What is going on with RDHL?
RedHill Biopharma Ltd. (RDHL) stock is higher today after the company announced that its lead clinical drug, opaganib, is expected to be unaffected by mutations associated with Omicron and other known Covid-19 variants of concern.
Opaganib is an orally-administered, SK2 selective inhibitor with dual anti-inflammatory and antiviral activity.
The drug is expected to be effective against emerging viral variants, having already demonstrated a strong reduction against the Delta variant.
Shares of RDHL increased 3.92% to $2.65 as of Monday at 10:27 am.
What does this mean for RedHill Biopharma?
Opaganib works by targeting the human host cell rather than the virus itself and is therefore not expected to be impacted by spike protein mutations.
This increases the potential that Omicron will be effective against both the Omicron and future Covid-19 variants.
Gilead Raday, RedHill's Head of R&D, commented, "Both opaganib and RHB-107 have unique human cell-targeted mechanisms of action that act independently of mutations at the spike protein."
"Given the gravity of the threat presented by Omicron, and the likely emergence of other variants, RedHill is pursuing development of these two promising COVID-19 pills as quickly and diligently as possible."
Opaganib has also received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer.
RedHill has submitted data packages to the U.S. FDA, the European Medicines Agency (EMA), and the UK (MHRA) seeking scientific advice on the potential path towards regulatory approval.
The company expects feedback from the EMA by the end of the year, with preliminary feedback from the FDA expected in January 2022.
