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Joined November 2020
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$nktr flop as expected.
$NKTR bears will still look at you with a straight face and tell you that an adverse event (ISRs) that led to a ***LESS THAN 1%*** discontinuation rate is the bear thesis…
The ISR brain damage done to y’all by those Lilly legal documents really is wild.
Good biotech investors know how to dodge biological FUD but apparently legal FUD is a one-shot kill for some.
You’ll see.
$orka 28-wk data poc for ultra-infrequent dosing:
--pasi 100 deepened passively to 71.4% (45/63) and pasi 90 to 87.3%
--zero drug administered since week 4 (responses climbing 6 months off-treatment)
--placebo crossover confirms rapid onset (40% pasi 100 at 12 wks)
--great tolerability: 0 isrs, 8% urti (only teae ≥5%), no ada impact on pk/efficacy. waiting on full tables.
--seems to de-risk 2x/yr maintenance floor; full 52-wk readout in dec '26 which tests the 1x/yr regimen.
ir.orukatx.com/news-releases…
$orka q2 update just dropped:
--fdmc: ~$7.7b (at $100/sh)👀 / cash: $1.1b funded through bla filing 💸
--orka-001 ph1 28-week data due late q3 2026, with 52-week data following in december 🤞
--orka-001 ph2b fully enrolled early (187 subjects); week 16 data accelerated to q4 2026 (phase 3 in 1h 2027) 👏
--orka-004 (half-life extended anti-tl1a) entering the clinic in q4 2026 for 2027 combination studies 🤔
$rare approval.
fda.gov/news-events/press-an…
$NVO went bargain hunting with preclinical bio-bucks instead of buying real, de-risked oral macrocycle tech. $PTGX is sitting right there with ph3 and commercial validation.
fiercebiotech.com/biotech/no…
@maziardoustdar @novonordisk @ProtagonistCEO @ProtagonistTx
$CGEM rezilient-3 zipalertinib very likely a new soc in 1l egfr ex20ins nsclc. hr = 0.5 w/ cns hr = 0.38. zero met toxicity + oral maintenance convenience.
$JNJ amivantamab has some competition. should be an interesting discussion @IASLC #wclc26
investors.cullinantherapeuti…
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great efficacy, but it looks like safety may be a challenge for a zipalertinib clean sweep across 1l egfr ex20ins nsclc. $cgem
financebully retweeted
The FDA has approved Pixclara® (floretyrosine F 18), Telix’s 18F-FET-PET imaging drug for glioma (brain cancer).
Pixclara is the only FDA-approved FET-PET imaging drug for glioma and is indicated for the differentiation of recurrent or progressive glioma from treatment-related change, in conjunction with other diagnostic evaluations, in adults and pediatric patients 1 month of age and older.
FET-PET imaging is already recommended in international clinical practice guidelines, but until now there has not been an FDA-approved product.
Pixclara will provide physicians in the U.S. with greater certainty in brain cancer diagnosis and treatment planning, addressing an important unmet need.
Read more on our website here: telixpharma.com/news-views/f…
SELECTED IMPORTANT SAFETY INFORMATION
● Image misinterpretation may occur with PIXCLARA PET. Equivocal findings may occur with PIXCLARA PET, including low-level or atypical uptake patterns, which may result in false positive or false negative interpretations.
● PIXCLARA involves exposure to small amounts of radioactivity; long-term cumulative radiation exposure is associated with increased cancer risk.
● Adverse reactions that occurred in ≥0.5% of patients receiving PIXCLARA were headache (0.5%).
● Adverse reactions that occurred in <0.5% of patients were nausea, injection site reaction, fatigue, and malaise.
● Overall, the safety profile observed in pediatric patients from the clinical study was consistent with the safety profile in adult patients.
This is not the full important safety information. The indications and full important safety information is available at telixpharma.com/pixclara-usp…
$tlx pixclara first fda approved fet/pet radiopharm for glioma imaging in the US.
telixpharma.com/news-views/f…
$TLX has secured U.S. FDA approval for Pixclara making it the first and only FDA-approved PET imaging drug for glioma (brain cancer). Indicated for adult and pediatric patients (1 month+). Great long process with approval opening new revenue opportunities.
