Bayer's Spanish Aspirin Plant Goes Carbon-Free as US Regulators Hand Down Two Pharma Approvals

Bayer gained FDA approvals for sevabertinib and Kerendia, advanced a EUR 17 million Spain decarbonization project, but faced Roundup litigation and a cautious JPMorgan note.

Bayer has secured a pair of regulatory wins in the United States while simultaneously pushing forward with an industrial decarbonization project in Spain, even as legal battles and cautious analyst commentary weighed on its share price.

The German life-sciences group received accelerated approval from the FDA for sevabertinib, a treatment aimed at adults with HER2-mutated non-small cell lung cancer in the first-line setting. In a separate decision, the agency cleared finerenone — marketed as Kerendia — for use in adults with chronic kidney disease linked to type 1 diabetes, widening the drug's reach in the cardiovascular and renal space. Both approvals strengthen Bayer's oncology and cardiorenal franchises at a time when the company is reshaping its pharmaceutical leadership: Dr. Christoph Koenen took over as Chief Medical Officer of the Pharma division effective October 1.

On the industrial side, Bayer's aspirin ingredient facility in Langreo, Asturias, has been recognized with a Convive award from utility Iberdrola for its decarbonization overhaul. The company is putting EUR 17 million into the site, where a new energy system is entering test operations and is slated for full service before the end of 2026. According to Bayer, Langreo will become Spain's first fully decarbonized pharmaceutical production plant, cutting more than 6,500 metric tons of CO2 annually. Process-related emissions from aspirin manufacturing will drop to nearly zero, positioning the factory among Europe's first decarbonized pharma production sites and helping safeguard its long-term competitiveness against tightening environmental rules.

Consumer Health and External Research Push

Bayer is also expanding its over-the-counter portfolio. In the US, it launched MiraSOFT, a stool softener built on docusate sodium, sold exclusively through CVS Pharmacy in more than 7,000 stores and via the chain's online channel. Meanwhile, management continues scouting for fresh pipeline ideas: at a Bayer Co.Lab showcase tied to a Boston conference, Asian biotech firms presented RNA-based technologies, with Bayer's business development and licensing teams exploring potential partnerships on site.

Courtroom Pressure and a Cautious Analyst Note

Legal disputes in the US continue to shadow the broader group. A trial involving three plaintiffs opened in Missouri over Roundup claims; the women allege the herbicide was defectively designed and unsafe, and they are not participating in a proposed USD 7.25 billion settlement. In a separate procedural development, a US federal judge declined motions by Pfizer, BioNTech and Moderna to dismiss patent suits brought by Bayer CropScience concerning mRNA technology — meaning those proceedings will move ahead.

Those legal overhangs, combined with a downbeat assessment from JPMorgan, pressured the stock. Analyst Richard Vosser described early consensus estimates for the third quarter as likely too optimistic. Shares fell 5.1% yesterday to close at EUR 45.31, and were trading at EUR 44.95 today, a further daily decline of 0.8%. Despite the recent softness, the stock remains up 21% since the start of the year.