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November 5, 2026 | Unsubscribe
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New Alert: MetaVia Inc. (NASDAQ: MTVA)
MTVA is our brand new NASDAQ biotech alert.
This is a hidden gem that not many have found, and we are amongst the first to bring it to your attention.
It is in one of the hottest areas in all of healthcare: the next generation of obesity drugs.
The company has a history of experiencing incredible upside volatility in a very short period of time.
Right now, MTVA is trading below 1.50 and could be on a verge of another big breakout opportunity.
MTVA is a NASDAQ listed “clinical-stage biotechnology company”.
MTVA is “focused on transforming cardiometabolic diseases”.
The company is “currently developing DA-1726 for treatment across multiple cardiometabolic indications and is developing vanoglipel (DA-1241) for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH).”
DA-1726 has “Potential best-in-class profile for weight loss, glucose control, direct liver benefit and safety shown in Phase 1 studies”.
DA-1726 is a “novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist”.
DA-1726 “Mimics a natural gut hormone released after meals”:
“GLP-1 Receptor Activation (3x): Reduces appetite, Decreases food intake”
“Glucagon Receptor Activation (1x): Increases energy expenditure, Boosts calorie burning”
The idea: eat less and burn more at the same time.
From the company’s investor presentation, Phase 1 Results at 48 mg with no titration, at Day 54:
“–9.1% body weight”
“–3.8 inches waist circumference”
“–0.22 HbA1c”
“–23.7% liver stiffness (VCTE)”
The company highlights that “Pre-diabetic subjects with mean HbA1c of 6% at baseline was reduced to 5.5% by Day 54.”
MTVA is “Positioned to Pursue Two Fast-Growing, Multi-Billion Dollar Markets”:
Obesity: “650M+ adults worldwide are clinically obese” and the “Market expected to grow from ~$10B today to $80B–$130B+ annually by 2030”
MASH: “high unmet need, growing clinical recognition and screening”. “Analysts forecast a $20B–$35B+ annual market as treatments enter the clinic and gain coverage”
Metabolic dysfunction-associated steatohepatitis (MASH) is a serious liver disease that develops when fat buildup in your liver causes inflammation.
Big Pharma is paying up for this space:
“Big Pharma has Committed Over $15 Billion in Obesity/MASH Licensing Deals in the Past 12 Months.”
In addition, Vanoglipel is an “Orally Available, Potential First-in-Class GPR119 Agonist” for the Treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH).
In a randomized, double-blind, placebo-controlled Phase 2a:
“Liver function improved: ALT reduced by 22.8 U/L”
“Inflammation & fibrosis markers improved: suggesting liver health benefits”
“Enhanced glucose control in patients with type 2 diabetes”
“Well-tolerated: no treatment-related discontinuations (only 1 in placebo)”
As the company recently announced:
“Vanoglipel Combined with Resmetirom Demonstrated Synergistic Hepatoprotective and Weight-Loss Effects in Preclinical MASH Model”
“Vanoglipel Combined with Metformin Demonstrated Enhanced Glycemic Control and Body Weight Reduction Versus Monotherapy in a Preclinical T2D Model”
The company has announced multiple accomplishments recently.
In August, the company announced:
“MetaVia Reports Second Quarter 2026 Financial Results and Provides Corporate Update”
"During the second quarter of 2026, and subsequently, we continued to execute across both of our clinical development programs while further strengthening the differentiated profile of DA-1726 as a dual GLP-1/glucagon receptor agonist," stated Hyung Heon Kim, President and Chief Executive Officer of MetaVia. "Most recently, all active patients in both cohorts of our ongoing Phase 1 Part 3 study successfully reached the highest planned dose levels of 48 mg and 64 mg, representing an important execution milestone as we prepare for our 16-week topline data readout, expected in the fourth quarter of 2026. Also of note, during the quarter, we presented additional data from our 48 mg Phase 1 study of DA-1726 at both the EASL and ADA scientific conferences, which demonstrated up to 9.1% mean weight loss after just eight weeks of treatment, meaningful reductions in waist circumference and encouraging liver-related findings, reinforcing our confidence in DA-1726's potential best-in-class profile and its ability to address multiple aspects of cardiometabolic disease. Based on the continued trajectory of weight loss through eight weeks without evidence of plateau on the 48 mg dosage, we believe the ongoing 16-week study evaluating the 48 mg and higher 64 mg dosages has the potential to provide a more complete assessment of the drug's effects on weight loss, waist circumference, cardiometabolic health and liver-related outcomes."
"In parallel, we continued to broaden the potential clinical utility of vanoglipel (DA-1241). During the quarter, we presented preclinical combination data at the ADA 2026 Scientific Sessions, demonstrating synergistic effects with both resmetirom in MASH and metformin in type 2 diabetes, while a peer-reviewed publication further highlighted the anti-fibrotic potential of GPR119 agonism. Together, these findings reinforce our strategy of advancing vanoglipel as a differentiated combination backbone for metabolic and liver diseases, designed to complement established and emerging therapies across cardiometabolic disorders."
Second Quarter 2026 and Subsequent Highlights
“July 2026: Announced the completion of dose titration in the 16-week, Phase 1 Part 3 study of DA-1726, with all active patients successfully reaching the highest planned dose levels of 48 mg and 64 mg.
