Development

Edgewise's EDG-7500 opens potential path in nonobstructive HCM beyond myosin inhibitors
EDG-7500 hypertrophic cardiomyopathy data from Boulder, Colorado-based Edgewise Therapeutics (Nasdaq: EWTX) are pointing toward a mechanistically distinct...

Trellis opens inhaled antibody route to tackle lung infections resistant to systemic therapy
Redwood City, California-based Trellis Bioscience LLC is advancing a first-in-human trial of inhaled TRL1068, a human monoclonal antibody designed to...

GSK advances passive malaria immunization with first-in-human monoclonal antibody trial
GlaxoSmithKline (NYSE: GSK) has initiated a first-in-human dose-escalation trial of GSK4425689A, a monoclonal antibody (mAb) intended for the prevention of...

InnovStone enters crowded aldosterone synthase inhibitor race with oral SYH2072
InnovStone Therapeutics Advances SYH2072 into First-in-Human Testing as Aldosterone Synthase Inhibitor Field Grows More Competitive

Otsuka and Harbour BioMed expand T-cell engager into autoimmune diseases beyond cancer
Otsuka and Harbour BioMed Move BCMAxCD3 T-Cell Engager HBM7020 into First-in-Human Autoimmune Trial

Italy's Thena launches first-in-human test of TfR1-aimed ferritin nanoparticle drug delivery
Italian biotech Thena Biotech S.r.l. has initiated [a first-in-human Phase I trial](https://app.allsci.com/clinical-trial/ASC-CT-0000001278980-1.0-1781270749) of THE-0504, an engineered human ferritin nanoparticle loaded with the topoisomerase I inhibitor Genz-644282, in patients with heavily pretreated solid tumors. The trial is notable for applying a conditionally activatable protein nanocage —

Takeda strengthens oveporexton's case ahead of FDA decision with new Phase III narcolepsy data
With a US FDA decision expected in Q3 2026, Takeda (TSE:4502/NYSE:TAK) presented secondary and exploratory endpoint data from its two pivotal Phase III...

Elicio's pancreatic cancer vaccine misses primary goal but hints at benefit in resected patients
A Phase II trial failure that may still open a door — but only if Elicio can secure financing before its cash runs out in Q4 2026.

Spyre's SPY002 sets anti-TL1A bar with largest histopathology win in ulcerative colitis
SPY002, Waltham, Massachusetts-based Spyre Therapeutics' (Nasdaq: SYRE) extended half-life anti-TL1A antibody, produced a statistically significant...

Mirum's zilurgisertib becomes first oral therapy to suppress FOP bone formation in Phase II
Pivotal Phase II data from the PROGRESS study of zilurgisertib in fibrodysplasia ossificans progressiva (FOP) indicate that the oral ALK2 inhibitor...

Navacaprant's double Phase III failure in depression forces Neumora into strategic reset
Navacaprant's failure to separate from placebo in two consecutive Phase III trials closes the door on kappa opioid receptor antagonism as a near-term...

Prolium brings T-cell engager format to systemic sclerosis
Prolium Bioscience has initiated a first-in-human Phase I trial of PRO-203, a subcutaneously administered CD20×CD3 bispecific T-cell engager, in patients...

Lilly's Jaypirca on course to reshape post-BTKi CLL treatment after beating venetoclax
Eli Lilly and Company (NYSE: LLY) reported Phase III data showing pirtobrutinib (Jaypirca) added to a time-limited venetoclax-based regimen cut the risk of...

Legend Bio's CD19/CD20 in vivo CAR-T demonstrates proof of concept in non-Hodgkin lymphoma
Early clinical data from Bridgewater, New Jersey-based Legend Biotech Corporation (Nasdaq: LEGN) suggest that LB2501, its investigational in vivo CD19/CD20...

Full Phase III data reinforce Intellia's lead in race to first In Vivo CRISPR approval
Full Phase III data for lonvoguran ziclumeran (lonvo-z) — published simultaneously in the New England Journal of Medicine and presented at the European...
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