October 30, 2025 | Read Online
📊 This Week’s Results (Oct 28–Nov 1)
VYVGART (ARGX)
Event: ADAPT-SERON Data
Outcome: ✅ Positive
Our PoA: 85%
PoA Accuracy: Hit
KYV-101 (KYTX)
Event: Phase 2 Interim
Outcome: ❌ Negative
Our PoA: 45%
PoA Accuracy: Miss
Telitacicept (RemeGen → VOR ex-China)
Event: Phase 3 Readout
Outcome: ✅ Positive
Our PoA: 80%
PoA Accuracy: Hit
Rosnilimab (ANAB)
Event: Phase 2b RA Data
Outcome: ✅ Positive
Our PoA: 70%
PoA Accuracy: Hit
INKmune (INMB)
Event: Phase 2 Prostate
Outcome: ✅ Positive
Our PoA: 25%
PoA Accuracy: Hit
DNTH103 / claseprubart (DNTH)
Event: MaGic Trial
Outcome: ✅ Positive
Our PoA: 80%
PoA Accuracy: Hit
PCRX-201 (PCRX)
Event: Phase 1 Gene Tx
Outcome: ⚠️ Ongoing
Our PoA: 15%
PoA Accuracy: Pending
📈 Our Accuracy This Week: 5/6 = 83% (pending excluded)
💡 Key Takeaways
- ARGX entrenched in gMG leadership.
- Autoimmune CAR-T shows signal; durability risk remains.
- gMG competitive set broadens with FcRn, C1s, and BAFF/APRIL plays.
NOVEMBER PIPELINE OVERVIEW
High-signal readouts and PDUFAs, prioritized by phase and PoA
Top Catalysts
• Arrowhead – plozasiran (FCS): PDUFA Nov 18, PoA 85%. Priority Review. Clear efficacy and pancreatitis-risk reduction profile in FCS. Arrowhead Pharmaceuticals, Inc.+1
• Kura – ziftomenib (NPM1-mut AML): PDUFA Nov 30, PoA 80%. First menin inhibitor decision for NPM1-mut R/R AML. Priority Review confirmed. Kura Oncology+1
• Ascendis – TransCon CNP (achondroplasia): PDUFA Nov 30, PoA 80%. Priority Review; clean public record. investors.ascendispharma.com+1
• Madrigal – Rezdiffra (MASH): Data Nov 11, PoA 90%. New clinical and real-world data at AASLD The Liver Meeting; drug is already approved. Madrigal Pharma+1
• Vera – atacicept (IgAN): Data Nov 6, PoA 65%. ORIGIN-3 plenary update at ASN Kidney Week. Durability and renal hard endpoints in focus. Yahoo Finance+1
• Sanofi – amlitelimab (AD): Data Nov 12, PoA 60%. Phase 3 met endpoints; effect size vs. dupilumab under scrutiny. Sanofi+1
• Takeda – TAK-279 (psoriasis): Data Nov 7, PoA 60%. Oral TYK2; class positioning vs Otezla and biologics. Drug Target Review+1
• Cogent – bezuclastinib (mastocytosis/GIST): Data in November window (TBD), PoA 60%. KIT-driven program; monitor hepatic safety profile.
• Novartis – Lu-PSMA-617 (mCRPC): Data Nov 14, PoA 40%. Radioligand expansion signal; earlier-stage risk. PMC
Removed as binary November catalysts
Brentuximab vedotin combo (already approved earlier in 2025), nirsevimab (US-approved 2023), etripamil (Dec 13, 2025 PDUFA), deucrictibant (topline guided for Q4, not pinned to Nov 6). ORLADEYO pediatrics appears as data only. (We will keep seasonal commercial notes out of the catalyst list.)
Week-by-Week Calendar
Only notable or binary-leaning items
• Nov 6: Vera – atacicept, IgAN, Data (ASN plenary). Yahoo Finance
• Q4: Pharvaris – deucrictibant, HAE, Topline expected Q4 window
• Nov 7: Takeda – TAK-279, psoriasis, Data. Drug Target Review
• Nov 7: BioCryst – ORLADEYO pediatrics, HAE, Data (line-extension context).
• Nov 12: Sanofi – amlitelimab, AD, Data. Sanofi
• Nov 12: Merck – pembrolizumab, HER2+ gastric, Data/label-expansion program.
• Nov 14: Novartis – Lu-PSMA-617, mCRPC, Data. PMC
• Nov 14: Sanofi – tolebrutinib, PPMS, Data.
• Nov 18: Arrowhead – plozasiran, FCS, PDUFA (binary). Arrowhead Pharmaceuticals, Inc.
Quick Themes
Appendix: Source Events (selected, updated)
• Vera – atacicept, IgAN, Data Nov 6, PoA 65%. Yahoo Finance
• Takeda – TAK-279, psoriasis, Data Nov 7, PoA 60%. Drug Target Review
• BioCryst – ORLADEYO pediatrics, HAE, Data early Nov, PoA 80%.
• Sanofi – amlitelimab, AD, Data Nov 12, PoA 60%. Sanofi
• Merck – pembrolizumab, HER2+ gastric, Data Nov 12, PoA 60%.
• Novartis – Lu-PSMA-617, mCRPC, Data Nov 14, PoA 40%. PMC
• Novartis – ribociclib (adjuvant), breast, Data Nov 17, PoA 60%.
• Arrowhead – plozasiran, FCS, PDUFA Nov 18, PoA 85%. Arrowhead Pharmaceuticals, Inc.
• Ascendis – TransCon CNP, achondroplasia, PDUFA Nov 30, PoA 80%. investors.ascendispharma.com
• Kura – ziftomenib, NPM1-mut AML, PDUFA Nov 30, PoA 80%. Kura Oncology
• Arvinas – ARV-471, ER+ breast, Data Nov 30, PoA 20%.
Coming Monday
Thesis cards for deucrictibant, atacicept, etripamil and CAN-2409 (SITC, Nov 7).