AARD: FDA Hold Lifted at Night, Trial Data at Dawn, Shares Down 65%

Data to the close of October 23, 2026 (ET). Sources checked October 25.

Aardvark Therapeutics put out two pieces of news, one on Thursday evening and one on Friday morning. On Thursday after the close it said the FDA had lifted the clinical hold on its lead drug. AARD opened Friday's pre-market at $5.40, up 37% from Thursday's $3.95 close. On Friday morning it published what it had learned from the Phase 3 trial it stopped earlier this year. AARD closed at $1.39, down 64.8%.

The first piece of news allowed the company to test the drug again. The second showed how much evidence it has, and the evidence is thin.

What the filings say

Thursday, 4:17 p.m. The first 8-K was accepted at 16:17:09 ET. The FDA had lifted the clinical hold on ARD-101, an oral drug for hyperphagia (constant, extreme hunger) in Prader-Willi syndrome. The background, from the release and the company's 10-Q:

• On February 27, Aardvark paused dosing after reversible ECG changes in a separate study in healthy volunteers.
• In May the FDA placed the program on clinical hold. In June the company terminated the Phase 3 HERO trial and its open-label extension (OLE).
• A new ECG study found no cardiac events at 200 mg and 400 mg twice daily.

The release also announced a webcast for 8:00 a.m. Friday to discuss data from the terminated trials.

Friday, 8:38 a.m. The second 8-K, accepted at 08:38:38 ET, carried the data release and the webcast slides. The key points, in the company's words where it matters:

• HERO randomized 67 of the 90 participants it planned. "All efficacy data are considered exploratory."
• At week two, there was "a modest reduction" in hunger scores (HQ-CT) on ARD-101 versus placebo.
• After treatment stopped, the ARD-101 group's scores returned to near baseline, while the placebo group moved back less. One slide puts it this way: "The effect observed with ARD-101 was lost after treatment stopped, while the placebo response largely persisted."
• The week-12 comparison on the slides rests on 11 participants on the drug and 13 on placebo, with no statistical adjustments.
• In the OLE, participants who switched from placebo to ARD-101 saw their scores fall by about 6 more points on average. The slide shows 9 participants at that point.
• There was one cardiac serious adverse event, at 800 mg twice daily, in a participant also taking pitolisant. The FDA agreed it was related to a drug-drug interaction.

The plan going forward: ask the FDA for a meeting on a new Phase 3 design, restart at a dose below 800 mg twice daily, and resume clinical work in Prader-Willi syndrome in 2027.

How the day traded

Prices come from FennEdge's minute data and the October 23 Daily. AARD gapped down, so it is not on that day's gap-up list. Its trading halts are in the close edition's halt list.

	Price	vs. prior close
Prior close (Oct 22)	$3.95
Pre-market high, 4:00 a.m.	$5.87	+48.5%
Last minute before the drop, 7:02 a.m.	$4.79	+21.3%
Pre-market low, 7:04 a.m.	$2.28	−42.3%
8:00 a.m., webcast starts	$3.70	−6.3%
Open, 9:30 a.m.	$2.99	−24.3%
Close, 4:00 p.m.	$1.39	−64.8%

The high came in the first minute of pre-market trading. From about 4:30 to 7:00 the stock traded between $4.76 and $5.07. In the minutes 7:03 and 7:04 it fell to $2.28. That was about an hour before the webcast and an hour and a half before the second 8-K was accepted. The regular session's high, $3.00, came in its first minute. Three volatility pauses followed, at 9:39, 9:45 and 9:51. The stock fell for the rest of the day and closed at $1.39, on 16.3 million shares, about three-quarters of the 21.9 million shares outstanding.

What we read into it

FennEdge's interpretation, not a recommendation.

A lifted hold allows more trials. It does not show the drug works. The evening news removed an obstacle. The morning news showed what the company knows about the drug: a trial stopped early, data the company calls exploratory, a placebo group that did nearly as well, and a new Phase 3 that has not been designed yet. The pre-market buyers at $5 were pricing the first piece of news before they had seen the second.

The filing time is not the time the news came out. The stock fell at 7:03, but the 8-K was accepted at 8:38. Companies often publish a press release first and file it with the SEC afterwards. If you only watch filings, you can be more than an hour late.

The market value is now below the last reported cash. At $1.39, 21.9 million shares are worth about $30 million. On June 30 the company had $73.9 million in cash and short-term investments, and said that would fund operations into late 2027. Both figures are old. The company has spent money since June, and that plan was made before it decided to run a new Phase 3. It also has a $150 million at-the-market agreement, unused as of June 30. At today's price, selling shares through it would dilute holders much more than at $4.

What we don't know

• When the data release went public. Neither filing gives a time, and the 7:03 drop came before both the webcast and the 8:38 filing.
• Why 1.4 million shares traded on October 22, against 70,000 to 320,000 a day in the weeks before. Daily data can't show whether that volume came before or after the 4:17 p.m. filing.
• Cash as of September 30, which the next quarterly report will show.
• What the FDA will say about a new Phase 3 design and the lower dose.

Some posts after the session gave the second filing's time as 12:38 p.m. The SEC's acceptance record shows 8:38:38 a.m. ET.

Check it yourself

• SEC filing: 8-K, FDA lifts clinical hold (Oct 22) · SEC filing: 8-K, HERO and OLE data (Oct 23) · SEC filing: 10-Q for the second quarter
• October 23 Daily · gap list · close edition and halts
• AARD research page · AARD minute chart in In-Play
• Glossary: pre-market · trading halt · LULD · catalyst · at-the-market offering · burn rate

This article explains common concepts; examples are not trading recommendations.