⚡This Week’s Pipeline Events
Total Catalysts 🔬 | High Confidence (>70%) 🟢 | Moderate Risk (40-70%) 🟡 | Speculative (<40%) 🔴 |
|---|---|---|---|
7 | 4 | 2 | 1 |
✅ Featured Catalysts This Week (Oct 27 – Nov 2)
VYVGART (Efgartigimod)
Argenx SE (ARGX)
Catalyst Date | Trial Data | Phase | PoA |
|---|---|---|---|
Oct 29 | ADAPT-SERON + CIDP Update | Phase 3 | 85% |
Indications: Seronegative gMG + CIDP
Type: Pivotal Phase 3 Data Presentation (AANEM/MGFA)
Investment Thesis
Argenx is a $50B+ blue-chip biotech
VYVGART already approved for AChR+ gMG and CIDP — this is label expansion
ADAPT-SERON (seronegative gMG) topline was positive in Aug 2025 — full data due
CIDP update could support subcutaneous formulation uptake
KYV-101
Kyverna Therapeutics (KYTX)
Catalyst Date | Trial Data | Phase | PoA |
|---|---|---|---|
Oct 29 | Interim Efficacy | Phase 2 | 45% |
Indication: Generalized Myasthenia Gravis (gMG)
Type: Interim Phase 2 Data (AANEM/MGFA)
Investment Thesis
First CAR-T in gMG — registrational KYSA-6 trial
Early autoimmune CAR-T data (e.g., lupus) has been compelling
Platform validation beyond oncology — could unlock broad autoimmune pipeline
Telitacicept
Vor Biopharma (VOR)
Catalyst Date | Trial Data | Phase | PoA |
|---|---|---|---|
Oct 28–29 | Phase 3 Readouts | Phase 3 | 80% |
Indications: Sjögren’s Syndrome + gMG
Type: Dual Phase 3 Data Presentations
Investment Thesis
BAFF/APRIL dual inhibitor — novel mechanism
Already approved in China (RemeGen)
U.S. path clarity depends on these global trials — investor focus on regulatory bridge
📅 Other Notable Readouts
Drug | Ticker | Date | Stage | Notes | PoA |
|---|---|---|---|---|---|
Rosnilimab | ANAB | Oct 29 | Phase 2b | RA oral presentation (ACR); novel PD-1+ T-cell depletion | 70% |
INKmune | INMB | Oct 30 | Phase 2 | Prostate cancer immunotherapy; follow-up expected Q4 2025 | 25% |
DNTH103 | DNTH | Oct 29 | Phase 2 | Top-line MaGic trial in gMG | 80% |
PCRX-201 | PCRX | Oct 28 | Phase 1 | Gene therapy for knee OA | 15% |
➡️ Looking Ahead
Drug | Ticker | Date | Stage | Notes |
|---|---|---|---|---|
Belapectin | GALT | Nov 10 | Phase 2b/3 | MASH cirrhosis data at AASLD – key readout for galectin-3 class |
✅ Recently Resolved
Drug | Ticker | Date | Status |
|---|---|---|---|
Revuforj | SNDX | Oct 24 | ✅ Approved for NPM1-mutant AML (87%) |
ZORYVE | ARQT | Oct 6 | ✅ Approved for pediatric AD (95%) |
Bitopertin | IRON | Sep 29 | 📥 NDA Filed for EPP (75%) |
📈 Market Context
Sector Uplift: The XBI's recent $3.2% gain reflects a risk-on sentiment, which typically provides a tailwind for trial readouts, especially for the high-risk, high-reward CAR-T platform of KYV-101 (KYTX).
Concentrated Risk: With three major readouts in the Generalized Myasthenia Gravis (gMG) space this week (ARGX, KYTX, DNTH), the market is primed for a reallocation of capital based on emerging best-in-class profiles.
Blue-Chip Influence: Given that Argenx (ARGX) is a large-cap biotech, any surprise in its VYVGART label expansion data could create volatility that registers across the entire sector, far beyond the typical small-cap swings of 40%.
💡 "PoA" (Probability of Approval) = drug development risk. A 70% PoA means: "Based on phase, data quality, and regulatory factors, this drug has a 7-in-10 chance of reaching FDA approval." PoA changes as new data emerges—a positive Phase 3 readout might boost PoA from 65% → 85%. We track these shifts for you weekly.
⚠️ Disclaimer
All estimates are heuristic and based on public data. Not investment advice. Verify with FDA and company filings.