AARD Jun 2, 2026AARDPhases
Aardvark Therapeutics (AARD) Faces Investor Scrutiny Amid 56% Drop On Clinical Pause For Lead Drug Candidate– Hagens Berman
Aardvark Therapeutics has paused its Phase 3 HERO trial for ARD-101, leading to a severe drop in share price by 56%. This decision was made due to concerns over serious safety risks identified during the trial. Following the announcement, shareholder rights firm Hagens Berman opened an investigation into whether the company misled investors regarding the drug's safety, efficacy, and communications with the FDA. As a result of these developments, several analysts have lowered their price targets for Aardvark's stock.
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AARD May 14, 2026AARDFDA Updates
Aardvark Therapeutics Plans to Unblind HERO and OLE Data to Inform Path Forward Following FDA Clinical Hold
Aardvark Therapeutics has announced that the FDA has placed a full clinical hold on its IND for ARD-101, affecting the ongoing clinical studies, including the Phase 3 HERO trial for treating hyperphagia in Prader-Willi Syndrome. In response, the company plans to unblind existing trial data to assess the overall efficacy and safety of ARD-101 and determine the path forward. Aardvark is engaged in discussions with the FDA to resolve the clinical hold while maintaining a strong commitment to the PWS community. Currently, the company has sufficient financial resources to sustain operations into mid-2027.
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AARD May 7, 2026AARDGeneral
Aardvark Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Updates ARD-101 and ARD-201 programs on voluntary pause; further guidance expected in Q2 2026 $91.2 million in cash, cash equivalen
Aardvark Therapeutics reported its financial results for Q1 2026, highlighting a cash position of $91.2 million which is expected to finance operations through mid-2027. The company placed its ARD-101 and ARD-201 programs on voluntary pause amidst cardiac safety concerns linked to a healthy volunteer trial. Aardvark is in discussions with the FDA to outline the next steps and intends to provide updates in Q2 2026. Despite the challenges, positive clinical findings for ARD-101 were published recently, indicating a reduction in hunger in trial participants.
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AARD Mar 24, 2026AARDPhases
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Aardvark Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Updates
Aardvark Therapeutics has reported its financial results for Q4 and the full year 2025, highlighting a voluntary pause in its Phase 3 trials for ARD-101, aimed at treating hyperphagia in Prader-Willi Syndrome. The company has $110 million in cash to fund operations through mid-2027. Further guidance on its programs is expected in Q2 2026, as they continue to engage with the FDA regarding the next steps.
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AARD Mar 23, 2026AARDPhases
Aardvark Therapeutics, Inc. Consolidated Balance Sheets (in thousands, except share amounts)
Aardvark Therapeutics has reported its financial results for 2025 and announced a voluntary pause of its Phase 3 HERO and OLE trials for ARD-101, following unexpected cardiac observations. The company also paused its ARD-201 obesity trials pending further guidance, expected in Q2 2026. Despite these setbacks, Aardvark maintains a strong cash position and believes it can fund operations through mid-2027. Recent data supporting ARD-101's efficacy and safety have been published, reinforcing the company's commitment to its therapeutic programs.
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AARD Mar 11, 2026AARDPhases
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Aardvark Therapeutics, Inc. Investigated by the Portnoy Law Firm
The Portnoy Law Firm has initiated an investigation into Aardvark Therapeutics, Inc. regarding possible securities fraud following a significant drop in stock price. This decline came after the company announced a voluntary pause of its Phase 3 HERO trial due to serious safety concerns related to cardiac issues. Aardvark is currently conducting a comprehensive review of the situation while the future of the HERO program remains uncertain. Investors are encouraged to contact the law firm for potential claims related to their losses.
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AARD Mar 2, 2026AARDPhases
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Aardvark Therapeutics Announces Voluntary Pause of Phase 3 HERO Trial in Prader-Willi Syndrome
Aardvark Therapeutics has voluntarily paused its Phase 3 HERO trial for ARD-101, aimed at treating hyperphagia in Prader-Willi Syndrome, due to cardiac safety concerns observed in a healthy volunteer study. The company is conducting a comprehensive review of the data before proceeding. This decision has delayed the anticipated topline data announcement to a later date.
