Aardvark Therapeutics, Inc.
AARD evidence brief
What we can confirm
- BioSniper Score:
- 7.7 / 10
- Market Cap:
- $112.3M
- Lead Asset:
- ARD-101 (Phase 3)
What it means
What to watch
Prepared research question
What matters most for AARD—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · AARD
Aardvark Therapeutics, Inc. (AARD) is a clinical-stage biopharmaceutical company developing small-molecule agonists of bitter taste receptors to treat metabolic diseases, with its lead candidate ARD-101 in Phase 3 for Prader-Willi Syndrome but currently under an FDA clinical hold.
Key risk: FDA clinical hold
BioSniper Score
Based on 3 of 6 signals
Limited data coverage
Market Cap
$112.3M
Cash Runway
—
Lead Asset
ARD-101 (Phase 3)
Next Catalyst
—
Financial data as of Jun 30, 2026.
Tracking 2 pipeline candidates · 3 clinical trials for Aardvark Therapeutics, Inc..
Aardvark Therapeutics, Inc. (AARD) is a clinical-stage biopharmaceutical company developing small-molecule agonists of bitter taste receptors to treat metabolic diseases, with its lead candidate ARD-101 in Phase 3 for Prader-Willi Syndrome but currently under an FDA clinical hold.
- Lead candidate ARD-101 is a gut-restricted small-molecule agonist of bitter taste receptors (TAS2Rs) that induces endogenous release of CCK and GLP-1 [pipeline].
- ARD-101 is in Phase 3 trials (HERO and open-label extension) for hyperphagia in Prader-Willi Syndrome, with unblinded data assessment planned for Q3 2026 [news · published 2026-08-11].
- The FDA placed a full clinical hold on the ARD-101 IND in May 2026; the company remains in active discussions with the FDA to resolve the hold [news · published 2026-05-14].
- Cash and equivalents were $73.8M as of June 30, 2026, supporting projected operations into late 2027 [latest reported financials (authoritative, structured)].
- Net loss was -$14.4M for the period ending June 30, 2026, with shareholders' equity of $74.8M [latest reported financials (authoritative, structured)].
What works
- ARD-101 targets a novel mechanism—activating gut bitter taste receptors to trigger endogenous GLP-1 and CCK release—which may offer a differentiated approach to treating hyperphagia [pipeline].
- The company has a cash runway into late 2027 ($73.8M as of June 30, 2026), providing financial buffer during the clinical hold period [latest reported financials (authoritative, structured)].
- Phase 3 HERO trial enrollment has expanded to include children aged 7+ in the U.S., and sites in Australia, Canada, and the U.K. are active [news · published 2026-02-10].
What to weigh
- The FDA has placed a full clinical hold on the ARD-101 program, creating significant regulatory uncertainty and delaying the path to approval [news · published 2026-05-14].
- The company reported a net loss of -$14.4M for the period ending June 30, 2026, with no approved products generating revenue [latest reported financials (authoritative, structured)].
- ARD-101 faces at least one competitor (Protara Therapeutics) in the same indication, and the clinical hold may allow competitors to advance [pipeline].
From the filings
Quoted directly from source documents.
FDA placed a full clinical hold on ARD-101 IND
“the U.S. Food and Drug Administration (FDA) has placed a full clinical hold on its investigational new drug application (IND) for ARD-101”
News · May 14, 2026
Cash position as of June 30, 2026
“$73.9 million in cash, cash equivalents and short-term investments as of June 30, 2026”
News · August 11, 2026
ARD-101 mechanism of action
“Oral gut-restricted small-molecule agonist of certain Bitter Taste Receptors (TAS2Rs) expressed in the gut lumen that activates these receptors to induce secretion of endogenous signaling molecules, including cholecystokinin (CCK) and glucagon-like peptide-1 (GLP-1)”
Planned unblinding of Phase 3 data in Q3 2026
“Assessing unblinded Phase 3 HERO and OLE data for ARD-101 in PWS in the third quarter of 2026 to support an informed determination of next steps”
News · August 11, 2026
Catalyst timeline
- 2022-05-27 · Phase 2 start for ARD-101 in PWS — Initiation of a single-arm, open-label Phase 2 study evaluating safety and efficacy in PWS patients.
