AARD Aardvark Therapeutics, Inc.
Price Chart
Executive Summary
Aardvark Therapeutics announced the FDA placed a full clinical hold on its IND for ARD-101, covering the Phase 3 HERO trial and open-label extension in Prader-Willi Syndrome. The company will unblind accumulated data to assess next steps, while holding $91.2M in cash to fund operations into mid-2027. This is a severe setback for a clinical-stage biotech with ARD-101 as its sole pipeline asset.
Actionable Insight
The clinical hold removes near-term upside catalysts for AARD. Monitor for FDA feedback and unblinded data readout — if data is negative, the stock could face further downside. Cash runway into mid-2027 provides some time but no revenue floor. Traders should expect high volatility on any regulatory or data updates.
Key Facts
- FDA placed a full clinical hold on ARD-101 IND, covering all ongoing studies including Phase 3 HERO trial (AVK-101-301) and OLE trial (AVK-101-302).
- Clinical hold follows a previously announced voluntary pause; no timeline for resolution provided.
- Aardvark intends to unblind HERO and OLE trial data to evaluate efficacy and safety for next steps.
- As of March 31, 2026, cash and equivalents totaled $91.2M, sufficient into mid-2027.
- 68 patients dosed in HERO trial and 19 in OLE trial as of February 27, 2026.
Financial Impact
Full clinical hold on sole pipeline asset (ARD-101) for PWS; $91.2M cash runway into mid-2027 provides limited buffer but no near-term revenue catalyst.
Risk Factors
- Full clinical hold may require additional clinical data or trial redesign before lifting, delaying program by years.
- Unblinded data could reveal safety or efficacy concerns that permanently end the ARD-101 program.
- With ARD-101 as the only pipeline asset, a program termination would leave Aardvark with no clinical-stage candidates.
- Cash burn without revenue could necessitate dilutive financing if hold persists beyond mid-2027.
Market Snapshot
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3295315 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
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Jun 11, 2026
2d ago
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Institutional Cluster
| $3.48 awaiting T+5 | awaiting T+5 | — | $3.90 (+12.07%) |
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May 14, 2026
29d ago
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Press Release
| $4.57 $4.54 | ▲ +0.66% | ▲ +1.62% | $3.90 (+14.66%) |
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May 7, 2026
5w ago
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8-K
| $5.60 $6.59 | ▼ −17.68% | ▼ −16.17% | $3.90 (+30.36%) |
|
Apr 6, 2026
9w ago
|
EFFECT
| $4.13 $4.01 | ▲ +2.91% | ▲ +7.04% | $3.90 (+5.57%) |
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Apr 3, 2026
10w ago
|
424B5
| $4.13 $4.01 | ▲ +2.91% | ▲ +7.04% | $3.90 (+5.57%) |
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Mar 24, 2026
11w ago
|
8-K
| $3.77 $3.77 | · 0.00% | ▲ +0.42% | $3.90 (+3.45%) |
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Mar 23, 2026
11w ago
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S-3
| $3.77 $3.77 | · 0.00% | ▼ −0.42% | $3.90 (−3.45%) |
|
Mar 23, 2026
11w ago
|
Press Release
| $3.77 $3.77 | · 0.00% | ▼ −0.42% | $3.90 (−3.45%) |
US Market Status
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