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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 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.

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Max move

+38.2%

RVOL

9.4x

Max high

$0.47

Fuel

1h 58m

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

RVOL

9.4x

Max high

$0.47

Fuel

1h 58m

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 ClinicalPositive Topline ResultsJul 24, 2026 · 8:49am ET

AMIXAutonomix Medical, Inc.

Autonomix Medical Announces Positive Preclinical Study Results for Neural Sensing Platform

Study demonstrated platform's ability to detect renal neural activity changes.

Regulatory and ClinicalPositive Topline ResultsJul 24, 2026 · 8:49am ET

AMIXAutonomix Medical, Inc.+46.0%

Autonomix Medical Announces Positive Preclinical Study Results for Neural Sensing Platform

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

Regulatory and ClinicalIND Cleared for StudyJul 17, 2026 · 7:02am ET

KLRSKalaris Therapeutics, Inc.

Kalaris Therapeutics Announces Additional Phase 1a Data Presentation for TH103

Company remains on track for Phase 1b/2 study data release in H1 2027.

Regulatory and ClinicalIND Cleared for StudyJul 17, 2026 · 7:02am ET

KLRSKalaris Therapeutics, Inc.+33.0%

Kalaris Therapeutics Announces Additional Phase 1a Data Presentation for TH103

Regulatory and ClinicalPositive Topline ResultsJul 9, 2026 · 8:10am ET

FBRXForte Biosciences, Inc.

Forte Biosciences Reports Statistically Significant Improvement in Vitiligo with FB102

Results observed at Week 24 after completion of 12-week treatment period.

Regulatory and ClinicalPositive Topline ResultsJul 9, 2026 · 8:10am ET

FBRXForte Biosciences, Inc.+85.3%

Forte Biosciences Reports Statistically Significant Improvement in Vitiligo with FB102

Regulatory and ClinicalFDA 510(k) ClearedJul 6, 2026 · 8:11am ET

ICCMIceCure Medical Ltd.

IceCure Medical Ltd. Highlights ProSense™ Cryoablation Expansion in Brazil

Follows FDA clearance for breast cancer treatment.

Regulatory and ClinicalFDA 510(k) ClearedJul 6, 2026 · 8:11am ET

ICCMIceCure Medical Ltd.+47.9%

IceCure Medical Ltd. Highlights ProSense™ Cryoablation Expansion in Brazil

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24

RVOL

14.2x

Max high

$0.30

Fuel

11h 10m

RVOL

11.0x

Max high

$5.30

Fuel

6m

RVOL

13.1x

Max high

$7.80

Fuel

26m

RVOL

15.3x

Max high

$6.25

Fuel

2h 48m

RVOL

13.7x

Max high

$38.96

Fuel

8h 15m

RVOL

8.4x

Max high

$7.87

Fuel

3m