Regulatory Science

Final 2.5-year Phase III results, published in The Lancet, back a traditional approval filing for atrasentan in IgA nephropathy later this year.

The acquisition adds gamgertamig, a BCMAxCD3 T cell engager, to Gilead's inflammation portfolio; registrational studies are expected as early as 2027.

All ten patients in GH Research's open-label trial achieved remission within two hours of a single inhaled dose of mebufotenin, the company reports.

Zamubafusp alfa now holds four orphan designations globally as Attralus advances the pan-amyloid removal antibody through a Phase 2 trial.

Phase III REPLENISH trial showed secukinumab achieved sustained remission in twice as many PMR patients as placebo at 52 weeks, with significant steroid sparing.

Amtagvi becomes the first T cell therapy approved for a solid tumour in Australia, the country with the world's highest melanoma incidence.

Candel Therapeutics' aglatimagene cut disease recurrence by 30% versus placebo in a 745-patient Phase 3 trial, with a BLA filing planned for Q4 2026.

Both doses of Abivax's oral miR-124 enhancer achieved placebo-adjusted remission rates above 39% at 44 weeks, with an NDA filing planned for

Updated Phase 2 data for DISC-0974 show durable anemia responses across all patient subgroups, with an FDA end-of-phase meeting expected by year

Phase 2 JASMINE data show nipocalimab reduced SLE disease activity through 52 weeks, with stronger responses in autoantibody-positive patients.

Vera Therapeutics has pulled forward its ORIGIN 3 eGFR analysis to Q3 2026, opening a path to full IgAN approval as early as 2027.

Amplia Therapeutics is initiating a daily-dosing Phase 2b study of its FAK inhibitor narmafotinib in advanced pancreatic cancer, with enrolment due by Q4 2026.

Idorsia's 2026 AGM approved three new board members and reaffirmed Jean-Paul Clozel as chairman, with a CEO search ongoing.

KIMMTRAK net sales grew 14% year-on-year in Q1 2026 as five-year trial data showed the drug doubled survival rates in metastatic uveal

Integra LifeSciences has appointed chairman Stuart Essig as president and CEO, replacing Mojdeh Poul in a permanent leadership change effective 1 May 2026.

Expanded analysis of 69 nodular BCC patients showed 200µg D-MNA achieving 55% histological clearance at Day 57, prompting FDA end-of-phase talks.

Orchestra BioMed has drawn a scheduled $15m royalty-financing tranche from Ligand, bringing total Ligand capital to $40m to fund two pivotal cardiovascular device trials.

The SynCardia parent raises $5m via shares and warrants at $0.30, using proceeds to repay senior secured notes and support working capital.

The UCLA-founded biotech will show preclinical data on its dCK inhibitor TRE-515 in optic neuritis at a Los Angeles summit on 21 May.

Zentalis Pharmaceuticals has opened enrolment in its confirmatory ASPENOVA Phase 3 trial of azenosertib in Cyclin E1-positive platinum-resistant ovarian cancer.