The deal is expected to close by the end of the 2026 financial year, subject to Telix shareholder and regulatory approvals.
With a $3.95m price tag, Fayuvi – a one-time gene therapy – is one of the most expensive drugs on the market.
On 14 September, the FDA held a public hearing where members of the public, including healthcare providers, patients, advocates, and industry stakeholders, were able to provide comments.
mAbxience will lead the development and production of the biosimilar candidate at its manufacturing facilities in Argentina and Spain.
The deal reflects a growing interest from big pharma in the compounds that bridge the gap between small molecules and biologics.
The deal grants Ona Therapeutics rights to develop an ADC targeting a single undisclosed target.
