SAN DIEGO, Feb. 13, 2026 (GLOBE NEWSWIRE) -- Aardvark Therapeutics, Inc. (Aardvark) (Nasdaq: AARD), a clinical-stage biopharmaceutical company focused on developing novel, small-molecule therapeutics to activate innate homeostatic pathways for the treatment of metabolic diseases, today announced that (i) on February 9, 2026, five new employees were granted inducement awards consisting of stock options to purchase an aggregate of 147,213 shares of common stock and (ii) on February 11, 2026, one new employee ...

Core Insights - Aardvark Therapeutics, Inc. has appointed Derrick C. Li as Chief Business Officer and expanded Nelson Sun's role to Chief Operating Officer, effective February 9, 2026, which is seen as pivotal for the company's growth as it advances its clinical programs [1][2] Company Developments - The appointments of Derrick Li and Nelson Sun are crucial as Aardvark progresses ARD-101 through Phase 3 development for hyperphagia associated with Prader-Willi Syndrome and continues Phase 2 development of ARD-201 for obesity-related conditions [2] - Derrick Li will lead Aardvark's business development strategy, focusing on financing, licensing, partnership strategy, and corporate development initiatives [2][3] Product Pipeline - Aardvark is developing ARD-101, an oral compound in Phase 3 clinical development for treating hyperphagia associated with Prader-Willi Syndrome, and ARD-201, a planned fixed-dose combination with a DPP-4 inhibitor, through two separate Phase 2 trials [4] - Topline Phase 3 data for ARD-101 is expected in the third quarter of 2026, which is a significant milestone for the company [3]

Core Viewpoint - Aardvark Therapeutics has established a new wholly-owned subsidiary, Ardia Therapeutics, to focus on developing a dermatology pipeline, particularly the lead asset DIA-615, aimed at treating inflammatory skin diseases like psoriasis [1][4]. Group 1: Company Overview - Aardvark Therapeutics is a clinical-stage biopharmaceutical company that develops small-molecule therapeutics targeting metabolic diseases and hunger-related conditions, with its lead compound ARD-101 in Phase 3 clinical development for Prader-Willi Syndrome [5]. - The newly formed Ardia Therapeutics will concentrate on DIA-615, a topical treatment designed to target inflammatory cells in the skin, utilizing a mechanism that involves specific G protein-coupled receptors [4]. Group 2: Leadership and Management - Bryan Jones, Ph.D., has been appointed as the CEO of Ardia, transitioning from his previous role as COO at Aardvark, bringing over 30 years of experience in biotech and specialty pharmaceuticals [2][3]. - Dr. Jones has a notable background, having held significant positions in various biotech companies and successfully leading multiple development programs throughout his career [3]. Group 3: Product Development - DIA-615 is positioned as a clinic-ready topical drug aimed at treating various inflammatory skin diseases, including psoriasis, by downregulating stressed endoplasmic reticulum in inflammatory cells [4]. - The development of DIA-615 is expected to address serious unmet needs in the treatment of severe skin diseases, with the potential for significant impact on patient care [2][3].

Core Viewpoint - Aardvark Therapeutics has received IRB approval for an amended protocol in its Phase 3 HERO trial, allowing participation of children aged 7 and older with Prader-Willi Syndrome (PWS) in the United States, aiming to enhance access and capture the potential impact of ARD-101 on hyperphagia in this population [1][2][3] Group 1: Trial Details - The HERO trial is a Phase 3 randomized, double-blind, placebo-controlled study assessing ARD-101 for hyperphagia in PWS patients, with plans to enroll 90 patients across multiple countries including the U.S., Australia, Canada, the UK, and South Korea [4] - The primary endpoint of the trial is the change in the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) score from baseline to Week 12, with secondary measures including changes in Caregiver Global Impression of Severity (CaGI-S) and Clinical Global Impression of Severity (CGI-S) scores [4] Group 2: Drug Information - ARD-101 is a gut-restricted small molecule agonist targeting specific taste receptors, stimulating the release of gut-peptide hormones like GLP-1 and cholecystokinin (CCK) to mediate hunger [5] - The drug has shown potential in reducing hunger both alone and in combination with existing GLP-1 therapies, and has received Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA for PWS [5][6] Group 3: Company Overview - Aardvark Therapeutics is focused on developing small-molecule therapeutics aimed at suppressing hunger for the treatment of PWS and other metabolic diseases, with ARD-101 being the lead compound in Phase 3 clinical development [7] - The company is also working on ARD-201, a fixed-dose combination of ARD-101 with a DPP-4 inhibitor, through two separate Phase 2 trials to address limitations of current GLP-1 therapies [8]

