Program/Compound NX-217 Β· EU5 Launch
Phase III

πŸ‡©πŸ‡ͺ Germany

Drill-down: 6 tasks Β· 7 risks Β· launch 15 Apr 2026

Status

Delayed

Launch slip: 1 mo

Readiness

7%

Baseline 5Y

€573.5M

Adjusted 5Y

€558.5M

-€15.0M vs baseline

Plan

Task
Aug 25
Sept 25
Oct 25
Nov 25
Dec 25
Jan 26
Feb 26
Mar 26
Apr 26
May 26
Regulatory
Market Access
Supply
Medical
Marketing
Marketing
Baseline On track In progress Delayed Gating task

Risks (7)

Medium
Lena Vogt

Single-source cold-chain partner β€” concentration risk for Q1 launch volume.

Low
Sofia Lang

MLR approval cycle running tight β€” risk of delayed HCP campaign go-live.

High
Anja Becker

EMA Filing & Approval delayed by 1 month β€” cascade from EMA Filing & Approval

High
Markus Hahn

G-BA Early Benefit Assessment delayed by 1 month β€” cascade from EMA Filing & Approval

High
Lena Vogt

Launch Stock Build (DE) delayed by 1 month β€” cascade from EMA Filing & Approval

Medium
Sofia Lang

HCP Campaign Activation delayed by 1 month β€” cascade from EMA Filing & Approval

Medium
Karl Reiter

Sales Force Training delayed by 1 month β€” cascade from EMA Filing & Approval

Files

Global Launch Playbook v3.2.pdf4.2 MB
EMA Submission Dossier β€” Module 1.zip38.1 MB
AMNOG Value Story DE.pptx12.4 MB
Global HCP Campaign Toolkit.zip120.6 MB
Master Messaging Framework v2.1.pdf3.4 MB
Phase III Topline Results β€” NX-217.pdf6.7 MB
EU5 Patient Journey Research.pdf14.2 MB
Global Brand Visual Identity.zip210.3 MB