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AARD Feb 13, 2026AARDGeneral
Aardvark Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Aardvark Therapeutics has announced inducement grants for new employees under Nasdaq Listing Rule 5635(c)(4). Five employees received stock options for 147,213 shares, while one received options for 5,125 shares. The options will vest over four years, supporting the company's growth and employee retention strategy.
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AARD Feb 12, 2026AARDGeneral
Aardvark Therapeutics Announces Establishment of New U.S. Subsidiary to Support Development of Its Dermatology Pipeline; Bryan Jones Named Chief Executive Officer
Aardvark Therapeutics has launched a new subsidiary, Ardia Therapeutics, to advance its dermatology pipeline, particularly focusing on DIA-615, a topical treatment for inflammatory skin diseases. Bryan Jones has been appointed as CEO of Ardia, transitioning from his role at Aardvark. The company aims to address unmet needs in skin disease treatment while navigating potential clinical and operational risks.
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AARD Feb 12, 2026AARDGeneral
Aardvark Therapeutics Announces Leadership Appointments
Aardvark Therapeutics has appointed Derrick C. Li as Chief Business Officer and expanded Nelson Sun's role to Chief Operating Officer. These changes are aimed at enhancing the company's leadership as it progresses with its clinical trials for ARD-101 and ARD-201. The appointments are expected to drive growth and unlock value for stakeholders.
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AARD Feb 10, 2026AARDPhases
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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 has received FDA submission and IRB approval for an amended protocol in its Phase 3 HERO trial, allowing participation for children as young as 7 years old with Prader-Willi Syndrome. This change aims to broaden access and capture the potential impact of ARD-101 on hyperphagia. The trial is progressing, with topline data expected in Q3 2026.
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AARD Jan 12, 2026AARDPhases
Disclaimer Aardvark Therapeutics, Inc. (the “Company”) does not (nor its respective affiliates, directors, members, officers, employees or agents) make any representation or warranty, express or implied, as
Aardvark Therapeutics has released a corporate presentation outlining its operations and future plans, specifically focusing on its drug ARD-101 aimed at treating hyperphagia in Prader-Willi Syndrome. The company acknowledges the uncertainties associated with its forward-looking statements and emphasizes that the information provided should not be solely relied upon. With funding secured until 2027 and upcoming data from the Phase 3 HERO trial expected in Q3 2026, Aardvark aims to tackle significant unmet medical needs in obesity and metabolism disorders. The presentation also discusses key developments related to ongoing clinical trials and market opportunities.
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AARD Dec 11, 2025AARDPhases
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Aardvark Therapeutics Announces First Patient Dosed in Australia in HERO Phase 3 Trial for Prader-Willi Syndrome
Aardvark Therapeutics has initiated dosing of the first patient in Australia for its Phase 3 HERO trial, which evaluates ARD-101 for hyperphagia in Prader-Willi syndrome. The trial has received regulatory clearance in Canada and the UK, with strong enrollment in the US. Topline data is anticipated in Q3 2026.
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AARD Nov 25, 2025AARDConferences/Events
Aardvark Therapeutics to Present at Upcoming Investor Conferences in December
Aardvark Therapeutics, Inc. will present at two major investor conferences in December, aimed at showcasing its clinical-stage developments. The company focuses on small-molecule therapeutics for metabolic diseases and is advancing its lead compound, ARD-101, in Phase 3 trials for hyperphagia related to Prader-Willi Syndrome. Future trials are planned to explore additional therapeutic options. Investors can access live webcasts of the presentations on the company's website.
