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Regulatory
Breakthrough Designation

Regulatory Event

Breakthrough Designation

FDA Breakthrough Therapy designations for candidates showing substantial improvement over available therapies.

Recent events: 5
Catalysts: 1
Companies: 3

Recent events(5)

ClinicalJune 19, 2026

Study on 'Yanjiu Needle' for Pharyngeal Dysphagia Shows Promise in Stroke Patients

'Yanjiu Needle' technique may improve swallowing function in stroke patients through specific acupoint stimulation.

ClinicalJune 17, 2026

Roche's ENSPRYNG shows 68% relapse reduction in Phase III MOGAD study

The Phase III METEOROID study demonstrated that ENSPRYNG (satralizumab) reduced the risk of relapses by 68% in MOGAD patients.

RegulatoryJune 16, 2026

FDA Grants Breakthrough Therapy Designation for Calderasib in KRAS G12C-Mutant NSCLC

Calderasib (MK-1084) received Breakthrough Therapy designation for first-line treatment of KRAS G12C-mutant NSCLC.

CompetitiveJune 16, 2026

Gilead and Merck Report Positive Phase 3 Results for Once-Weekly HIV Treatment Islatravir/Lenacapavir

Gilead and Merck announced positive topline results from two Phase 3 studies for Islatravir/Lenacapavir, a novel oral HIV treatment.

ClinicalJune 10, 2026

Pridopidine Phase 3 Trial Initiated for ALS Efficacy and Safety Evaluation

A Phase 3 clinical trial is underway to evaluate the efficacy and safety of pridopidine in treating amyotrophic lateral sclerosis (ALS).

Historical activity(1)

Topline Data

— Trial Update

Monitor results from the trial for potential breakthroughs in understanding MORC2-related disorders and implications for treatment.

June 19, 2026 · N/A

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