Akero Therapeutics will present clinical data from its SYMMETRY study on January 27, 2025, at 8 a.m. ET.
Quiver AI Summary
Akero Therapeutics, Inc. is set to hold an investor webcast on January 27, 2025, at 8:00 a.m. ET to present preliminary topline results from its SYMMETRY study, which evaluates the efficacy of efruxifermin (EFX) in patients with compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH). The SYMMETRY study is a Phase 2b, randomized, double-blind, placebo-controlled trial involving 182 patients to assess the treatment's effectiveness and safety over 36 weeks. EFX, Akero’s lead candidate, has shown promise in reversing fibrosis and improving liver health in earlier studies. With the increasing prevalence of MASH cirrhosis projected to affect millions by 2030, Akero aims to address this serious metabolic disease through its ongoing clinical trials and comprehensive research efforts.
Potential Positives
- Akero Therapeutics will present preliminary topline results from the SYMMETRY study, a significant step forward in clinical research for efruxifermin (EFX) targeting a serious metabolic disease.
- The SYMMETRY study has enrolled 182 patients, indicating substantial progress in developing EFX as a treatment for compensated cirrhosis due to MASH, highlighting the company's commitment to addressing high unmet medical needs.
- By showcasing promising clinical data in an investor webcast, Akero is likely to strengthen investor confidence and interest in its product pipeline and ongoing clinical studies.
Potential Negatives
- The upcoming webcast is intended to present preliminary topline results, which may indicate that definitive outcomes from the SYMMETRY study are still pending, raising concerns about the timeline for data releases.
- The forward-looking statements contain extensive disclaimers about uncertainties and risks, signaling potential volatility and unpredictability in Akero's clinical developments and future performance.
- The press release highlights a serious health issue (MASH cirrhosis) for which Akero is conducting research, which could raise apprehensions about the efficacy of their treatments in addressing such a critical condition.
FAQ
What is the date and time of the Akero Therapeutics investor webcast?
The investor webcast will be held on Monday, January 27, 2025, at 8:00 a.m. ET.
What clinical study results will Akero present during the webcast?
Akero will present preliminary topline week 96 results from its SYMMETRY study evaluating efruxifermin (EFX) in patients with compensated cirrhosis due to MASH.
How can I access the Akero Therapeutics webcast?
The live webcast will be available on Akero's Events & Presentations page, with registration required for access.
What is the purpose of the SYMMETRY study?
The SYMMETRY study evaluates the efficacy of efruxifermin (EFX) in patients with compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH).
What conditions does efruxifermin (EFX) aim to treat?
EFX is designed to treat metabolic dysfunction-associated steatohepatitis (MASH) and its complications, including cirrhosis and liver injury.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$AKRO Insider Trading Activity
$AKRO insiders have traded $AKRO stock on the open market 52 times in the past 6 months. Of those trades, 0 have been purchases and 52 have been sales.
Here’s a breakdown of recent trading of $AKRO stock by insiders over the last 6 months:
- ANDREW CHENG (President and CEO) has made 0 purchases and 9 sales selling 234,593 shares for an estimated $7,405,956.
- JONATHAN YOUNG (Chief Operating Officer) has made 0 purchases and 13 sales selling 133,787 shares for an estimated $4,050,022.
- CATRIONA YALE (Chief Development Officer) has made 0 purchases and 18 sales selling 101,436 shares for an estimated $3,055,108.
- WILLIAM RICHARD WHITE (Chief Financial Officer) has made 0 purchases and 6 sales selling 101,790 shares for an estimated $2,760,714.
- TIMOTHY ROLPH (Chief Scientific Officer) has made 0 purchases and 4 sales selling 9,155 shares for an estimated $281,165.
- PATRICK LAMY (Senior VP, Commercial Strategy) has made 0 purchases and 2 sales selling 1,925 shares for an estimated $57,610.