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AARD Nov 13, 2025AARDPhases
Aardvark Therapeutics Reports Third Quarter 2025 Financial Results and Provides Pipeline and Business Updates Aardvark has aligned with the FDA to reduce the minimum age of eligibility from 13 to 10 years old for pediatr
Aardvark Therapeutics reported its financial results for Q3 2025, highlighting updates on its pipeline and business strategies. The company aligned with the FDA to lower the minimum age for pediatric trial eligibility in its ARD-101 HERO trial. They presented encouraging preclinical data on ARD-201, which shows potential for improved glucose control and weight management. Aardvark's financial position remains strong, with $126.4 million in cash projected to fund operations into 2027, despite an increase in net losses compared to the previous year due to rising R&D costs.
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AARD Nov 11, 2025AARDGeneral
Aardvark Therapeutics Announces Inducement Grant Under Nasdaq Listing Rule 5635(C)(4)
Aardvark Therapeutics announced the grant of a stock option to a new employee as part of its 2025 Inducement Equity Incentive Plan. The option allows the purchase of 4,881 shares at a price of $10.44, vesting over four years. This move supports the company's commitment to attract talent while focusing on developing treatments for metabolic diseases.
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AARD Nov 6, 2025AARDConferences/Events
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Disclaimer Aardvark Therapeutics, Inc. (the “Company”) does not (nor their respective affiliates, directors, members, officers, employees or agents) make any representation or warranty, express or implied,
Aardvark Therapeutics, Inc. issued a disclaimer during their ObesityWeek Investor Webinar regarding the reliability of their projections and future performance. They emphasized that the information provided is based on significant assumptions and may not be accurate, with actual results potentially differing materially from expectations. Furthermore, the products discussed, notably ARD-101 and ARD-201, are still under clinical investigation and have not yet received FDA approval. Aardvark clarified that there is no liability for inaccuracies within their presentation.
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AARD Nov 4, 2025AARDPhases
Aardvark Therapeutics Presents Data Supporting its Metabolic Obesity Pipeline Programs at ObesityWeek 2025
Aardvark Therapeutics presented promising data on its metabolic obesity programs, particularly ARD-201, at ObesityWeek 2025. The data suggests ARD-201 may effectively enhance glucose control and support weight management after GLP-1RA therapy discontinuation. The company plans to initiate Phase 2 trials, POWER and STRENGTH, to further assess ARD-201's potential.
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AARD Nov 3, 2025AARDConferences/Events
Aardvark Therapeutics to Present at Upcoming Investor Conferences in November
Aardvark Therapeutics, a clinical-stage biopharmaceutical company, announced its participation in several investor conferences in November. The company focuses on developing small-molecule therapeutics for metabolic diseases, with its lead compound ARD-101 in Phase 3 trials for treating hyperphagia associated with Prader-Willi Syndrome. Presentations will be accessible via live webcasts on their website.
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AARD Nov 3, 2025AARDGeneral
Aardvark Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(C)(4)
Aardvark Therapeutics, Inc. announced inducement grants under Nasdaq Listing Rule 5635(c)(4) for new employees. On October 20 and 28, 2025, the company granted stock options to four new hires, totaling 73,417 shares, with a final grant on November 3, 2025. These options will vest over four years, supporting employee commitment. The company is advancing innovative therapies, notably for Prader-Willi Syndrome and obesity-related conditions.
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AARD Oct 22, 2025AARDConferences/Events
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Aardvark Therapeutics to Present Data on Pipeline Programs at Upcoming ObesityWeek
Aardvark Therapeutics will present data on its pipeline programs at ObesityWeek 2025, including findings on ARD-101 and WE-868. The company is also hosting an investor webinar to discuss these findings and their implications for obesity treatment. ARD-101 is currently in Phase 3 trials for Prader-Willi Syndrome, while ARD-201 is advancing in Phase 2 trials.
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AARD Oct 9, 2025AARDFDA Updates
forward-looking statement, whether as a result of new information, future events or otherwise. ### Contact : Carolyn Hawley, Inizio Evoke Comms (619) 849-5382 Carolyn.hawley@inizioevoke.com
Aardvark Therapeutics has announced FDA alignment on a protocol amendment for its Phase 3 HERO trial, allowing participation for children aged 10 and above with Prader-Willi Syndrome (PWS). This expansion is aimed at accessing a broader patient population and is supported by evidence that younger patients may benefit more from early intervention. The trial evaluates ARD-101, a small molecule designed to reduce hyperphagia, and Aardvark expects topline data readout in Q3 2026. The company holds Orphan Drug and Rare Pediatric Disease Designations for ARD-101.
