FDA Grants Orphan Drug Status for Gastric Cancer Treatment
Dewpoint Therapeutics secured FDA Orphan Drug Designation for DPTX3186, an oral condensate modulator targeting the Wnt/β-catenin pathway in gastric...
Jon Napitupulu
gMG Biologics Expand in Early Treatment, Newcomers Challenge
Retention on first-line biologics in generalized myasthenia gravis sits at 90% in US practice, with Alexion’s Ultomiris and argenx’s...
IN8BIO Expands INB-100 Phase 1 Trial to Ohio State Site
Previously reported readouts from the Phase 1 INB-100 program have shown no severe graft-versus-host disease, persistence of allogeneic γδ...
Medicus & Gorlin Alliance Seek Compassionate Use for Skinject
An interim analysis from Medicus Pharma’s randomized, double-blind, placebo-controlled Phase 2 study (SKNJCT-003) reported more than 60% clinical clearance...
Avalo Completes Enrollment for Phase 2 LOTUS Trial in HS
Avalo Therapeutics has fully enrolled its Phase 2 LOTUS study of AVTX-009 in hidradenitis suppurativa, randomizing roughly 250 adults...
BlossomHill’s Promising Early Trial Data for NSCLC Drug
In the dose escalation of the first-in-human SOLARA study, BH-30643 was administered to 39 previously treated EGFR-mutant NSCLC patients...
Flare Therapeutics Reveals FX-909 Phase 1 Study Results
In Part A of a Phase 1 study in advanced urothelial carcinoma (UC), FX-909 monotherapy produced five objective responses...
Successful Phase 1 Data for REM-422 in Cancer Patients
REM-422, an oral small-molecule mRNA degrader targeting MYB, produced a 43% overall response rate by RECIST in the efficacy...
Halda’s New Prostate Cancer Drug Shows Encouraging Activity
In a first-in-human Phase 1/2 study of HLD-0915 in metastatic castration-resistant prostate cancer, 31% of all 31 treated patients...
Evolving Urticaria Treatment Highlights Unmet Patient Needs
Two-thirds of U.S. physicians report high unmet need in chronic spontaneous urticaria (CSU) despite two recent FDA approvals, according...