ASX Health Stocks: High fives as Telix gets expanded FDA approval, Prescient's PTX-100 returns good results

Telix Pharma gets FDA approval
Prescient shows good data from Phase 1b clinical trial
Incannex plans to open multiple psychedelic-assisted psychotherapy clinics in Australia and overseas

Telix Pharma (ASX:TLX) announced the US FDA has approved a supplementary New Drug Application (sNDA) for Illuccix, a kit for the preparation of gallium Ga 68 gozetotide injection.

The approval was this time given for the use of Illuccix on patients with metastatic prostate cancer, for whom lutetium-177 (177Lu) PSMA-directed therapy is indicated.

To qualify for radioligand therapy, the FDA said patients must be imaged with an approved gallium-based PSMA-PET agent.

This expansion means Illuccix can now be used in the US to identify and select patients who are candidates for the only FDA-approved prostate-specific membrane antigen (PSMA)-directed radioligand therapy (Pluvicto).

It is estimated that 32,000 patients per year in the US may be considered for PSMA-directed radioligand therapy.

Efficacy for Prescient’s PTX-100

Prescient Therapeutics’ (ASX:PTX) Phase 1b clinical trial of PTX-100 in relapsed and refractory T cell lymphomas (TCL) continues to show encouraging results.

The study has demonstrated several clinical responses, including two patients with relapsed and refractory peripheral TCL (PTCL) that have had complete responses (complete eradication of cancer) since the prior update in November.

These responses are not generally expected in this disease.

Although the primary goal of the study is to evaluate safety, PTX-100 continues to exhibit encouraging clinical activity in the difficult-to-treat patient population, especially when considered against responses expected from current standards of care.

Meanwhile, PTX-100 also continues to exhibit good safety profile at the highest dose of 2000 mg/m2, with very few serious adverse events.

The study is being led by globally renowned haematologist, Professor H. Miles Prince, at Epworth Hospital in Melbourne.

Other notable ASX healthcare news today

Lumos Diagnostics (ASX: LDX) announced that it has entered into three new agreements with US-based women’s healthcare company Hologic that will provide Lumos with up to US$5.9 million in total in non-dilutive funding.

This includes $4.2m from the sale and leaseback agreement for some of Lumos’ capital equipment, and $1.7m from additional work on existing projects.

Incannex (ASX:IHL) says it plans to commercialise its psychedelic clinics business in collaborative partnership with leading psychedelic experts.

The company plans to open multiple psychedelic-assisted psychotherapy clinics in Australia and overseas, with the first clinic opening in Melbourne in 2023, followed by rapid expansion based on development of sound operating model.