--ris-rez w/ 18.5 mo mos is an unprecedented landmark in 2l sclc, but the 11.7% ild signal is a real regulatory hurdle for @GSK in western populations.
--tam-peli delivered on tmalin's dual cleavage platform safety thesis (4.9% ild, 46% gr 3+) and earned a simultaneous nejm paper. @Roche needs to initiate global studies next.
--elfe-d + pumi is early (3.2 mo f/u), but 92% 1l orr and activity post-tarlatamab suggests pd(l)1-vegf + b7-h3 adc may be the future frontline backbone. @BioNTech_Group and dualitybio may be a formidable competitor in this space.
#wclc26
strong validation for $ADAG with third arc bio partnership expansion. peter lebowitz is tough to please so this certainly builds more confidence in the story. adding to my position.
investor.adagene.com/news-re…
financebully retweeted
Kura Oncology spins out diabetes R&D w/$50M from Eli Lilly, T1D Fund, Kura CEO Troy Wilson + more
"like I have in every other company, I put my money where my mouth is & I was thrilled to be 1 of the significant investors in Caspian" Wilson told @endpts
endpoints.news/kura-oncology…
$PTGX $300m share repurchase program.
feeds.issuerdirect.com/news-…
ziihera officially incorporated into asco guidelines for 1l her2+ gea. next catalyst is nccn compendium listing in the next few weeks (category 1 expected for triplet). $ZYME $JAZZ
✅ Zanidatamab- and HER2-targeting antibody-based regimens were recently incorporated into frontline therapy for HER2-positive gastroesophageal cancer in an updated ASCO Living Guideline recommendations.
Full details 📰: onclive.com/view/asco-guidel…
#esocsm #oncology
after horizon lpa ($NVS) - the next big cvot to watch: cetp inhibitor readout in q4'26-h1'27.
accelerate ($lly) vs prevail ($NAMS):
-- early clinical signal: eva was dead-neutral (hr 1.01). obi already generated an exploratory 21% 4p-mace reduction (hr 0.79; 95% ci: 0.54–1.15) at just 52 weeks in p3 broadway (n=2,530)—an early divergence signal eva never demonstrated.
-- apob clearance vs artifact: evacetrapib’s -37% ldl-c was mostly a measurement artifact stripping cholesteryl esters without clearing particle cores (apob -15.9%). obicetrapib drives ldlr-mediated particle clearance, cutting apob -24% to -30% (mono) and >40% (fdc)—clearing nearly double the atherogenic particle burden.
-- near-complete target engagement: eva left 10–20% cetp activity intact. obi achieves 98% target inhibition at 10 mg, depleting hepatic sterols to upregulate ldl receptors via srebp-2 and accelerate sterol excretion, matching statin/pcsk9 moa.
-- baseline & absolute particle delta: horizon and accelerate enrolled heavily pre-treated cohorts (baseline ldl-c ~80 mg/dl), yielding absolute apob drops of only ~8–14 mg/dl. prevail enriched for statin-refractory pts with baseline ~100 mg/dl. paired with deeper % drops, its absolute apob delta (~22–38+ mg/dl) is 2–3x larger which could drive deeper mace risk reduction.
-- trial duration & curve separation: reveal proved cetp event curves don't separate until years 2–4. accelerate was halted for futility at median 26 months—likely too brief to show separation. prevail is an event-driven trial powered for 3+ years median exposure.
-- 2x lp(a) suppression: accelerate lowered lp(a) by 22%, whereas obi achieves 46–56% in p3. while isolated lp(a) lowering is insufficient (as horizon showed), cutting lp(a) in half alongside deep apob clearance could synergistically remove an atherothrombotic amplifier.
-- clean vascular/safety profile: eva showed off-target bp increases, hscrp elevation (+4.6% vs -8% pbo), and higher apoc-iii. obi is completely neutral on bp and hscrp with zero vascular liabilities across 3,000+ p3 patients.
