MarketPulse

orphan drug designation

9 articles
BenzingaBenzinga··Vandana Singh

Gilead Bolsters Inflammation Arsenal With $1.675B Ouro Medicines Deal

Gilead acquires Ouro Medicines for $1.675B upfront, targeting inflammation pipeline expansion. Galapagos NV partners to co-develop lead asset OM336.
GILDACLXGLPGacquisitionorphan drug designation
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Galapagos and Gilead Team Up on Breakthrough T Cell Engager for Autoimmune Diseases

Galapagos and Gilead plan to jointly develop an Ouro T cell engager for autoimmune diseases, splitting acquisition costs while Galapagos leads development and Gilead commercializes, freeing $500M in Galapagos cash.
GILDGLPGautoimmune diseasesorphan drug designation
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Galapagos, Gilead in Advanced Talks on T-Cell Therapy Partnership

Galapagos and Gilead are in advanced partnership talks for a first-in-class T-cell engager for autoimmune diseases, with 50% cost-sharing and €500 million capital freed for Galapagos.
GILDGLPGstrategic partnershipclinical development
BenzingaBenzinga··Soligenix, Inc.

Soligenix's HyBryte Shows Promise Against Cutaneous Lymphoma at 2026 Workshop

Soligenix's HyBryte™ cutaneous lymphoma therapy shows positive results ahead of 2026 presentation, with FDA awarding $2.6M development grant.
SNGXPhase 3 clinical trialFDA approval
BenzingaBenzinga··Nabaparna Bhattacharya

AIM ImmunoTech Surges 73% on Japanese Patent Victory for Cancer Therapy

AIM ImmunoTech ($AIMT) surged 73.66% after securing Japanese patent approval for Ampligen cancer therapy through 2039, strengthening its immuno-oncology portfolio.
AIMintellectual propertyorphan drug designation
GlobeNewswire Inc.GlobeNewswire Inc.··Telix Pharmaceuticals Limited

Telix Resubmits FDA Application for Brain Cancer Imaging Drug Pixclara

Telix resubmits FDA application for Pixclara, a brain cancer imaging agent with Orphan Drug and Fast Track designations, addressing a regulatory Complete Response Letter.
TLXorphan drug designationradiopharmaceuticals
GlobeNewswire Inc.GlobeNewswire Inc.··Pmv Pharmaceuticals, Inc.

PMV Pharma's Rezatapopt Shows Promise, But Cash Clock Ticks Toward 2027

PMV Pharmaceuticals reports 50% response rate for ovarian cancer drug rezatapopt, but faces funding pressure with cash runway extending only to Q2 2027.
PMVPclinical trial resultsorphan drug designation
GlobeNewswire Inc.GlobeNewswire Inc.··Can-Fite Biopharma Ltd.

Can-Fite's Namodenoson Clears Safety Hurdle in Pancreatic Cancer Study

Can-Fite's namodenoson meets primary safety endpoint in Phase IIa pancreatic cancer trial with no new safety signals; survival data pending.
CANFclinical developmentorphan drug designation
BenzingaBenzinga··Prnewswire

Soligenix Wins EMA Backing for SGX945 Orphan Drug Status in Behçet's Disease

Soligenix wins EMA orphan drug designation backing for SGX945 treating Behçet's Disease, following positive Phase 2a results and prior FDA support.
SNGXrare diseaseclinical trial