View Financial HealthAardvark Therapeutics 配当と自社株買い配当金 基準チェック /06Aardvark Therapeutics配当金を支払った記録がありません。主要情報n/a配当利回り-0.5%バイバック利回り総株主利回り-0.5%将来の配当利回り0%配当成長n/a次回配当支払日n/a配当落ち日n/a一株当たり配当金n/a配当性向n/a最近の配当と自社株買いの更新更新なしすべての更新を表示Recent updatesSeeking Alpha • May 18Aardvark Therapeutics: Regulatory Uncertainty Clouds ARD-101 Path ForwardSummary Aardvark Therapeutics, Inc. faces a pivotal regulatory setback as the FDA placed a clinical hold on ARD-101 due to unexpected cardiac signals. AARD now trades as a cash-backed option, with the stock reflecting little value beyond its $91M cash position and a 1.15x price-to-book ratio. Unblinding pivotal trial data could provide rapid safety clarity, but risks trial integrity and likely necessitates an additional confirmatory Phase 3 study. I maintain a neutral/hold stance on AARD until there is clearer FDA guidance, as regulatory resolution is the critical near-term catalyst. Read the full article on Seeking AlphaPrice Target Changed • May 17Price target decreased by 8.6% to US$15.44Down 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.お知らせ • May 16Aardvark Therapeutics, Inc. Plans To Unblind HERO And OLE Data To Inform Path Forward Following FDA Clinical HoldAardvark 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.お知らせ • Mar 24Aardvark 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 OfferingNew Risk • Mar 22New minor risk - Market cap sizeThe 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 02New major risk - Share price stabilityThe 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 02Price target decreased by 9.8% to US$29.60Down 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.お知らせ • Feb 28Aardvark Therapeutics Announces Voluntary Pause of Phase 3 Hero Trial in Prader-Willi SyndromeAardvark 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.お知らせ • Feb 12Aardvark Therapeutics, Inc. Announces Appointment of Executive, Effective February 9, 2026Aardvark 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.お知らせ • Feb 10Aardvark 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 SyndromeAardvark 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 15CEO, Secretary & Director recently bought US$101k worth of stockOn 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.お知らせ • Dec 11Aardvark Therapeutics Announces First Patient Dosed in Australia in Hero Phase 3 Trial for Prader-Willi SyndromeAardvark 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.お知らせ • Nov 05Aardvark Therapeutics, Inc. Presents Data Supporting its Metabolic Obesity Pipeline Programs at ObesityWeek 2025Aardvark 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.お知らせ • Oct 08Aardvark Therapeutics Announces Fda Alignment on Protocol Amendment Expanding Phase 3 Hero Trial Population for Prader-Willi SyndromeAardvark 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 14CEO, Secretary & Director recently bought US$161k worth of stockOn 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 01CEO, 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.お知らせ • Aug 12Aardvark 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 TherapyAardvark 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.お知らせ • Feb 14Aardvark 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決済の安定と成長配当データの取得安定した配当: AARDの 1 株当たり配当が過去に安定していたかどうかを判断するにはデータが不十分です。増加する配当: AARDの配当金が増加しているかどうかを判断するにはデータが不十分です。配当利回り対市場Aardvark Therapeutics 配当利回り対市場AARD 配当利回りは市場と比べてどうか？セグメント配当利回り会社 (AARD)n/a市場下位25% (US)1.4%市場トップ25% (US)4.3%業界平均 (Pharmaceuticals)2.1%アナリスト予想 (AARD) (最長3年)0%注目すべき配当: AARDは最近配当金を報告していないため、配当金支払者の下位 25% に対して同社の配当利回りを評価することはできません。高配当: AARDは最近配当金を報告していないため、配当金支払者の上位 25% に対して同社の配当利回りを評価することはできません。株主への利益配当収益カバレッジ: AARDの 配当性向 を計算して配当金の支払いが利益で賄われているかどうかを判断するにはデータが不十分です。株主配当金キャッシュフローカバレッジ: AARDが配当金を報告していないため、配当金の持続可能性を計算できません。高配当企業の発掘7D1Y7D1Y7D1YUS 市場の強力な配当支払い企業。View Management企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/05/21 19:38終値2026/05/21 00:00収益2026/03/31年間収益2025/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Aardvark Therapeutics, Inc. 10 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。12 アナリスト機関Tazeen AhmadBofA Global ResearchWilliam WoodB. Riley Securities, Inc.Suranjit MukherjeeBTIG9 その他のアナリストを表示
Seeking Alpha • May 18Aardvark Therapeutics: Regulatory Uncertainty Clouds ARD-101 Path ForwardSummary Aardvark Therapeutics, Inc. faces a pivotal regulatory setback as the FDA placed a clinical hold on ARD-101 due to unexpected cardiac signals. AARD now trades as a cash-backed option, with the stock reflecting little value beyond its $91M cash position and a 1.15x price-to-book ratio. Unblinding pivotal trial data could provide rapid safety clarity, but risks trial integrity and likely necessitates an additional confirmatory Phase 3 study. I maintain a neutral/hold stance on AARD until there is clearer FDA guidance, as regulatory resolution is the critical near-term catalyst. Read the full article on Seeking Alpha
Price Target Changed • May 17Price target decreased by 8.6% to US$15.44Down 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.
お知らせ • May 16Aardvark Therapeutics, Inc. Plans To Unblind HERO And OLE Data To Inform Path Forward Following FDA Clinical HoldAardvark 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.
お知らせ • Mar 24Aardvark 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 22New minor risk - Market cap sizeThe 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 02New major risk - Share price stabilityThe 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 02Price target decreased by 9.8% to US$29.60Down 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.
お知らせ • Feb 28Aardvark Therapeutics Announces Voluntary Pause of Phase 3 Hero Trial in Prader-Willi SyndromeAardvark 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.
お知らせ • Feb 12Aardvark Therapeutics, Inc. Announces Appointment of Executive, Effective February 9, 2026Aardvark 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.
お知らせ • Feb 10Aardvark 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 SyndromeAardvark 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 15CEO, Secretary & Director recently bought US$101k worth of stockOn 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.
お知らせ • Dec 11Aardvark Therapeutics Announces First Patient Dosed in Australia in Hero Phase 3 Trial for Prader-Willi SyndromeAardvark 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.
お知らせ • Nov 05Aardvark Therapeutics, Inc. Presents Data Supporting its Metabolic Obesity Pipeline Programs at ObesityWeek 2025Aardvark 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.
お知らせ • Oct 08Aardvark Therapeutics Announces Fda Alignment on Protocol Amendment Expanding Phase 3 Hero Trial Population for Prader-Willi SyndromeAardvark 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 14CEO, Secretary & Director recently bought US$161k worth of stockOn 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 01CEO, 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.
お知らせ • Aug 12Aardvark 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 TherapyAardvark 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.
お知らせ • Feb 14Aardvark 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