Welcome to our dedicated page for Akero Therapeutics news (Ticker: AKRO), a resource for investors and traders seeking the latest updates and insights on Akero Therapeutics stock.
Akero Therapeutics, Inc. (Nasdaq: AKRO) is a clinical-stage biotechnology company based in South San Francisco, developing innovative treatments for major metabolic diseases, including non-alcoholic steatohepatitis (NASH). Focused on creating best-in-class medicines, Akero's lead clinical program centers on efruxifermin (EFX), a modified FGF21 protein designed to reduce liver fat, inflammation, and fibrosis. EFX is engineered to target both the liver and adipose tissue, offering potential comprehensive benefits to NASH patients.
Building on over two decades of FGF21 research, Akero has achieved significant milestones. Their Phase 2b HARMONY study, evaluating EFX in pre-cirrhotic NASH patients, demonstrated impressive results at Week 96, including substantial fibrosis improvement and liver health biomarkers. Additionally, the SYNCHRONY program encompasses multiple Phase 3 clinical trials aimed at both cirrhotic and pre-cirrhotic NASH patients, further validating the efficacy and safety profile of EFX.
Akero's rigorous clinical trials and outstanding engagement with the FDA underscore their commitment to addressing high unmet medical needs. Their recent public stock offering has bolstered financial stability, ensuring sustained progress in their groundbreaking research and development efforts. For more information, visit Akero Therapeutics and follow them on LinkedIn and Twitter.
Akero Therapeutics (NASDAQ: AKRO) has successfully closed its upsized public offering, raising approximately $402.5 million in gross proceeds. The offering consisted of two components: 6,427,170 shares of common stock priced at $48.00 per share (including the full exercise of underwriters' option for additional 1,093,750 shares), and 1,958,247 pre-funded warrants at $47.9999 per warrant with a $0.0001 exercise price.
The offering was managed by J.P. Morgan, Morgan Stanley, and Jefferies as joint book-running managers, with UBS Investment Bank acting as co-manager. The securities were offered through an automatically effective shelf registration statement previously filed with the SEC.
Akero Therapeutics (Nasdaq: AKRO) has announced the pricing of an upsized public offering, consisting of 5,333,420 shares of common stock at $48.00 per share and pre-funded warrants to purchase 1,958,247 shares at $47.9999 per warrant. The pre-funded warrants have an exercise price of $0.0001 per share.
The company expects to raise approximately $350.0 million in gross proceeds before deducting underwriting costs and expenses. Akero has granted underwriters a 30-day option to purchase up to an additional 1,093,750 shares. The offering is expected to close around January 30, 2025.
J.P. Morgan, Morgan Stanley, and Jefferies are serving as joint book-running managers, with UBS Investment Bank acting as co-manager for the offering.
Akero Therapeutics (NASDAQ: AKRO), a clinical-stage company focused on metabolic disease treatments, has announced a proposed public offering of $300.0 million of common stock shares. The company plans to grant underwriters a 30-day option to purchase up to an additional $45.0 million of shares at the public offering price, less underwriting discounts and commissions.
The offering will be managed by J.P. Morgan, Morgan Stanley, and Jefferies as joint book-running managers. The securities will be offered through an automatically effective shelf registration statement previously filed with the SEC. The completion of the offering is subject to market and other conditions, with no guarantee of completion or final terms.
Akero Therapeutics (NASDAQ: AKRO) has announced significant topline results from its Phase 2b SYMMETRY study evaluating efruxifermin (EFX) in patients with compensated cirrhosis due to MASH. The study demonstrated statistically significant reversal of cirrhosis at Week 96:
- Among patients with baseline and week 96 biopsies, 39% of the 50mg EFX group showed ≥1 stage improvement in fibrosis with no worsening of MASH, compared to 15% for placebo (24% effect size).
- In the Intent to Treat analysis, 29% of the 50mg EFX group demonstrated improvement, compared to 12% for placebo (17% effect size).
The study revealed stronger results in patients not taking GLP-1 at baseline, with 45% showing cirrhosis reversal in the 50mg group versus 17% for placebo. EFX was generally well-tolerated, with most adverse events being grade 1 or 2 gastrointestinal issues.
Akero Therapeutics (NASDAQ: AKRO) has announced an upcoming investor webcast scheduled for Monday, January 27, 2025, at 8:00 a.m. ET. The company will present preliminary topline week 96 results from its SYMMETRY Phase 2b study, which evaluates efruxifermin (EFX) in patients with compensated cirrhosis (F4) due to metabolic dysfunction-associated steatohepatitis (MASH).
The study is designed as a double-blind, placebo-controlled trial. The presentation will include a webcast with slides, available on the Events & Presentations page of Akero's website, with recording and presentation materials to be made available immediately after the event.
Akero Therapeutics has completed enrollment of the double-blind portion of its Phase 3 SYNCHRONY Real-World study, focusing on the safety and tolerability of Efruxifermin (EFX) in patients with MASH or MASLD. A total of 601 patients have been enrolled since the study's initiation in November 2023. The study assesses the safety and tolerability of EFX, administered once-weekly in 50mg doses, over 52 weeks.
The SYNCHRONY Real-World study is a randomized, double-blind, placebo-controlled trial, with primary endpoints on safety and tolerability. Secondary endpoints include changes in non-invasive markers of liver fibrosis and injury, as well as lipoproteins, glycemic control, and body weight. An open-label cohort includes patients previously assigned to placebo in Phase 2b studies. Data from this study are expected in the first half of 2026.
Akero's Chief Development Officer, Kitty Yale, noted the rapid enrollment as indicative of the significant need for MASH treatments and optimism surrounding EFX's potential. Previous Phase 2 studies have shown improvements in liver histology and non-invasive liver health markers.
Akero Therapeutics (Nasdaq: AKRO), a clinical-stage company focused on developing treatments for serious metabolic diseases, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. The company's management will deliver a presentation on Tuesday, January 14, 2025, at 11:15 a.m. Pacific Time.
Interested parties can access a live webcast of the presentation through the investor relations section of Akero's website at www.akerotx.com. An archived version of the presentation will also be made available on the company's website following the live broadcast.
Akero Therapeutics (Nasdaq: AKRO) has announced its participation in the 7th Annual Evercore ISI HealthCONx Conference. The company's management will engage in a fireside chat on Tuesday, December 3, 2024, at 9:10 a.m. ET. The presentation will be accessible through a live webcast via the investor relations section of Akero's website at www.akerotx.com, with an archived replay available afterward. Akero is a clinical-stage company focused on developing treatments for serious metabolic diseases with high unmet medical needs.
Akero Therapeutics presented new analyses of its Phase 2b HARMONY study for efruxifermin (EFX) in treating metabolic dysfunction-associated steatohepatitis (MASH). Over 40% of participants treated with EFX 50mg for 96 weeks showed regression of liver fibrosis across three measures, compared to 0% for placebo. 30% of participants receiving EFX 50mg achieved almost complete MASH disease reversal. The study demonstrated consistent improvements in liver health markers, with AI-based digital pathology confirming conventional histopathology assessments. The 50mg dose showed superior results compared to the 28mg dose, with significant reductions in fibrosis in both perisinusoidal and periportal zones of the liver.
Akero Therapeutics (Nasdaq: AKRO) has announced its upcoming participation in the Jefferies London Healthcare Conference. The company's management will engage in a fireside chat on Tuesday, November 19, 2024, at 12:00 p.m. GMT. Akero, which focuses on developing treatments for serious metabolic diseases, will make the presentation available via live webcast through their investor relations website. An archived replay will be accessible on www.akerotx.com following the live event.
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