AKRO Akero Therapeutics Inc.

37.67
-2.25  -6%
Previous Close 39.92
Open 39.8
52 Week Low 10.78
52 Week High 41.16
Market Cap $1,080,514,188
Shares 28,683,679
Float 12,998,559
Enterprise Value $955,459,187
Volume 598,233
Av. Daily Volume 360,096
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Drug Pipeline

Drug Stage Notes
AKR-001
Nonalcoholic steatohepatitis (NASH)
Phase 2a
Phase 2a
Phase 2a dose groups all met primary endpoint - March 31, 2020. Further data released June 30, 2020 noted 48% of patients achieved at least a one-stage improvement in fibrosis without worsening of NAFLD activity score (NAS) and 28% achieved at least a two-stage improvement in fibrosis.

Latest News

  1. SOUTH SAN FRANCISCO, Calif., July 10, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic non-alcoholic steatohepatitis (NASH) company developing pioneering medicines designed to restore metabolic balance and improve the overall health of NASH patients, announced today the closing of its upsized underwritten public offering of 6,012,390 shares of its common stock at a public offering price of $36.00 per share, which includes the exercise in full by the underwriters of their option to purchase up to an additional 784,224 shares of common stock in this offering. The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, were approximately $216.4 million

    SOUTH SAN FRANCISCO, Calif., July 10, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic non-alcoholic steatohepatitis (NASH) company developing pioneering medicines designed to restore metabolic balance and improve the overall health of NASH patients, announced today the closing of its upsized underwritten public offering of 6,012,390 shares of its common stock at a public offering price of $36.00 per share, which includes the exercise in full by the underwriters of their option to purchase up to an additional 784,224 shares of common stock in this offering. The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, were approximately $216.4 million.

    J.P. Morgan Securities LLC, Morgan Stanley & Co. LLC, Jefferies LLC and Evercore Group L.L.C. acted as joint book-running managers for the offering.

    Registration statements relating to these securities became effective on July 7, 2020.  The offering was made only by means of a prospectus, copies of which may be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions 1115 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by email at ; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; Jefferies LLC, 520 Madison Avenue, 2nd Floor, New York, NY 10022, Attention: Equity Syndicate Prospectus Department, by telephone at (877) 547-6340, or by email at ; or Evercore Group L.L.C., c/o Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Akero Therapeutics

    Akero is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering medicines designed to restore metabolic balance to improve overall health. The company's lead product candidate, Efruxifermin (EFX), formerly known as AKR-001, is currently being evaluated in an ongoing Phase 2a clinical trial.

     

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  2. SOUTH SAN FRANCISCO, Calif., July 7, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic non-alcoholic steatohepatitis (NASH) company developing pioneering medicines designed to restore metabolic balance and improve the overall health of NASH patients, announced today the pricing of an underwritten public offering of 5,228,166 shares of its common stock at a public offering price of $36.00 per share, before underwriting discounts and commissions. All of the shares in the offering are to be sold by Akero. In addition, Akero has granted the underwriters a 30-day option to purchase up to an additional 784,224 shares of its common stock. The gross proceeds from the offering, before deducting underwriting discounts and…

    SOUTH SAN FRANCISCO, Calif., July 7, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic non-alcoholic steatohepatitis (NASH) company developing pioneering medicines designed to restore metabolic balance and improve the overall health of NASH patients, announced today the pricing of an underwritten public offering of 5,228,166 shares of its common stock at a public offering price of $36.00 per share, before underwriting discounts and commissions. All of the shares in the offering are to be sold by Akero. In addition, Akero has granted the underwriters a 30-day option to purchase up to an additional 784,224 shares of its common stock. The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $188.2 million, excluding any exercise of the underwriters' option to purchase additional shares. The offering is expected to close on or about July 10, 2020, subject to customary closing conditions.

    J.P. Morgan Securities LLC, Morgan Stanley & Co. LLC, Jefferies LLC and Evercore Group L.L.C. are acting as joint book-running managers for the offering.

    Registration statements relating to these securities became effective on July 7, 2020.  The offering is being made only by means of a prospectus, copies of which may be obtained, when available, from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions 1115 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by email at ; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; Jefferies LLC, 520 Madison Avenue, 2nd Floor, New York, NY 10022, Attention: Equity Syndicate Prospectus Department, by telephone at (877) 547-6340, or by email at ; or Evercore Group L.L.C., c/o Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at .  

