Anuncio • Aug 18
Aardvark Therapeutics, Inc. Faces Shareholder Class Action Lawsuit Gainey McKenna & Egleston announced that a securities class action lawsuit has been filed in the United States District Court for the Southern District of California on behalf of all persons or entities who purchased or otherwise acquired Aardvark Therapeutics, Inc. (a) common stock pursuant and/or traceable to the Offering Documents issued in connection with the Company’s initial public offering conducted on or about February 13, 2025 (the “IPO” or “Offering”); and/or (b) Aardvark securities between February 13, 2025 and May 14, 2026, both dates inclusive (the “Class Period”). The Complaint alleges that Defendants failed to disclose to investors that: (i) ARD-101 was less safe than Defendants had led investors to believe; (ii) accordingly, ARD-101’s clinical, regulatory, and commercial prospects were overstated; and (iii) as a result, Defendants’ public statements were materially false and misleading at all relevant times. The Complaint alleges that the truth began to emerge on February 27, 2026, when Aardvark issued a press release “announc[ing] it is voluntarily pausing the Phase 3 Hunger Elimination or Reduction Objective (HERO) trial.” The Complaint alleges that Aardvark attributed the decision to “reversible cardiac observations at above target therapeutic doses found during routine safety monitoring in a healthy volunteer study” and said that it “has voluntarily paused ongoing enrollment and dosing in the HERO trial” while “conducting a comprehensive review of the data to inform next steps. New Risk • Jul 10
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 21% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$62m free cash flow). Share price has been highly volatile over the past 3 months (21% average weekly change). Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$117m net loss in 3 years). New Risk • Jul 01
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$62m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$62m free cash flow). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$117m net loss in 3 years). Share price has been volatile over the past 3 months (15% average weekly change). Anuncio • Jun 30
Aardvark Therapeutics, Inc., Annual General Meeting, Aug 14, 2026 Aardvark Therapeutics, Inc., Annual General Meeting, Aug 14, 2026. Price Target Changed • May 17
Price target decreased by 8.6% to US$15.44 Down from US$16.90, the current price target is an average from 9 analysts. New target price is 238% above last closing price of US$4.57. Stock is down 54% over the past year. The company is forecast to post a net loss per share of US$3.74 next year compared to a net loss per share of US$2.93 last year. Anuncio • May 16
Aardvark Therapeutics, Inc. Plans To Unblind HERO And OLE Data To Inform Path Forward Following FDA Clinical Hold Aardvark Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has placed a full clinical hold on its investigational new drug application (IND) for ARD-101 related to the Company’s previously announced voluntary pause. The clinical hold applies to all ongoing clinical studies under the IND, including the Phase 3 HERO trial (AVK-101-301) evaluating ARD-101 for the treatment of hyperphagia in patients with Prader-Willi Syndrome (PWS) and the Phase 3 open-label extension (OLE) trial (AVK-101-302). The Company remains in active discussions with the FDA to support resolution of the clinical hold and determine a path forward for the ARD-101 program. In parallel with its ongoing engagement with the FDA, Aardvark intends to unblind the clinical data accumulated to date across both the HERO trial and the OLE trial to assess the totality of available efficacy and safety data and to support an informed determination of next steps for the ARD-101 program. As of February 27, 2026, Aardvark had dosed 68 patients in the randomized controlled HERO trial and 19 patients in the OLE trial. As of March 31, 2026, Aardvark held $91.2 million in cash, cash equivalents and short-term investments, which the Company believes is sufficient to fund projected operations into mid-2027. ARD-101 is an oral, small-molecule therapeutic designed to stimulate the release of gut-peptide hormones through activation of bitter taste receptors. ARD-101 was being evaluated in the Phase 3 HERO trial as a treatment for hyperphagia associated with Prader-Willi Syndrome, a rare genetic disorder characterized by insatiable hunger. Anuncio • Mar 24
