Parabilis is set to receive $125m, including a $50m upfront payment and a $75m investment, subject to agreed conditions.
The WHO has classed this outbreak as “extraordinary” due to the lack of therapeutic options and epidemiological trends.
VER-01 offers an investigational approach distinct from traditional treatment paradigms.
The wider US HHS is going through a leadership upheaval, as Republicans aim to keep voters on side amid the looming midterm elections.
The approval is based on Phase III FIBRONEER-IPF and FIBRONEER-ILD clinical trials conducted in parallel.
The approval covers the use of Enhertu in both the neoadjuvant and adjuvant treatment settings for adult patients.