Aardvark Therapeutics Pauses Phase 3 Trial After Cardiac Signals, Shares Drop 61%
Aardvark paused its Phase 3 HERO trial for Prader-Willi Syndrome after reversible cardiac observations at higher-than-target doses, delaying anticipated Q3 2026 topline data. Shares plunged 61% as the company starts a comprehensive safety review and works with the FDA on next steps for ARD-101.
1. Phase 3 HERO Trial Pause
Aardvark Therapeutics voluntarily paused its Phase 3 HERO trial for Prader-Willi Syndrome after routine safety monitoring detected reversible cardiac observations at doses above target levels. The decision delays anticipated Q3 2026 topline data and initiates a comprehensive review of safety data for its ARD-101 program.
2. Market Reaction and Technical Indicators
Shares fell nearly 61% on the trial update, reflecting investor concerns over program risks. The stock is trading below its 20-day and 100-day moving averages, with neutral RSI at 50 and bearish MACD pressure suggesting mixed market momentum.
3. Regulatory Path and Future Prospects
The company is collaborating closely with the FDA and the Prader-Willi Syndrome community to assess next steps, including possible early unblinding of the study. Analysts have lowered price targets but maintain buy ratings, highlighting the importance of safety outcomes for future valuation and cash runway sustainability.