Aardvark Therapeutics, Inc. has filed a Follow-on Equity Offering in the amount of $150 million. Aardvark Therapeutics, Inc. has filed a Follow-on Equity Offering in the amount of $150 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering New Risk • Mar 22
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: US$88.6m This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (20% average weekly change). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$126m net loss in 3 years). Market cap is less than US$100m (US$88.6m market cap). New Risk • Mar 02
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 21% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (21% average weekly change). Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$126m net loss in 3 years). Price Target Changed • Mar 02
Price target decreased by 9.8% to US$29.60 Down from US$32.80, the current price target is an average from 5 analysts. New target price is 441% above last closing price of US$5.47. Stock is down 57% over the past year. The company is forecast to post a net loss per share of US$2.93 next year compared to a net loss per share of US$5.15 last year. Anuncio • Feb 28
Aardvark Therapeutics Announces Voluntary Pause of Phase 3 Hero Trial in Prader-Willi Syndrome Aardvark Therapeutics, Inc. announced it is voluntarily pausing the Phase 3 Hunger Elimination or Reduction Objective (HERO) trial. The HERO trial is a Phase 3 randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of ARD-101 as a treatment for hyperphagia in patients with Prader-Willi Syndrome (PWS). Based on the ongoing activities in the ARD-101 program, Aardvark no longer anticipates announcing topline data from the HERO trial in the third quarter of 2026 and expects to provide further guidance in the second quarter of this year. ARD-101 has demonstrated an ability to reduce hunger when used alone or in combination with currently available GLP-1 therapies. The FDA has granted ARD-101 both Orphan Drug Designation and Rare Pediatric Disease Designation for Prader-Willi Syndrome. Anuncio • Feb 12
Aardvark Therapeutics, Inc. Announces Appointment of Executive, Effective February 9, 2026 Aardvark Therapeutics, Inc. announced the appointment of Derrick C. Li as Chief Business Officer, as well as the expansion of Nelson Sun’s role to include Chief Operating Officer, in addition to his current role as Chief Financial Officer. The appointments are effective as of February 9, 2026. In Mr. Li’s new role, he will lead Aardvark's business development strategy and execution with responsibility for financing, licensing, partnership strategy and corporate development initiatives. Mr. Li is a seasoned biotechnology executive with more than 20 years of global experience in biopharmaceutical business development, investment banking and corporate strategy. Prior to joining Aardvark, he served as Chief Strategy Officer at ODC Life Sciences, a Latin America-focused clinical research organization, where he drove growth strategy and global partnerships. He has also held senior leadership roles, including Head of Strategy and Investor Relations at Cellular Biomedicine Group (now AbelZeta). Additionally, he has extensive investment banking and investment management experience, most recently, serving as a Managing Director in the Healthcare Investment Group at Robert W. Baird. Mr. Li earned a dual bachelor's degree in accountancy and finance from Villanova University. Anuncio • Feb 10
Aardvark Therapeutics Announces Fda Submission and Irb Approval of Amended Trial Protocol for Lead Candidate Ard-101, Expanding Eligibility in Phase 3 Study of Prader-Willi Syndrome Aardvark Therapeutics, Inc. announced that Institutional Review Board (IRB) approval has been granted in the United States for an amended protocol to its ongoing Phase 3 HERO pivotal clinical trial evaluating ARD-101 for the treatment of hyperphagia in individuals with Prader-Willi Syndrome (PWS). The amended protocol, submitted to the U.S. Food and Drug Administration (FDA), lowers the minimum age of eligibility for trial participation from 10 to 7 years old. This protocol amendment reflects Aardvark's