AI Intelligence
1 critical, 2 warnings
Based on 14,253 sources (24h)
SEC filings, FDA docs, earnings
30-day rolling average
Phase 3 Data Release
10 minutes agoArgenx released Vyvgart Hytrulo data for CIDP. Primary endpoint met with statistical significance (p<0.001). Stock up 8% pre-market.
Insider Sell-Off Detected
about 1 hour agoSignificant insider selling detected at Moderna. C-Suite executives sold $12M in shares over past 5 days.
FDA Advisory Committee Scheduled
about 3 hours agoFDA AdCom date set for Ionis Donidalorsen (hereditary angioedema). Meeting scheduled for March 15, 2025.
Trial Delay Detected
about 5 hours agoPrimary completion date for NCT05678901 (Revolution Medicines) slipped from Q1 2025 to Q3 2025. 6-month delay indicates potential enrollment challenges.
Launch Trajectory Above Consensus
about 8 hours agoVyvgart Q4 sales tracking 15% above Street estimates based on specialty pharmacy data. Strong momentum in gMG indication.
FDA Advisory Committee Briefing Docs
Ionis Pharmaceuticals - Donidalorsen (HAE)
450-page PDF analyzed in 12 seconds
Key Efficacy Data
Primary endpoint met (p<0.001). 74% reduction in HAE attack rate vs placebo.
Safety Signal
2 cases of transient liver enzyme elevation. Resolved without intervention.
Commercial Impact
Broad label expected. Peak sales: $800M-1.2B. Takeda down 4%.
Biotech Sector Sentiment
Based on 14,253 news articles & SEC filings (24h)
FDA approves expanded label for Vyvgart in CIDP patients
Clinical hold placed on novel Alzheimer's antibody trial
M&A speculation heats up in mid-cap oncology sector
Biotech sector rallies on positive Phase 3 readouts