Catalyst Category

FDA Fast Track

Live feed of every FDA Fast Track catalyst in Regulatory and Clinical.

CATALYSTS IN FEED

167

AVG MAX MOVE

+101.8%

POSITIVE MOVES

100%

LARGEST MOVE

+664.1%

Regulatory and ClinicalFDA Fast TrackAug 31, 2026 · 8:01am 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 · 8:01am ET

XAIRBeyond Air, Inc.+61.4%

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

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 · 7:02am 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 · 7:02am 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 · 8:03am 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 · 8:03am ET

LABTLakewood-Amedex Biotherapeutics Inc.+317.1%

Lakewood-Amedex Biotherapeutics Highlights Nu-3 Resistance Data

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FDA Fast Track

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

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

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

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

Femasys Secures FDA Approval for Modular PMA Pathway for FemBloc

Femasys Secures FDA Approval for Modular PMA Pathway for FemBloc

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

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

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

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

Lakewood-Amedex Biotherapeutics Highlights Nu-3 Resistance Data

Lakewood-Amedex Biotherapeutics Highlights Nu-3 Resistance Data

Every Second Counts.Don't Trade Without a Real-Time sparker alert.

FDA Fast Track

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

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

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

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

Femasys Secures FDA Approval for Modular PMA Pathway for FemBloc

Femasys Secures FDA Approval for Modular PMA Pathway for FemBloc

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

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

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

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

Lakewood-Amedex Biotherapeutics Highlights Nu-3 Resistance Data

Lakewood-Amedex Biotherapeutics Highlights Nu-3 Resistance Data

Every Second Counts.
Don't Trade Without a Real-Time sparker alert.