Regulatory Event

Breakthrough Designation

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

Recent events: 10
Catalysts: 2
Companies: 3

Recent events(10)

ClinicalJuly 5, 2026

Discovery of EGFR L858R-targeting peptide shows promise against ovarian cancer

Peptide-1 demonstrates strong binding affinity to EGFR L858R and antiproliferative activity against ovarian cancer cells.

ClinicalJune 29, 2026

Scotiaderm Initiates Trial for Novel Barrier Cream Against Moisture Associated Skin Damage

Scotiaderm is conducting a clinical trial to evaluate the efficacy of its Dermategrity 'Anti-fecal' Barrier Cream against standard zinc oxide creams for treating moisture-associated skin damage.

ClinicalJune 27, 2026

Study on Topical Infliximab for Autoimmune Dry Eye Disease in Sjögren's Syndrome

A clinical trial is underway to evaluate the safety and efficacy of topical infliximab for treating severe dry eye in Sjögren's syndrome.

ClinicalJune 22, 2026

Deucravacitinib shows promise in Pityriasis Rubra Pilaris study by Mayo Clinic

A study is underway to evaluate the safety and effectiveness of Deucravacitinib in patients with Pityriasis Rubra Pilaris.

ClinicalJune 22, 2026

Phase I Trial of 8-Chloroadenosine and Venetoclax in Relapsed/Refractory AML

A phase I trial is underway to evaluate the safety and efficacy of 8-chloroadenosine combined with venetoclax in relapsed/refractory acute myeloid leukemia patients.

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(2)

Topline Data

— Rigshospitalet

Monitor results from this study for potential breakthroughs in psychotropic therapies and receptor-targeted treatments.

July 4, 2026 · N/A

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

Related companies

Gilead →

Merck →

Roche →

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