- Aardvark was studying the efficacy and safety of ARD-101 as a treatment for hyperphagia in patients with Prader-Willi Syndrome in the trial.
- In September, Acadia Pharmaceuticals scrapped development of intranasal Carbetocin after it failed to meet the key goals in a late-stage PWS trial.
- Soleno Therapeutics’ VYKAT XR is the first approved treatment specifically for hyperphagia in PWS patients.
Shares of Aardvark Therapeutics (AARD) dived 53% after hours on Friday after the company announced that it is voluntarily pausing its late-stage trial in Prader-Willi Syndrome (PWS).
The company was studying the efficacy and safety of ARD-101 as a treatment for hyperphagia in patients with Prader-Willi Syndrome in the trial. Prader-Willi syndrome is a rare genetic neurodevelopmental disorder caused by an abnormality in the gene expression on chromosome 15, estimated to occur in one in every 15,000 live births. The disorder is defined by hyperphagia, an intense, persistent sensation of hunger, which could be life-threatening.
Why Is Aardvark Pausing Trial?
The company said that the decision was based on certain cardiac observations made during routine safety monitoring in a healthy volunteer study. The company is reviewing the data to determine next steps, it said, while adding that it has also paused enrollment and dosing in the trial as it completes its evaluation.
The firm also added that it no longer expects data from the trail in the third quarter of 2026.
Other Names To Quit PWS Drug Development
In September, Acadia Pharmaceuticals scrapped development of intranasal Carbetocin after it failed to meet the key goals in a late-stage PWS trial.
The company then said that intranasal Carbetocin did not demonstrate a statistically significant improvement over placebo to week 12 on the Hyperphagia Questionnaire for Clinical Trials and also announced its intent to stop investigating the drug further.
Soleno’s Approved Drug
Soleno Therapeutics, meanwhile, received FDA approval of VYKAT XR in early 2025, making it the first approved treatment specifically for hyperphagia in PWS patients.
However, in August, Scorpion Capital revealed a short position against Soleno stock, alleging several risks associated with Vykat XR, including high risk of pre-diabetes/diabetes, pulmonary edema, and congestive heart failure. Scorpion Capital also stated that it intends to submit an emergency Citizen Petition shortly, requesting that the FDA urge Soleno to conduct a voluntary recall of Vykat XR from the market.
Weeks later, in September, the company stated in a filing with the Securities and Exchange Commission that it is aware of a serious adverse event reported in the U.S. Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS) involving a deceased patient. However, the existence of a report in the data does not establish causation, the company said.
Soleno said that its assessment of the death is the same as the treating physician, who said that the death is not related to the treatment with Vykat XR.
How Did Stocktwits Users React?
On Stocktwits, retail sentiment around AARD rose from ‘bullish’ to ‘extremely bullish’ territory over the past 24 hours, while message volume increased from ‘low’ to ‘extremely high’ levels.
AARD stock has dropped 7% over the past 12 months.
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