June 2026: Presented new late-breaking data at the ADA 2026 Scientific Sessions supporting DA-1726's differentiated obesity profile and demonstrating the combination potential of vanoglipel with resmetirom in MASH and metformin in type 2 diabetes.
May 2026: Presented additional data from the 48 mg Phase 1 trial of DA-1726 at EASL Congress 2026, demonstrating up to 9.1% mean body weight reduction without evidence of plateau and exploratory improvements in liver-related biomarkers, supporting the potential of DA-1726 in obesity and MASH.
May 2026: Announced the publication of peer-reviewed preclinical research in Biomolecules & Therapeutics, supporting the anti-fibrotic potential of vanoglipel and the differentiated role of GPR119 agonism in MASH.
April 2026: Dosed the first patient in Part 3 of the 16-week Phase 1 clinical trial evaluating DA-1726 in obese, otherwise healthy adults using one-step titration to 48 mg and two-step titration to 64 mg to safely achieve higher target doses and optimize tolerability.”
Anticipated Clinical Milestones
DA-1726 in Obesity:
Data readout from Phase 1 Part 3, 16-week titration studies, evaluating titration to 48 mg in one step and 64 mg via a two-step regimen, is expected in the fourth quarter of 2026.
Vanoglipel (DA-1241) in MASH:
The Company is currently working to schedule an End-of-Phase 2 meeting with the FDA during the second half of 2026 to discuss the clinical development pathway for the vanoglipel combination therapy.
In September, the company announced:
“MetaVia Announces Preclinical Findings Supporting Biological Rationale for DA-1726's Waist Circumference Reduction”
“Tissue Distribution Study Shows Highest Exposure in Adipose Tissue and Prolonged Retention Consistent with Once-Weekly Dosing Findings Provide Mechanistic Support for the Differentiated Profile of DA-1726”
Here are some of the company’s comments from this press release:
"We believe these findings provide important mechanistic support for the differentiated profile we continue to observe with DA-1726," stated Hyung Heon Kim, President and Chief Executive Officer of MetaVia. "In our previously reported Phase 1 study, patients receiving the 48 mg dose of DA-1726 achieved a mean reduction in waist circumference of 9.8 cm after only eight weeks of treatment (Day 54). We believe the preferential distribution of DA-1726-derived radioactivity to adipose tissue observed in this preclinical study provides an important biological rationale that is consistent with these encouraging clinical findings. In addition, the prolonged retention of DA-1726-derived radioactivity in tissues observed throughout the study may contribute to the sustained pharmacokinetic exposure of DA-1726 and may also help explain the excellent tolerability profile observed across our clinical studies, to date. Together, these findings further reinforce our confidence in the unique potential of DA-1726 as a next-generation obesity therapy. As patients in our ongoing 24-week dose-titration study continue to receive extended treatment at their highest achieved dose levels, we look forward to evaluating whether longer treatment can further enhance reductions in waist circumference, weight loss and other important cardiometabolic measures. We anticipate reporting 16-week topline data in the fourth quarter of this year, followed by 24-week topline results in the first quarter of 2027."
In October, the company announced:
“MetaVia Appoints Seasoned Clinical Development Executive Sarah Browne, M.D., as Chief Medical Officer”
“Brings Extensive Experience Leading Liver and Metabolic Disease Drug Development Programs, Including MASH, and Successfully Advancing Therapies Through Phase 2 and Into Phase 3 Development”
“Deep Expertise in Dual GLP-1/Glucagon Receptor Agonist Development, Including Pemvidutide”
Here are some of the comments from this press release:
"Sarah brings an exceptional combination of clinical development leadership and regulatory expertise, particularly in advancing novel therapies for liver and other cardiometabolic diseases, including MASH," stated Hyung Heon Kim, President and Chief Executive Officer of MetaVia. "Her extensive experience leading the clinical development of pemvidutide, a dual GLP-1/glucagon receptor agonist, through Phase 2 and establishing Phase 3 development strategies, will be invaluable as we plan the next stages of development for DA-1726. Sarah joins MetaVia at an important time as we prepare for the anticipated fourth quarter 2026 topline data readout from Part 3 of our Phase 1 clinical trial of DA-1726, evaluating higher target doses of 48 mg and 64 mg. We look forward to leveraging her expertise as we continue advancing our cardiometabolic pipeline, including DA-1726 and vanoglipel (DA-1241), which is being developed for the treatment of MASH."
Dr. Browne added, "MetaVia is approaching a key inflection point in the development of DA-1726. My experience developing therapies for obesity and liver disease, including dual GLP-1/glucagon receptor agonists, aligns closely with MetaVia's clinical programs. I look forward to working with the team to evaluate the upcoming Phase 1 Part 3 results, help shape the next stages of development for DA-1726, and advancing vanoglipel for the treatment of MASH. I believe these programs have the potential to address significant unmet medical needs across cardiometabolic diseases."
Most recently, the company announced:
“MetaVia to Present Phase 1 Clinical Trial Data for DA-1726 in Oral Presentation at the Precision Liver Symposium 2026”
We believe MTVA could be positioned for significant upside.
Make sure to do your own due diligence.
Happy Trading!
SmallCapStocks Team
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