Fatty Liver

This historic acquisition reduces barriers that prevent people from taking control of their lifelong health. Full Body MRI scan now takes just 22 minutes instead of 60 minutes, costs $499 instead of over $1,500 NEW YORK, May 5, 2025 /PRNewswire/ -- Function Health has acquired Ezra and is launching a Full Body MRI with an FDA-cleared AI that cuts scan time from 60 minutes to 22 minutes, and $1500 to $499. This dramatic reduction in both time and cost makes annual scanning possible, creating a more comprehensive 360-degree view inside your body. By combining Function's extensive lab testing foundation with Ezra's FDA-cleared AI-powered imaging, they've integrated these two approaches into one seamless platform designed to keep you healthy for life. Function and Ezra together represent the exact data needed to create the new standard of care. By merging Function's extensive lab testing with Ezra's imaging, they're creating a dataset that will allow AI to become truly predictive—potentially identifying health issues before they occur. "I wish I could see millions of patients," says Mark Hyman, MD, co-founder and Chief Medical Officer of Function Health. "This is the most powerful approach I've seen in my entire career—and for the first time, it can truly scale to millions. It's the new standard of care—if you're reading this: get your labs, get your scan, every year. It could save and radically improve your life." The new 22-minute Full Body MRI is designed to help detect cancer early—often prior to any symptoms. Beyond cancer, the scan can also reveal hidden issues you otherwise might not know about, like silent strokes that could lead to cognitive decline and developing aneurysms before they rupture. Additional scans now being offered by Function look for spinal issues affecting mobility, early-stage fatty liver disease, and body composition details more precise than what DEXA scans provide. "Adding imaging was part of our vision from day one," says Jonathan Swerdlin, co-founder and CEO of Function Health. "Our brilliant team first focused on making comprehensive lab testing affordable and widely available. Now with Ezra becoming a part of Function, we complete the picture. It's time everyone owns their health, every year. This is the best use of AI—applying it directly to human life." Before AI, annual full body scans were simply not possible at scale. The prohibitive cost and lengthy scan times meant they could only be done as one-off procedures for a select few. AI has fundamentally changed this equation. For half the scan time and a third of the price, scanning every year is now practical and affordable. "A single health snapshot is like one frame from a movie—you miss the story," says Dan Sodickson, MD, PhD, Chief Scientific Advisor of Ezra. "Finally, reducing the cost and scan time of full body MRI unlocks the ability to capture an annual imaging baseline. This longitudinal dataset reveals subtle changes over time that catch immediate issues and can predict disease before symptoms even appear. This fundamentally transforms medicine." By making advanced MRI technology more affordable and accessible, Function is establishing a new standard of health. The integration creates a more complete view of individuals' health, combining detailed lab testing with advanced medical imaging in a single, cohesive platform, at an affordable price. "I started Ezra with a clear mission: to detect cancer early for everyone in the world," says Emi Gal, founder of Ezra. "This mission is deeply personal for me—if my mother had detected cancer early, she would still be alive today. Over the past six years my team and I have helped countless people find cancer, many of whom are now cancer free. We are now scaling this to millions together with Function." Scans are now immediately available for every Function member at nearly 100 locations across the US, with plans to expand to over 1,000 locations in the coming months. Function's lab testing platform is already available at all 2,200 Quest Diagnostics locations nationwide. AI is revolutionizing healthcare beyond language models. Ezra's FDA-cleared AI technology cuts scan time from 60 minutes to 22 minutes, while Function's nationwide platform makes these scans accessible to members across the country. This transforms yesterday's luxury into today's essential—Full Body MRI scans at $499 instead of $1,500. For more information on Function, visit . About Function Health Function Health is a personal health platform that pioneered accessible annual lab testing with over 160 tests at 2,000+ locations nationwide, serving hundreds of thousands of members. The platform tracks all results over time and provides clear clinical explanations alongside actionable insights based on comprehensive medical research. About Ezra Ezra developed FDA-cleared AI technology that makes full body MRI