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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–

Showing 7 of 168

Regulatory and ClinicalIND FiledMay 5, 2026 · 7:36pm ET

IFRXInflaRx N.V.

InflaRx Announces Development of Izicopan for AAV Treatment

Company to focus on oral C5A receptor inhibitor for kidney disorder.

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Max move

+46.6%

RVOL

9.2x

Max high

$2.86

Fuel

1h 22m

Regulatory and ClinicalIND FiledMay 5, 2026 · 7:36pm ET

IFRXInflaRx N.V.+46.6%

InflaRx Announces Development of Izicopan for AAV Treatment

RVOL

9.2x

Max high

$2.86

Fuel

1h 22m

Regulatory and ClinicalMay 4, 2026 · 9:30am ET

FATEFATE THERAPEUTICS INC

Fate Therapeutics Announces Data Presentation at ASGCT Annual Meeting

Company to showcase off-the-shelf CAR T-Cell programs.

Regulatory and ClinicalMay 4, 2026 · 9:30am ET

FATEFATE THERAPEUTICS INC+33.8%

Fate Therapeutics Announces Data Presentation at ASGCT Annual Meeting

Regulatory and ClinicalMay 4, 2026 · 8:03am ET

FDA Approves Clene Inc.'s Data Submission for ALS Treatment Pathway

Regulatory milestone achieved for Clene's proposed drug application.

Regulatory and ClinicalMay 4, 2026 · 8:03am ET

CLNNClene Inc.+63.0%

FDA Approves Clene Inc.'s Data Submission for ALS Treatment Pathway

Regulatory and ClinicalFeb 9, 2026 · 7:26pm ET

PHIOPhio Pharmaceuticals Corp.

Phio Pharmaceuticals Concludes Safety Review for PH-762 in Phase 1b Trial

The Safety Monitoring Committee completed its planned safety review.

Regulatory and ClinicalFeb 9, 2026 · 7:26pm ET

PHIOPhio Pharmaceuticals Corp.+74.2%

Phio Pharmaceuticals Concludes Safety Review for PH-762 in Phase 1b Trial

Regulatory and ClinicalFeb 9, 2026 · 3:59pm ET

EVMNEvommune, Inc.

Evommune Reports Top-Line Results from Phase 2a Trial of EVO301

The trial was randomized, double-blind, and placebo-controlled.

Regulatory and ClinicalFeb 9, 2026 · 3:59pm ET

EVMNEvommune, Inc.+123.0%

Evommune Reports Top-Line Results from Phase 2a Trial of EVO301

Regulatory and ClinicalFeb 9, 2026 · 7:00am ET

BFRIBiofrontera Inc.

Biofrontera Announces Positive Phase 3 Results for Ameluz PDT in AKs Treatment

Company reveals successful outcomes in clinical study on extremities, neck, and trunk.

Regulatory and ClinicalFeb 9, 2026 · 7:00am ET

BFRIBiofrontera Inc.+41.7%

Biofrontera Announces Positive Phase 3 Results for Ameluz PDT in AKs Treatment

Regulatory and ClinicalJan 14, 2026 · 6:29pm ET

GTBPGT Biopharma Inc. Common Stock

GT Biopharma Submitted IND Application for GTB-5550 TriKE

Company seeks FDA approval for B7-H3-targeted NK cell engager.

Regulatory and ClinicalJan 14, 2026 · 6:29pm ET

GTBPGT Biopharma Inc. Common Stock+31.9%

GT Biopharma Submitted IND Application for GTB-5550 TriKE

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24

RVOL

10.4x

Max high

$2.06

Fuel

8h 52m

RVOL

5.2x

Max high

$9.78

Fuel

26m

RVOL

5.7x

Max high

$1.58

Fuel

2h 5m

RVOL

5.9x

Max high

$38.00

Fuel

48m

RVOL

13.6x

Max high

$1.14

Fuel

5m

RVOL

15.7x

Max high

$0.87

Fuel

56m