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Worst case scenario for $MLTX's SLK (IL-17A/F nanobody) at
#AAD2023
this weekend:
BIMZELX (IL-17A/F mAb) significantly underwhelmed vs expectations in HS on HiSCR50/HiSCR75.
izokibep (IL-17A small kDa mAb) results are ambiguous due to more mild patients enrolled.
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$ALPN tracking -54% UPCR at 24 weeks with 80mg low dose q4w versus-36% $KDNY $NVS q2w. Largest bear thesis outside of efficacy around having thin TI via hypogammaglobulinemia given potency addressed as povetacicept shows 0% gr3 AEs and 0% hGG - can dose higher/elongate interval…
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$FDMT is a non-starter. Capped at 3e10 dose showing a 4 letter *loss* at high dose, with a marginal 80% rescue-free rate in 5 patients.
Lower doses ineffective - rescue free rates of 40% - less than $EYPT $OCUL that can be redosed! Also large *mean* CST increase in 1e10 arm.
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Checking in on the hot new nanobody companies we have:
$SLRN
HS, HiSCR75
❌160mg QW failed vs pbo
❌160mg Q2W failed vs pbo
$MLTX
PsO, PASI100
❌30mg failed vs COSENTYX
❌60mg failed vs COSENTYX
❌120mg failed vs COSENTYX
❌120mg w/ LD failed vs COSENTYX
PsA, ACR50
❌60mg NI…
Worst case scenario for $MLTX's SLK (IL-17A/F nanobody) at
#AAD2023
this weekend:
BIMZELX (IL-17A/F mAb) significantly underwhelmed vs expectations in HS on HiSCR50/HiSCR75.
izokibep (IL-17A small kDa mAb) results are ambiguous due to more mild patients enrolled.
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$EYPT's DAVIO 2 trial is reading out imminently, offering the opportunity to close the book on an asset that is very clearly a 0.
From the start, $EYPT's EYP-1901 (vorolanib) is less potent than sunitinib (recall $GRAY failure) and significantly less potent than axitinib $OCUL.
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$VTYX guided to a "mid-23" readout of their ER formulation work to ensure they have a QD formulation for phase 3s and commercialization. $VTYX CEO: "we're not going to compromise on the profile."
They just kicked that readout to 4Q23. Meanwhile, $VTYX executive suite/top holders…
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Big posturing in $PTGX new deck out today, stating TYK2/JAKs provide a low bar and appear to be posturing toward PASI75 >90% *as an oral*
$VTYX laying out bar for orals as < injectables but convenient; noting complete IL-23i > partial inhibition via SOTYKTU (TI widening TBD)
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$ACRS "There was no notable differentiation between zunsemetinib and placebo across any measures of efficacy at week 12."
$ACRS enjoys the unique pleasure of their drug performing *worse* than placebo.
Might be because their drug was a weak cytokine inhibitor with minimal TNF-a…
If I'm $ACRS and I whiff on HS ahead of RA & PsA, I would want to provide some hint of mechanistic and disease relevant activity, but the company gave no slides on cytokine inhibition...🐟
Good luck owning into RA/PsA with poor selectivity for IL-6 (key to RA)
Cash of ~$3/share
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$VTYX TYK2
Efficacy results did not meet the internal target to support further development of VTX958 in psoriasis; Ventyx to terminate Phase 2 trials of VTX958 in plaque psoriasis and psoriatic arthritis.
Goodnight.
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What are these analyses from $VTYX, pitching a PD-efficacy relationship for S1PR modulation?
Established correlation? Strong rationale?
$ARNA differentiated by lack of dose titration, faster time to steady state, on-off effects, clean cardiac safety, and trial design...not PD
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$KPTI 24-wk SVR35 of 92% at 60mg compares very well to $CNST/ $MOR 68% in MANIFEST
Patients staying therapy longer, with only 1 (7%) discontinuation due to AEs vs 12 (14%) discontinuations due to TEAEs (also 12/14% gr3 thrombocytopenia)
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If anyone is writing off the importance of a superior delta over the HUMIRA reference arm in phase 2, it is to their peril:
$MLTX has consistently guided publicly that the phase 3 trial(s) in HS will be superiority trials vs HUMIRA and the reference arm in phase 2 serves as a…
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$ELEV 38% ORR/57% DCR in all, 47% ORR/65% DCR in GC cohort
relatively clean safety for an ADC w/ only 24% AEs gr3+, 2 gr3 nausea and vomiting at 3 mpk
*at 11/5/2022 cutoff* - so more mature data at ASCO
MC ~$73MM w/ $74MM cash at 1Q23e. Comp to $AZN/Keymed $63MM uf + $1.1bn ms
$ELEV First-in-human dose escalation and expansion study of SYSA1801, an antibody-drug conjugate targeting claudin 18.2 in patients with resistant/refractory solid tumors.