Upgrades - CFRA upgraded Pool Corp. (POOL) to Buy from Hold with a price target of $304 [2] - Piper Sandler upgraded SEI Investments (SEIC) to Overweight from Neutral with a price target of $102, increased from $93, citing SEI as a "clear beneficiary" of the expanding alternatives landscape [2] - TD Cowen upgraded Ametek (AME) to Buy from Hold with a price target of $230, up from $180, noting that backlog remains near highs and is expected to grow [3] Downgrades - TD Cowen downgraded Janus Henderson (JHG) to Hold from Buy with a price target of $49 after the company agreed to be acquired for $7.4 billion or $49.00 per share [4] - Piper Sandler downgraded Clearwater Analytics (CWAN) to Neutral from Overweight with a price target of $24.55, down from $27, following its agreement to be acquired for $24.55 per share in cash [4] - BMO Capital downgraded Brown & Brown (BRO) to Market Perform from Outperform with a price target of $88, down from $90, due to lower consensus organic growth estimates for 2026 [5] - Evercore ISI downgraded Coty (COTY) to In Line from Outperform with a price target of $7, citing a lack of visibility on timing and catalysts for potential value unlock [6] Initiations - Oppenheimer initiated coverage of Spruce Biosciences (SPRB) with an Outperform rating and a price target of $283, supported by FDA confirmation of compelling clinical biomarker data [7] - LifeSci Capital initiated coverage of Sionna Therapeutics (SION) with an Outperform rating and a price target of $60, highlighting multiple quality shots on goal with its therapies [7] - Oppenheimer initiated coverage of Aardvark Therapeutics (AARD) with an Outperform rating and a price target of $35, noting the company's differentiated obesity franchise [7] - JonesResearch initiated coverage of Septerna (SEPN) with a Buy rating and a price target of $43, forecasting $2.5 billion in unadjusted U.S. peak sales in 2035 [7] - Loop Capital initiated coverage of Malibu Boats (MBUU) with a Buy rating and a price target of $34, indicating the marine industry is in the late stages of inventory rationalization [7]

Core Insights - Aardvark Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small-molecule therapeutics for Prader-Willi Syndrome (PWS) and metabolic diseases [1] - The lead compound, ARD-101, is currently in Phase 3 clinical development for hyperphagia associated with PWS, with the first patient dosed in Australia [1][2] - Regulatory clearance for clinical trial site enrollment has been obtained in Canada and the United Kingdom [2] Clinical Development - Aardvark's Phase 3 HERO clinical trial for ARD-101 is progressing well, with strong enrollment in the U.S. and international expansion [3] - Topline data readout for the clinical trial is anticipated in the third quarter of 2026 [3] Market Opportunity - The global total addressable market (TAM) for PWS is estimated at approximately $10 billion, with only one approved treatment currently available [4] - Aardvark is also developing ARD-201, a fixed-dose combination therapy, which could target a TAM of at least $100 billion [5] Financial Position - There is a notable disconnect between Aardvark's current market value of $304 million and the potential of its lead program ARD-101 [6] - The company has cash, cash equivalents, and short-term investments totaling $126.4 million, sufficient to fund operations into 2027 [6] Stock Performance - Aardvark Therapeutics shares experienced a decline of 6.28%, trading at $14.63 at the time of publication [6]

