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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

6 catalysts

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).

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Max move

+61.4%

RVOL

14.1x

Max high

$6.94

Fuel

3m

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

RVOL

14.1x

Max high

$6.94

Fuel

3m

Regulatory and ClinicalFDA Fast TrackAug 26, 2026 · 7:08am ET

VNRXVOLITIONRX LTD

VolitionRX LTD Announced Clinical Validation of Nu.Q® NETs Biomarker in Sepsis

The validation was announced on a recent press release.

Regulatory and ClinicalFDA Fast TrackAug 26, 2026 · 7:08am ET

VNRXVOLITIONRX LTD+67.8%

VolitionRX LTD Announced Clinical Validation of Nu.Q® NETs Biomarker in Sepsis

Regulatory and ClinicalFDA Fast TrackAug 19, 2026 · 9:00am ET

FEMYFEMASYS INC

Femasys Secures FDA Approval for Modular PMA Pathway for FemBloc

The approval is for FemBloc, a non-surgical permanent birth control solution.

Regulatory and ClinicalFDA Fast TrackAug 19, 2026 · 9:00am ET

FEMYFEMASYS INC+70.0%

Femasys Secures FDA Approval for Modular PMA Pathway for FemBloc

Regulatory and ClinicalFDA Fast TrackAug 5, 2026 · 8:29am ET

SBEVSPLASH BEVERAGE GROUP, INC.

Splash Beverage Group Partners to Advance CannEpil® Through FDA Veterinary Pathway

Collaboration with cannabinoid drug-development experts announced.

Regulatory and ClinicalFDA Fast TrackAug 5, 2026 · 8:29am ET

SBEVSPLASH BEVERAGE GROUP, INC.+38.2%

Splash Beverage Group Partners to Advance CannEpil® Through FDA Veterinary Pathway

Regulatory and ClinicalFDA Fast TrackJul 27, 2026 · 7:00am ET

GOSSGossamer Bio, Inc.

Gossamer Bio Announces FDA Regulatory Update and Reacquisition of Worldwide Rights for Seralutinib

Company provides a business update alongside the announcement.

Regulatory and ClinicalFDA Fast TrackJul 27, 2026 · 7:00am ET

GOSSGossamer Bio, Inc.+120.2%

Gossamer Bio Announces FDA Regulatory Update and Reacquisition of Worldwide Rights for Seralutinib

Regulatory and ClinicalFDA Fast TrackJul 22, 2026 · 8:02am ET

LABTLakewood-Amedex Biotherapeutics Inc.

Lakewood-Amedex Biotherapeutics Highlights Nu-3 Resistance Data

Company responds to National Action Plan on antibiotic resistance.

Regulatory and ClinicalFDA Fast TrackJul 22, 2026 · 8:02am ET

LABTLakewood-Amedex Biotherapeutics Inc.+317.1%

Lakewood-Amedex Biotherapeutics Highlights Nu-3 Resistance Data

RVOL

5.5x

Max high

$0.71

Fuel

1h 58m

RVOL

14.4x

Max high

$3.69

Fuel

34m

RVOL

9.4x

Max high

$0.47

Fuel

1h 58m

RVOL

14.2x

Max high

$0.30

Fuel

11h 10m

RVOL

13.1x

Max high

$7.80

Fuel

26m