#ASCO23
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If I'm $ACRS and I whiff on HS ahead of RA & PsA, I would want to provide some hint of mechanistic and disease relevant activity, but the company gave no slides on cytokine inhibition...🐟
Good luck owning into RA/PsA with poor selectivity for IL-6 (key to RA)
Cash of ~$3/share
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I wonder why $VTYX decided to remove the $ARNA phase 2 CR rate for etrasimod of ~26% pbo-adj for comparison to today's data, but noted it in their corporate deck 8/10, along with a bar of needing ~15-25% pbo-adj rate (sell side bar notes bar was 20-25%).
Also, so much for the…
What are these analyses from $VTYX, pitching a PD-efficacy relationship for S1PR modulation?
Established correlation? Strong rationale?
$ARNA differentiated by lack of dose titration, faster time to steady state, on-off effects, clean cardiac safety, and trial design...not PD
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Where were the signs? $VTYX
$VTYX guided to a "mid-23" readout of their ER formulation work to ensure they have a QD formulation for phase 3s and commercialization. $VTYX CEO: "we're not going to compromise on the profile."
They just kicked that readout to 4Q23. Meanwhile, $VTYX executive suite/top holders…
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$REGN really nice data from PULSAR trial of 8mg EYLEA, makes it much tougher for $RHHBY faricimab and long-duration plays $OCUL $EYPT
Rescue criteria closely reflects real world (which is in-line with ph2 CANDELA...), ~80% of pts out to 16 wks, CRT overlaps with 2mg, IOI <1%
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@jeromeleonard5
@buysidebio
No, not the same receptor occupancy - $PTGX is gut, $MORF is blood. $MORF is also using manganese-free assay to get most conservative look at Ctrough (many others don't - many times exaggerates RO). But mgmt guiding to >90% which is also consensus.
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$APLS “[USPI now includes] the previously reported rare events of retinal vasculitis with or without occlusion in patients treated with SYFOVRE. The Company pursued this update in collaboration with the U.S. Food and Drug Administration.
The estimated rate of events of retinal…
So do you think it’s going to ultimately be deemed drug related or not? Only thing that matters with any of this commentary.
I’ll put my stake in the ground and say it’ll be found to not be drug related and will be solved soon, taking a quarter or two to have the ReST committee…
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If there's anyone who loves a thread from
@biotechinvstr
, it's me - one of the best around across the board, as I've often said privately.
IMHO, "body language" into data is driven more by standard sell side reining in expectations than an internal change of the bar at $RXDX
$RXDX
What should be the objective bar forclinical remission for a non-oral therapy in a biosimilar TNF-alpha world
To start off, 10-15% delta is sellside bullshit. Look at these 2021 comments from CEO ("obviously no need for another 12% delta") and CMO "not here for 12-15%")-
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$MORF Homerun data
25.7% CR rate, 6.4-pt change in RHI, 98% RO at trough, clean safety
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$SLRN
The primary endpoint of HiSCR75 at week 16 did not meet statistical significance in the Non-Responder Imputation (NRI) primary analysis
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This is biotech gold. I wish all of my firesides were this good. “You may think we have 99 problems, I think we have none, but cash ain’t 1.”🔥 $TGTX
$TGTX -link to call - if you been investor in $TGTX for any length of time - worth your time listening to WEISS have little fun with analyst today that clearly does not know $TGTX well at all
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$GMTX confirms that supraphysiologic levels of CFH via GEM103 is unable to inhibit the complement cascade deep enough to bring patients to normal Ba/C3a levels, reflected in the lack of lesion growth separation from the contralateral eye
@sentivcapital
@coyotebioscav
@buysidebio
250ug/500ug isn't expected to show dose dependent biomarker reductions as drug concentrations are already so high...if dosed q4w up to 6 mos w/ minimal impact to biomarkers, how would that show GEM103 is active?
