Clinical Trials
15
5 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2018
Active, not recruiting
5
33.3%
Completed
5
33.3%
Recruiting
5
33.3%
No approval data available
- The global NASH treatment market is projected to grow from USD 8.75 billion in 2025 to USD 46.87 billion by 2032, expanding at a CAGR of 27.1%. - Madrigal's Rezdiffra, approved in March 2024, created the first dedicated liver-directed prescription pathway for noncirrhotic NASH with moderate-to-advanced fibrosis. - Novo Nordisk's Wegovy gained FDA approval in August 2025 for MASH with F2–F3 fibrosis, connecting liver treatment to established obesity and diabetes care networks. - Late-stage pipeline candidates from Eli Lilly, Akero Therapeutics, 89bio, Inventiva, and Boehringer Ingelheim could create a multi-mechanism, segmented treatment market.
- D&D Pharmatech completed a $165 million convertible bond issuance to accelerate development of its MASH drug DD01 and pipeline expansion. - The company's shares surged 14% on expectations for 48-week tissue biopsy results from DD01's Phase 2 trial to be presented at EASL. - DD01, a dual GLP-1/glucagon receptor agonist, showed early signals of liver fat reduction and fibrosis improvement in U.S. patients at 12 and 24 weeks. - Positive results could trigger licensing discussions as major pharma companies invest billions in MASH treatments, with recent acquisitions reaching up to $5.2 billion.
- Abivax shares soared over 850% following positive Phase III data in ulcerative colitis, creating an "Abivax effect" that has reshaped market dynamics and reignited investor confidence in European biotech. - The NEXT BIOTECH index climbed 13.7% year-to-date with most gains driven by a sharp rally since April's "Liberation Day," while companies trading below cash dropped from 20% to 16%. - Major pharmaceutical companies accelerated M&A activity in September, with Pfizer acquiring Metsera for up to $7.3 billion and Genmab acquiring Merus for $8 billion, confirming pharma's willingness to pay premium for late-stage assets. - Investors are now laser-focused on companies with pivotal readouts within 12 months, with Valneva's Lyme disease vaccine and Nanobiotix's head and neck cancer therapy emerging as key European watchlist names.
- The biopharmaceutical sector experienced a significant surge in high-value acquisitions during Q3 2025, with four of the year's five largest deals occurring in the past four months. - Major transactions totaled approximately $55.7 billion in Q3, including Merck's $10 billion acquisition of Verona and Genmab's $8 billion bid for bispecific antibody specialist Merus. - The number of deals increased from 15 in Q1 to 21 in Q3, with analysts attributing the surge to lowered interest rates and companies seeking to replace revenue losses from patent expirations.
- Roche has completed the acquisition of 89bio to strengthen its cardiometabolic drug development portfolio and build a comprehensive metabolic franchise. - The acquisition positions Roche to develop combination-ready therapies that extend beyond the current GLP-1 receptor agonist market competition. - This strategic move represents Roche's commitment to expanding its presence in the rapidly growing metabolic disease treatment landscape. - The deal allows Roche to access 89bio's pipeline assets and expertise in cardiometabolic therapeutic development.
- Roche announced a definitive merger agreement to acquire 89bio for $14.50 per share in cash plus contingent value rights, totaling up to $3.5 billion. - The acquisition centers on pegozafermin, a Phase III FGF21 analog designed to treat moderate to severe MASH fibrosis with anti-fibrotic and anti-inflammatory mechanisms. - MASH affects an estimated 5-7% of the global adult population, with the US expected to have approximately 14 million F2-F4 MASH patients by 2030. - The deal strengthens Roche's cardiovascular, renal, and metabolic disease portfolio and offers potential for combination development with incretins.
- 89bio reported a net loss of $111.5 million in Q2 2025, reflecting increased investment in late-stage clinical trials and production capacity for pegozafermin. - The company achieved regulatory alignment with FDA and EMA for accelerated approval pathways for its lead candidate targeting MASH and severe hypertriglyceridemia. - The ENTRUST Phase 3 trial for SHTG is fully enrolled with topline data expected in Q1 2026, while ENLIGHTEN program for MASH continues enrollment with histology data anticipated in 1H 2027 and 2028. - 89bio maintains strong financial position with $561.2 million in cash and equivalents as of June 30, 2025, providing funding runway through 2027.
- 89bio reported Q2 2025 financial results with $561.2 million in cash, cash equivalents, and marketable securities as of June 30, 2025. - The company expects topline histology data from ENLIGHTEN-Fibrosis Phase 3 trial in non-cirrhotic MASH patients in first half of 2027 and ENLIGHTEN-Cirrhosis data in 2028. - ENTRUST Phase 3 trial topline data for pegozafermin in severe hypertriglyceridemia is anticipated in first quarter of 2026. - Research and development expenses increased to $103.9 million in Q2 2025, driven by Phase 3 MASH trials and a $42.4 million payment for commercial-scale production facility construction.
- TREM2-expressing macrophages play crucial roles in metabolic dysfunction-associated steatohepatitis (MASH) by regulating both lipid metabolism and immune homeostasis through specialized signaling pathways. - These macrophages facilitate lipid clearance and cholesterol efflux while suppressing pro-inflammatory cytokines, potentially serving as a compensatory mechanism against hepatic lipotoxicity and chronic inflammation. - Soluble TREM2 levels show promise as an early diagnostic biomarker for MASH, appearing before other laboratory markers in both patients and mouse models. - Therapeutic targeting of TREM2 presents opportunities for stage-specific interventions, though careful consideration is needed as these macrophages may shift toward pro-fibrotic roles in advanced disease stages.
- 89bio completed enrollment in the Phase 3 ENTRUST trial for severe hypertriglyceridemia (SHTG), with topline data expected in the second half of 2025. - The Phase 3 ENLIGHTEN program, targeting metabolic dysfunction-associated steatohepatitis (MASH), continues to enroll patients in both non-cirrhotic and cirrhotic arms. - 89bio's financial position is strong, with approximately $440 million in cash, cash equivalents, and marketable securities as of December 31, 2024.
