Biotech Catalysts This Week: FDA Decisions, Readouts & Earnings (Sep 13–Sep 20, 2026)
Here’s what’s on the biotech calendar for September 13–September 20: 1 FDA decision dates, 2 trial catalysts, and 0 earnings reports from tracked companies.
💊 FDA Decisions (PDUFA Dates)
| Date | Ticker | Drug | Indication | Type |
|---|---|---|---|---|
| 2026-09-18 | NUVL | — | adult patients with locally advanced or metastatic ROS1-posi | NDA |
🧪 Trial Catalysts & Milestones
- CORT — 2026-09-15: REVERSE: Improving Treatment-resistant Post Traumatic Stress Disorder (PTSD) with Glucocor
- VRTX — 2026-09-17: An Efficacy, Safety, and Tolerability Study of VX-880 in Participants With Type 1 Diabetes
📡 Run-up Radar Highlights
Stocks entering the pre-catalyst window with the strongest setups (full radar is a Premium feature):
- IBRX — Phase 1, Phase 2 — Active Trial in 17 days, score 63/100
- SNDX — Phase 1 — Recruiting in 18 days, score 60/100
- EWTX — N/A — Active Trial in 17 days, score 54/100
📈 Last Week’s Biggest Gainers
- MLYS +10.32% (volume 2.3x average)
- SSL +9.62% (volume 3.5x average)
- CMPS +8.05% (volume 2.3x average)
- MRNA +7.29% (volume 0.8x average)
- AXSM +7.20% (volume 0.4x average)
Track your tickers on the BioRadar dashboard →
This digest is for informational purposes only and is not investment advice. Always do your own research.