C3i's inhibit ~99% C3 with slowing of lesion growth at 2,3,6 mos
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$SNDX CR/CRh expectations were ~27% re cowen vs 23% topline today
QTC prolongation bogey 10% or less vs 14% topline
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$STOK is going to cash if they show seizure reduction <50% in the 45mg arm.
Per recent KOL commentary, if mix skews younger, bar should really be ~70% reduction. $STOK guided to at least 6/10 new patients will be in the younger group (2-12 y.o.), so math works out that the bar…
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$ADAP Additional responses across the platform.
In addition, ADP-A2AFP chosen for oral presentation at ILC in August.
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$APLS Generated U.S. net product revenues of $18.4 million for SYFOVRE™ (pegcetacoplan injection) and $20.4 million for EMPAVELI® (pegcetacoplan)
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Did $MLTX SLK hit the bogey of >10% delta over the HUMIRA reference arm?
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Please post the model
Wow, Merck is paying Daiichi $4 billion upfront to collaborate on three ADCs!
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$SNDX JPM KOL call this morning [paraphrasing]: "There is no reason why KMT2a ALL should perform worse than AML - they should perform the same or maybe ALL even better."
Given that 37 patients were not evaluated in the efficacy calculation, placed in a "safety" population…
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Oh no, another pass on $GPCR :(
Roche enters into a definitive merger agreement to acquire Carmot Therapeutics, including three clinical stage assets with best-in-class potential in obesity and diabetes.
$2.7B upfront and additional milestone payments of up to USD 400 million.
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No - if $EYPT is not ≤ 2 letters vs 2mg EYLEA at 6 months then it's hardly different than 8mg EYLEA HD. This is reflected by $EYPT management updating the slide to note data from EYLEA HD in PULSAR.
But who cares about BCVA in phase 2 statistics - it's all about durability with…
Does anybody actually seriously believe these efficacy scenario bars $EYPT is setting?
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« A ship in harbor is safe - but that is not what ships are built for. » J Shedd
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So 19% *relative* improvement over HUMIRA, 43% SLK vs 36% in HUMIRA?
A 7 percentage-point difference - under the 10%+ bogey set by the company...the 240mg dose overlapping with HUMIRA?
How can one go confidently into phase 3 superiority trial(s) after failing to meet their…
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From Barclays: $SNDX DoR of 6.4 months is also well under 9+ months bar via KOL checks; similarly CR/CRh rates below ~27% expected (25-30% range).
$SNDX CR/CRh expectations were ~27% re cowen vs 23% topline today
QTC prolongation bogey 10% or less vs 14% topline
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Big positive, and quite mind-blowing to me that $RETA gets no REMS given liver, cardiac, and embryo-fetal observations.
Many nuances, but look at comparative observations for liver and embryo-fetal tox for $TVTX, which requires a REMS program.
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This is entertaining…I remember my first three days digging into these studies for work on $TVTX with similar initial reactions before educating myself. $KDNY
MW is short $KDNY. We believe its lead drug, atrasentan, will never get FDA approval. Trial data have shown it's a) inefficacious and b) increases cardiac and mortality risks. AbbVie and KDNY have manipulated and misrepresented trial data to conceal
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Why would 70mg be expected to be more effective when they're showing overlap with 45mg with N=8, knowing that data gets worse with higher N?
$STOK has maxed their PK/PD response with 30mg, 45mg didn't show improvements in PK/PD, so adding more drug without a PK/PD relationship…
At the 45 mg dose, median seizure activity was reduced by 18% in today's update, versus 55% last November. Wrong direction. Stoke $STOK hopes 70 mg dose will be more effective.
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Really fun math problem for an imminent binary event for a little-known company looking to dethrone Pomalyst (>$3bn in 2020 revs) as the backbone of choice in MM
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BBG: Merck & Co. edged out competitors including AbbVie Inc. and Bristol Myers Squibb Co. to prevail in its $10.8 billion takeover of biotechnology company Prometheus Biosciences Inc, according to people familiar with the matter.
h/t locked acct; $RXDX $MRK $ABBV $BMY
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"RINVOQ-like efficacy with ENTYVIO-like safety."