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AARD Oct 8, 2025AARDFDA Updates
Aardvark Therapeutics Announces FDA Alignment on Protocol Amendment Expanding Phase 3 HERO Trial Population for Prader-Willi Syndrome
Aardvark Therapeutics has received FDA approval for a protocol amendment in its Phase 3 HERO trial, lowering the minimum age for participation from 13 to 10 years. This change aims to include more patients with Prader-Willi Syndrome, potentially improving treatment outcomes. The company anticipates topline data readout in Q3 2026.
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AARD Sep 23, 2025AARDConferences/Events
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Aardvark Therapeutics to Present at the Stifel 2025 Virtual Cardiometabolic Forum
Aardvark Therapeutics, a clinical-stage biopharmaceutical company, will present at the Stifel 2025 Virtual Cardiometabolic Forum on September 30, 2025. The presentation will focus on their novel therapeutics aimed at treating metabolic diseases, including their lead compound ARD-101, which is in Phase 3 development for Prader-Willi Syndrome. A live webcast will be available on their website.
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AARD Sep 3, 2025AARDGeneral
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Corporate Presentation September 2025 Disclaimer Aardvark Therapeutics, Inc. (the “Company”) does not (nor their respective affiliates, directors, members, officers, employees or agents) make any representa
Aardvark Therapeutics, Inc. presented a disclaimer outlining the limitations and uncertainties regarding its forecasts and projections, emphasizing that no warranties are made about the information in the presentation. The company is focused on developing ARD-101 for treating hyperphagia associated with Prader-Willi Syndrome and has ongoing trials aimed at addressing significant unmet medical needs. The upcoming Phase 3 HERO trial is projected to read out data in Q3 2026, and the potential market opportunity for their therapies is underscored, although they highlight the inherent risks in their projections.
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AARD Aug 27, 2025AARDConferences/Events
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Aardvark Therapeutics to Present at Upcoming Investor Conferences in September
Aardvark Therapeutics, Inc. (AARD) has announced its participation in several investor conferences scheduled for September 2025, including the Cantor Fitzgerald Global Healthcare Conference and the Morgan Stanley 23rd Annual Global Healthcare Conference. The company is focused on developing novel therapeutics targeted at metabolic diseases, particularly for patients dealing with insatiable hunger related to Prader-Willi Syndrome. Aardvark's lead product, ARD-101, is currently in Phase 3 trials, indicating promising advancements in their clinical pipeline. The presentations will be accessible via live webcasts on the company's website.
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AARD Aug 13, 2025AARDGeneral
Aardvark Therapeutics Reports Second Quarter 2025 Financial Results and Provides Pipeline and Business Updates
Aardvark Therapeutics reported its Q2 2025 financial results and provided updates on its clinical pipeline. The company plans to expand the Phase 3 HERO trial of ARD-101 to include patients under 13 years old, aiming to enhance treatment accessibility for PWS. Additionally, promising preclinical results for ARD-201 have led to the initiation of two Phase 2 trials, replacing the previously planned EMPOWER trial.
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AARD Aug 12, 2025AARDPhases
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Aardvark Therapeutics 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
Aardvark Therapeutics announced positive preclinical data for ARD-201, highlighting its effectiveness in achieving significant weight loss and improving weight maintenance when combined with low-dose GLP-1RA therapy. The treatment led to a 19% reduction in body weight after 30 days in validated animal models. Furthermore, the company plans to initiate two Phase 2 clinical trials, focusing on the therapy's efficacy in preventing weight regain and enhancing weight loss. Aardvark positions ARD-201 as a novel oral option in obesity management, capable of supporting patients both during and after GLP-1RA treatment.
