EU considers retracting Blenrep's authorisation after GSK trial

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EU considers retracting Blenrep's authorisation after GSK trial
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GSK's Blenrep, a treatment for multiple myeloma, has shown improved progression-free survival rates in a phase III trial, according to the latest results released today. The UK-based pharmaceutical company reported a significant trend toward overall survival among patients with relapsed myeloma. In light of these findings, GSK is expanding the study to gather more robust evidence of Blenrep's efficacy.

Despite these positive results, Blenrep faces regulatory challenges in Europe. Today, the EU proposed withdrawing the drug's conditional marketing authorisation, which could affect GSK's third-quarter revenue of £10 million. This proposition follows earlier setbacks, including advice from the FDA that led to Blenrep's discontinuation in the US market.

The recent trial success comes as a contrast to previous issues Blenrep encountered. Last November, the drug failed to outperform an alternative therapy in a late-stage study. Nonetheless, when used in combination with other treatments, Blenrep has proven effective for patients with relapsed or refractory multiple myeloma.

GSK's disclosure of the successful pivotal trial positions Blenrep as a potential second-line therapy for myeloma, achieving its primary goal of halting disease progression. As GSK continues to investigate Blenrep's long-term benefits, regulatory bodies will likely weigh these new findings against past performance issues before making final decisions on the drug's market availability.

InvestingPro Insights

In the wake of GSK's latest clinical trial results for Blenrep, investors and analysts are closely monitoring the pharmaceutical giant's financial health and market performance. According to real-time data from InvestingPro, GSK boasts a solid market capitalization of $72.89 billion and an attractive P/E ratio of 9.5, indicating a potentially undervalued stock relative to its earnings. The company's revenue growth over the last twelve months as of Q3 2023 stands at 2.16%, reflecting a steady upward trajectory despite the challenges faced.

Two InvestingPro Tips that are particularly pertinent to GSK at this juncture include the company's high return on assets, which stands at 10.78%, and the fact that analysts have revised their earnings upwards for the upcoming period. These insights suggest that GSK is efficiently managing its assets and that there is optimism about its future earnings potential.

For investors seeking more in-depth analysis, there are additional tips available on InvestingPro. Notably, GSK has maintained dividend payments for 23 consecutive years, and with a current dividend yield of 3.71%, it remains an attractive option for income-seeking shareholders.

It's worth noting that the InvestingPro subscription, which includes these and other valuable tips, is now on a special Cyber Monday sale with a discount of up to 55%. For those interested in exploring all 12 tips provided for GSK, visiting the dedicated page on InvestingPro could offer further strategic insights into the company's performance and potential investment opportunities.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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