GSK plc (LSE/NYSE: GSK), a global pharmaceutical leader with a market capitalization of $68.5 billion and an impressive gross profit margin of 72%, announced today that its investigational drug, GSK'227, has been granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) for the treatment of relapsed or refractory osteosarcoma in adults.
According to InvestingPro analysis, GSK maintains a "GREAT" financial health score, positioning it well to advance its innovative pipeline. This designation is intended to expedite the development and review process for drugs that show potential in treating serious conditions and offer significant improvement over existing therapies.
The FDA's decision is based on promising early data from the phase II ARTEMIS-002 study, which evaluated the safety and efficacy of GSK'227 in patients with osteosarcoma, a rare and aggressive bone cancer. The study, presented at the 2024 American Society of Clinical Oncology Annual Meeting, involved more than 60 participants, including 42 with osteosarcoma.
GSK'227 is an antibody-drug conjugate targeting B7-H3, a protein often found on the surface of cancer cells. The drug is composed of a monoclonal antibody linked to a topoisomerase inhibitor, a type of chemotherapy. The Breakthrough Therapy Designation follows GSK'227's previous regulatory milestones, including the European Medicines Agency's Priority Medicines (PRIME) designation and an FDA Breakthrough Therapy Designation for extensive-stage small-cell lung cancer.
Osteosarcoma primarily affects children and young adults and is the most prevalent form of primary bone cancer. With an incidence rate of 3.3 patients per million annually in the US, it represents less than 1% of all new cancer diagnoses. The prognosis for patients with relapsed or refractory osteosarcoma after two lines of therapy is particularly poor, as no FDA-approved treatments are currently available.
Hesham Abdullah, GSK's Senior Vice President and Global Head of Oncology R&D, highlighted the urgent need for new treatments for patients with relapsed or refractory osteosarcoma, emphasizing the limited benefit of chemotherapy in such cases.
GSK is a global biopharma company focused on uniting science, technology, and talent to combat diseases. Its oncology portfolio is expanding, with a focus on hematologic malignancies, gynecologic cancers, and solid tumors. The company is committed to improving patient outcomes through innovations in immuno-oncology and targeted therapies.
With revenue growth of 5.59% in the last twelve months and currently trading near its 52-week low, GSK appears undervalued according to InvestingPro's Fair Value analysis. For detailed insights and access to the comprehensive Pro Research Report covering GSK and 1,400+ other stocks, consider an InvestingPro subscription.
This news is based on a press release statement and reflects the ongoing efforts by GSK to provide new therapeutic options for challenging cancers like osteosarcoma. InvestingPro data reveals 8 additional key insights about GSK's financial strength and market position, including its 24-year track record of consistent dividend payments. Unlock these valuable insights and more with an InvestingPro subscription.
In other recent news, GSK plc has seen several significant developments. The company's drug Nucala has been approved in China for nasal polyp treatment, marking it as the sole anti-IL-5 treatment for this condition in the country.
GSK also reported successful outcomes from its phase III FIRST trial, which evaluated the efficacy of Zejula and Jemperli in treating advanced ovarian cancer. Additionally, Jemperli received Breakthrough Therapy Designation from the US Food and Drug Administration for treating patients with locally advanced mismatch repair deficient rectal cancer.
The company's investigational drug, GSK'227, was granted the Priority Medicines designation by the European Medicines Agency for the treatment of relapsed extensive-stage small-cell lung cancer. Moreover, Jemperli received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for the expansion of its usage combined with chemotherapy for treating endometrial cancer.
Lastly, GSK revised and extended its collaboration with Chongqing Zhifei Biological Products Co., Ltd. in China until 2034, focusing on the commercialization of its shingles vaccine, Shingrix. However, financial analysts from Jefferies and Guggenheim downgraded GSK's stock due to expectations of subdued growth in 2025.
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