scanning faster and more affordable. The company's technology helps visualize early signs of potential cancer and other health conditions before symptoms appear. SOURCE Function Health WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Madrigal Pharmaceuticals’ fatty liver disease drug Rezdiffra generated $137 million in sales during the first quarter of 2025, well above analysts’ consensus expectation of $112 million. Since its historic FDA approval in March 2024 as the first medication for the treatment of the prevalent liver disease metabolic dysfunction-associated steatohepatitis (MASH), Madrigal Pharmaceuticals’ Rezdiffra has handily beat Wall Street’s sales projections for the fourth straight quarter.On a roll, Rezdiffra generated $137 million in sales during the first quarter of 2025, well above analysts’ average expectation of $112 million. The haul also marked a sequential increase from the fourth quarter’s $103 million, which also beat consensus, bringing the drug’s sales in the first 12 months on the market to $317 million.“By any measure, this is an exceptional launch,” Madrigal CEO Bill Sibold said on an investor call Thursday.“Importantly, the Rezdiffra launch continues to be driven by strong underlying patient demand,” Leerink Partners analysts wrote in a Thursday note.As of the end of March, more than 17,000 MASH patients were actively taking Rezdiffra, compared with more than 11,800 at year-end 2024, according to Madrigal. Rezdiffra’s speed of adding new patients matches that from other top-tier specialty launches, Sibold said.The launch is still at an early stage, as Madrigal is targeting 315,000 patients who fall under Rezdiffra’s FDA-approved label and are currently treated by the company’s target prescribers. Among the 6,000 top MASH prescribers targeted by Madrigal, 70% have prescribed Rezdiffra, Sibold said. Before Rezdiffra’s approval, investors were worried that the FDA would require patients to undergo a liver biopsy to determine treatment eligibility. Now that the drug’s label doesn’t require that test, a potential restriction by payers has become a new investor concern.A key opinion leader in the MASH field—who leads the fatty liver clinic at an academic center in California that takes care of about 3,000 MASH patients—recently told Leerink that he has not encountered a single payer requiring liver biopsy before granting access to Rezdiffra.The expert indicated that 90% of his patients have remained on Rezdiffra after a year of treatment, with a small percentage of discontinuations related to tolerability or lack of treatment response, according to a Leerink note on Thursday.In what Sibold described as a standard move for medicines, payers may require reauthorization of Rezdiffra after a year of treatment based on a patient’s performance. The company doesn’t see that as an issue, he said, as physicians’ feedback so far suggests the drug's efficacy has exceeded expectations.“Physicians and patients continue to highlight meaningful improvements they see on the efficacy measures that matter most to patients such as liver stiffness, liver fat, liver enzymes, LDL and triglycerides,” Sibold said on the call.Competition may be coming, though, potentially first in the form of Novo Nordisk’s formidable GLP-1 semaglutide later this year.Novo is targeting a market that’s “multiples” the size of Madrigal’s target population of 315,000 patients, Sibold noted. Given that Rezdiffra has only penetrated 5% of its own target population, Madrigal still sees “years of growth” ahead, he said.About 25% of Rezdiffra takers are already on a GLP-1 product, Sibold noted, suggesting that there’s still a need for other MASH treatments despite the GLP-1 drugs having been around for more than a decade, albeit not specifically for MASH.Semaglutide is “only going to accelerate diagnosis and add to that” target, Sibold added, suggesting Novo will expand the market to the benefit of Madrigal as well. Putting potential geographic market expansion in its own hands, Madrigal is expecting a regulatory opinion from the European Medicines Agency and subsequent EU market authorization in mid-2025. The company plans to launch first in Germany in the second half of the year.While Rezdiffra is currently approved for stage F2 and F3 non-cirrhotic MASH, also known as nonalcoholic steatohepatitis (NASH), Madrigal is also aiming to unlock the F4 cirrhotic population.The company will present detailed two-year data from the compensated MASH cirrhosis arm of the phase 3 Maestro-NAFLD-1 trial next week at the European Association for the Study of the Liver Congress. Outcomes data from the large Maestro-NASH Outcomes trial in compensated cirrhosis are expected in 2027.The expansion to F4 cirrhosis is “a key pillar of our long-term NASH leadership strategy,” Sibold said, noting that the indication could double Rezdiffra’s market opportunity.

