Watch the October 23 webcast for efficacy/safety data from the terminated HERO and OLE trials; the data will inform the probability of a successful Phase 3 restart. Further FDA alignment on trial design is the next catalyst.
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Executive Summary
FDA lifted the clinical hold on Aardvark's IND for ARD-101 in Prader-Willi Syndrome, allowing clinical development to resume. The hold was placed in May 2026 after reversible ECG changes in a healthy volunteer study; a thorough ECG study at 200 mg and 400 mg BID showed no cardiac events. The company will host a webcast on October 23, 2026 to review data from the terminated Phase 3 HERO and OLE trials.
Key Facts
- FDA lifted clinical hold on ARD-101 IND for hyperphagia in PWS
- Clinical hold placed May 2026 after reversible ECG changes in healthy volunteers
- Thorough ECG study at 200 mg and 400 mg BID showed no cardiac events
- Company plans to resume clinical development after further FDA alignment on Phase 3 design
- Webcast to review HERO and OLE trial data scheduled for October 23, 2026
Financial Impact
Clinical hold removal removes a binary overhang for a single-asset clinical-stage biotech; ARD-101 is the company's only disclosed pipeline candidate
Risk Factors
- FDA may not agree with proposed Phase 3 design or may require additional studies
- HERO and OLE trials were terminated early and not powered to assess efficacy
- Single-asset clinical-stage company with no approved products
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3386889 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 23, 2026 3d ago | 8-K | $1.39 $1.08 | ▼ −22.30% | ▼ −23.01% | $1.08 (−22.30%) |
Oct 22, 2026 4d ago | 8-K | $1.39 $1.08 | ▼ −22.30% | ▼ −23.01% | $1.08 (−22.30%) |
Oct 22, 2026 4d ago | Press Release | $1.39 $1.08 | ▼ −22.30% | ▼ −23.01% | $1.08 (−22.30%) |
Oct 8, 2026 18d ago | 3 | $4.76 $4.45 | ▼ −6.51% | ▼ −6.45% | $1.08 (−77.31%) |
Oct 8, 2026 18d ago | 8-K | $4.76 $4.45 | ▼ −6.51% | ▼ −6.45% | $1.08 (−77.31%) |
Aug 12, 2026 10w ago | Institutional Cluster | $6.57 $6.41 | ▲ +2.44% | ▲ +3.13% | $1.08 (+83.56%) |
Aug 11, 2026 10w ago | 8-K | $6.57 $6.41 | ▲ +2.44% | ▲ +3.13% | $1.08 (+83.56%) |
Aug 11, 2026 10w ago | Press Release | $6.57 $6.41 | ▲ +2.44% | ▲ +3.13% | $1.08 (+83.56%) |
Jun 11, 2026 19w ago | Institutional Cluster | $3.64 $3.90 | ▲ +7.14% | ▲ +6.60% | $1.08 (−70.33%) |
May 14, 2026 23w ago | Press Release | $4.57 $4.36 | ▲ +4.60% | ▲ +4.53% | $1.08 (+76.37%) |
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