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AARD Jul 18, 2025AARDGeneral
Aardvark Therapeutics Announces Inducement Grants Under NASDAQ Listing Rule 5635(C)(4)
Aardvark Therapeutics, Inc. has issued inducement grants of stock options to two new employees, as part of its 2025 Inducement Equity Incentive Plan. The grants include options to purchase a total of 10,372 shares at prices reflecting recent closing values. The vesting schedule allows for shares to vest over four years, supporting employee retention. Aardvark continues to focus on developing therapeutics for metabolic diseases, particularly targeting Prader-Willi Syndrome with its lead compound, ARD-101, currently in Phase 3 clinical trials.
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AARD Jun 24, 2025AARDConferences/Events
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Aardvark Therapeutics to Join Prader-Willi Syndrome Community at the 2025 United in Hope Conference
Aardvark Therapeutics, a clinical-stage biopharmaceutical company, announced its participation in the 2025 United in Hope Conference for the Prader-Willi Syndrome (PWS) community. The conference will take place from June 24 to 28 in Phoenix, Arizona, where Aardvark will present data from its Phase 2 study of ARD-101, highlighting its safety and potential to reduce hyperphagia. The CEO expressed pride in contributing to the dialogue around PWS and emphasized the importance of partnerships within the community. The ongoing Phase 3 HERO study is also a key focus of the company's efforts.
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AARD May 19, 2025AARDGeneral
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Aardvark Therapeutics Bolsters Leadership Team with Strategic Hires Across Scientific, Commercial, Regulatory and Legal Functions
Aardvark Therapeutics has announced the appointment of several key leaders including Timothy Kieffer, Ph.D. as Chief Scientific Officer, Danny Villeneuve as Chief Commercial Officer, Terrie Kellmeyer, Ph.D. as Senior Vice President of Regulatory Affairs, and Christian Zapf, J.D. as General Counsel. These hires are aimed at bolstering the company's leadership as they advance with the Phase 3 HERO study of ARD-101, a treatment for hyperphagia associated with Prader-Willi Syndrome. This strategic expansion of the team is expected to enhance Aardvark's expertise and insight into its clinical development and commercial strategies.
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AARD May 14, 2025AARDPhases
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Aardvark Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Highlights • Phase 3 HERO trial of ARD-101 for the treatment of hyperphagia associated with Prader-Willi Syndrome (PWS); dat
Aardvark Therapeutics, Inc. reported its financial results for the first quarter of 2025, highlighting a cash position of $151.3 million, which is expected to sustain operations into 2027. The company is focusing on its lead candidate, ARD-101, targeted for the treatment of hyperphagia associated with Prader-Willi Syndrome and plans to release data from its Phase 3 HERO trial in early 2026. However, the company also reported a net loss that has increased compared to the previous year, alongside rising research and development expenses.
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AARD May 7, 2025AARDConferences/Events
Aardvark Therapeutics to Present at Upcoming Investor Conferences in May
Aardvark Therapeutics, Inc. will present at several investor conferences in May, including the Bank of America Global Healthcare Conference and H.C. Wainwright's BioConnect Investor Conference. The presentations will showcase the company's pipeline, particularly focused on novel therapeutics for metabolic diseases such as hyperphagia associated with Prader-Willi Syndrome. Aardvark's lead candidate, ARD-101, is currently undergoing Phase 3 clinical trials, reflecting its commitment to addressing significant health challenges. Access to live webcasts and recordings will be available on the company's website.
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AARD Mar 31, 2025AARDPhases
Aardvark Therapeutics Reports Full Year 2024 Financial Results and Provides Business Highlights • Lead candidate ARD-101 demonstrated clinical activity and was generally well tolerated in a two-part Phase 2 trial
Aardvark Therapeutics reported strong financial results for the year 2024, highlighted by successful clinical outcomes of its lead candidate ARD-101 in a Phase 2 trial for Prader-Willi Syndrome. The trial indicated significant reductions in hyperphagia and favorable changes in body composition. Aardvark's successful IPO in early 2025 has reinforced its financial stability, enabling further development of its clinical pipeline, including a currently ongoing Phase 3 trial for ARD-101. The company plans to address potential market needs in obesity treatment through additional clinical trials in the coming years.
