Announcements and Reminders

26-Jan-2026 Study Updates

January 26, 2026

Thank you for all your efforts on this study so far! 

Study Reminders

Enrollment Update

The 302 study has approximately 250 enrollment slots left.  

IP Storage Concerns Survey

Please use the link below to report any concerns for IP storage your site may have regarding the autoinjector rollout.  

The Responses are required by end of the day, 30Jan2026.  

As a reminder, IRT will begin to dispense on a 30-day supply strategy. This will result in sites receiving IP on a once-a-week basis.

IRT Reminder for Resuming IP after 2 Consecutive Missed Doses

The IRT System keeps track of the participant’s number of consecutive doses missed. Each time a dose is skipped, 1 is added to the participant’s number of consecutive doses missed. When a visit is recorded with drug assigned, the participant’s number of consecutive doses missed gets reverted to 0.

If a participant is resuming drug after 2 or more consecutive doses missed, site should select the option to “Stay on assigned dose” in IRT. IRT System will automatically assign the participant’s dose per Temporary Discontinuation Guidance in the protocol based on the participant’s number of consecutive doses missed prior to the visit. If the participant previously permanently down-titrated due to tolerability, the site will not be prompted to select action to take at visit (such as “Stay on assigned dose”). The system will automatically assign the appropriate dose per Temporary Discontinuation Guidance in the protocol.

ECG Acquisition and Submission Manual V5.0

Please see a previous email for the attached the updated ECG Acquisition and Submission Manual V5.0.