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Home›Catalysts›Regulatory and Clinical

Catalyst Category

Regulatory and Clinical

Live feed of every catalyst classified under Regulatory and Clinical.

CATALYSTS IN FEED

168

AVG MAX MOVE

+116.8%

POSITIVE MOVES

100%

LARGEST MOVE

+664.1%

DSMB Efficacy Met FDA 510(k) Cleared FDA Approval FDA Fast Track FDA Meeting FDA Meeting Granted Generic Drug Approved Inconclusive Topline Results IND Cleared for Study IND Filed NDA Resubmission Orphan Drug Designation Positive Subgroup Data Positive Topline Results Primary Endpoint Met SPA Agreement Study Complete Trial Enrollment Complete

Range–Clear

1 catalyst

Regulatory and ClinicalFDA MeetingSep 9, 2026 · 7:42am ET

IRDOpus Genetics, Inc.

Opus Genetics Announces Favorable Safety Profile in Low-Dose Cohort 1 of BIRD-1 Trial

No serious adverse events or dose-limiting toxicities observed.

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Max move

+53.4%

RVOL

2.8x

Max high

$7.07

Fuel

2h 1m

Regulatory and ClinicalFDA MeetingSep 9, 2026 · 7:42am ET

IRDOpus Genetics, Inc.+53.4%

Opus Genetics Announces Favorable Safety Profile in Low-Dose Cohort 1 of BIRD-1 Trial

RVOL

2.8x

Max high

$7.07

Fuel

2h 1m