Over 40% of participants treated with EFX 50mg for 96 weeks, compared with 0% for placebo, showed regression of liver fibrosis by all of three orthogonal measures: (1) ≥1-stage fibrosis improvement by NASH-CRN stage (conventional histopathology), (2) 30% reduction of liver stiffness by FibroScan ® (imaging fibrosis biomarker), and (3) 0.5 point decrease in ELF TM score (serum fibrosis biomarker) Analysis of biopsies by... Read More

SOUTH SAN FRANCISCO, Calif., Nov. 13, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today announced that management will participate in a fireside chat at the Jefferies London Healthcare Conference on Tuesday, November 19, 2024, at 12:00 p.m. GMT. A live webcast... Read More

First patients dosed in Phase 3 SYNCHRONY Outcomes study of lead candidate efruxifermin (EFX) in patients with compensated cirrhosis (F4) due to MASH Phase 3 SYNCHRONY Real-World and Histology studies on track to report results for their respective primary endpoints in 2026 and the first half of 2027 Phase 2b SYMMETRY study week 96 results expected to readout in February 2025 SOUTH SAN FRANCISCO, Calif., Nov. 08, 2024 (GLOBE... Read More

SOUTH SAN FRANCISCO, Calif., Oct. 21, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today announced an upcoming oral presentation and two late-breaking poster presentations at the 75 th Annual American Association for the Study of Liver Diseases (AASLD) The Liver... Read More

SOUTH SAN FRANCISCO, Calif., Sept. 30, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today announced that management will participate in a fireside chat at the H.C. Wainwright 8 th Annual MASH Virtual Conference on Monday, October 7, 2024, at 11:00 a.m. E.T. A... Read More

Outcomes is the third study in the Phase 3 SYNCHRONY clinical trial program SOUTH SAN FRANCISCO, Calif., Sept. 09, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today reported the first patient was dosed in the Phase 3 SYNCHRONY Outcomes trial. The study will... Read More

SOUTH SAN FRANCISCO, Calif., Aug. 28, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today announced that management will present at the Morgan Stanley 22 nd Annual Global Healthcare Conference on Wednesday, September 4, 2024, at 7:45 a.m. E.T. in New York, NY. A... Read More

Initiated Phase 3 SYNCHRONY Outcomes Trial of Lead Candidate Efruxifermin (EFX) in Patients with Compensated Cirrhosis (F4) Due to MASH Presented Poster and Late-breaking Oral Presentation on EFX at the EASL Congress 2024 Leadership Team Expanded with Addition of Scott Gangloff as Chief Technical Officer SOUTH SAN FRANCISCO, Calif., Aug. 09, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage... Read More

SOUTH SAN FRANCISCO, Calif., June 11, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today announced initiation of the SYNCHRONY Outcomes study, a Phase 3 trial evaluating the efficacy and safety of efruxifermin (EFX) in patients with compensated cirrhosis,... Read More

SOUTH SAN FRANCISCO, Calif., June 08, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage biotechnology company developing transformational treatments for patients with serious metabolic disorders marked by high unmet medical need, today announced two presentations featuring its lead product candidate efruxifermin (EFX) at the European Association for the Study of the Liver (EASL) Congress... Read More

SOUTH SAN FRANCISCO, Calif., May 29, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today announced that management will present at the Jefferies Global Healthcare Conference on Wednesday, June 5, 2024, at 4:00 p.m. E.T. in New York, NY. A live webcast of the... Read More

Statistically significant week 96 results from the Phase 2b HARMONY study of EFX in patients with pre-cirrhotic MASH reported during the first quarter of 2024 Phase 3 SYNCHRONY Histology and SYNCHRONY Real-World studies in patients with pre-cirrhotic MASH (F2-F3) continue to enroll; SYNCHRONY Outcomes study in patients with compensated cirrhosis due to MASH (F4) on track to be initiated in second quarter of 2024 SOUTH SAN... Read More

SOUTH SAN FRANCISCO, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. ( Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today announced that management will present at the BofA Securities 2024 Health Care Conference on Tuesday, May 14, 2024, at 5:00 p.m. P.T. in Las Vegas, NV. A live webcast of the... Read More

SOUTH SAN FRANCISCO, Calif., April 30, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease, today announced the appointment of Scott Gangloff as Chief Technology Officer. "I am delighted to welcome Scott to Akero. His depth of experience leading drug manufacturing for both national and multi-national... Read More

SOUTH SAN FRANCISCO, Calif., March 08, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease marked by high unmet medical need, announced today the closing of its previously announced underwritten public offering of 12,650,000 shares of its common stock at a public offering price of $29.00 per share, which... Read More

