The Telix Pharmaceuticals Ltd (ASX: TLX) share price is heading north during late morning trade following a company announcement.
At the time of writing, the biotechnology company's shares are selling for $4.56 apiece, up 9.88%.
Image source: Getty Images
What did Telix announce?
Investors are pushing Telix shares higher after investors digest the company's latest announcement to the ASX.
According to its release, Telix advised it has been granted Orphan Drug Designation (ODD) from the United States Food and Drug Administration (FDA) for its bone marrow conditioning treatment, TLX66.
Bone marrow conditioning is performed prior to hematopoietic stem cell transplantation (HSCT).
The latter is a procedure where a patient's healthy stem cells are collected from blood or bone marrow before treatment. The stem cells are then safely stored, and given back to the patient after treatment.
The Orphan Drug Act was created by the FDA to motivate biopharmaceutical companies in developing potential medicines for rare or 'orphan' diseases. The ODD provides preferential treatment that enhances a company's standing with the agency.
HSCT is being used increasingly in malignant hematological conditions, such as multiple myeloma and acute myeloid leukemia, and in non-hematological malignancies and rare/immune-mediated diseases.
In 2018, more than 22,700 HSCTs were performed in the United States.
The welcomed decision enables the company to receive special benefits of achieving incentivised targets. This includes eligibility for seven years of market exclusivity after FDA approval, discounted tax credits of 50% of drug testing costs, additional protocol assistance, reduced review times and specific marketing authorisation application fees waived.
Telix chief medical officer, Dr Colin Hayward added:
The granting of an Orphan Drug Designation by the FDA for TLX66, combined with recent encouraging data from prior studies in hematological malignancies and autoimmune disease provides a strong impetus to advance our development plans for TLX66.
This treatment has potential application in a number of hematological cancers and rare diseases and potentially also in the future for conditioning for cell and gene therapies.
Telix share price summary
It's been a challenging couple of months for Telix shareholders, with the company's share price down 42% in 2022.
However, when looking at the past 12 months, the company's shares are hovering around 2% higher.
On valuation grounds, Telix presides a market capitalisation of roughly $1.4 billion.
