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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 ResultsAug 17, 2026 · 4:00pm ET

AMLXAmylyx Pharmaceuticals, Inc.

Amylyx Pharmaceuticals Announces Topline Results from Phase 3 LUCIDITY Trial of Avexitide

Company to reveal outcomes for Avexitide in post-bariatric hypoglycemia patients.

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Max move

+65.1%

RVOL

1.0x

Max high

$35.39

Fuel

11h 57m

Regulatory and ClinicalPositive Topline ResultsAug 17, 2026 · 4:00pm ET

AMLXAmylyx Pharmaceuticals, Inc.+65.1%

Amylyx Pharmaceuticals Announces Topline Results from Phase 3 LUCIDITY Trial of Avexitide

RVOL

1.0x

Max high

$35.39

Fuel

11h 57m

Regulatory and ClinicalOrphan Drug DesignationAug 13, 2026 · 11:44am ET

BYSIBeyondSpring Inc.

BeyondSpring's SEED Therapeutics Receives FDA Orphan Drug Designation for Neuroblastoma Treatment

The designation was granted for ST-01156, a drug targeting neuroblastoma.

Regulatory and ClinicalOrphan Drug DesignationAug 13, 2026 · 11:44am ET

BYSIBeyondSpring Inc.+77.6%

BeyondSpring's SEED Therapeutics Receives FDA Orphan Drug Designation for Neuroblastoma Treatment

Regulatory and ClinicalPositive Topline ResultsAug 11, 2026 · 9:34am ET

NTHINEONC TECHNOLOGIES HOLDINGS, INC.

NEONC Technologies Holdings, Inc. Brain Cancer Phase 2 Data Expected to Spark Triple Confluence

Company anticipates significant developments in its brain cancer treatment research.

Regulatory and ClinicalPositive Topline ResultsAug 11, 2026 · 9:34am ET

NTHINEONC TECHNOLOGIES HOLDINGS, INC.+39.1%

NEONC Technologies Holdings, Inc. Brain Cancer Phase 2 Data Expected to Spark Triple Confluence

Regulatory and ClinicalPositive Topline ResultsAug 10, 2026 · 6:37am ET

ABCLAbCellera Biologics Inc.

AbCellera Biologics Inc. Announces Positive Phase 2 Results for ABCL635

The trial demonstrated significant symptom reduction and favorable tolerability.

Regulatory and ClinicalPositive Topline ResultsAug 10, 2026 · 6:37am ET

ABCLAbCellera Biologics Inc.+33.6%

AbCellera Biologics Inc. Announces Positive Phase 2 Results for ABCL635

Regulatory and ClinicalPositive Topline ResultsAug 7, 2026 · 4:29pm ET

ABCLAbCellera Biologics Inc.

AbCellera to Announce Top-Line Results from Phase 2 Trial of ABCL635 for Menopause Symptoms

Company to disclose outcomes for moderate-to-severe vasomotor symptoms treatment.

Regulatory and ClinicalPositive Topline ResultsAug 7, 2026 · 4:29pm ET

ABCLAbCellera Biologics Inc.+44.4%

AbCellera to Announce Top-Line Results from Phase 2 Trial of ABCL635 for Menopause Symptoms

Regulatory and ClinicalFDA ApprovalAug 7, 2026 · 7:59am ET

NRXPNRX Pharmaceuticals, Inc.

NRx Pharmaceuticals Receives FDA First-Cycle Review Completion for Preservative-Free Ketamine ANDA

Company awaits final packaging certification for approval.

Regulatory and ClinicalFDA ApprovalAug 7, 2026 · 7:59am ET

NRXPNRX Pharmaceuticals, Inc.+34.7%

NRx Pharmaceuticals Receives FDA First-Cycle Review Completion for Preservative-Free Ketamine ANDA

Regulatory and ClinicalPositive Topline ResultsAug 6, 2026 · 8:40am ET

PPCBPropanc Biopharma, Inc.

Propanc Biopharma Announced New Preclinical and Translational Data for PRP in Pancreatic Ductal Adenocarcinoma

The data demonstrated >90% Tumor Growth Inhibition and Significant Survival Benefit.

Regulatory and ClinicalPositive Topline ResultsAug 6, 2026 · 8:40am ET

PPCBPropanc Biopharma, Inc.+40.4%

Propanc Biopharma Announced New Preclinical and Translational Data for PRP in Pancreatic Ductal Adenocarcinoma

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RVOL

3.6x

Max high

$1.35

Fuel

33m

RVOL

12.1x

Max high

$5.26

Fuel

6h 53m

RVOL

2.0x

Max high

$10.01

Fuel

6h 42m

RVOL

14.6x

Max high

$10.01

Fuel

12h 4m

RVOL

10.8x

Max high

$4.15

Fuel

2h 12m

RVOL

3.1x

Max high

$1.60

Fuel

4h 17m