Core Insights - Aardvark Therapeutics is progressing with its Phase 3 HERO trial for ARD-101, targeting hyperphagia in Prader-Willi syndrome (PWS), with topline data expected in Q3 2026 [1][4][6] Group 1: Clinical Trial Progress - The first patient has been dosed in Australia, and regulatory clearance for enrollment has been received in Canada and the UK [1][2] - Strong enrollment is reported in the US, with all patients from the completed 12-week trial participating in the Open Label Extension trial, indicating high patient engagement [2][3] - Aardvark anticipates that it will not need to activate previously planned sites in the EU to meet enrollment goals for the HERO trial [2] Group 2: Trial Details - The HERO trial is a Phase 3 randomized, double-blind, placebo-controlled study enrolling 90 patients across multiple countries [4] - The primary endpoint is the change in the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) score from baseline to Week 12, with secondary measures including caregiver and clinical global impressions of severity [4] Group 3: Product Information - ARD-101 is a gut-restricted small molecule agonist that stimulates the release of gut-peptide hormones to mediate hunger, showing potential to reduce hunger when used alone or with GLP-1 therapies [5][6] - The FDA has granted ARD-101 Orphan Drug Designation and Rare Pediatric Disease Designation for PWS [5] Group 4: Company Overview - Aardvark Therapeutics focuses on developing small-molecule therapeutics to suppress hunger for metabolic diseases, with ARD-101 as its lead compound in clinical development for hyperphagia associated with PWS [7][8]

Aardvark Therapeutics FY Conference Summary Company Overview - **Company**: Aardvark Therapeutics (NasdaqGS:AARD) - **Focus**: Development of oral small molecule drugs targeting obesity and rare diseases, specifically Prader-Willi syndrome Core Product Information - **Drug**: ARD-101 - **Mechanism**: Activates gut-brain signaling via the vagus nerve, engaging GPCR on enteroendocrine cells to release gut peptide hormones that regulate hunger [6][11] - **Formulation**: Gut-restricted with minimal systemic absorption, designed to avoid taste perception [31] Product Variants - **Single Agent**: ARD-101 for rare diseases - **Combination Agent**: ARD-101 with Sitagliptin for general obesity - **Sitagliptin**: A DPP-4 inhibitor that prolongs the action of gut hormones, enhancing weight loss effects [7][12] Clinical Data and Trials - **Phase 2 Study**: - **Results**: 1.3 kg weight loss in obese patients over 28 days without diet/exercise [29][30] - **Comparison**: Semaglutide (2.4 mg) resulted in approximately 1.6 kg weight loss in a similar timeframe [29] - **Preclinical Data**: - **Combination Therapy**: 19% body weight loss in high-fat-fed mice within 30 days, comparable to Tirzepatide's 20.5% [21] - **Upcoming Trials**: - **HERO Trial**: Phase 3 trial for Prader-Willi syndrome, with top-line data expected in Q3 2026 [32] Primary Endpoint - **Hunger Measurement**: HQ-CT9 score, focusing on hyperphagia rather than weight loss as the primary outcome [33][34] Competitive Landscape - **Competitor**: ViCat (diazoxide choline) - **Differentiation**: Aardvark's drug does not have renal insufficiency exclusions and may improve insulin sensitivity [39] - **Endpoint Similarity**: Both drugs use the HQ-CT9 score for measuring hyperphagia [40] Additional Insights - **Mechanistic Insights**: The combination therapy is believed to invoke multiple gut peptide hormone releases, enhancing therapeutic benefits beyond single-agent effects [53] - **Exploratory Endpoints**: Addressing hyperanxiety, systemic inflammation, and gut transit issues in Prader-Willi patients [52] Conclusion - Aardvark Therapeutics is positioned to address significant unmet needs in obesity and rare diseases with its innovative drug formulations and ongoing clinical trials, showing promising early results and a clear differentiation strategy against competitors.