continued focus on reducing barriers to participation and expanding access for those affected by PWS, a rare genetic disorder characterized by chronic hyperphagia. Expanding eligibility reflects Aardvark's commitment to addressing the urgent need in the PWS community for a differentiated therapy and aim to ensure broad and equitable access. The Hunger Elimination or Reduction Objective (HERO) trial (NCT06828861) is a Phase 3 randomized, double-blind, placebo-controlled trial assessing ARD-101 for thetreatment of hyperphagia in patients with Prader-Willi syndrome (PWS). Aardvark plans to enroll 90 patients in this clinical trial across the U.S., Australia, Canada, the United Kingdom and South Korea. The primary endpoint is change in the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) score from baseline to Week 12. Secondary outcome measures include change in Caregiver Global Impression of Severity (CaGI-S) for hyperphagia in PWS patients and change in Clinical Global Impression of Severity ("CGI-S") score for hyperphagia inPWS patients. All participants who complete the 12-week clinical trial will have the option to participate in an Open Label Extension trial. More information about the study can be found at <URL> The FDA has granted ARD-101 both Orphan Drug Designation and Rare Pediatric Disease Designation for Prader-Willi Syndrome ("PWS"). ARD-101 is being evaluated in the Phase 3 HERO trial for hyperphagia associated with PWS associated with PWS. Recent Insider Transactions • Dec 15
CEO, Secretary & Director recently bought US$101k worth of stock On the 11th of December, Tien-Li Lee bought around 7k shares on-market at roughly US$14.49 per share. This transaction amounted to less than 1% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Tien-Li has been a buyer over the last 12 months, purchasing a net total of US$359k worth in shares. Anuncio • Dec 11
Aardvark Therapeutics Announces First Patient Dosed in Australia in Hero Phase 3 Trial for Prader-Willi Syndrome Aardvark Therapeutics, Inc. announced that the first patient has been dosed in Australia in its Phase 3 HERO pivotal clinical trial assessing ARD-101 for the treatment of hyperphagia in individuals with Prader-Willi syndrome (PWS). Additionally, regulatory clearance for enrollment by clinical trial sites in Canada and the United Kingdom has also been received. Based on strong enrollment in the US and continued progress in advancing the clinical trial internationally, the clinical trial continues to track towards a topline data readout in third quarter 2026. US trial sites are actively enrolling, and sites in Australia started enrolling in November. The Hunger Elimination or Reduction Objective (HERO) trial (NCT06828861) is a Phase 3 randomized, double-blind, placebo-controlled trial assessing ARD-101 For the treatment of hyperphagIA in patients with Prader-Willi Syndrome (PWS). Aardvark plans to enroll 90 patients in this clinical trial across the US, Australia, Canada, the United Kingdom, and South Korea. The primary endpoint is change in the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) score from baseline to Week 12. Secondary outcome measures include change in Caregiver Global Impression of Severity (CaGI-S) for hyperphagia in PWS patients and change in Clinical Global Impression of Severity ("CGI-S") score for hyperphagia inPWS patients. ARD-101 has demonstrated an ability to reduce hunger when used alone or in combination with currently available GLP-1 therapies. The FDA has granted ARD-101 both Orphan Drug Designation and Rare Pediatric Disease Designation for PWS. ARD-101 is being evaluated in the Phase 3 HERO trial for hyperphagia associated with PWS associated with PWS. Anuncio • Nov 05
