Jan. 9 at 4:23 PM
$ATRA if you want another similar play with PDUFA April 2026 and super low market Cap.
$GRCE please do your DD.
Drug: GTx-104 (IV nimodipine)
PDUFA: April 23, 2026
Indication: Subarachnoid hemorrhage
First FDA drug: ✅ Yes
Why this is Tier 1
Phase 3 met primary endpoint
Demonstrated reduced hypotension vs oral nimodipine
Same active drug → 505(b)(2) regulatory advantage
Safety improvement in ICU neuro-critical patients is meaningful
FDA mindset:
“Same drug, safer delivery in a fragile population.”
