Welcome to our dedicated page for 89Bio news (Ticker: ETNB), a resource for investors and traders seeking the latest updates and insights on 89Bio stock.
News for 89bio, Inc. (ETNB) centers on its role as a clinical-stage biopharmaceutical company developing therapies for liver and cardiometabolic diseases, as well as its corporate transition following its acquisition by Roche. Company press releases and SEC reports highlight pegozafermin, a fibroblast growth factor 21 (FGF21) analog engineered with glycoPEGylated technology, as its lead product candidate in Phase 3 development for metabolic dysfunction-associated steatohepatitis (MASH) with advanced fibrosis and severe hypertriglyceridemia (SHTG).
Visitors to this ETNB news page can review historical announcements about 89bio’s clinical programs, including updates on the ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis Phase 3 trials in MASH and the ENTRUST Phase 3 trial in SHTG. Releases describe trial designs, planned topline data timing, and the company’s expectations regarding potential regulatory pathways, as well as operational items such as construction of a commercial-scale production facility for pegozafermin.
The news flow also covers corporate and capital markets activity. This includes inducement stock option grants under Nasdaq Listing Rule 5635(c)(4), participation in major healthcare and biopharma investor conferences, and quarterly financial updates that discuss research and development spending and general and administrative expenses in the context of advancing the Phase 3 programs.
A key development in the ETNB news record is the announcement of an Agreement and Plan of Merger with Roche Holdings, Inc., followed by the commencement and completion of a tender offer. Related communications describe the cash consideration, the structure of non-tradeable contingent value rights (CVRs) tied to pegozafermin milestones, and the subsequent delisting of ETNB from The Nasdaq Global Market as 89bio became a wholly owned subsidiary of Roche. Investors and researchers can use this page as an archive of 89bio’s historical news, from clinical milestones to the closing of the Roche transaction.
89bio (Nasdaq: ETNB) has appointed Dr. Teresa Perney as Chief Regulatory and Quality Officer, effective immediately. Dr. Perney brings over 20 years of experience in the biotech and pharmaceutical industry, with expertise in regulatory affairs, product development, and quality assurance. This appointment comes as 89bio advances pegozafermin through multiple global Phase 3 studies for liver and cardiometabolic diseases.
CEO Rohan Palekar emphasized that Dr. Perney's expertise will be important in shaping the company's global regulatory strategy and potentially accelerating the delivery of pegozafermin to patients worldwide. Dr. Perney expressed excitement about joining 89bio at this pivotal moment and leveraging her experience to address unmet needs in liver and cardiometabolic diseases.
89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focusing on liver and cardiometabolic diseases, has announced its participation in three upcoming investor conferences in September 2024:
- Wells Fargo 2024 Healthcare Conference on September 5 at 12:45 PM ET (Fireside Chat)
- H.C. Wainwright 26th Annual Global Investment Conference on September 9 at 11:30 AM ET (Presentation)
- 2024 Cantor Global Healthcare Conference on September 17 at 11:30 AM ET (Fireside Chat)
Webcasts of these presentations will be available on 89bio's website, with replays accessible for approximately 30 days after each conference.
89bio (Nasdaq: ETNB) has announced the approval of Inducement Grants by its Compensation Committee. These grants include non-qualified stock options for 19,800 shares to two new employees and 350,000 shares to the newly-hired Chief Operating Officer, Francis Sarena. The grants, made on August 5, 2024, are part of the company's 2023 Inducement Plan and comply with Nasdaq Listing Rule 5635(c)(4).
The exercise price of the options is equal to 89bio's closing stock price on the grant date. The vesting schedule spans four years, with 25% vesting after one year and the remainder vesting in 12 equal quarterly installments, contingent on continued employment.
89bio (Nasdaq: ETNB) has appointed Francis Sarena as Chief Operating Officer, effective August 5, 2024. This strategic move comes as the company advances its Phase 3 clinical program for pegozafermin and prepares for potential scale-up, regulatory filings, and commercialization. Sarena brings 25 years of experience in the biotech industry, including leadership roles at Apexigen, Five Prime Therapeutics, and PDL BioPharma.
