A day after asserting a $400m convertible bond providing, Telix Prescribed drugs has had a brand new drug utility (NDA) accepted by the US Meals and Drug Administration (FDA) for prostate most cancers imaging agent TLX007-CDx.
The company has set a prescription drug person charge act (PDUFA) objective date of 24 March 2025, as per a 24 July press launch.
Radiopharmaceutical specialist Telix mentioned its goal is to additional improve affected person entry to prostate-specific membrane antigen (PSMA) PET imaging.
PSMA is a protein particular to prostate most cancers cells, and the take a look at can detect elevated areas of its uptake in cells by linking it with a radioisotope. The approach is seen as superior to traditional imaging strategies for prostate most cancers monitoring, however points with accessibility and regulatory necessities imply many prostate most cancers sufferers don’t bear the scan.
Telix’s TLX007-CDx is a so-called “chilly package” to organize PSMA-PET imaging. The Australia-based firm mentioned the package may help with PSMA imaging product utilisation at areas that aren’t near a nuclear pharmacy, a requirement for a lot of present gallium-68 brokers.
There are at present round 350-450 licensed nuclear pharmacists within the US. Cardinal Well being operates the biggest radiopharmaceutical community within the nation.
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The package is designed to facilitate extra versatile manufacturing and contains larger exercise gallium-68.
Telix already has an FDA-approved imaging agent, a gallium-68 gozetotide injection marketed below the model title Illuccix. The corporate’s group CEO Dr Christian Behrenbruch mentioned the submitting acceptance for the chilly package is a step in the direction of “bettering fairness of entry”.
Behrenbruch added: “We now stay up for working with the FDA to convey TLX007-CDx to American males residing with prostate most cancers, together with these residing in underserved communities and areas the place entry to state-of-the-art imaging stays restricted.”
As Telix waits for the FDA assessment, it has set its sights on label expansions for its different diagnostic imaging brokers. On 23 July, Telix supplied $398m in convertible bonds, which will likely be used to fund the mandatory research and pivotal trials for kidney and mind most cancers remedy programmes.
At present listed on the Australian Securities Change, Telix had been planning on going public on Nasdaq earlier this yr. The corporate U-turned on the IPO, nonetheless, citing market circumstances on the time.
Eli Lilly has joined Telix within the rising radiopharmaceutical house, buying POINT Biopharma in a $1.4bn deal in October 2023. The drugmaker then partnered with Radionetics Oncology in a $140m deal earlier this month, which included an unique choice to amass the companion for $1bn.
Bristol Myers Squibb and Novartis have additionally carried out their very own radiopharma acquisitions for $4.2bn and $1.75bn respectively previously yr.
