89bio

64 articles about 89bio

• 89bio Reaches Alignment with the FDA and EMA on Phase 3 Program for Pegozafermin in Nonalcoholic Steatohepatitis (NASH); Program Initiation Planned in the First Half of 2024

  12/4/2023

  89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced a successful end-of-Phase 2 Meeting with the U.S. Food & Drug Administration (FDA), supporting the advancement of pegozafermin into Phase 3 in NASH.

• 89bio Announces New Positive Long-Term Data from the ENLIVEN Phase 2b Trial of Pegozafermin in Patients with Nonalcoholic Steatohepatitis (NASH)

  11/27/2023

  89bio, Inc. today announced positive topline data from the blinded extension phase of its Phase 2b ENLIVEN trial evaluating treatment with pegozafermin in patients with nonalcoholic steatohepatitis (NASH).

• 89bio Announces Additional Data from the ENLIVEN Phase 2b Trial of Pegozafermin in Patients with Compensated Cirrhotic (F4) Nonalcoholic Steatohepatitis (NASH) at AASLD The Liver Meeting® 2023

  11/12/2023

  89bio, Inc. announced additional data from a post-hoc analysis of the ENLIVEN Phase 2b trial evaluating treatment with pegozafermin in a subgroup of patients with F4 NASH.

• 89bio Reports Third Quarter 2023 Financial Results and Provides Corporate Updates

  11/8/2023

  89bio, Inc. reported its financial results for the third quarter ended September 30, 2023.

• 89bio to Participate in the H.C. Wainwright 7ᵗʰ Annual NASH Investor Conference

  10/17/2023

  89bio, Inc. announced that the Company’s Management will participate in a fireside chat and one-on-one investor meetings at the H.C. Wainwright 7th Annual NASH Investor Conference being held on Tuesday, October 24, 2023.

• 89bio Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - October 03, 2023

  10/3/2023

  89bio, Inc. announced that the Compensation Committee of the Company’s Board of Directors approved the grant of non-qualified stock options to purchase an aggregate of 116,000 shares of the Company’s common stock to four new employees on the later of September 28, 2023 and the employee’s commencement of employment with the Company.

• 89bio Announces U.S. FDA has Granted Breakthrough Therapy Designation for Pegozafermin in Nonalcoholic Steatohepatitis (NASH)

  9/21/2023

  89bio, Inc. today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to pegozafermin in patients with nonalcoholic steatohepatitis (NASH).

• 89bio to Participate in the 2023 Cantor Global Healthcare Conference

  9/20/2023

  89bio, Inc. today announced that the Company’s Management will participate in a fireside chat and one-on-one investor meetings at the 2023 Cantor Global Healthcare Conference, being held in New York, NY on Tuesday, September 26, 2023 at 11:40 AM ET.

• 89bio to Participate in the H.C. Wainwright 25th Annual Global Investment Conference

  9/5/2023

  89bio, Inc. today announced that the Company’s Management will participate in a fireside chat and one-on-one investor meetings at the H.C. Wainwright 25th Annual Global Investment Conference, being held in New York, NY on Monday, September 11, 2023 at 7:00 pm.

• 89bio Reports Second Quarter 2023 Financial Results and Provides Corporate Update

  8/9/2023

  89bio, Inc., a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, reported its financial results for the second quarter ended June 30, 2023.

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  Demise of Intercept’s NASH Program Highlights Safety Hurdles Facing the Space

  7/31/2023

  Intercept’s failure to secure FDA approval for obeticholic acid (OCA) tablets in non-alcoholic steatohepatitis shines a light on safety challenges in the space, experts told BioSpace.

• 89bio Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4) - July 12, 2023

  7/12/2023

  89bio, Inc. announced that the Compensation Committee of the Company’s Board of Directors approved the grant of non-qualified stock options to purchase an aggregate of 2,600 shares of the Company’s common stock to one new employee on the later of July 6, 2023 and the employee’s commencement of employment with the Company.

• Data from 89bio’s ENLIVEN Phase 2b Trial of Pegozafermin in Patients with NASH Published in The New England Journal of Medicine and Simultaneously Presented in a Late-breaker Session at the EASL International Liver Congress

  6/24/2023

  89bio, Inc. announced that data from the Phase 2b ENLIVEN trial evaluating treatment with pegozafermin in patients with nonalcoholic steatohepatitis were published online in the New England Journal of Medicine.

• 89bio Publishes Positive Results from Phase 2 ENTRIGUE Trial of Pegozafermin in Patients with Severe Hypertriglyceridemia (SHTG) in Nature Medicine

  6/24/2023

  89bio, Inc. announced that the previously reported positive data from the Phase 2 ENTRIGUE trial of pegozafermin in patients with severe hypertriglyceridemia were published online in Nature Medicine.

• 89bio Announces Late-Breaker Oral Presentation of Data from the Phase 2 ENLIVEN Study of Pegozafermin at EASL International Liver Congress 2023

  6/7/2023

  89bio, Inc. today announced that pegozafermin data in nonalcoholic steatohepatitis (NASH) will be featured in a late-breaker oral presentation during the European Association for the Study of the Liver (EASL) Congress 2023 to be held June 21-24, 2023 in Vienna.

• 89bio Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - June 07, 2023

  6/7/2023

  89bio, Inc. announced that the Compensation Committee of the Company’s Board of Directors approved the grant of non-qualified stock options to purchase an aggregate of 138,100 shares of the Company’s common stock to six new employees on the later of June 1, 2023 and the employee’s commencement of employment with the Company.

• 89bio Initiates Phase 3 ENTRUST Trial of Pegozafermin in Patients with Severe Hypertriglyceridemia (SHTG)First FGF21 analog to enter Phase 3 development

  5/23/2023

  89bio, Inc. today announced the initiation of ENTRUST, a Phase 3 trial evaluating the efficacy, safety and tolerability of pegozafermin in patients with severe hypertriglyceridemia (SHTG).

• 89bio Reports First Quarter 2023 Financial Results and Provides Corporate Update

  5/4/2023

  89bio, Inc., a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases, reported its financial results for the first quarter ended March 31, 2023.

• 89bio to Participate in Upcoming Investor Conferences - May 2, 2023

  5/2/2023

  89bio, Inc. today announced that the Company’s Management will participate in the following upcoming conferences in May.

• 89bio, Inc. Announces Upsized Pricing of $275 Million Public Offering of Common Stock

  3/24/2023

  89bio, Inc. today announced the pricing of its previously announced underwritten public offering of 16,923,077 shares of its common stock at a public offering price per share of $16.25.