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AARD News
AARD Events
Aardvark Cash and Investments Decrease to $73.9M
As of June 30, Aardvark had cash, cash equivalents and short-term investments of $73.9M, compared to $91.2M as of March 31. Based on current operating plans, Aardvark believes that its existing cash, cash equivalents and short-term investments will be sufficient to fund projected operations into late 2027. "Patients and families in the PWS community are at the center of every decision we make, and our team is laser focused on establishing a clear path forward for ARD-101 in PWS," said Tien Lee, founder and CEO of Aardvark. "Over the last several months, we have continued to work collaboratively with the FDA. Additionally in the third quarter of this year, we are assessing the unblinded data from the HERO and OLE trials, which will allow us to understand the totality of the efficacy and safety results generated to date."
Aardvark Therapeutics Inc Trading Halted Due to Volatility Trading Pause
Aardvark Therapeutics Inc trading halted, volatility trading pause
Aardvark Therapeutics ARD-101 Clinical Trials Fully Paused by FDA
Aardvark Therapeutics announced that the U.S. Food and Drug Administration has placed a full clinical hold on its investigational new drug application for ARD-101, related to the company's previously announced voluntary pause. The clinical hold applies to all ongoing clinical studies, including the Phase 3 HERO trial evaluating ARD-101 for the treatment of hyperphagia in patients with Prader-Willi Syndrome. In parallel with its ongoing engagement with the FDA, Aardvark intends to unblind the accumulated clinical data across its trials to assess efficacy and safety and determine a path forward. As of March 31, the company held $91.2M in cash, cash equivalents and short-term investments, which it expects to fund operations into mid-2027.
Aardvark CEO Discusses Progress on ARD-101 Trial
"We have been working closely with the FDA to comprehensively evaluate the data following the reversible cardiac observations in the healthy volunteer trial and are committed to determining the best path forward for our programs, patients and the broader PWS community," said Tien Lee, Founder and Chief Executive Officer of Aardvark. "We remain focused on establishing a clear path forward for the Phase 3 HERO trial evaluating ARD-101 in PWS, our lead program, and look forward to providing an update in the second quarter."
Trump Postpones Strikes on Iranian Energy, Market Sentiment Improves
Hopes for de-escalation in the Middle East conflict helped restore positive sentiment as President Trump's Truth Social post that strikes on Iranian energy infrastructure would be postponed after "productive" talks with Tehran boosted equities and dented geopolitical premium in the energy markets. Consumer Discretionary and Materials were the best performing areas on the benchmark S&P 500, though all 11 sectors ended Monday in the positive - including Energy in spite of Oil prices falling back below $90 per barrel. In the opening hour of the evening session, S&P 500 futures are up another 0.2% and Nasdaq 100 is trading up 0.3% while WTI Crude is just off the closing lows above $89. In precious metals, risk aversion which had boosted USD and punished Gold and Silver prices has reversed, and the two contracts are trading firmer around $4.435 and $70 per ounce respectively.Among the key headlines of the afterhours session continued to remind investors that the primary source of concern are still present. Core Labsissued a below-consensus Q1 pre-announcement as the company cited regional instability in the Middle East, including client-driven project delays, travel constraints, and supply-chain disruptions. Private Credit worries also cropped up via reports from Bloomberg stating that Apollo Globalhas joined some of the other asset managers in capping private equity redemptions due to high volume of requests by investors to liquidate their positions.Check out this evening's top movers from around Wall Street, compiled by The Fly.HIGHER AFTER EARNINGS -BARKup 6.4%Bionano Genomicsup 4.1%DOWN AFTER EARNINGS -Core Laboratoriesdown 1.8% after Q1 pre-announcementAardvark Therapeuticsdown 1.5%ALSO LOWER -Comtech Telecommunicationsdown 3.9% after equity offeringApollo Global Managementdown 2.1% after Bloomberg report of capped private equity redemptions
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