Really exciting data from $RXDX with a drug that has dual potential to be first choice for both biologic naïve and experienced/failures as well as offer the 1st precision medicine approach for IBD patients
$PFE ph2a was 24% (tMCS*; typical caveats noted) in more heavily pre-tx pts. If you do your algebra, you're likely in-line w/ ENTYVIO in tougher, exp patients and likely in-line w/ IFX in naïve pts.
Everybody is wary of translational risk, but $RXDX positioning should prevail.
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Ouch - confirmed this is relative difference, so whiffed on 10%+ delta over HUMIRA.
CANTOR: Humira arm performance in this trial was similar to its Phase 3 PIONEER-2 HS trial and showed ~36% HiSCR75 vs. SLK 43% (relative difference of 19%).
So 19% *relative* improvement over HUMIRA, 43% SLK vs 36% in HUMIRA?
A 7 percentage-point difference - under the 10%+ bogey set by the company...the 240mg dose overlapping with HUMIRA?
How can one go confidently into phase 3 superiority trial(s) after failing to meet their…
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$KPTI kicker is 100% SVR35 in pts w/ 5mg BID (sub-tx doses of RUX) versus ~56% in patients <10mg BID+ in $CNST
This SVR35 rate by background RUX by $CNST at ASH20 was final nail in coffin to bear thesis as it proved additive
~6 months later $MOR acquired $CNST for $1.7bn
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$STOK misses 45mg bar of >50% with only 19% seizure reduction going from N=6 to N=16.
Tries spinning with adding in 70mg data (was initially guided to 2H23) to save face - but even with 80% reduction in tiny N at 3 months, the day 29-3 month data is only -42% with highest N…
$STOK is going to cash if they show seizure reduction <50% in the 45mg arm.
Per recent KOL commentary, if mix skews younger, bar should really be ~70% reduction. $STOK guided to at least 6/10 new patients will be in the younger group (2-12 y.o.), so math works out that the bar…
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Wow, did not expect such positive sentiment from the FDA around the safety profile of SKYCLARYS...now time to see if real world use will continue to support that sentiment, along with efficacy. $RETA
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So do you think it’s going to ultimately be deemed drug related or not? Only thing that matters with any of this commentary.
I’ll put my stake in the ground and say it’ll be found to not be drug related and will be solved soon, taking a quarter or two to have the ReST committee…
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$MYOK Big binary coming up in EXPLORER-HCM
Two biggest concerns are wheter Mavacamten can replicate efficacy on the peak-VO2 endpoint, and what the corresponding placebo responder rate will be.
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At >$1bn valuation, is $NUVL NVL-520 really differentiated from $TPTX repotrectinib and
@AnheartTx
taletrectinib, enough for stock to work?
Let’s see durability (not in PR??), safety table, *confirmed* ORR, and more specifics on patient characteristics…
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Almost half the effect size of $APLS... $ISEE goes 3/3 on failure to replicate earlier trial results...skewness.
$ISEE IAnnounces Positive Topline Data from Zimura GATHER2 Phase 3 Clinical Trial in Geographic Atrophy.
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WOW - $APLS APL-2 is superior to $ALXN Soliris
HOME RUN on all endpoints:
1) >2.5g/dL increase in hemoglobin vs Soliris @ 16 wks
2) 85% of patients were transfusion independence (HUGE for these patients!)
3) +ve trends on LDH, Retics, QoL (FACIT)
4) SAFETY COMPARABLE TO SOLIRIS
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@bigpharmaguy
So $TERN is worse than $VKTX and undifferentiated-to-worse than $MDGL in ~1/4 the amount of patients trialed...how will this differentiate on the endpoints that matter in phase 3 reading out years from now?
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$APLS Evercore ISI suggests market pricing in ~40% PoS for DERBY & OAKS trials
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@drug_smolecules
Some selling from tourists and no headline (if no $APLS announcement by open) but only ~5-10% max imho. It’s Astellas with their commercial and pipeline needs raising debt to buy, not $REGN $RHHBY $NVS with varying ophtho expertise placing a bet on the out of consensus winner.
