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89bio, Inc. (Nasdaq: ETNB) is a clinical-stage biopharmaceutical company headquartered in San Francisco, California. Since its founding in 2018, 89bio has been committed to developing and commercializing innovative therapies for the treatment of liver and cardio-metabolic diseases, addressing critical unmet medical needs.
The company’s lead product candidate is pegozafermin (formerly BIO89-100), a specifically engineered glycoPEGylated analog of fibroblast growth factor 21 (FGF21). Pegozafermin has shown promise in treating nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). This candidate targets metabolic dysfunction-associated steatohepatitis (MASH), which can lead to severe liver complications, including cirrhosis and liver failure.
89bio is actively advancing pegozafermin through various phases of clinical trials. Recently, the company announced a successful end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), allowing them to proceed to Phase 3 trials. Two Phase 3 trials, ENLIGHTEN-Cirrhosis and ENLIGHTEN-Fibrosis, are set to enroll patients in 2024. The ENLIGHTEN program aims to evaluate the efficacy and safety of pegozafermin in patients with different stages of liver fibrosis.
Pegozafermin has demonstrated strong anti-fibrotic and anti-inflammatory properties in the liver, as well as improved lipid metabolism, insulin resistance, and glycemic control. It has received Breakthrough Therapy designation from the FDA and Priority Medicines (PRIME) status from the European Medicines Agency (EMA), emphasizing its therapeutic potential and the urgency for such treatments.
Financially, 89bio reported substantial cash reserves, ensuring robust support for ongoing clinical activities. As of December 31, 2023, the company had $578.9 million in cash and equivalents. This strong financial position enables continued development and potential scaling up for commercial production.
89bio maintains strategic partnerships to bolster its clinical and commercialization efforts. These collaborations are crucial as the company aims to bring pegozafermin to market, providing solutions for patients with liver and cardio-metabolic diseases who lack effective treatment options.
For more detailed updates, recent financial results, and upcoming milestones, visit their official website or follow their LinkedIn profile.
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.
89bio, Inc. announced the approval of non-qualified stock options for four new employees under the 2023 Inducement Plan. The options allow the purchase of 48,150 shares of the Company's common stock at the closing price on May 6, 2024. The options will vest over a four-year period, contingent on continued employment.
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