Merck KGaA, Darmstadt, Germany, announced that the first patient was dosed in its Phase 3 lupus program ELOWEN‑1 and ELOWEN‑2 on April 30, 2026. The program evaluates enpatoran, an oral selective toll‑like receptor 7/8 inhibitor, in patients with active cutaneous lupus.
Enpatoran targets key inflammatory pathways in lupus and aims to reduce skin disease activity while preserving broader immune function. The Phase 3 trials build on Phase 2 data in which more than 60% of patients achieved significant improvement in CLASI scores, supporting the drug’s potential to address a major unmet need for oral therapy in lupus.
The first‑dose milestone is a critical step toward regulatory approval and expands Merck KGaA’s immunology portfolio beyond its established oncology and vaccine businesses. The company highlighted the opportunity to offer a convenient oral option for patients who currently rely on injectable biologics.
On the same day, Merck & Co., Inc. reported its Q1 2026 earnings. The company posted a non‑GAAP loss per share of $1.28, a beat of $0.23 versus the consensus estimate of a $1.51 loss. Revenue rose to $16.3 billion, up 5% year‑over‑year and beating the $15.90 billion estimate. The results were driven by strong performance in oncology, particularly Keytruda sales that increased 8% to $8 billion, and growth in animal health. A $3.62‑per‑share charge related to the acquisition of Cidara Therapeutics contributed to the loss.
Management raised its full‑year 2026 revenue guidance to $65.8 billion–$67.0 billion, up from the prior $65.5 billion–$67.0 billion range, and adjusted EPS guidance to $5.04–$5.16, slightly above the previous $5.00–$5.15 range. The guidance lift reflects confidence in continued demand for key products and the impact of the Cidara acquisition charge being a one‑time event.
Investors reacted to the earnings announcement with a pre‑market decline in Merck & Co.’s stock, driven by concerns over the sizable one‑time charge for the Cidara acquisition that pushed the company into a GAAP net loss. The lupus study announcement, however, was viewed positively as it signals progress in a high‑need therapeutic area.
The combination of a robust earnings beat, a raised guidance outlook, and a milestone in the lupus program positions Merck KGaA and Merck & Co. to strengthen their respective portfolios and potentially unlock new revenue streams in the coming years.
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