As reported previously, the addition of EFX to GLP-1 receptor agonist therapy had a safety and tolerability profile comparable to that of EFX alone and led to statistically significant improvements in non-invasive markers of liver injury and fibrosis and of metabolic health Results indicate potential of EFX to improve resolution of steatohepatitis and fibrosis for patients with MASH and type 2 diabetes already taking a GLP-1... Read More

SOUTH SAN FRANCISCO, Calif., March 05, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease marked by high unmet medical need, announced today the pricing of an underwritten public offering of 11,000,000 shares of its common stock at a public offering price of $29.00 per share. All of the shares in the... Read More

SOUTH SAN FRANCISCO, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease marked by high unmet medical need, announced today that it has commenced an underwritten public offering of $300.0 million of shares of its common stock. All of the shares in the proposed offering are being offered... Read More

50mg (75%, p<0.001) and 28mg (46%, p=0.07) EFX groups demonstrated ≥1 stage improvement in fibrosis without worsening of MASH, approximately three- and two-fold the placebo rate (24%) 50mg (36%, p<0.01) and 28mg (31%, p<0.01) EFX groups demonstrated ≥2 stage improvement in fibrosis without worsening of MASH, more than 10-fold the placebo rate (3%) EFX-treated patients experienced statistically significant improvements on... Read More

SOUTH SAN FRANCISCO, Calif., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease, will hold an investor conference on Monday, March 4 at 8:00 a.m. ET to share results after 96 weeks of treatment for its HARMONY study, a double-blind, placebo-controlled Phase 2b study evaluating the efficacy of... Read More

SOUTH SAN FRANCISCO, Calif., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today reported fourth quarter and full year financial results for the period ending December 31, 2023. “We concluded 2023 by dosing the first patients in our two Phase 3 SYNCHRONY... Read More

SOUTH SAN FRANCISCO, Calif., Jan. 03, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today announced that management will present at the 42 nd Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2024, at 09:45 a.m. P.T. in San Francisco, CA. A live... Read More

Week 96 Phase 2b HARMONY Results for Treatment of Patients with Pre-Cirrhotic NASH/MASH (F2-F3) to be Reported in March 2024 End-of-Phase 2 FDA Meeting Scheduled for the first quarter of 2024 to Review Phase 3 Study and Regulatory Path for Treatment of NASH/MASH Patients with Compensated Cirrhosis (F4) SOUTH SAN FRANCISCO, Calif., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage... Read More

Phase 3 SYNCHRONY studies actively screening and on track to begin enrolling by the end of 2023 SOUTH SAN FRANCISCO, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today reported third quarter financial results for the period ending September 30,... Read More

Phase 2b SYMMETRY 36-week data, including new subgroup analysis, showed that EFX is active in patients with advanced cirrhosis and support continued development of EFX for treatment of cirrhosis due to NASH/MASH 22% and 10% of patients with more advanced cirrhosis in the 50mg and 28mg dose groups, respectively, had at least a one-stage improvement in fibrosis without worsening of NASH, over 7 and 3 times, respectively, the... Read More

SOUTH SAN FRANCISCO, Calif., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease marked by high unmet medical need, today announced management will present at the following investor conferences this month: Jefferies London Healthcare Conference: Fireside chat on Wednesday, November 15 at 5:00... Read More

SOUTH SAN FRANCISCO, Calif., Oct. 17, 2023 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease marked by high unmet medical need, today announced management will present virtually at the H.C. Wainwright 7 th Annual NASH Conference on Tuesday, October 24, 2023, at 12:00 p.m. E.T. A live webcast of the fireside... Read More

22% (28mg EFX) and 24% (50mg EFX) of patients experienced at least a one-stage improvement in liver fibrosis with no worsening of NASH by week 36, compared to 14% for placebo 4% of patients in each EFX dose group experienced a three- or two-stage reversal of fibrosis with no worsening of NASH, compared to 0% for placebo 63% (28mg EFX) and 60% (50mg EFX) of patients experienced NASH resolution, representing statistically... Read More

SOUTH SAN FRANCISCO, Calif., Oct. 09, 2023 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease marked by high unmet medical need, will hold an investor conference on Tuesday, October 10 at 8:00 a.m. ET to share topline week 36 results from its SYMMETRY study, a double-blind, placebo-controlled Phase 2b study... Read More

As previously reported, the study met its primary endpoint of improvement in liver fibrosis without worsening of NASH at week 24, and key secondary endpoints including NASH resolution without worsening of fibrosis Authors conclude robust data set indicates the potential of EFX to improve NASH histopathology and establish healthier whole-body metabolism SOUTH SAN FRANCISCO, Calif., Oct. 04, 2023 (GLOBE NEWSWIRE) -- Akero... Read More

