Breakthrough Designation

Aethlon Medical advances its Hemopurifier for oncology and Long COVID, but a shrinking cash reserve and rising quarterly loss test its lean science strategy.

After a major trial failure tanked its stock, Rezolute pins its hopes on a second drug program and a crucial FDA meeting to chart a path forward.

With its Phase 1 trial fully enrolled, Senti Bio’s logic-gated CAR-NK therapy shows deep, durable remissions, charting an expedited path for R/R AML.

IN8bio promotes Kate Rochlin to President, signaling a strategic push to advance its promising gamma-delta T cell pipeline amid a challenging market.

With a promising spinal cord injury drug nearing late-stage trials, NervGen appoints interim leader Dr. Adam Rogers as permanent CEO to guide the breakthrough.

MetaVia's drug vanoglipel gets a major boost from AI modeling, validating its potential to treat complex metabolic diseases like MASH and Type 2 Diabetes.

An expanded partnership aims to deliver a once-daily oral tablet for hypoparathyroidism, potentially revolutionizing treatment for thousands of patients.

Affinia Therapeutics gets the green light for a human trial of AFTX-201, a one-time therapy for a devastating genetic heart disease, BAG3 DCM.

With crucial data on its novel oral inflammation inhibitor looming, NodThera brings in seasoned leader Geoff McDonough to navigate the path to Phase 3.

New 4-year real-world data shows Zevra's drug stabilizes the rare, fatal 'Childhood Alzheimer's' disease, marking a milestone for patients and families.

As X4 Pharmaceuticals preps for a key investor summit, all eyes are on its pivotal trial for chronic neutropenia and the commercial fate of XOLREMDI®.