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$ZYNE Mavoglurant studies disproved the relevance of methylation status to efficacy subgroup analysis long ago.
Additionally, $ZYNE did not hit ANY of the primary or secondary endpoints needed to file.
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$SLNO is getting very close to releasing results of their phase 3 study of DCCR in Prader-Willi Syndrome...
With a fully diluted MC of about ~$200MM, success would likely take the stock to >$10/sh while a fail will tank the stock to cash at $0.3/sh. Place your bets accordingly.
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In patients having moderate-to-severe itch at baseline, the seladelpar treated group improved their pruritus at 6 months compared to those in the placebo group (p<0.005) $CBAY
$CBAY Seladelpar Achieves High Statistical Significance for the Primary and Key Secondary Endpoints in the Phase 3 RESPONSE Trial in Primary Biliary Cholangitis.
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@plainyogurt21
@NoseRubInvest
@Sports_bios
Odd that $BBIO's stated blended rate flattens out around 18 months while all others see acceleration in event rate despite tracking ATTR-ACT at 12 months...
And given NYHA Class I/II WT patients accounted for 40% of wins on deaths/40% of wins on # CVHs in ATTR-ACT and $BBIO…
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Hey Europeans, especially Swedes, if your science is so good please lend your shares for us non-believers to short and risk getting our faces ripped off.
I guess I’ll reach out directly next time.
$SYNACT -87% in🇸🇪today, the dream story that a 5-people co could develop a blockbuster drug in RA is now over
co blaming high PBO RR on ACR20 in ph2b, how original
single asset/biology co➡️RIP
post-hoc 'in-depth' analysis landing in 3, 2, 1... (amazing spins by 🇸🇪 bios lately)
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$RXDX additional data for the APOLLO-CD study in
#ECCO23
abstract compares nicely to the landscape.
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So per $EYPT management, EYP-1901 will need to thread the needle on all:
○ ≤ -1.4 letters versus EYLEA on BCVA to be similar to 8mg EYLEA HD
○ ≤ 30 µm increase in fluid via OCT
○ >50% rescue free up to 6 months
○ >50% reduction in treatment burden
○ clean safety
Good luck
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Spot on - especially looking at the large difference in *trough* receptor occupancy achieved by PN-943:
100mg QD: ~25%
1000mg QD: ~79%
450mg BID: ~79%
@NoseRubInvest
@MSollender
I don't see any reason for this to have inverse dose response.
In previous Ph2a the company presented "a dose response".
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This is a reminder to text your $MLTX $VTYX $DICE $PTGX $BMY shareholders
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$KZR Still only seeing SLEDAI-2K reduction of ~30% at higher doses, below the bar of 60-80%.
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$SLNO No. Hyperphagia is the only important endpoint for PWS, and it was p=0.1983.
CGI-I and Body Fat Mass do not matter - and certainly won't matter to FDA. Those were p=0.025 and p=0.029.
You can just buy generic Proglycem if you want to reduce body fat mass!
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@sentivcapital
@avidresearch
@bigpharmaguy
@Sports_bios
Given the history of how $RETA interacts w/ regulators, feigns transparency to the market regarding those interactions, and the black box surprises that came from bardoxolone BDs etc - even considering $AMLX corollary + nuances - less public exposure will increase nervousness
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@bigpharmaguy
$TERN has worse effects on key biomarkers as well compared to $MDGL, $VKTX, and their own phase 1 data at 15 days versus 12 weeks here!
Differentiation thesis killed.
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@biotechinvstr
@BiotechPort
This risk factor was added in 2017 10-K and hasn't changed since. Where is it said explicitly that both endpoints need to be SS for approval?
If you want a notable addition to a filing, see $ALBO's claim what is clinically meaningful *while they're in the midst of data clean up*
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Why would you own $ALNY here?
Where have you seen a spontaneous improvement in 6MWT like in APOLLO-B, ever? In PAH, Fabry, DMD, or HF?
Lots of issues - 0 effect in class III patients - huge part of the market now/in future - and without ROW driving effect, 6MWT delta ~10 meters
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First, the read through on IL-17A/F biology being additive (or not...) to IL-17A in HS:
Expectations the last few years captured by Cowen physician/payer polls: to become 1L agent over COSENTYX, new entrants must show ~60% HiSCR50 and ~55% HiSCR75.
