Core Viewpoint - Akero Therapeutics, Inc. has announced an upsized underwritten public offering of common stock and pre-funded warrants, aiming to raise approximately $350 million in gross proceeds to support its clinical development efforts in treating serious metabolic diseases [1][5]. Group 1: Offering Details - The offering consists of 5,333,420 shares of common stock priced at $48.00 per share and pre-funded warrants to purchase 1,958,247 shares at a price of $47.9999 each [1]. - Akero has granted underwriters a 30-day option to purchase an additional 1,093,750 shares at the public offering price [1]. - The offering is expected to close on or about January 30, 2025, subject to customary closing conditions [1]. Group 2: Underwriters - J.P. Morgan, Morgan Stanley, and Jefferies are acting as joint book-running managers for the offering, while UBS Investment Bank serves as co-manager [2]. Group 3: Regulatory Information - The securities are being offered under an automatically effective shelf registration statement previously filed with the U.S. Securities and Exchange Commission (SEC) [3]. - A preliminary prospectus supplement was filed with the SEC on January 27, 2025, with the final prospectus to be filed subsequently [3]. Group 4: Company Overview - Akero Therapeutics is focused on developing treatments for serious metabolic diseases, including metabolic dysfunction-associated steatohepatitis (MASH) [5]. - The lead product candidate, efruxifermin (EFX), is currently in three ongoing Phase 3 clinical studies targeting different patient populations with MASH [5].

Core Insights - Akero Therapeutics' shares doubled following positive results from a study on its experimental liver disease treatment, efruxifermin (EFX) [1][6] Study Results - A 96-week Phase 2b study showed that 39% of patients with cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH) experienced reversal of cirrhosis after receiving a 50mg dosage of EFX, compared to only 15% in the placebo group [2] - A subgroup of patients not on GLP-1 weight-loss medications showed even better outcomes, suggesting these medications did not contribute to the improvement [3] Expert Commentary - Dr. Mazen Nourredin, the principal investigator, highlighted the lack of effective treatments for compensated cirrhosis due to MASH until now, expressing optimism about EFX's potential if approved [4] - CEO Dr. Andrew Cheng emphasized EFX's "transformational potential" and mentioned ongoing evaluation in a Phase 3 trial [4] Market Reaction - Following the announcement, Akero Therapeutics' shares approached their all-time high set over two years ago [5]

On Monday, Akero Therapeutics, Inc. AKRO released preliminary topline week 96 results from SYMMETRY Phase 2b study evaluating the efficacy and safety of its lead product candidate efruxifermin (EFX) in patients with biopsy-confirmed compensated cirrhosis (F4), Child-Pugh Class A, due to metabolic dysfunction-associated steatohepatitis (MASH).Among patients with baseline and week 96 biopsies (n=134), 39% of patients treated with 50mg EFX (n=46) experienced reversal of cirrhosis with no worsening of MASH, rep ...

Among patients with baseline and week 96 biopsies, 39% of the 50mg EFX group (p=0.009) demonstrated ≥1 stage improvement in fibrosis with no worsening of MASH, representing a 24% effect size over placebo at 15% By ITT analysis, with all missing week 96 biopsies treated as failures, 29% of the 50mg EFX group (p=0.031) demonstrated ≥1 stage improvement in fibrosis with no worsening of MASH, representing a 17% effect size over placebo at 12% Investor webcast at 8:00 am ET Monday, January 27, 2025 SOUTH SAN FR ...

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-contro ...

NEW YORK, Jan. 24, 2025 /PRNewswire/ -- Kuehn Law, PLLC, a shareholder litigation law firm, is investigating whether certain officers and directors of Akero Therapeutics, Inc. (NASDAQ: AKRO) breached their fiduciary duties to shareholders. The investigation concerns potential self-dealing. Shareholders may be entitled to damages and corporate governance reforms.If you are a long-term AKRO stockholder please contact Justin Kuehn, Esq. here, by email at [email protected], or call (833) 672-0814. The consultat ...

-- 601 patients have been enrolled in the double-blind portion of the SYNCHRONY Real-World study since initiation in November 2023 -- -- Data from SYNCHRONY Real-World study anticipated in the first half of 2026 -- SOUTH SAN FRANCISCO, Calif., Jan. 13, 2025 (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 it has completed enrollment of pa ...

Core Insights - Akero Therapeutics is a clinical-stage company focused on developing treatments for serious metabolic diseases with high unmet medical needs, particularly MASH [2] Group 1: Company Overview - Akero's lead product candidate, EFX, is currently being evaluated in three ongoing Phase 3 clinical trials targeting patients with pre-cirrhotic MASH (F2-F3) and compensated cirrhosis (F4) due to MASH [2] - The SYNCHRONY program builds on the results of two Phase 2b clinical trials, including the completed HARMONY study and the ongoing SYMMETRY study, with over 300 patients treated with EFX or placebo for up to 96 weeks [2] - The company is headquartered in South San Francisco and provides additional information through its website and social media platforms [2] Group 2: Upcoming Events - Management will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 14, 2025, at 11:15 a.m. P.T. [1] - A live webcast of the presentation will be available on the company's investor relations section, with an archived replay accessible afterward [1]

-- 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 ELFTM score (serum fibrosis biomarker) – -- Analysis of biopsies by AI-based Digital Pathology (qFibrosis®, Histoindex) corroborated the extent of impr ...

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 of the Company presentation will be available through the investor relations section ...