Pegozafermin, 89bio's lead candidate, is positioned as a potentially best-in-class FGF21 therapy for MASH patients with advanced fibrosis and compensated cirrhosis, as well as for SHTG patients. The company aims to capitalize on pegozafermin's promising clinical data to address significant unmet medical needs and capture substantial market opportunities.
89bio (Nasdaq: ETNB) reported Q2 2024 financial results and corporate updates. The company is advancing three Phase 3 trials for pegozafermin in MASH (metabolic dysfunction-associated steatohepatitis) and SHTG (severe hypertriglyceridemia). Key highlights include:
1. Initiated ENLIGHTEN-Cirrhosis Phase 3 trial for MASH patients with compensated cirrhosis (F4).
2. Ongoing enrollment in ENLIGHTEN-Fibrosis for non-cirrhotic MASH and ENTRUST for SHTG.
3. Cash position of $531.4 million as of June 30, 2024.
4. Q2 2024 net loss of $48.0 million, up from $38.4 million in Q2 2023.
5. R&D expenses increased to $44.9 million in Q2 2024 from $34.9 million in Q2 2023.
The company expects topline data from the ENTRUST trial in 2025 and is preparing for potential commercialization of pegozafermin.
89bio, Inc. (Nasdaq: ETNB) has appointed Dr. Charles McWherter to its Board of Directors, effective July 30, 2024. Dr. McWherter, former Chief Scientific Officer and President of Research and Development at CymaBay Therapeutics, brings extensive expertise in drug development and liver disease. His appointment comes as 89bio advances Phase 3 trials for pegozafermin in non-cirrhotic and cirrhotic MASH (Metabolic dysfunction-Associated SteatoHepatitis) and SHTG (Severe HyperTriglyceridemia).
CEO Rohan Palekar highlighted Dr. McWherter's valuable experience in liver inflammation and fibrosis, which aligns with 89bio's goal to establish pegozafermin as a potential cornerstone therapy. Dr. McWherter expressed enthusiasm about joining 89bio, citing pegozafermin's promising potential based on the Phase 2b ENLIVEN trial results, including benefits in fibrosis reduction and metabolic improvement.
On July 12, 2024, 89bio, a clinical-stage biopharmaceutical firm, announced the approval of non-qualified stock options for six new employees. The compensation committee of the board of directors granted these options on July 9, 2024, under the 2023 Inducement Plan, aligning with Nasdaq Listing Rule 5635(c)(4). The options allow the purchase of 125,000 shares at the closing price of the company's stock on the grant date. These options will vest over four years: 25% after one year of employment and the remaining shares in 12 equal quarterly installments, contingent on continued employment.
89bio announced the approval of inducement grants under Nasdaq Listing Rule 5635(c)(4) by its Compensation Committee. The grants, totaling 25,500 shares of common stock, were extended to two new employees on June 10, 2024, as part of the company's 2023 Inducement Plan. The exercise price for these stock options matches 89bio's closing stock price on the grant date. These grants will vest over four years, with 25% vesting after one year, followed by quarterly vesting contingent upon continued employment.
89bio, a clinical-stage biopharmaceutical company, will present 48-week data from its Phase 2b ENLIVEN trial evaluating pegozafermin in patients with metabolic dysfunction-associated steatohepatitis (MASH) at the EASL International Liver Congress in Milan, Italy, from June 5 to 8, 2024. The data highlights pegozafermin as the first FGF21 analog showing positive, sustained benefits over 48 weeks in patients with advanced MASH. The presentation will cover the drug's efficacy, tolerability, and improvements in liver health markers, and will be delivered by Dr. Rohit Loomba on June 8.
89bio has initiated the Phase 3 ENLIGHTEN-Cirrhosis trial for pegozafermin in patients with MASH and compensated cirrhosis (F4). This is the first FGF21 analog to reach this trial stage for this patient subset. The trial will involve 760 patients, assessing fibrosis regression at 24 months, potentially supporting accelerated approval in the U.S. and Europe. The trial's primary goal is to observe clinical outcome events for confirmatory or full approval. The ENLIGHTEN-Cirrhosis trial builds on promising Phase 2b results showing improvements in liver health markers, aiming to meet the urgent need for effective therapies in MASH with compensated cirrhosis.
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