Aardvark Therapeutics, Inc. Presents Data Supporting its Metabolic Obesity Pipeline Programs at ObesityWeek 2025 Aardvark Therapeutics, Inc. presented data at the ObesityWeek 2025 conference demonstrating the mechanistic rationale and therapeutic potential of two of its metabolic obesity programs, including ARD-201. Preclinical - ARD-201 (Validated Diet-Induced Obesity (DIO) Mouse Model): ARD-201 reduced fat mass comparable to high-dose tirzepatide but, unlike tirzepatide, preserved lean mass; ARD-201 alone achieved glucose control comparable to high-dose tirZepatide, and in combination with low-dose tirzepatides delivered the most rapid glucose clearance; Previously reported preclinical data demonstrated ARD-201 reduced body weight by 19% after 30 days, which was comparable to high-dose tir Zepatide; Previously reported preclinical data demonstrates ARD-201 ~30% weight loss when combined low-dose dirzepatide; Clinical - ARD-101 (Randomized, Placebo-Controlled, Phase 2A Study in Adults with Obesity): ARD-101 showed signals of weight control, reduced hunger, and improved metabolic parameters, particularly among participants with elevated baseline values; ARD-101 was well tolerated, with no serious adverse events or treatment discontinuations, reflecting a distinct profile from the effects associated with current anti-obesity therapies; WE-868 is a small molecule isoflavonoid designed to modulate oxidative phosphorylation and represents a potentially novel pathway for promoting weight loss and additional metabolic benefits: In preclinical studies, WE-868 dose-dependently prevented high-fat diet (HFD)-induced weight gain, with the higher dose inducing net weight loss; In DIO mice, significant weight loss was seen in medium and high dose WE-868 compared to semaglutide. Anuncio • Oct 08
Aardvark Therapeutics Announces Fda Alignment on Protocol Amendment Expanding Phase 3 Hero Trial Population for Prader-Willi Syndrome Aardvark Therapeutics, Inc. announced alignment with the U.S. Food and Drug Administration (FDA) on a protocol amendment to the company's Phase 3 HERO trial of ARD-101 for the treatment of hyperphagia associated with Prader-Willi Syndrome (PWS). The protocol amendment changes the minimum age of eligibility to participate in the trial from 13 to 10 years old. ARD-101 has demonstrated an ability to reduce hunger when used alone or in combination with currently available GLP-1 therapies. The FDA has granted ARD-101 both Orphan Drug Designation and Rare Pediatric Disease Designation for PWS. ARD-101 is being evaluated in the Phase 3 HERO trial for hyperphagia associated with PWS associated with PWS. Recent Insider Transactions • Sep 14
CEO, Secretary & Director recently bought US$161k worth of stock On the 12th of September, Tien-Li Lee bought around 20k shares on-market at roughly US$8.03 per share. This transaction amounted to 1.3% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was Tien-Li's only on-market trade for the last 12 months. Recent Insider Transactions Derivative • Sep 01
CEO, Secretary & Director exercised options to buy US$143k worth of stock. On the 28th of August, Tien-Li Lee exercised options to buy 17k shares at a strike price of around US$4.24, costing a total of US$73k. This transaction amounted to 1.2% of their direct individual holding at the time of the trade. Since December 2024, Tien-Li's direct individual holding has decreased from 2.91m shares to 1.51m. This was the only transaction from an insider over the last 12 months. Anuncio • Aug 12
Aardvark Therapeutics, Inc. Announces ARD-201 Preclinical Obesity Data Showing Significant Weight Loss as A Monotherapy, Enhancement of Glp-1Ra Therapy in Combination, and Effective Maintenance Following Discontinuation of Glp-1Ra Therapy Aardvark Therapeutics, Inc. announced new positive preclinical data demonstrating the potential of ARD-201 for the treatment of metabolic obesity and obesity-related conditions. Data in the validated diet-induced obesity (DIO) mouse model (a conventional model recognized for its strong translational relevance in the field of glucagon-like peptide-1 receptor agonists (GLP-1RAs)) demonstrated potential applications for ARD-201, including for the attenuation of weight gain after withdrawal from GLP-1RA therapies, as a monotherapy for weight loss without GLP-1RA therapy, as well as for weight loss in combination with GLP-1RA therapy. These two focused trials will replace the previously planned EMPOWER trial and are designed to enhance the precision and clarity of data collection compared to the EMPOWER trial. Anuncio • Feb 14
Aardvark Therapeutics, Inc. has completed an IPO in the amount of $94.208 million. Aardvark Therapeutics, Inc. has completed an IPO in the amount of $94.208 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 5,888,000
Price\Range: $16
Discount Per Security: $1.12
Transaction Features: Reserved Share Offering; Sponsor Backed Offering