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Regulatory Intelligenceportfolio dashboard

One screen for a biotech portfolio's regulatory posture — every program, its submission state, and the catalysts ahead.

6
Active programs
3
Submissions in flight
44d
Next catalyst — RD-101 pdufa action date
2
Programs needing attention

Portfolio

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PROGRAMPHASESUBMISSIONNEXT MILESTONESTATUS
RD-101Rheumatoid arthritisPhase 3NDA under reviewPDUFA action dateSep 28, 2026 · 44dON TRACK
RD-207IgA nephropathyPhase 2bPre-Phase 3 (EOP2)End-of-Phase-2 meetingOct 15, 2026 · 61dWATCH
RD-330Moderate-to-severe psoriasisPhase 3BLA plannedBLA submissionApr 30, 2027 · 258dON TRACK
RD-042Chronic heart failure (label expansion)MarketedsNDA under reviewAdvisory committeeNov 05, 2026 · 82dAT RISK
RD-114Acute myeloid leukemiaPhase 1IND activeDose-escalation dataDec 08, 2026 · 115dON TRACK
RD-518Friedreich's ataxiaPhase 3Pivotal ongoingPivotal readoutMar 22, 2027 · 219dON TRACK

Catalyst runway

AUGSEPOCTNOVDECJAN '27FEBMARAPRMAYJUNTODAYRD-101RD-101 — PDUFA action date · Sep 28, 2026PDUFA action dateRD-207RD-207 — End-of-Phase-2 meeting · Oct 15, 2026End-of-Phase-2 meetingRD-207 — Phase 3 first patient in · Mar 15, 2027RD-330RD-330 — Pre-BLA meeting · Nov 10, 2026RD-330 — BLA submission · Apr 30, 2027BLA submissionRD-042RD-042 — Advisory committee · Nov 05, 2026Advisory committeeRD-042 — PDUFA action date · Feb 14, 2027PDUFA action dateRD-114RD-114 — Dose-escalation data · Dec 08, 2026Dose-escalation dataRD-518RD-518 — Pivotal readout · Mar 22, 2027Pivotal readout

RD-101Rheumatoid arthritis

ON TRACK

Oral small molecule · Phase 3 · NDA under review

Label negotiations underway; no major information requests open.

MILESTONES

  • NDA submittedNov 24, 2025
  • Filing acceptedJan 23, 2026
  • Mid-cycle reviewMay 12, 2026
  • PDUFA action dateSep 28, 2026 · 44d

RECENT REGULATORY EVENTS

  • Aug 04, 2026Draft labeling comments returned to division
  • Jul 18, 2026Late-cycle meeting held — no AdCom planned
  • May 12, 2026Mid-cycle communication: review on schedule

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