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Akero Therapeutics

    Akero is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering medicines designed to restore metabolic balance to improve overall health. The company's lead product candidate, Efruxifermin (EFX), formerly known as AKR-001, is currently being evaluated in an ongoing Phase 2a clinical trial.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of federal securities laws, which are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. Such forward-looking statements include statements regarding Akero's expectations with respect to the completion and timing of the proposed public offering. Risks and uncertainties that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the proposed offering.  Additional risks and uncertainties that could affect Akero's financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operation" and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2019 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, as well as in its other reports filed with the U.S. Securities and Exchange Commission, including the registration statement relating to the proposed offering. The forward-looking statements in this press release are based on information available to Akero as of the date hereof, and Akero disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Akero's views as of any date subsequent to the date of this press release.

     

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  3. SOUTH SAN FRANCISCO, Calif., July 6, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic non-alcoholic steatohepatitis (NASH) company developing pioneering medicines designed to restore metabolic balance and improve the overall health of NASH patients, announced today that it has commenced an underwritten public offering of 4,750,000 shares of its common stock. All of the shares in the offering will be sold by Akero. In addition, Akero expects to grant the underwriters a 30-day option to purchase an additional 712,500 shares of its common stock in the offering. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to…

    SOUTH SAN FRANCISCO, Calif., July 6, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic non-alcoholic steatohepatitis (NASH) company developing pioneering medicines designed to restore metabolic balance and improve the overall health of NASH patients, announced today that it has commenced an underwritten public offering of 4,750,000 shares of its common stock. All of the shares in the offering will be sold by Akero. In addition, Akero expects to grant the underwriters a 30-day option to purchase an additional 712,500 shares of its common stock in the offering. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    J.P. Morgan Securities LLC, Morgan Stanley & Co. LLC, Jefferies LLC and Evercore Group L.L.C. are acting as joint book-running managers for the proposed offering.

    A registration statement on Form S-1 relating to these securities has been filed with the U.S. Securities and Exchange Commission but has not yet become effective. These securities may not be sold nor may offers to buy these securities be accepted prior to the time the registration statement becomes effective.

    The offering will be made only by means of a prospectus. A copy of the preliminary prospectus relating to this offering may be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions 1115 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by email at ; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; Jefferies LLC, 520 Madison Avenue, 2nd Floor, New York, NY 10022, Attention: Equity Syndicate Prospectus Department, by telephone at (877) 547-6340, or by email at ; or Evercore Group L.L.C., c/o Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of federal securities laws, which are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. Such forward-looking statements include statements regarding Akero's expectations with respect to the completion, timing and size of the proposed public offering and granting the underwriters a 30-day option to purchase additional shares. Risks and uncertainties that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the proposed offering.  Additional risks and uncertainties that could affect Akero's financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operation" and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2019 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, as well as in its other reports filed with the U.S. Securities and Exchange Commission, including the registration statement relating to the proposed offering. The forward-looking statements in this press release are based on information available to Akero as of the date hereof, and Akero disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Akero's views as of any date subsequent to the date of this press release.

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  4. SOUTH SAN FRANCISCO, Calif., June 30, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO) today announced results of a 16-week analysis of secondary and exploratory endpoints in its Phase 2a BALANCED study of efruxifermin (EFX), formerly known as AKR-001, in patients with nonalcoholic steatohepatitis (NASH). Notably, of the 40 treatment responders who had end-of-treatment biopsies, we observed that 48% achieved at least a one-stage improvement in fibrosis without worsening of NAFLD activity score (NAS) and 28% achieved at least a two-stage improvement in fibrosis. In addition, 48% of responders achieved NASH resolution with no worsening of fibrosis. Improvements in glycemic control and dyslipidemia, as well as weight loss, were also…

    SOUTH SAN FRANCISCO, Calif., June 30, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO) today announced results of a 16-week analysis of secondary and exploratory endpoints in its Phase 2a BALANCED study of efruxifermin (EFX), formerly known as AKR-001, in patients with nonalcoholic steatohepatitis (NASH). Notably, of the 40 treatment responders who had end-of-treatment biopsies, we observed that 48% achieved at least a one-stage improvement in fibrosis without worsening of NAFLD activity score (NAS) and 28% achieved at least a two-stage improvement in fibrosis. In addition, 48% of responders achieved NASH resolution with no worsening of fibrosis. Improvements in glycemic control and dyslipidemia, as well as weight loss, were also observed across all dose groups. Treatment with EFX was generally reported to be well tolerated.