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AARD Feb 13, 2025AARDGeneral
Aardvark Therapeutics Announces Pricing of Initial Public Offering
Aardvark Therapeutics, a clinical-stage biopharmaceutical company, announced the pricing of its initial public offering, selling 5,888,000 shares at $16.00 each. This move is expected to yield approximately $94.2 million before deductions. The shares are scheduled to start trading on the Nasdaq under the ticker symbol 'AARD' on February 13, 2025. Additionally, underwriters have a 30-day option to purchase more shares as part of the offering.
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AARD Jan 9, 2025AARDGeneral
Aardvark Therapeutics Appoints Renowned Biopharma Leaders Roy D. Baynes and Susan E. Graf to its Board of Directors
Aardvark Therapeutics has appointed Roy D. Baynes and Susan E. Graf to its Board of Directors. Baynes, a former Chief Medical Officer at Merck, and Graf, a seasoned biotech executive, will provide strategic guidance as Aardvark advances its obesity therapy pipeline. The company is focused on developing treatments for conditions like Prader-Willi Syndrome.
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AARD Sep 12, 2024AARDGeneral
Aardvark Therapeutics Expands Management Team with Two Key Hires
Aardvark Therapeutics has appointed Manasi Jaiman, M.D., as Chief Medical Officer and Tom Bicsak, Ph.D., as Head of Regulatory Affairs. These hires aim to expedite the development of ARD-101, a novel treatment targeting hunger suppression, particularly for Prader-Willi Syndrome. The company emphasizes the drug's unique mechanism and promising clinical data.
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AARD Aug 17, 2024AARDPhases
Interview with NYSE: Revolutionizing Obesity Treatment with ARD-101
Dr. Tien Lee, CEO of Aardvark Therapeutics, discussed the innovative obesity drug ARD-101 in an interview. The drug targets bitter taste receptors to reduce hunger and has shown promising results in Phase 2 trials for Prader-Willi syndrome and general obesity. Aardvark aims to minimize side effects typical of other treatments and is preparing for future trials focused on maintaining weight loss.
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AARD Jul 23, 2024AARDGeneral
Dr. Tien Lee, Founder and CEO of Aardvark Therapeutics, interviews on accomplishments with Nasdaq
Dr. Tien Lee, the Founder and CEO of Aardvark Therapeutics, recently spoke with Nasdaq about the company's achievements, including securing new funding. He highlighted the company's focus on gut-brain interaction, particularly in relation to inflammation and metabolism. This interview showcases Aardvark's commitment to advancing research in these critical areas.
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AARD May 10, 2024AARDGeneral
Aardvark Therapeutics Announces $85 Million Oversubscribed Series C Financing
Aardvark Therapeutics has announced an $85 million oversubscribed Series C financing led by Decheng Capital. The funds will be used to complete clinical trials for ARD-101, aimed at treating hyperphagia in Prader-Willi Syndrome. The drug has shown promising results in early trials and has received FDA designations that facilitate its development.
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AARD Sep 12, 2023AARDGeneral
Biotech execs vie for a share of obesity drug boom: ‘It’s the early innings’
The article discusses the competitive landscape among biotech executives aiming to capitalize on the growing market for obesity drugs. It emphasizes that the market is still in its early stages, suggesting potential for future growth and innovation. The executives are actively seeking opportunities to establish their presence in this emerging field.
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AARD Aug 5, 2023AARDPhases
Aardvark Therapeutics Announces Receipt of FDA Rare Pediatric Disease Designation for Prader-Willi Syndrome and Expands the Ongoing Phase 2 Clinical Trial
Aardvark Therapeutics has received FDA Rare Pediatric Disease Designation for ARD-101, aimed at treating Prader-Willi Syndrome (PWS). The Phase 2 clinical trial is expanding enrollment based on promising early results. This designation allows Aardvark to qualify for a Priority Review Voucher upon approval. PWS is characterized by extreme hunger and obesity, and no approved treatments currently exist for its hyperphagia.
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