Company Description
89bio, Inc. (ETNB) is a clinical-stage biopharmaceutical company that focuses on the development and commercialization of therapies for liver and cardiometabolic diseases. According to company disclosures, 89bio is dedicated to developing therapies for patients who lack optimal treatment options in these areas. The company is headquartered in San Francisco and its common stock has been listed on The Nasdaq Global Market under the symbol ETNB.
The company’s work centers on serious metabolic and liver conditions, including metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG). These diseases are highlighted in 89bio’s public communications as key focus areas where there is significant unmet medical need. 89bio describes itself as a clinical-stage organization, which means its product candidates are undergoing clinical trials and have not been approved for commercial sale.
Core therapeutic focus and lead candidate
89bio’s lead product candidate is pegozafermin, which the company describes as a specifically engineered fibroblast growth factor 21 (FGF21) analog. Public materials state that pegozafermin uses a glycoPEGylated technology designed to optimize biological activity through an extended half-life. The company is advancing pegozafermin through Phase 3 clinical development for two primary indications:
- Metabolic dysfunction-associated steatohepatitis (MASH) with advanced fibrosis, including patients with compensated cirrhosis (F4 MASH).
- Severe hypertriglyceridemia (SHTG).
89bio reports that it is conducting global Phase 3 trials for pegozafermin in these indications. For MASH, the company has disclosed two Phase 3 trials, ENLIGHTEN-Fibrosis in non-cirrhotic (F2-F3) MASH and ENLIGHTEN-Cirrhosis in compensated cirrhotic (F4) MASH. For SHTG, the company has described ENTRUST as a randomized, double-blind, placebo-controlled global study evaluating the efficacy, safety, and tolerability of pegozafermin in patients with severe hypertriglyceridemia.
Clinical development and trial design highlights
In its public updates, 89bio has outlined key design elements of its Phase 3 programs. For SHTG, the ENTRUST trial randomizes patients to receive pegozafermin at different doses or placebo once weekly for 52 weeks, with a primary endpoint based on the percent change from baseline in fasting triglycerides at Week 26 compared to placebo. For MASH, the ENLIGHTEN trials include histology cohorts intended to generate data that the company believes could support regulatory pathways such as accelerated approval, based on alignment with agencies including the U.S. Food and Drug Administration and the European Medicines Agency, as described in its communications.
Across its disclosures, 89bio emphasizes that pegozafermin is being studied for its potential therapeutic profile in both liver disease and cardiometabolic settings. The company highlights attributes such as histology endpoints in MASH, safety and tolerability, and dosing approach as areas of focus in its development program, while noting that outcomes remain subject to clinical and regulatory evaluation.
Corporate developments and acquisition by Roche
In September 2025, 89bio announced that it had entered into an Agreement and Plan of Merger with Roche Holdings, Inc. and a Roche subsidiary. Under this merger agreement, an affiliate of Roche commenced a tender offer to acquire all outstanding shares of 89bio common stock for a cash amount per share plus a non-tradeable contingent value right (CVR) per share, as described in detail in the company’s press release and Form 8-K. The CVRs entitle holders to potential additional cash payments upon achievement of specified milestones related to pegozafermin, including regulatory and commercial milestones outlined in the CVR Agreement.
According to an 8-K filed on October 30, 2025, the tender offer expired on October 29, 2025, and a sufficient number of shares were validly tendered and not withdrawn to satisfy the minimum tender condition. Following acceptance of the tendered shares, Merger Sub merged with and into 89bio, with 89bio continuing as the surviving corporation and becoming a wholly owned subsidiary of Roche Holdings, Inc. At the effective time of the merger, each share of 89bio common stock (with specified exceptions) was automatically canceled and converted into the right to receive the offer price, consisting of the cash amount and one CVR per share, subject to the terms of the merger agreement.
In connection with the closing of the merger, 89bio notified The Nasdaq Global Market that the merger had been consummated and requested that Nasdaq halt trading and delist the company’s common stock. The company also indicated its intention to file a Form 25 to remove its listing and a Form 15 to terminate registration of its shares and suspend its reporting obligations under the Securities Exchange Act of 1934. As a result, ETNB no longer trades on Nasdaq, and 89bio operates as a private, wholly owned subsidiary within Roche’s Pharmaceuticals Division as described in the merger-related disclosures.
Business context and regulatory reporting
Before the completion of the merger, 89bio operated as a publicly traded clinical-stage biopharmaceutical issuer, filing periodic and current reports with the U.S. Securities and Exchange Commission (SEC). Its filings and press releases emphasize its focus on liver and cardiometabolic diseases, its San Francisco headquarters, and its development-stage status. The company has also disclosed activities such as inducement stock option grants under Nasdaq Listing Rule 5635(c)(4), participation in healthcare and biopharma investor conferences, and the construction of a commercial-scale production facility for pegozafermin in support of a planned Biologics License Application.
Following the acquisition by Roche and the associated delisting and deregistration steps described in its 8-K filings, 89bio’s public reporting obligations are expected to cease upon the effectiveness of its Form 15 filing. Historical SEC filings and press releases remain key sources for understanding the company’s development programs, clinical trial designs, and the terms of the merger and CVR structure.
ETNB as a historical ticker
Because 89bio has become a wholly owned subsidiary of Roche and its shares have been delisted from Nasdaq, the ETNB ticker now primarily serves as a historical reference for investors and researchers reviewing the company’s past trading history, corporate actions, and clinical development disclosures. The company’s ongoing activities, including any further development and potential commercialization of pegozafermin, are expected to be reflected within Roche’s broader corporate and regulatory reporting framework, as indicated in the acquisition-related communications.