Recent 8-K filings for AARD
Highest-materiality recent filing
FDA places full clinical hold on Aardvark's ARD-101 IND; HERO and OLE trials paused
- FDA full clinical hold on IND for ARD-101, affecting Phase 3 HERO trial (AVK-101-301) and OLE trial (AVK-101-302).
- Company to unblind accumulated data from 68 HERO patients and 19 OLE patients to inform next steps.
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FDA places full clinical hold on Aardvark's ARD-101 IND; HERO and OLE trials paused
FDA full clinical hold on IND for ARD-101, affecting Phase 3 HERO trial (AVK-101-301) and OLE trial (AVK-101-302).
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Aardvark Q1 net loss $21.6M; ARD-101/ARD-201 programs on voluntary pause
Net loss of $21.6M for Q1 2026 vs. $9.3M for Q1 2025, driven by higher R&D expenses.
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Aardvark enters $150M equity distribution agreement with Piper Sandler
May sell up to $150M of common stock at market through Piper Sandler as agent.
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Net loss $57.6M for FY2025 vs $20.6M in FY2024; cash $110.0M supports operations into Q2 2027.
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Aardvark Therapeutics pauses Phase 3 HERO trial for ARD-101 in PWS due to cardiac signals
Voluntary pause of Phase 3 HERO trial (NCT06828861) and open-label extension (NCT07197034) for ARD-101 in Prader-Willi Syndrome.
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Aardvark COO exits to lead new dermatology subsidiary; CFO Sun adds COO role
Bryan Jones stepped down as COO of Aardvark on Feb 9, 2026, to become CEO of wholly-owned subsidiary Ardia Therapeutics.
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Aardvark Therapeutics expands Phase 3 HERO trial age eligibility to 7+ years for ARD-101 in PWS
IRB approved amended protocol lowering minimum age from 10 to 7 years for Phase 3 HERO trial evaluating ARD-101.
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Aardvark Therapeutics files updated corporate presentation; no material disclosures.
Updated corporate presentation dated January 2026 filed with SEC.
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Aardvark doses first patient in Australia Phase 3 HERO trial; Q3 2026 data readout on track
First patient dosed in Australia in Phase 3 HERO trial for ARD-101 for hyperphagia in Prader-Willi syndrome.
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Aardvark Therapeutics Q3 net loss $16.3M; cash $126.4M; FDA expands PWS trial age to 10 years
Cash, equivalents, and short-term investments of $126.4M as of Sep 30, 2025; expected to fund operations into 2027.
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Filed presentation lacks specific clinical results or financial figures.
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ARD-201 (ARD-101+sitagliptin) in DIO mice reduced body weight ~19% in 30 days, comparable to high-dose tirzepatide, and preserved lean mass.
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Aardvark gets FDA alignment to lower Phase 3 PWS trial min age to 10
FDA aligned on protocol amendment for Phase 3 HERO trial of ARD-101, lowering minimum age from 13 to 10 years old.
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Aardvark Therapeutics updates corporate presentation; no material specifics disclosed
Company updated corporate presentation dated September 2025 for investor meetings.
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Net loss of $14.4M in Q2 2025 vs $5.4M in Q2 2024; R&D expenses rose to $13.1M.
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Aardvark reports ARD-201 preclinical data: 19% weight loss in mice; plans two Phase 2 trials
ARD-201 monotherapy achieved ~19% body weight reduction in DIO mice after 30 days.
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Aardvark Therapeutics Q1 net loss $9.3M; cash $151.3M; Phase 3 PWS data expected early 2026
Net loss was $9.3M in Q1 2025 vs $2.2M in Q1 2024, driven by higher R&D and G&A costs.
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Aardvark Therapeutics reports FY 2024 net loss $20.6M; advances ARD-101 Phase 3 PWS trial
Net loss $20.6M in 2024 vs $7.2M in 2023; R&D expenses $17.4M (up $12.9M YoY).
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Aardvark Therapeutics completes IPO; issues 5.888M shares at $16.00, raises $94.2M gross
IPO of 5,888,000 shares at $16.00 per share completed on Feb 14, 2025.
Earnings & guidance
Materiality & sentiment trend
Max materiality 0.90 · Median 0.65 · Most common event other_material