Akero Therapeutics Inc. (NASDAQ: AKRO) stock declined by 0.047% at the last close whereas the AKRO stock price gained by 5.69% in the after-hours trading session. Akero Therapeutics is a cardio-metabolic company that focuses on creating innovative methods to treat patients with non-alcoholic steatohepatitis (NASH). Currently NASH is a disease that has no testified or approved therapies available.
AKRO stock’ on a spike,
On October 19, 2021, Akero Therapeutics informed its shareholders that the company has received Fast track designation from FDA, for its major program that is made to evaluate efruxifermin (EFX). This is a treatment that is designed for the cure of NASH patients. NASH is a deadly disease, it causes liver failure and is a major factor behind liver transplantation on an international level. To look at the stats, 17million people in the USA had NASH in the year 2016, the concern arises as the given value is anticipated to increase to 27 million by the year 2030.
The benefit of Fast track designation is that it helps in the manufacturing process of new drugs for the treatment of any critical health problem. The designation also makes the communication process easy for the company with FDA as well as there are more chances of getting priority review of products only when the clinical data supports it.
EFX is in the process of evaluation in NASH patients as two parallel Phase 2b clinical trials.
- The first is the HARMONY study in adults who have F2/F3 fibrosis
- And the second is SYMMETRY study in adults with final stage cirrhotic NASH (F4). These are the individuals who have the greater chance to face liver failure and have major unfulfilled medical requirements.
President and CEO of Akero, Andrew Cheng stated that,
The Fast track designation for EFX is a significant move in order to make it available for as many people who are suffering from NASH. It is expected that EFX can be the first most effective treatment to get approved for individuals with NASH disease, both advanced fibrotic (F2/F3) and cirrhotic (F4). The treatment has highly positive clinical data. The company however is extremely happy and looking ahead to work with FDA for the core reason of developing the best possible therapies for NASH patients.