We have established a track record of efficient and consistent achievement.
HARMONY Phase 2b Week 96 Study Readout
We reported topline week 96 data showing statistically significant histological improvements, demonstrating ≥1- and ≥2-stage fibrosis improvement without worsening of MASH at both 50mg and 28mg doses of EFX.
Public Follow-On Offering
Following topline week 96 HARMONY data, we closed a public offering with gross proceeds of approximately $366.9M.
Public Offering
$334.8 million in net proceeds raised through Akero’s ATM Facility and underwritten registered direct offering of common stock.
SYMMETRY Cohort D Readout
Results from the expansion cohort of the Phase 2b SYMMETRY study met safety and tolerability endpoints and showed adding EFX to GLP-1 therapy significantly improved non-invasive markers of MASH, offering benefit over GLP-1 therapy alone.
SYMMETRY Phase 2b Week 36 Readout
We reported results from a 36-week analysis of the Phase 2b SYMMETRY study of EFX in F4 patients which showed a trend on fibrosis improvement, which was not statistically significant, and statistically significant results for MASH resolution, markers of liver injury and fibrosis, insulin sensitization and lipoproteins.
Phase 3 SYNCHRONY Program Initiated
We initiated and dosed the first patients in two parallel, randomized, placebo-controlled Phase 3 trials: SYNCHRONY Histology evaluating the efficacy and safety of EFX in patients with biopsy-confirmed pre-cirrhotic MASH, and SYNCHRONY Real-World assessing safety and tolerability of EFX in patients with non-invasively diagnosed MASH or metabolic dysfunction-associated steatotic liver disease (MASLD).
HARMONY Phase 2b Study Readout
Our topline Ph 2b data achieved statistical significance on both primary and secondary histology endpoints after 24 weeks in patients with pre-cirrhotic MASH (F2-F3).
Upsized Public Follow-On Offering
Following topline HARMONY data, we closed an upsized underwritten public offering with gross proceeds of approximately $230M.
Breakthrough Therapy Designation
Lead candidate EFX was granted Breakthrough Therapy Designation from the US FDA for the treatment of MASH.
BALANCED Expansion Cohort Readout
We reported early evidence that EFX has the potential to reverse fibrosis for cirrhotic MASH patients.
Phase 2b HARMONY and SYMMETRY Study Initiation
Parallel studies in pre-cirrhotic and cirrhotic MASH are the next step toward a potential commercialization of EFX, if approved.
Phase 2a BALANCED Study Readouts
Our topline liver fat, liver injury, metabolic and biopsy data showed strongly positive and consistent improvements across multiple parameters for MASH.
$216M Upsized Follow-On Offering
Our cumulative financing surpassed $400M with an upsized follow-on offering at the top of the marketing range.
New Corporate Headquarters
We completed renovation of our new corporate headquarters in South San Francisco, CA.
$45M Series A Financing and Amgen License
We entered an exclusive, global license from Amgen to develop EFX, backed by blue-chip investors.
$45.5M Series B Financing
Our crossover financing with a dozen top-tier private investors paved the way for a successful IPO.
Manufacturing Partnerships
We partnered with Boehringer-Ingelheim and Vetter Pharma to ensure high quality API and drug product.