UK-based GlaxoSmithKline PLC (GB:GSK) today announced that its experimental antibody-drug conjugate, GSK’227, has received breakthrough therapy designation by the US FDA (Food and Drug Administration). GSK’227 is intended for adults with relapsed or refractory osteosarcoma (bone cancer) who have not responded to at least two previous treatments.
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Osteosarcoma is a rare and aggressive form of bone cancer, primarily impacting children and young adults. It represents 20-40% of all bone cancers, with approximately 3.3 new cases per million people annually in the US. GSK shares fell by 0.74% as of writing.
Based in the UK, GlaxoSmithKline is a global pharmaceutical company with a presence in roughly 80 countries.
FDA Recognizes GSK’s Cancer Drug
GSK stated that the recognition by the FDA is based on encouraging early data indicating significant potential improvements compared to existing treatments. Additionally, this designation aims to accelerate the development and evaluation of drugs that have the potential to enhance treatment for serious conditions.
Notably, this marks the third regulatory designation for GSK’227. Previously, the drug has also been granted Priority Medicines (PRIME) designation by the European Medicines Agency and the breakthrough therapy designation by the FDA for its potential in treating advanced small-cell lung cancer.
In recent years, GSK has intensified its focus on cancer treatment development, driven by challenges in its vaccines division. Earlier this December, GSK reached a significant milestone in its ovarian cancer trial. The company achieved promising outcomes in ovarian cancer treatment with its drugs, Jemperli and Zejula.
Is GSK a Good Share to Buy?
According to the consensus on TipRanks, GSK stock has received a Hold rating backed by seven Hold, three Buy, and two Sell recommendations. The GSK share price forecast is set at 1,628p, indicating a projected increase of 21.58% from the current level.