    "These substantial improvements observed in multiple measures of liver health, particularly the one- and two-stage improvements in fibrosis, are extremely encouraging and among the strongest biopsy results reported in NASH to date," said Stephen Harrison, M.D., medical director of Pinnacle Clinical Research. "I believe Efruxifermin continues to set itself apart as one of the most promising drug candidates in NASH, with impressive histology results after just 16 weeks of treatment."

    Summary of Week 16 Biopsy Endpoints1

    Measure (Mean)

    Placebo

    (N=2)

    All EFX

    (N=40)

    28mg

    (N=13)

    50mg

    (N=13)

    70mg

    (N=14)

    Improvement in at least one stage of fibrosis

    without worsening NAS (%)2

    0

    48

    46

    62

    36

    Improvement in at least two stages of

    fibrosis (%)2

    0

    28

    31

    38

    14

    Resolution of NASH without worsening of

    fibrosis (%)2

    50*

    48

    46

    54

    43

    Combination of improvement in at least one

    stage of fibrosis and NASH resolution (%)2

    0

    28

    31

    39

    14

    NAS Reduction ≥2 points without worsening

    of fibrosis (%)2

    50*

    78

    77

    77

    79

    1 Secondary and exploratory histological endpoints were not powered for statistical significance

    2 Liver Biopsy Evaluable Analysis Set (all patients who had Baseline and end-of-treatment liver biopsy results)

    * A single placebo responder lost 25 pounds over 16 weeks (11% weight reduction)

    The BALANCED study underscored EFX's potential to address multiple important NASH comorbidities. We observed that all dose groups had mean weight loss over the 16-week study, with the 70 mg dose group achieving a statistically significant 3.7kg (about 8 pounds) reduction in body weight at Week 16. Clinically meaningful improvements in glycemic control were observed, including significant reductions in HbA1c in the 50 and 70 mg dose groups of 0.4 and 0.5, respectively. EFX also improved dyslipidemia, including significant increases in HDL cholesterol and significant decreases in triglycerides observed across all EFX dose groups.

    Summary of Cardio-Metabolic Biomarkers

    Measure (Mean Change From Baseline)

    Placebo

    (N=21)

    28 mg

    (N=19)

    50 mg

    (N=20)

    70 mg

    (N=20)

    Body Weight (kg)1

    +0.1

    -0.3

    -2.3

    -3.7*

    HbA1C (%, absolute)1

    +0.1

    -0.1

    -0.4*

    -0.5**

    Triglycerides (%)1

    +8

    -37***

    -45***

    -43***

    HDL Cholesterol (%)1

    0

    +32***

    +40***

    +40***

    Non-HDL Cholesterol (%)1

    0

    -20***

    -13*

    -15**

    LDL Cholesterol (%)1

    +1

    -14*

    0

    -3

    1 Full Analyses Set (all patients randomized into the study)

    *p<0.05, **p<0.01, ***p<0.001, versus placebo

    EFX was reported to be generally well tolerated. There were no deaths in the study, and there were two Serious Adverse Events, one of which occurred prior to dosing. Across EFX groups, the most frequent AEs were grade 1 or 2 gastrointestinal events, which were transient in nature. There were no discontinuations due to treatment-emergent adverse events in the 50 mg dose group and no discontinuations due to the most common adverse event, diarrhea. There were no treatment-related effects on blood pressure, heart rate or bone mineral density.

    "We believe the BALANCED study data, which exceeded our expectations, demonstrate the strong potential of efruxifermin to be a foundational monotherapy for the treatment of NASH," said Andrew Cheng, M.D., Ph.D., president and CEO of Akero. "We look forward to the continued development of efruxifermin and are working diligently to deliver this potentially leading treatment to patients. We are extremely grateful to all of our investigators and study patients, particularly given that this study cohort was completed amidst the COVID-19 pandemic."

    The BALANCED study is an ongoing randomized, double-blind, placebo-controlled study in NASH patients. The company previously reported that each of the 28, 50 and 70 mg EFX dose groups met the primary endpoint compared to placebo, with absolute reductions of 12, 13 and 14 percent of liver fat, respectively, compared with 0.3 percent for placebo, and relative reductions of 63, 71 and 72 percent, compared to 0 percent for placebo. All of these results were highly statistically significant at p<0.001.

    Conference Call / Webcast Details

    The company will host a conference call and webcast with slide presentation at 4:30 p.m. ET (1:30 p.m. PT) today, June 30. The webcast of the conference call will be made available on the company's website at www.akerotx.com under the Investors tab in the Events, Presentations & Webcasts section. To access the call via dial-in, please dial 1-866-652-5200 (U.S. toll free) or 1-412-317-6060 (international) five minutes prior to the start time. Following the live audio webcast, a replay will be available on the company's website for 90 days.

