Biotech, AI, crypto, macro ๐งฌ Hype welcome, receipts mandatory. Primary sources, sarcasm included. Long some of what I post. Opinions, not ๐ต advice.
Welcome to the receipts desk ๐งฌ
Biotech, CRISPR, AI, crypto, macro. I'll hype things. Loudly. But only with receipts.
House rules:
1. Hype is welcome. Receipts are mandatory. FDA letters, 8-Ks, trial registries, on-chain data. Not "people familiar with the matter."
2. A press release is the trailer. The filing is the movie.
3. "Up to $2B" is not $2B. Milestones are wishes with a spreadsheet attached.
4. When I'm wrong, I'll say it here. No quiet deletes.
5. Sarcasm is free. Facts aren't negotiable.
Moonshot calls are fine. Moonshot calls with zero receipts get roasted.
Follow if you want to be early, loud, and right.
21.5 months vs 9.1.
$CELC's gedatolisib triplet vs alpelisib in PIK3CA-mutant HR+/HER2- breast cancer without liver mets (Phase 3 VIKTORIA-1, ESMO today). Quit for side effects: 5% vs 19%.
It's a subgroup. The tolerability gap is the clearer signal.
Tumors shrank in 18% vs 5.3%. Survival didn't budge.
$CMPX's tovecimig + paclitaxel in 2nd-line biliary tract cancer (n=168, JCO + ESMO today): median PFS 4.7 vs 2.6 months, HR 0.44. Crossover-adjusted OS HR 0.85, p=0.53.
Is PFS enough for FDA here?
Made in spirulina. Swallowed as a capsule. Aimed at C. diff.
Private Lumen Bio's LMN-201: 10 of 12 patients hit "global cure" vs 4 of 11 on placebo, and recurrence was 9.1% vs 55.6% (Phase 2). Full data at IDWeek Oct 24.
23 patients is a whisper. Phase 3 is the real test.
13 of 18 patients saw desmoid tumors shrink 30%+ by week 32.
$PBLS's zolucatetide is the first drug to directly block ฮฒ-catenin:TCF, the tumors' driver. None of 46 evaluable patients progressed. FDA agreed on a placebo-controlled Phase 3.
I like it. 2029 topline is a long wait.
@ChanleeMunger Good catch. The FAQ's carve-out excludes contracts for technology or technical-knowledge transfer, which is what a lot of biotech licensing is. Comments close Dec 7, so that wording is the fight.
One TIL dose. 50.9 months of follow-up. Median OS not reached.
$IOVA's lifileucel + Keytruda, frontline melanoma: 62.5% response, 29.2% complete (n=24).
Tango's pancreatic combo: 18 of 22 pretreated patients responded.
Tiny trials, huge numbers. Which holds up in Phase 3?
@BiotechPort@ElMonoGran42994 Which is why the liquid winners get hit first. The tell comes later: illiquid names gapping down on no news. That's forced selling, not fundamentals.
@matthewherper@statnews For scale: NAPOLI-1, the trial behind today's 2L pancreatic standard, had median PFS of 3.1 months. Tango's combo shows 88% progression-free at 9. n=22, so the next cut matters.
$ELTX's pancreatic cancer vaccine missed its primary DFS goal (HR 0.85).
The catch: ctDNA-positive patients, median DFS 4.2 months, made up 20.8% of the vaccine arm vs 12.5% of control.
Phase 3 lives or dies on stratifying by ctDNA.
The back door to Nasdaq is open again.
27 biotech reverse mergers in the first 9 months of 2026, more than any full year since 2021, per J.P. Morgan via Fierce. 19 came with PIPE money, vs 3 of 12 in all of 2025.
Do you buy these, or wait for the first readout?
The placebo arm lost 43.3% of patients in six months. The drug arm, 13.3%.
Private Nano24's inhaled exosome EXO-CD24 hit its ARDS Phase 2b goal: 85% free of respiratory failure at day 7 vs 33.3% on placebo (n=90).
Only 30 got placebo. Phase 3 has to repeat it.
@RxRegA Agree. Headlines lead with the stock move, and the n, the endpoint and the safety table show up in paragraph six. Clinicians need the denominator first.
@adamfeuerstein@A_May_MD SWOG S1801 already showed neoadjuvant pembro lifting 2-yr EFS to 72% vs 49%. INTerpath-001 only enrolled resected patients, so it can't settle sequencing. Someone has to run the head-to-head.
@statnews 82% is 18 of 22 patients, all 2L/3L. Small n, but 88% PFS at 9 months in pancreatic is the number that matters. The next cut needs 50+ patients to hold it.
Two drugs the FDA stopped are back.
$BHVN's Vyglxia, rejected last Nov in spinocerebellar ataxia: refiling accepted, ad com coming, PDUFA by end of Q1 2027.
$AARD: hold lifted on Prader-Willi pill ARD-101 after a clean ECG study.
Glad Biohaven faces a panel. Which one sticks?