Bayer's Two Clocks: An FDA Approval, a 3 Billion Euro Deal, and One Judge in Missouri - ad-hoc-news.de
Article excerpt
Bayer's oncology pipeline delivered the kind of headline the company has been starved of for years. On September 9, the US Food and Drug Administration granted accelerated approval to Hyrnuo, a drug whose active ingredient, sevabertinib, is now cleared as a first-line option for adults with locally advanced or metastatic non-squamous non-small cell lung cancer carrying specific activating mutations in the HER2 tyrosine kinase domain. In the SOHO-01 trial, the therapy produced an objective response rate of 75 percent among previously untreated patients. That result is more than a scientific footnote. It is evidence that Bayer's research spending is producing commercial assets, and it arrives alongside a second regulatory milestone: a filing submitted roughly two weeks ago for Kerendia in Japan, where the company is seeking approval for the treatment of non-diabetic chronic kidney disease. Yet the laboratory momentum stands in sharp relief against the legal machinery still grinding in the United States. The company's shares slipped 1.1 percent in the latest session to EUR 48.69, and stood at EUR 48.79 in pre-market trading, down 1.2 percent since last Monday's court hearing on the Roundup settlement. Investors are left to weigh the promise of new molecules against the financial uncertainty of litigation that has shadowed Bayer for years. The central question is whether Bayer...
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The May 2026 agreement to acquire Perfuse Therapeutics for up to USD 2.45 billion - comprising a USD 300 million upfront payment plus success-based milestone payments - strengthens development efforts in ophthalmology.