    About NASH

    NASH (non-alcoholic steatohepatitis) is a serious form of NAFLD (non-alcoholic fatty liver disease) and is estimated to affect 17 million Americans. NASH is closely linked to the obesity and diabetes epidemics seen around the world. NASH is characterized by an excessive accumulation of fat in the liver that causes stress and injury to liver cells, leading to inflammation and fibrosis, which can progress to cirrhosis, liver failure, cancer and eventually death. NASH is a leading cause of liver transplants in the US and Europe.

    About the BALANCED Study

    The Phase 2a BALANCED study is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial in biopsy-confirmed adult patients with NASH. The main study enrolled a total of 80 patients. Participants were randomized to receive weekly subcutaneous doses of efruxifermin (EFX), formerly known as AKR-001, or placebo for up to 16 weeks, with safety and tolerability followed through week 20. The primary efficacy endpoint for the study is absolute change from baseline in hepatic fat fraction measured by magnetic resonance imaging – proton density fat fraction (MRI-PDFF) at week 12. Secondary measures include change from baseline in ALT at 12 weeks, the number of patients who had a decrease of ≥2 points in the NAFLD activity score (NAS) at 24 weeks and safety and tolerability measures.

    About Efruxifermin

    Efruxifermin (EFX), formerly known as AKR-001, is Akero's lead product candidate for NASH, currently being evaluated in the ongoing Phase 2a BALANCED study. EFX is designed to reduce liver fat and inflammation, reverse fibrosis, increase insulin sensitivity and improve lipoproteins. This holistic approach offers the potential to address the complex, multi-system disease state of NASH, including improvements in lipoprotein risk factors linked to cardiovascular disease – the leading cause of death in NASH patients. Engineered to mimic the biological activity profile of native FGF21, EFX offers convenient once-weekly dosing and has been generally well-tolerated in clinical trials to date.

    About Akero Therapeutics

    Akero is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering medicines designed to restore metabolic balance to improve overall health. The company's lead product candidate, Efruxifermin (EFX), formerly known as AKR-001, is currently being evaluated in an ongoing Phase 2a clinical trial. Akero Therapeutics is headquartered in South San Francisco, CA. For more information, please visit www.akerotx.com.

    Forward Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Akero's guidance regarding its business plans and objectives for EFX, including the therapeutic potential and clinical benefits thereof, as well as the safety and tolerability of EFX and future clinical development plans; Akero's Phase 2a BALANCED clinical trial, including its initial primary efficacy results; and the potential impact of COVID-19 on patient retention, strategy, future operations and clinical trials.

    Any forward-looking statements in this statement are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: risks related to the impact of public health epidemics affecting countries or regions in which we have operations or do business, such as COVID-19, including potential negative impacts on Akero's employees, manufacturers, supply chain and production as well as on global economies and financial markets; the company's ability to execute on its strategy; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; regulatory developments in the United States; and risks related to the competitive landscape. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Akero's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in the company's 2019 Annual Report on Form 10-K filed with the United States Securities and Exchange Commission (SEC) and quarterly reports on Form 10-Q filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in Akero's other filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Akero undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

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  5. SOUTH SAN FRANCISCO, Calif., June 29, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO) today announced that the company plans to discuss new efficacy and safety data, including biopsy results, from its Phase 2a BALANCED study of AKR-001 in patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH) in a post-market press release and webcast to be held on Tuesday, June 30, 2020.

    Conference Call / Webcast Details

    The company will host a conference call and webcast with slide presentation at 4:30 p.m. ET (1:30 p.m. PT) tomorrow afternoon, June 30. The webcast of the conference call will be made available on the company's website at www.akerotx.com under the Investors tab in the Events, Presentations & Webcasts section. To access the call via dial-in, please dial 1-866-652-5200 (U.S. toll free) or 1-412-317-6060 (international) five minutes prior to the start time. Following the live audio webcast, a replay will be available on the company's website for 90 days.

    About Akero Therapeutics

    Akero is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering medicines designed to restore metabolic balance to improve overall health of NASH patients. The company's lead product candidate, AKR-001, is currently being evaluated in an ongoing Phase 2a clinical trial. Akero Therapeutics is headquartered in South San Francisco, CA. For more information, please visit www.akerotx.com.

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