Aardvark Therapeutics FY Conference Summary Company Overview - **Company**: Aardvark Therapeutics (NasdaqGS:AARD) - **Founded**: 2017 by Dr. Tien Lee - **Focus**: Development of treatments for rare diseases, specifically in the metabolic space, including Prader-Willi syndrome and obesity [3][4] Pipeline and Research Focus - **Key Programs**: - **Prader-Willi Syndrome**: Lead compound ARD-101, a bitter taste receptor agonist targeting hunger pathways [4][5] - **Obesity**: ARD-201, a combination of ARD-101 and sitagliptin (Januvia), aimed at enhancing incretin release and prolonging their half-life [4][5] Mechanism of Action - **ARD-101**: Targets bitter taste receptors in the gut to release incretins (GLP-1 and CCK), signaling the brain to reduce hunger and appetite [4][5] - **ARD-201**: Combines the effects of ARD-101 with sitagliptin to enhance the incretin pathway and maintain weight loss [41][42] Clinical Trials - **Phase 3 Trial for Prader-Willi Syndrome**: Ongoing, with top-line data expected in Q3 2026 [10][11] - **Phase 2 Data**: Showed significant reduction in hyperphagia in most patients, with a focus on safety and tolerability [12][13] - **Hyperphagia Questionnaire (HQCT)**: Used to assess treatment efficacy, with a one-point difference considered clinically meaningful [17][18] Patient Demographics and Inclusion Criteria - **Age Range**: Phase 3 trial includes patients aged 10 and above, previously 13 and above, to target younger patients who experience hyperphagia earlier [20][21] - **Antipsychotic Use**: Patients on antipsychotics are included to ensure real-world representation, with 20%-30% of the Prader-Willi population typically using them [33][34] Geographic Distribution - **Trial Sites**: Approximately one-third of patients are from the U.S., with the remainder from countries including Canada, Australia, South Korea, and various EU nations [35] Quality Control Measures - **Assessment Consistency**: Caregivers and physicians remain consistent throughout the trial to minimize variability in HQCT scores [24][26] - **Blinded Checks**: Implemented to ensure quality control of assessments [26] Future Studies - **Weight Maintenance Study**: Anticipated preliminary data by the end of next year, focusing on maintaining weight after GLP-1 receptor agonist treatment [41][43] - **Weight Induction Study**: Aims to evaluate the effectiveness of ARD-201 in driving greater weight loss compared to existing treatments [50] Conclusion - Aardvark Therapeutics is positioned to make significant advancements in the treatment of Prader-Willi syndrome and obesity through innovative drug mechanisms and robust clinical trial designs, with key data expected in the coming years [51][52]

Core Insights - Aardvark Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small-molecule therapeutics aimed at treating metabolic diseases, particularly through the activation of innate homeostatic pathways [2] Company Overview - Aardvark is developing novel therapeutics designed to suppress hunger, specifically targeting conditions like Prader-Willi Syndrome (PWS) and other metabolic diseases [2] - The lead compound, ARD-101, is currently in Phase 3 clinical development for hyperphagia associated with PWS and is also being studied for hypothalamic obesity [2] - Aardvark is also working on ARD-201, a fixed-dose combination of ARD-101 with a DPP-4 inhibitor, to address limitations of existing GLP-1 therapies for obesity and related conditions [2] Upcoming Events - Aardvark will present at the Piper Sandler 37th Annual Healthcare Conference in New York on December 3 at 8:00 a.m. ET [4] - The company will also present at the Evercore ISI 8th Annual Healthcare Conference in Miami on December 4 at 11:15 a.m. ET [4] - Live webcasts of these presentations will be available on the company's website, with archived recordings accessible for approximately one month [1]