Pharmaceutical Executive Daily: FDA Approves New Indication for Kerendia

Welcome to Pharmaceutical Executive Daily, your quick briefing on the top news shaping the pharmaceutical and life sciences industry.

In today's Pharmaceutical Executive Daily, FDA approves Bayer's Kerendia as the first new treatment in more than 30 years for chronic kidney disease in adults with type 1 diabetes, a dealmaking roundup covers Novo’s more-than-$1.4-billion partnership with Orbis Medicines, Roche's up-to-$1-billion collaboration with Dualitas Therapeutics, and Aethlon Medical's merger with North Immunology, and Thani Jambulingam of Saint Joseph's University argues that the real battle in GLP-1s is now over the patient journey, not the molecule.

FDA approves Bayer's Kerendia (finerenone) to reduce urinary albumin-to-creatinine ratio in adults with chronic kidney disease associated with type 1 diabetes, the first new treatment for this population in more than 30 years. The approval is based on the Phase III Fine-One trial, in which Kerendia reduces UACR by 22% at month three and 28% at month six compared to placebo. Hyperkalemia occurs more often with Kerendia than placebo, at 10.1% versus 3.3%, with 1.7% of patients discontinuing treatment because of it.

Three biopharma deals highlight the rush toward AI-driven drug discovery and portfolio consolidation this week. Orbis Medicines enters a partnership with Novo worth more than $1.4 billion in upfront and milestone payments, plus an equity investment, to apply Orbis's AI-driven nGen platform to discovering oral macrocycle therapeutics for cardiometabolic diseases. Separately, Roche partners with Dualitas Therapeutics in a collaboration worth up to $1 billion, including a $36.5 million upfront payment, to screen more than 300,000 bispecific antibody combinations against immunology and inflammation targets. And Aethlon Medical merges with North Immunology in an all-stock deal paired with a roughly $180 million private placement, funding operations into the second half of 2028 to advance Nor-101, a bispecific antibody in development for atopic dermatitis and other immune-mediated diseases.

Finally, Thani Jambulingam, professor of Pharmaceutical & Healthcare Business at Saint Joseph's University, argues that competition in the GLP-1 market is shifting from a race over which molecule works best to a battle over who controls the entire patient journey, from prescribing through pharmacy access to long-term adherence. Jambulingam contends that success requires orchestration across a fragmented ecosystem of digital-health platforms, integrated healthcare companies, manufacturers, providers, and payers, rather than any one player trying to own every step, pointing to CVS's move to cut MinuteClinic weight-loss visits to $29 as a sign of how aggressively that access race is already underway.

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