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$RNA splicing effect of -15% in the *selected 4-gene panel* is drastically under 30-50% target via $IONS work, no dose response between 2 mg/kg and 4 mg/kg, let alone -10% splicing on 22-gene panel...
I think this very obviously doesn't achieve activity within the nucleus
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Biotwitter, who is:
- the best biotech (therapeutics) investor(s) that you know/know of? Ideally based on hit rate, drawdown control, etc vs vain metrics
- the best binary event/event-driven investor(s)/trader(s)?
- the best short seller(s)?
Please DM me 🙂 Thanks in advance!
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What is the value proposition of $ASLN? AD asset scarcity? Of course you're going to get quicker, deeper EASI reductions with weekly injections versus q2w dupi.
Big move expected by Jefferies into the updated MAD (qw) data for ASLAN004 in AD...
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$RNA vHOT 4 mg/kg -3 seconds from baseline - Cowen KOL noted 2 seconds is within SD and *minimum* of 4 seconds to be clinically meaningful
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@AnheartTx
$NUVL cORR is 67% (6/9) in ROS1 muts and 38% (8/21) in all evaluable --> $TPTX degraded significantly from 50-60% in early phase 1 to ~30-35% in later phase 1/2 with larger N
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$APLS approval or not, what happens to $ISEE if $NGM data is on par with $APLS? OCT/NOV implied move ~40-60% ref ~$12
Guided to 4Q, "followed by planned presentation of results at a medical conference in the same quarter."
Data being presented at Retina Society on 11/03/22
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This scenario of mid teens CR + real trend in CD should satisfy valuation "concerns" as 1) that suggests UC CDx+ will be leading & 2) CD data opens up another huge market before UC cohort 2 CDx+/- rates, SQ data and dosing in ph3, etc.
++ upside if >20% pbo-adj CR in UC cohort 1
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@gcbioinv
@Biohazard3737
@Sanctuary_Bio
Endoscopies are centrally read, so the focus on “open-label” nature is null.
I get what you and many others are stating - it’s a good guide post that will save you a lot of money in most examples. But you’ve got to break the rules and go outside the guide posts in certain cases.
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$IMGN hits
mPFS 5.62 vs 3.98 HR=0.65
OS: 16.5 vs 12.8 months
ORR 42% vs 16%
TEAE-discontinuation 9% vs 16%
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75µm threshold and no separate CST-based criteria alone = 🥱 Let's see how many investigators rescue at their discretion $OCUL
don't underestimate the significance of upcoming $OCUL TKI AMD data at AAO on sept 30, first look at data in pts w/o fluid present at baseline
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No question that $PTGX PN-943 success in UC is at best a coin flip, but what are the strongest points supporting undeniable activity proving this drug is not inert?
The clinical remission rate after the reread?
The Histologic remission rate in the 900mg QD arm?
Something else?
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Assuming by the language here that $APLS has been granted a full label for both foveal and extrafoveal, but let's see.
Aside from a trade, time to see the rubber hit the road commercially for $ISEE in extrafoveal patients (I am assuming approval).
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@BiotechPort
@ohadhammer
Superiority certainly not priced in given caution around 6MWD as an endpoint, no dose response with tafamidis, changes to inc/exc vs ATTR-ACT, etc…
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@Biohazard3737
@gcbioinv
@Sanctuary_Bio
my brother in christ, ~90% of those patients were naïve to biologics vs ~30-40% have "advanced-therapy" experience (JAKs,S1Ps, etc) in $MORF
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This messaging was also reiterated at $MLTX's Capital Markets Day 4/19/2023.
In addition a delta clearly superior to HUMIRA, $MLTX messaging to dose separation between the 120mg arm and the 240mg arm.
Interestingly, the data from the 240mg arm was not included in the PR but…
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Well done, Mark and team. Incredible execution concluded with a well deserved outcome. Excited to see how this target evolves.
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The bar is not much higher than 15%, though. It's definitely NOT 25%+, and NOT being compared to JAKs (topic of reimbursement for a later date...).
Blockbuster ENTYVIO has ~18% CR rate in biologic naïve/exp groups in VARSITY at 14 wks (adj for typical pbo rates). And it's safe.
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