- 2024-07-23 · Phase 3 open-label extension start — Start of a multicenter, open-label extension study to assess long-term safety and efficacy of ARD-101 in PWS.
- 2024-12-20 · Phase 3 randomized, double-blind, placebo-controlled start — Initiation of the pivotal Phase 3 HERO trial for hyperphagia in PWS.
Risks & what to watch (3)›
Key risks
- FDA clinical hold — Full clinical hold on ARD-101 IND; resolution timeline uncertain [news · published 2026-05-14]
- No approved products — Company has no marketed products; net loss of -$14.4M as of June 30, 2026 [latest reported financials (authoritative, structured)]
- Competitive pressure — At least one competitor (Protara Therapeutics) in Phase 2/3 for same indication [pipeline]
What to watch
- Resolution of the FDA clinical hold on ARD-101 and any related regulatory guidance [news · published 2026-05-14].
- Unblinded Phase 3 HERO and OLE data assessment planned for Q3 2026 [news · published 2026-08-11].
- Cash burn rate and whether the $73.8M runway extends into late 2027 as projected [latest reported financials (authoritative, structured)].
- Any updates on competitive landscape, particularly Protara Therapeutics' progress [pipeline].
Sources: Catalysts · News · Pipeline · Generated October 11, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 3 of 6 signals · derived from public data
Cash runway data unavailable
D/E 0.09 · 0% dilution
Lead: Phase 3
2 candidates
No upcoming catalysts tracked
No insider transactions in the last 180 days
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
79
Total value held
$38.3M
| Holder | Shares | Value |
|---|---|---|
| decheng capital llc | 3,917,299 | $14.8M |
| citadel advisors llc | 1,242,777 | $4.7M |
| laurion capital management lp | 1,034,459 | $3.9M |
| blackrock, inc. | 792,571 | $3.0M |
| vanguard capital management llc | 554,101 | $2.1M |
| tetragon partners gp ltd | 316,621 | $1.2M |
| geode capital management, llc | 309,449 | $1.2M |
| adage capital partners gp, l.l.c. | 300,000 | $1.1M |
| state street corp | 199,322 | $751K |
| two sigma investments, lp | 163,355 | $616K |
Showing top 10 of 79 institutional holders of Aardvark Therapeutics, Inc.. Open the full 13F history after sign-in.
Short Interest
as of May 19, 2026- % of float
- 8.8%
- Days to cover
- 7.0
- Shares short
- 1,261,941
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
AARD short interestGovernance
Frequently asked questions
What is the AI investment thesis for Aardvark Therapeutics, Inc.?
Aardvark Therapeutics, Inc. (AARD) is a clinical-stage biopharmaceutical company developing small-molecule agonists of bitter taste receptors to treat metabolic diseases, with its lead candidate ARD-101 in Phase 3 for Prader-Willi Syndrome but currently under an FDA clinical hold.
What is Aardvark Therapeutics, Inc.'s lead drug candidate?
Aardvark Therapeutics, Inc.'s most advanced tracked candidate is ARD-101 (Phase 3) for Hyperphagia; Prader-Willi Syndrome.
Who is the CEO of Aardvark Therapeutics, Inc.?
Dr. Tien-Li Lee M.D. is the chief executive officer of Aardvark Therapeutics, Inc. (AARD).
Where is Aardvark Therapeutics, Inc. headquartered?
Aardvark Therapeutics, Inc. (AARD) is headquartered in San Diego, CA, United States.
What therapeutic areas does Aardvark Therapeutics, Inc. focus on?
Aardvark Therapeutics, Inc. develops therapies across Rare Disease.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.