA320 @Miljenkoz ORR, C797S cohort, n=33. Everyone else was focused on first line. At EV ~ 95m, I was more interested in that intracranial cohort in experienced patients and if there's any bzz about inhibition of de novo CNS mets.
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@JacobPlieth Thats AE are cumulative for 200 mg, they cumulatively dropped by 80% for 135 mg! Pick your numbers, if you can!
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$BDTX Silevertinib safety is not the best, but it is not at "alarming level". If 150 mg (or lower) continue to deliver...CNS activity is definitive big plus. Will see how will potential partner react?
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$BDTX is claiming a 15.2 mo preliminary mPFS in 1L NSCLC, but median follow-up is only 11.2 months. Look at the KM curve: it's resting precariously at ~55% with a tiny denominator.
With only 8 patients at risk by month 12, just ONE progression drops the curve below 50%.
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@spontonic Serious TRAEs did not change, lower dose. They can not selectively negotiate with partner without public release of data, think partnering is on table.
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@Miljenkoz Haven't a clue. After abstract, last thing I expected in CC was a PFS number. So many shares short, expecting < 14 months. In experienced patients, "serious treatment-related adverse events (TRAEs) were reported in 7 (11%) pts".
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@spontonic 200 mg has +60% G3 AE, so it is eliminated as option for p3. 100 will be lower, and 150 mg optional, if FDA agree. Think, they have a real shot! Partner would help(counting on it). Why did they broke ASCO embargo? Partner negotiation!
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@Miljenkoz "demonstrated antitumor activity at 200 mg orally once daily in patients with recurrent NSCLC, EGFR NCMs, and acquired resistance C797S mutation with a safety profile consistent with the EGFR TKI class"
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@AAMortazavi @JMaraganore From frontline science to approved drug roads are long, way too long. You know that! How long it took (by chance) to develop AI chip???
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What is the moat of biotech? We lost our way after $ALNY $MRNA spectacular inventions? Where ate the new drug modalities or new therapeutics classes $XBI @JMaraganore
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@BiotechObserver @DmitryKovalchuk @adamfeuerstein @CloisterRes Nonetheless, $REGN run P3 from "robust" P1 data, and something went wrong! They should know better! $$$$ (and time) were/are wasted!
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@BiotechObserver @DmitryKovalchuk @adamfeuerstein @CloisterRes If it is "new" indication that approved drug is targeting (in combination with unapproved candidate), than figuring out each single agent contribution is not that bad. However, anti-PD1 for melanoma is well characterized, and single agent was not necessary.
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Why was there $7 billion of market cap embedded in $REGN for their LAG3??
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@Miljenkoz @DmitryKovalchuk @adamfeuerstein @CloisterRes 4x dose level u can thank FDA for that. They demand unethical subtherapeutic doses now to show dose response. Same thing with "contribution of parts" pointless cohort of lib mono when fda wont approve it for melanoma anyway (but identical to keytruda). Bad luck that underpowered
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@BiotechObserver @DmitryKovalchuk @adamfeuerstein @CloisterRes Why they tested 4-fold dose level difference? It is more common sense failure (bad judgement) than simple "bad luck"! Why so large spread in PFSs, so chance that observed effect are for real are not with needed confidence??? Bad luck? Do not think so??? Bad FK/FD? Probably...
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@DmitryKovalchuk @adamfeuerstein @CloisterRes No offense bro, but the market never, ever bought these comments.
Irony here is they are in the commercial position they are in because of their R&D capabilities.
Market doubts they can repeat successes.
Fianlimab outcome (& il33 COPD trial during Covid) seems bad luck to me.
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Miljenko Zuanic retweetledi
This is the American criminal justice system in action.
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@spontonic At ~$150M $BDTX should be no-brainer (bit of luck expected) and 3-5X return (at current level) should not be surprise, I think. Will see, when this general extreme bad view toward bios improve bit.
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@Miljenkoz Well, that was bad wording, but you know what I mean.... they are targeting the trans configuration, given that cis is probably a no-go. As I said elsewhere, however, this is not an area where I have expertise. Wonderful day to have been a believer, big loss triple down.
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@spontonic Are they looking specifically for cis-configuration of the C797S mutation? Still, I would prefer less of-target reactivity (bonding probably activate chemical reaction, but ...it may develop on its own)! As recent $BDTX SH also looking forward to ASCO. [C797 mut will further>>>
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@Miljenkoz Toxicities are considerable and, to my knowledge, characteristic of EGFR targeting. But I consider every "drug" worthy of off target tox, so ??? Looking forward to ASCO, C797S-focused data. and intervening three weeks.
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@Miljenkoz Ocrevus losing patent in 5 years or so, and Zunovo is a massive 23 cc bolus injected into your abdomen with quite a lot of injection-site reactions. And Ocrevus has crap gap, with drug wearing off before six months. (Zunovo is a somewhat larger dose, so might avoid that).
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From latest GS report, these CD20 graphs are informative showing just how much room for growth there still is for $TGTX
Note GS still predicts some $4.4 peak billion in sales for the BTKi class despite safety concerns (2 cases of Hy's Law and 8-1 death imbalance) for fenebrutinib, which with remibrutinib seem to be the last BTKi's still standing.
Peter Suzman@Biomaven
On the $TGTX call the following was casually mentioned in response to a question about subq: "We feel actually very confident in our ability to deliver a quarterly product." It's important to understand that Briumvi will be the only product that offers optionality between IV and self-administered subq. So for a pt that isn't sure which they will end up using, it makes for the safe choice. Other nuggets: Now the leader in dynamic market share (i.e., new starts plus switches) in the private office setting. Persistence is "better than they initially modeled." They bought back $100 million worth of shares in Q1, with more still in reserve. This is a "sleep well at night" biotech. Steady growth over the next several years as they make steady inroads into an existing market with a drug that is at least somewhat better than the existing drugs. The subq will have a very clear advantage. Only real risk I see is if Roche and Novartis can play games with the PBMs, leveraging their large installed base. That game gets harder as Briumvi market share increases.
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$CYTK How much of the short interest will be covered by secondary, from bankers?
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