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Highlights
- Telix has been granted an FDA approval for Orphan Drug Designation for bone marrow conditioning treatment.
- Telix is a biopharmaceutical business specialising in commercialising and producing therapeutic and diagnostic products.
- The European Medicines Agency previously awarded TLX66 ODD status in Europe for the medical treatment.
Shares of healthcare giant, Telix Pharmaceuticals Limited (ASX:TLX), closed 0.879% stronger at AU$4.560 per share on Tuesday after the company shared that the FDA has approved Orphan Drug Designation (ODD) for bone marrow conditioning treatment. The Food and Drug Administration (FDA) is a government department in the U.S.
Telix is a biopharmaceutical business specialising in commercialising and producing therapeutic and diagnostic products utilising Molecularly Targeted Radiation (MTR).
Though the overall healthcare sector has been bearish during the past one year, the company's stock has gained 3% in that time. If we look at the firm's recent performance, it has disappointed investors, down by 46% on year to date (YTD) and down 27% in last six months. TLX has been unable to generate traction in the last one month, falling by 14%.
Today, TLX's share price moved in lockstep with the broader S&P 500 Health Care (SPXHC), which jumped 0.74 % higher at 1,601.48 on ASX at 1:45 PM AEDT.
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FDA's nod for ODD
Telix Pharmaceuticals Limited has declared today that FDA has granted ODD for TLX66 (90Y-besilesomab), indicated for conditioning treatment before hematopoietic stem cell transplant (HSCT).
The issuance of an ODD for TLX66 will allow Telix to qualify for different drug development incentives, such as waived FDA prescription drug user fees, R&D tax credits, and FDA managed market exclusivity for seven years.
Source: © Mkkans | Megapixl.com
However, prior to HSCT, bone marrow conditioning is conducted. HSCT is a procedure that involves removing cells from a patient's bone marrow and replacing them with stem cells to encourage the formation of new bone marrow that generates healthy blood cells.
In addition, the European Medicines Agency previously awarded TLX66 ODD status in Europe for medical treatment in hematopoietic stem cell transplantation. In the U.S, 22,729 HSCTs were conducted in 2018.
Management remark
Colin Hayward, Chief Medical Officer at Telix, said:
Road ahead
TLX66 may increase the depth of conditioning in the future, eliminating other disease-causing cells. Furthermore, TLX66's potential to lessen the toxicity of current conditioning regimens might expand the number of patients suitable for transplantation.
Also read: IBX & TLX: How these two ASX healthcare stocks fared in 2021