VAMOS analysis highlights link between EVAF and reduced muscle quality Case series reports success with combination tesamorelin/GLP-1 receptor agonist therapy MONTREAL, May 02, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, today announced two poster presentations at the 19th Annual American Conference for the Treatment of HIV (ACTHIV 2025), taking place May 1-3 in Chicago, Ill. Both presentations focus on issues surrounding excess visceral abdominal fat (EVAF), a common comorbidity in people with HIV (PWH). One poster presents a new analysis of data from the Visceral Adiposity Measurement and Observations Study (VAMOS), in which EVAF was associated with reduced muscle quality in aging PWH. VAMOS is the first trial designed to improve the understanding of the impact of EVAF on cardiovascular disease, steatotic liver disease, insulin resistance, and other metabolic parameters in PWH. The second presentation reports on a first-of-its-kind case series in which the combination of tesamorelin and glucagon-like peptide-1 (GLP-1) receptor agonist (RA) therapy was highly effective in reducing both EVAF and obesity in a real-world setting. “We are proud to continue our exploration into the complexities of excess visceral abdominal fat in people with HIV,” said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer of Theratechnologies. “As people with HIV live longer, analyses such as the data we are presenting at ACTHIV are critical to addressing this population’s evolving health needs. Our research adds to the growing understanding that body composition, most importantly EVAF, is a key factor in aging-related functional decline in HIV, and we are committed to investigating this complex relationship.” VAMOS Analysis Poster Title: Reduced Muscle Quality is Highly Prevalent in Aging People with HIV (PWH) and is Associated with Excess Visceral Abdominal Fat (EVAF) First Author: Zachary Henry, DO, AIDS Healthcare Foundation, Fort Lauderdale, Fla. In the latest analysis from the multicenter VAMOS study, researchers investigated how EVAF, compared to subcutaneous fat, is associated with muscle quality in PWH on modern anti-retroviral regimens, and explored potential drivers of this relationship. Among the 170 participants, EVAF prevalence was 58%. Muscle quality was found to be lower with increasing age of participants (r= -0.465; p<0.0001), but was not significantly correlated with body mass index (BMI) (r= -0.118; p=0.124). EVAF was associated with lower skeletal muscle quality, as demonstrated by lower muscle mean attenuation (r= -0.445; p<0.0001). The researchers concluded that increased levels of visceral fat – more so than subcutaneous fat or increasing BMI – strongly correlate with reduced skeletal muscle quality, which may amplify age-related functional declines. Tesamorelin/GLP-1 RA Case Series Poster Title: High Levels of Treatment Success Seen with Combined Use of Tesamorelin and GLP1-RAs in People with HIV First Author: Daniel Lee, MD, University of California San Diego Department of Medicine, San Diego, Calif. In the case series, investigators reported on the real-world use of tesamorelin for the treatment of EVAF in PWH, in combination with GLP-1 RAs, which are commonly used for diabetes and obesity management in the general population. Among the seven PWH evaluated in the case series, tesamorelin was initiated first in all cases to address EVAF, with a mean reduction in waist circumference of 1.3 inches. The principal reasons for adding a GLP-1-RA included improving BMI and diabetic control. Following at least six months of combination therapy, patients saw mean reductions in weight (-13 pounds), BMI (-2.2 kg/m2), and waist circumference (-3.4 inches), with six of the seven patients achieving their metabolic and body composition goals. Combination therapy is ongoing in most of the patients (6/7). This is the first known report of the dual use of these agents in PWH, highlighting their complementary but distinct mechanisms of action.​ “The combination of tesamorelin and GLP-1 medications represents a new frontier in metabolic care for people with HIV,” noted Dr. Marsolais. “By distinguishing between and targeting both excess visceral abdominal fat and generalized obesity, treatment strategies can be tailored to address the specific needs of people living with HIV.” Both posters can be found at www.theratech.com and www.acthiv.org following the conference. About Theratechnologies Theratechnologies (TSX: TH) (NASDAQ: THTX) is a specialty biopharmaceutical company focused on the commercialization of innovative therapies that have the potential to redefine standards of care. Further information about Theratechnologies is available on the Company's website at www.theratech.com, on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Follow Theratechnologies on LinkedIn and X. Forward-Looking Information This press release contains forward-looking statements and forward-looking information (collectively, the “Forward-Looking Statements”), within the meaning of applicable securities laws, that are based on our management’s beliefs and assumptions and on information currently available to our management. You can identify Forward-Looking Statements by terms such as "may", "will", "should", "could", “promising”, “would”, "outlook", "believe", "plan", "envisage", "anticipate", "expect" and "estimate", or the negatives of these terms, or variations of them. The Forward-Looking Statements contained in this press release include, but are not limited to, statements regarding the Company’s commitment to investigate the relationship between body composition and aging and the tailoring of treatment strategies for PWH. Forward-looking statements involve a number of assumptions, risks and uncertainties. Some of these assumptions include, but are not limited to, the duration of treatment and the responses to the administered drugs by PWH. Some of the risks include that PWH may not respond similarly when they take medicines and results may differ from what those were observed and reported through VAMOS and the tesamorelin/GLP-1 RA case series. The Company refers current and potential investors to the “Risk Factors” section of the Company’s Annual Information Form filed on Form 20-F dated February 26, 2025 available on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov under Theratechnologies’ public filings for the risks associated with the business of Theratechnologies. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-Looking Statements reflect current expectations regarding future events and speak only as of the date of this press release and represent the Company’s expectations as of that date. The Company undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law. Contacts: Media inquiries:Julie SchneidermanSenior Director, Communications & Corporate Affairscommunications@theratech.com514-336-7800 Investor Inquiries:Joanne ChoiSenior Director, Investor Relationsjchoi@theratech.com551-261-0401