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Roche Holding, Pre-Market

Roche reports vamikibart data, FDA decision expected by July 2027: stock pre-market at EUR 386.65

Published on 10/13/2026 at 08:37 | Editorial responsibility: Rafael Müller, Editor-in-Chief AD HOC NEWS

Roche reported sustained vamikibart improvements through 52 weeks and said the FDA accepted its application. Roche Holding stock was at EUR 386.65 at Lang & Schwarz at 8:36 a.m. CEST.

Key points in brief

  • Roche presented 52-week vamikibart data from two Phase III studies.
  • The FDA accepted Roche’s application, with a decision expected by July 2027.
  • Roche Holding stock was at EUR 386.65 at Lang & Schwarz before the Xetra open.
Automatisches Diagnostik-Laborgerät mit Touchscreen-Oberfläche im klinischen Labor
Roche Holding AG CH0012032048 – Diagnostik-Analysegerät verarbeitet biologische Proben im modernen klinischen Labor, Illustration mit AI erstellt.

Roche Holding stock was at EUR 386.65 at Lang & Schwarz at 8:36 a.m. CEST on October 13, 2026, ahead of the Xetra open.

What matters today

The FDA is expected to decide on Roche’s vamikibart application by July 2027. The MEERKAT and SANDCAT Phase III studies reported data through 52 weeks. Approximately two-thirds of eligible patients required no retreatment after 16 weeks.

Vamikibart data and FDA filing

In a company release dated October 10, Roche said vamikibart demonstrated sustained improvements in vision and reductions in macular thickness at 52 weeks in the MEERKAT and SANDCAT studies. The company also said the U.S. Food and Drug Administration had accepted its Biologics License Application for the treatment of uveitic macular edema, with an approval decision expected by July 2027. The data were presented at the American Academy of Ophthalmology 2026 Annual Meeting in New Orleans. Roche

Market context: Market report SMI.

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