SOUTH SAN FRANCISCO, Calif., Aug. 31, 2023 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today announced that management will present at the following investor conferences this month: Morgan Stanley Annual Global Healthcare Conference: Fireside chat on Tuesday,... Read More

SOUTH SAN FRANCISCO, Calif., Aug. 28, 2023 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today announced that all samples and data required for a readout of topline results from the Phase 2b SYMMETRY study have been collected, which supports the expected timing of... Read More

Positive Results from Phase 2b SYMMETRY Cohort D, an expansion cohort of Type 2 diabetic, pre-cirrhotic NASH patients treated with EFX or placebo in combination with a GLP-1 receptor agonist, reported during the second quarter of 2023 Phase 3 SYNCHRONY studies on track to begin enrolling in the second half of 2023 36 Weeks Results from the Phase 2b SYMMETRY study, evaluating treatment of patients with compensated cirrhosis... Read More

SOUTH SAN FRANCISCO, Calif., June 23, 2023 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease marked by high unmet medical need, today announced two presentations of secondary and post-hoc analyses of the Phase 2b HARMONY study of efruxifermin (EFX) in patients with pre-cirrhotic nonalcoholic steatohepatitis... Read More

Patients treated with EFX for 12 weeks combined with GLP-1 achieved a 65% relative reduction in liver fat, compared to a 10% relative reduction for GLP-1 alone 88% of patients treated with EFX combined with GLP-1 had normalized liver fat at week 12, compared with 10% of those treated with GLP-1 alone EFX-treated patients also experienced statistically significant improvements in liver enzymes and noninvasive markers of... Read More

SOUTH SAN FRANCISCO, Calif., June 01, 2023 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease marked by high unmet medical need, will hold an investor conference on Monday, June 5 at 8:00 a.m. ET to share results from Cohort D of the Phase 2b SYMMETRY study. The primary aim of the 12-week study was to assess... Read More

SAN FRANCISCO, May 31, 2023 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease marked by high unmet medical need, today announced that management will present at the Jefferies Healthcare Conference Wednesday, June 7, 2023, at 10:30 a.m. (ET) in New York, NY. A live webcast of the Company presentation will be... Read More

SOUTH SAN FRANCISCO, Calif., May 16, 2023 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease marked by high unmet medical need, today announced the pricing of an underwritten offering of 5,238,500 shares of its common stock at a price of $42.00 per share, before deducting underwriting discounts and... Read More

Results from Cohort D, an expansion cohort of type 2 diabetic, pre-cirrhotic NASH patients treated with EFX or placebo in combination with a GLP-1 agonist, to be reported during the second quarter of 2023 SYNCHRONY Phase 3 studies on track to begin enrolling in the second half of this year Results from the Phase 2b SYMMETRY study, evaluating treatment of patients with compensated cirrhosis due to NASH, on track to be... Read More

The planned Phase 3 program consists of three trials, SYNCHRONY Histology, SYNCHRONY Real-World, and SYNCHRONY Outcomes to evaluate the safety and efficacy of efruxifermin (EFX) in patients with NASH SYNCHRONY Histology and SYNCHRONY Real-World are expected to begin enrollment in the second half of this year Consistent with the encouraging clinical profile to date reported for 28mg and 50mg EFX, Akero will continue to... Read More

SOUTH SAN FRANCISCO, Calif., March 17, 2023 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today reported fourth quarter and full year financial results for the period ending December 31, 2022. “The wins we celebrated in 2022 further solidify our confidence in... Read More

SOUTH SAN FRANCISCO, Calif., Jan. 10, 2023 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease marked by high unmet medical need, today announced the appointment of Patrick Lamy as Senior Vice President, Commercial Strategy. “Akero is thrilled to welcome Patrick to the team, especially following last year’s... Read More

SOUTH SAN FRANCISCO, Calif., Jan. 04, 2023 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today announced that management will present at the 41 st Annual J.P. Morgan Healthcare Conference on Tuesday, January 10, 2023, at 10:30 a.m. P.T. in San Francisco, CA. A live... Read More

Results of the main study in patients with compensated cirrhosis due to NASH (F4) expected in fourth quarter of 2023 Results of the cohort D expansion to evaluate EFX in combination with GLP-1 therapy in patients with pre-cirrhotic NASH expected in second quarter of 2023 Following designation of EFX as a Breakthrough Therapy, a meeting has been scheduled for March 2023 with FDA to review results of the Phase 2b HARMONY study... Read More