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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

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Showing 7 of 168

Regulatory and ClinicalPositive Topline ResultsSep 22, 2026 · 7:04am ET

VKTXViking Therapeutics, Inc.

Viking Therapeutics Announced Positive Topline Results from Maintenance Study of GLP-1/GIP Agonist VK2735

The study demonstrated the promise of multiple maintenance dosing regimens.

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Max move

+45.9%

RVOL

2.7x

Max high

$45.93

Fuel

27m

Regulatory and ClinicalPositive Topline ResultsSep 22, 2026 · 7:04am ET

VKTXViking Therapeutics, Inc.+45.9%

Viking Therapeutics Announced Positive Topline Results from Maintenance Study of GLP-1/GIP Agonist VK2735

RVOL

2.7x

Max high

$45.93

Fuel

27m

Regulatory and ClinicalPositive Topline ResultsSep 22, 2026 · 7:01am ET

CLDXCelldex Therapeutics, Inc.

Celldex Therapeutics Announces Positive Phase 3 Results for Barzolvolimab

Studies met primary and all key secondary endpoints.

Regulatory and ClinicalPositive Topline ResultsSep 22, 2026 · 7:01am ET

CLDXCelldex Therapeutics, Inc.+39.5%

Celldex Therapeutics Announces Positive Phase 3 Results for Barzolvolimab

Regulatory and ClinicalPositive Subgroup DataSep 21, 2026 · 4:05am ET

CUECue Biopharma, Inc.

Cue Biopharma Reports 60% Complete Hives Resolution for CUE-221 in Phase 2 Study

Post hoc analysis shows improvement over Omalizumab.

Regulatory and ClinicalPositive Subgroup DataSep 21, 2026 · 4:05am ET

CUECue Biopharma, Inc.+43.2%

Cue Biopharma Reports 60% Complete Hives Resolution for CUE-221 in Phase 2 Study

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.

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

Regulatory and ClinicalPrimary Endpoint MetSep 8, 2026 · 6:03am ET

ROIVRoivant Sciences Ltd.

Roivant Sciences Ltd. Announces Positive Phase 2 PHocus Trial Results for Mosliciguat in PH-ILD

Roivant Sciences Ltd. and Pulmovant, Inc. announced the results on September 8, 2026.

Regulatory and ClinicalPrimary Endpoint MetSep 8, 2026 · 6:03am ET

ROIVRoivant Sciences Ltd.+31.4%

Roivant Sciences Ltd. Announces Positive Phase 2 PHocus Trial Results for Mosliciguat in PH-ILD

Regulatory and ClinicalFDA Meeting GrantedAug 31, 2026 · 8:04am ET

CVKDCadrenal Therapeutics, Inc.

Cadrenal Therapeutics Receives Positive FDA Type D Meeting Outcome for CAD-1005 Phase 3 Study

The FDA meeting supports the design of the Phase 3 registration study.

Regulatory and ClinicalFDA Meeting GrantedAug 31, 2026 · 8:04am ET

CVKDCadrenal Therapeutics, Inc.+43.1%

Cadrenal Therapeutics Receives Positive FDA Type D Meeting Outcome for CAD-1005 Phase 3 Study

Regulatory and ClinicalFDA Fast TrackAug 31, 2026 · 8:00am ET

XAIRBeyond Air, Inc.

Beyond Air, Inc. Granted FDA Breakthrough Device Designation for LungFit® GO

Designation for treating Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD).

Regulatory and ClinicalFDA Fast TrackAug 31, 2026 · 8:00am ET

XAIRBeyond Air, Inc.+61.4%

Beyond Air, Inc. Granted FDA Breakthrough Device Designation for LungFit® GO

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RVOL

1.1x

Max high

$53.65

Fuel

6m

RVOL

1.2x

Max high

$65.24

Fuel

1h 8m

RVOL

2.8x

Max high

$7.07

Fuel

2h 1m

RVOL

11.9x

Max high

$46.09

Fuel

4m

RVOL

12.2x

Max high

$2.29

Fuel

2h 14m

RVOL

14.1x

Max high

$6.94

Fuel

3m