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CAMBRIDGE/LONDON - Spero Therapeutics, Inc. (NASDAQ:SPRO) and GSK plc (LSE/NYSE:GSK), a prominent pharmaceutical player with an $88 billion market cap and robust 71.7% gross profit margin, announced positive results from their Phase 3 PIVOT-PO trial evaluating tebipenem HBr for complicated urinary tract infections (cUTIs), according to a press release issued Tuesday.According to InvestingPro analysis, GSK maintains a "GREAT" financial health score, suggesting strong positioning for bringing new treatments to market. Get access to 12+ exclusive ProTips and comprehensive analysis through InvestingPro’s research reports.
The pivotal trial, which was stopped early for efficacy in May, demonstrated that oral tebipenem HBr was non-inferior to intravenous imipenem-cilastatin in hospitalized patients with cUTIs, including pyelonephritis. Tebipenem HBr achieved a 58.5% overall success rate compared to 60.2% for the intravenous treatment. With annual revenues of $43.4 billion and consistent dividend payments for 25 consecutive years, GSK brings substantial resources to commercialize this potential breakthrough.
The safety profile was reported as generally similar to other carbapenem antibiotics, with diarrhea and headache being the most frequently reported adverse events among patients receiving tebipenem HBr. These events were described as mild or moderate and non-serious.
"These ground-breaking data show for the first time that cUTIs, including pyelonephritis, can be treated with an oral carbapenem antibiotic as effectively as with an intravenous one," said Tony Wood, Chief Scientific Officer at GSK.
Complicated UTIs represent a significant health issue with an estimated 2.9 million cases treated annually in the U.S. alone. Current standard treatments for drug-resistant infections include carbapenem antibiotics, which are only available in intravenous form.
Secondary endpoints showed clinical cure rates of 93.5% for tebipenem HBr compared to 95.2% for imipenem-cilastatin. Microbiological response rates were 60.3% and 61.3%, respectively.
GSK plans to work with U.S. regulatory authorities to include the data as part of a filing in Q4 2025. If approved, tebipenem HBr would be the first oral carbapenem antibiotic in the U.S. for patients with cUTIs.
The development of tebipenem HBr is supported in part with federal funds from the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority.
In other recent news, GSK has announced plans to invest $30 billion in research and development and supply chain infrastructure across the United States over the next five years. This initiative includes a $1.2 billion commitment to advanced manufacturing facilities, artificial intelligence, and digital technologies, which the company states will create hundreds of highly skilled jobs. Additionally, the China National Medical Products Administration has expanded the approval of GSK’s Shingrix vaccine for shingles prevention to include adults aged 18 and over who are at increased risk due to immunodeficiency or immunosuppression. In leadership developments, Luke Miels has been named CEO designate and will assume full responsibilities as chief executive officer on January 1, 2026, following the planned departure of current CEO Dame Emma Walmsley. Furthermore, GSK’s former autism drug, leucovorin, has received FDA approval for improving symptoms related to cerebral folate deficiency, a condition associated with neuropsychiatric symptoms. Meanwhile, ViiV Healthcare’s Dovato has shown non-inferior efficacy compared to Biktarvy in maintaining viral suppression in adults with HIV-1, with less weight gain and fewer drug-related adverse events. These developments highlight significant strides in GSK’s product offerings and strategic direction.
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