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TLX - Telix Pharmaceuticals

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Beat me to it.
Within expectations, slightly on the good side.
 
TLX, my ex-love, whom I disposed of after becoming too hot and was only watching sideways. They had several announcements as soon as I entered, and the price dropped to put me red-faced.
I thought FDA announcement would be a great booster, too


$650 M convertible bond meaning dilution so market reacted


@debtfree
 
Up 3% the day after, on a down day.
Sure its a dilution but its a good deal and helps the company expand without the costs of a USA float or heavy interest rates.
The interest rate of the convertible shares is only 2.375% and the conversion takes place at a price of $24.78, well above the reference rate of $18.70. So think of it as a raising to remove the need for loans that also shows big investors want to have a share of the company.
 
Telix has posted a move to a net profit of $29.7 million on sales up 65 per cent to $364 million for the six months ending June 30.

It said it expected to meet guidance for 2024 revenue between $US490 million and US$510 million ($745 million and $776 million), representing a 48 to 54 per cent increase on financial 2023.
 
My youngest brother got this but just when all seemed hopeless his body recognised the cancer and it stopped.

Gliomas are very diffusely infiltrative tumours that affect the surrounding brain tissue. They are the most common form of central nervous system (CNS) neoplasm that originates from glial cells, accounting for approximately 30% of all brain and CNS tumours and 80% of all malignant brain tumours[11].

Melbourne (Australia) | 28 August 2024

Telix today announces it has submitted a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX101-CDx, (Pixclara®[1], 18F-floretyrosine or 18F-FET), an investigational PET[2] agent for the characterisation of progressive or recurrent glioma (brain cancer) from treatment related changes in both adult and pediatric patients.

Given the potential to address significant unmet medical need, Pixclara®1 has been granted Orphan Drug[3] and Fast Track[4] designation by the FDA, which facilitates expedited review and closer consultation with the agency during the review process. FET PET (Pixclara®1)is already included in international clinical practice guidelines for the imaging of gliomas[5], however there is currently no FDA-approved targeted amino acid PET agent for adult and pediatric brain cancer imaging commercially available in the U.S.
 
TLX has taken over RLS which is a similar company based in the USA.
Commentary is that it is neutral to profit.
The reason to buy is to increase footprint in the USA and to obtain as manufacturing capacity. It is also a wise move in safety as if Trump gets in then they can avoid the tariffs more easily.

The business will be operating separately, no name change.
 
FDA Accepts New Drug Application and Grants Priority Review for TLX101-CDx (Pixclara®) Brain Cancer Imaging Agent
24th October.

Always nice to get priority.
 
Miner said:
TLX is continuing like a sweet charm as tomorrow's Pfizer and CSL
Click to expand...

...and a bit more help.

The US Centers for Medicare & Medicaid Services (CMS) published a decision to start separate payments for specialised diagnostic radiopharmaceuticals.

“This is a major win for the molecular imaging industry, promising relative price stability and continued patient access to radiopharmaceutical diagnostics once their TPT periods expire,” sid Wilsons analyst Dr Shane Storey.

This will benefit both TLX Telix and CU6 Clarity Pharmacueticals.

Telix’s CEO for precision medicine Kevin Richardson says the ruling, which applies to outpatients, will “provide certainty for patients and physicians seeking access to safe and effective diagnostic radiopharmaceuticals”.

He says it will also encourage investment in new imaging agents “as there is a clear commercial pathway to recouping the investment.”

The ruling potentially also could benefit Clarity Pharmaceuticals (ASX:CU6). Clarity is at phase III stage of trialling developing a copper-isotope based prostate imaging agent. With a longer half-life, this agent could enable detection of additional lesions not apparent on day one.

“The ruling] brings price stability for incumbents and therefore nullifies opportunities to grab opportunistic adoption or market share based on TPT-status alone,” Dr Storey says.
 
great reference. Looked into CU 6 site on ASX. They did not provide any disclosure on the potential benefits. Was it deliberate and to be clarified tomorrow? Price has increased however
 
Miner said:
great reference. Looked into CU 6 site on ASX. They did not provide any disclosure on the potential benefits. Was it deliberate and to be clarified tomorrow? Price has increased however
Click to expand...
Maybe CU6 do not consider it applies to them yet as it they do not have a product in the market and the ruling will simply be in place when they do
 
TlX spreaded it's wings with a significant acquisition.
Market price went down. Possibly anticipating an immediate cash out flow and a near CR to fund the deal.
I see it gives an opportunity to return to TLX.
 
Brain cancer imaging drug approval expected soon. Continuing highs. Believe it may be the top performing top 100 company for this year.
 
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