This section highlights FDA-related milestones and regulatory updates for drugs developed by 89BIO (ETNB).
Over the past two years, 89BIO has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Pegozafermin and Pegozafermin. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Pegozafermin - FDA Regulatory Timeline and Events
Pegozafermin is a drug developed by 89BIO for the following indication: In the Treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Pegozafermin
- Announced Date:
- January 13, 2025
- Indication:
- In the Treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Announcement
89bio, Inc today provided a corporate update and business outlook for 2025.
AI Summary
89bio, Inc provided a corporate update and business outlook for 2025, emphasizing its strong positioning for future growth. The company is confident in building on the momentum from the enrollment of its ENLIGHTEN Phase 3 program in patients with metabolic dysfunction-associated steatohepatitis (MASH) and the completed enrollment of the ENTRUST Phase 3 trial in patients with severe hypertriglyceridemia (SHTG). Topline 26‐week data from the ENTRUST trial are expected in the second half of 2025. CEO Rohan Palekar highlighted the potential of pegozafermin, the company’s lead candidate, as a potent anti-fibrotic agent offering broad cardio-metabolic benefits. In addition, 89bio’s bolstered financial position—with approximately $440 million in cash, cash equivalents, and marketable securities—combined with a strengthened leadership team and commercial-scale manufacturing capabilities, sets the stage for moving advanced Phase 3 programs toward potential regulatory submissions.
Read Announcement- Drug:
- Pegozafermin
- Announced Date:
- November 15, 2024
- Indication:
- In the Treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Announcement
89bio, Inc. announced new analyses of data from the Phase 2b ENLIVEN trial evaluating pegozafermin in metabolic dysfunction-associated steatohepatitis (MASH) patients with advanced fibrosis. T
AI Summary
89bio, Inc. announced new analyses from its Phase 2b ENLIVEN trial, which evaluated pegozafermin in patients with metabolic dysfunction-associated steatohepatitis (MASH) and advanced fibrosis. The post-hoc data, presented at The American Association for the Study of Liver Diseases’ Liver Meeting, indicate that pegozafermin may reverse fibrosis and help prevent progression to cirrhosis. The analyses showed improvements in noninvasive markers such as FAST scores, along with both MASH resolution and fibrosis improvement. These early results boost confidence in the design of the upcoming Phase 3 trials for both cirrhotic and non-cirrhotic MASH patients. By demonstrating notable benefits in key biomarkers, pegozafermin shows promise as a treatment option that could reduce the need for invasive procedures like liver biopsies, providing a new avenue for addressing advanced liver complications in high-risk MASH patients.
Read Announcement- Drug:
- Pegozafermin
- Announced Date:
- May 22, 2024
- Indication:
- In the Treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Announcement
89bio, Inc announced that data from the 48-week extension phase of the Phase 2b ENLIVEN trial evaluating pegozafermin in patients with metabolic dysfunction-associated steatohepatitis (MASH) with fibrosis will be presented in an oral and poster presentation at the European Association for the Study of the Liver (EASL) Congress to be held June 5 to 8, 2024 in Milan, Italy.
AI Summary
89bio, Inc. recently announced that it will present new data from the 48-week extension phase of its Phase 2b ENLIVEN trial at the upcoming European Association for the Study of the Liver (EASL) Congress in Milan, Italy, from June 5 to 8, 2024. The trial evaluated pegozafermin in patients with metabolic dysfunction-associated steatohepatitis (MASH) with fibrosis. During this extension phase, both a 30mg weekly and a 44mg every-two-week dosing regimen of pegozafermin showed significant and sustained improvement in key markers of liver health over a 48-week period. The data, which will be presented orally and through a poster session, supports pegozafermin as the first FGF21 analog candidate to demonstrate lasting benefits in advanced MASH patients, setting the stage for further confirmation in the ongoing Phase 3 program.
Read Announcement
Pegozafermin (NASH) - FDA Regulatory Timeline and Events
Pegozafermin (NASH) is a drug developed by 89BIO for the following indication: Non-alcoholic steatohepatitis (NASH).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Pegozafermin (NASH)
- Announced Date:
- May 14, 2024
- Indication:
- Non-alcoholic steatohepatitis (NASH)
Announcement
89bio, Inc announced the initiation of ENLIGHTEN-Cirrhosis, a Phase 3 trial of pegozafermin in patients with MASH with compensated cirrhosis (F4).
Read Announcement
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