Status Epilepticus: The company announces constructive end-of-Phase 2 meeting with the FDA.
Patient enrollment is expected to begin in Q3 with topline data expected in H1 2022.
CDKL5 Deficiency Disorder: Enrollment has been
completed in Phase 3 Marigold Study. The company remains on-track to
report top‑line data in Q3 with no expected material delays due to
COVID-19. Marinus has begun preparations for an NDA filing.
Tuberous Sclerosis Complex: Marinus intends to
start screening patients in a Phase 2 trial this quarter with top line
data expected in Q1 2021.
PCDH19 Related Epilepsy (PCDH19-RE): Marinus will
transition the ongoing Phase 3 Violet Study to a proof-of-concept (POC)
trial evaluating allopregnanolone sulfate as a biomarker in patients
with a confirmed PCDH19 mutation.
The company has decided to limit trial enrollment and announce results of this POC trial in H1 2021.
As on March 31, 2020, the Company had cash and
cash equivalents and investments totaling $77.8M compared to $91.7M on
December 31, 2019.
https://seekingalpha.com/news/3568227-marinus-pharma-updates-business-shares-down-7-premarket
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