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
$AKRO Hedge Fund Activity
We have seen 79 institutional investors add shares of $AKRO stock to their portfolio, and 71 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- WELLINGTON MANAGEMENT GROUP LLP added 2,782,029 shares (+54.4%) to their portfolio in Q3 2024, for an estimated $79,816,412
- POINT72 ASSET MANAGEMENT, L.P. added 1,303,323 shares (+inf%) to their portfolio in Q3 2024, for an estimated $37,392,336
- BRAIDWELL LP removed 1,084,400 shares (-100.0%) from their portfolio in Q3 2024, for an estimated $31,111,436
- DEEP TRACK CAPITAL, LP added 689,784 shares (+inf%) to their portfolio in Q3 2024, for an estimated $19,789,902
- YIHENG CAPITAL MANAGEMENT, L.P. removed 675,410 shares (-47.1%) from their portfolio in Q3 2024, for an estimated $19,377,512
- SG AMERICAS SECURITIES, LLC added 583,486 shares (+4022.1%) to their portfolio in Q4 2024, for an estimated $16,232,580
- MORGAN STANLEY removed 498,458 shares (-52.7%) from their portfolio in Q3 2024, for an estimated $14,300,760
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
Investor webcast on Monday, January 27, 2025, at 8:00 a.m. ET to present clinical data
SOUTH SAN FRANCISCO, Calif., Jan. 24, 2025 (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, January 27, 2025, at 8:00 a.m. ET to share preliminary topline week 96 results from its SYMMETRY study, a double-blind, placebo-controlled Phase 2b study evaluating the efficacy of efruxifermin (EFX) in patients with compensated cirrhosis (F4) due to metabolic dysfunction-associated steatohepatitis (MASH).
Conference Call / Webcast Details
The company will host a conference call and webcast with slide presentation at 8:00 a.m. ET on Monday, January 27.
Please click
here
to register for the event.
The live webcast will be available on the
Events & Presentations page
of the Akero website, with the recording and presentation available immediately following the event.
About Cirrhosis Due to MASH
Cirrhosis due to MASH (metabolic dysfunction-associated steatohepatitis) is a life-threatening disease with high risk of liver failure, cancer, and eventually death. By 2030, an estimated 3 million Americans are projected to have MASH cirrhosis, which is the fastest growing cause of liver transplants and liver cancer in the United States and Europe.
About the SYMMETRY Study
The Phase 2b SYMMETRY study is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial in adult patients with biopsy-confirmed compensated cirrhosis (F4, Child-Pugh A) due to MASH. The study enrolled a total of 182 patients, randomized to receive once-weekly subcutaneous dosing of 28mg or 50mg EFX, or placebo for 36 weeks, 181 of whom received at least one study dose. The primary efficacy endpoint for the study was the proportion of patients who achieve at least one-stage fibrosis improvement without worsening of MASH at week 36. Week 96 secondary measures included ≥1 stage fibrosis improvement and no worsening of MASH, MASH resolution, change from baseline in liver enzymes, noninvasive markers of liver fibrosis, glycemic control, and lipoproteins, as well as safety and tolerability measures.
About EFX
Efruxifermin (EFX), Akero’s lead product candidate for MASH, is currently being evaluated in three ongoing Phase 3 studies. In multiple Phase 2 studies, EFX has been observed to reverse fibrosis (including compensated cirrhosis), resolve MASH, reduce non-invasive markers of fibrosis and liver injury, and improve insulin sensitivity and lipoprotein profile. This holistic profile offers the potential to address the complex, multi-system disease state of all stages of MASH, including improvements in lipoprotein risk factors linked to cardiovascular disease – the leading cause of death among MASH patients. Engineered to mimic the biological activity profile of native FGF21, EFX is designed to offer convenient once-weekly dosing and has been generally well-tolerated in clinical trials to date.
About Akero Therapeutics
Akero Therapeutics is a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, including metabolic dysfunction-associated steatohepatitis (MASH). Akero's lead product candidate, EFX, is currently being evaluated in three ongoing Phase 3 clinical studies: SYNCHRONY
Histology
in patients with pre-cirrhotic MASH (F2-F3 fibrosis), SYNCHRONY
Outcomes
in patients with compensated cirrhosis due to MASH, and SYNCHRONY
Real-World
in patients with MASH or MASLD (Metabolic Dysfunction Associated Steatotic Liver Disease). The Phase 3 SYNCHRONY program builds on the results of two Phase 2b clinical trials, the HARMONY study in patients with pre-cirrhotic MASH and the SYMMETRY study in patients with compensated cirrhosis due to MASH. Akero is headquartered in South San Francisco. Visit us at
akerotx.com
and follow us on
LinkedIn
and
X
for more information.
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, including, but not limited to, statements regarding Akero’s business plans and objectives, including future plans or expectations for EFX, and ongoing clinical studies, the therapeutic effects of EFX, as well as the dosing, safety, and tolerability of EFX. Any forward-looking statements in this press release 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; the success, cost, and timing of Akero’s product candidate development activities and planned clinical trials; Akero’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 foreign countries; Akero’s ability to fund operations; as well as those risks and uncertainties set forth more fully under the caption "Risk Factors" in Akero’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, as filed with the Securities and Exchange Commission (SEC) as well as discussions of potential risks, uncertainties, and other important factors in Akero’s other filings and reports 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.
Investor Contact:
Christina Tartaglia
Precision AQ
212.362.1200
[email protected]
Media Contact:
Peg Rusconi
Deerfield Group
617.910.6217
[email protected]