Drug Development
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Bepirovirsen Delivers a Functional Cure in About One in Five Chronic Hepatitis B Patients in Phase 3 Trials
GSK's antisense drug bepirovirsen cleared chronic HBV in 20% and 19% of patients across two Phase 3 trials, versus none on placebo, the NEJM reports.
Cogent's Bezuclastinib-Sunitinib Combo Nearly Doubles Progression-Free Survival in Second-Line GIST, the First Positive Phase 3 in Two Decades
Cogent's bezuclastinib plus sunitinib reached 16.5-month median PFS versus 9.2 months in second-line GIST, with FDA Priority Review and a November 30 PDUFA date.
Selinexor Plus Ruxolitinib Shrinks Spleens but Misses Its Symptom Goal in Phase 3 SENTRY, With an Early Survival Signal in Myelofibrosis
The SENTRY trial of selinexor plus ruxolitinib met its spleen-volume endpoint and missed its symptom endpoint, with an immature overall survival signal favoring the combination.
MoonLake's Sonelokimab Holds 67% Response at Week 52 in Phase 3 Hidradenitis Suppurativa Trials, Setting Up a September FDA Filing
Full Week 52 data from MoonLake's VELA program show sustained response rates for the IL-17 Nanobody, nine months after one of its two pivotal trials missed its primary endpoint.
Relacorilant Becomes the First Glucocorticoid Receptor Antagonist Approved for Ovarian Cancer as Full ROSELLA Data Land in The Lancet
Corcept's relacorilant plus nab-paclitaxel cut the risk of death 35% in platinum-resistant ovarian cancer, raising median survival to 16 months from 11.9, with the phase 3 ROSELLA results published in The Lancet.
Ionis's Zilganersen Becomes First Drug to Show Disease-Modifying Effect in Alexander Disease as FDA Sets September Decision
An antisense drug stabilized walking speed in a 54-patient pivotal trial; the FDA accepted Ionis's NDA for Priority Review with a target action date of September 22, 2026.
Takeda's Zasocitinib Beats Deucravacitinib Head-to-Head in Phase 3 Psoriasis Trial, More Than Doubling Complete Skin Clearance
In the LATITUDE Atlas trial, more than 35% of patients on Takeda's oral TYK2 inhibitor reached completely clear skin at week 16 — more than 2.5 times the rate seen with Bristol Myers Squibb's deucravacitinib.
Viridian's Veligrotug Nears a June 30 FDA Decision for Thyroid Eye Disease, Pitching a Five-Infusion Course Against Tepezza
An FDA decision on Viridian's IGF-1R antibody veligrotug is due June 30, 2026, after Phase 3 trials hit their endpoints in both active and chronic thyroid eye disease.
Atacicept Cuts Proteinuria 46% in Phase 3 ORIGIN Trial for IgA Nephropathy, Setting Up a July FDA Decision
Vera Therapeutics' dual BAFF/APRIL inhibitor reduced proteinuria 45.7% at week 36 in the NEJM-published ORIGIN 3 trial, with an FDA accelerated-approval decision due July 7.
Eli Lilly's Retatrutide Cuts Body Weight 28.3% in Phase 3 TRIUMPH-1 as Triple-Agonist Data Land at ADA 2026
Eli Lilly presented phase 3 results for retatrutide at ADA 2026 on June 6, showing 28.3% mean weight loss at 80 weeks in obesity and a companion diabetes trial published in The Lancet.
Ivonescimab Beats a PD-1 Standard in First-Line Squamous Lung Cancer at ASCO, the First China-Originated Drug to Reach the Society's Plenary
HARMONi-6 showed Akeso's PD-1/VEGF bispecific cut the risk of death by 34% versus tislelizumab plus chemotherapy, and reached the ASCO plenary for the first time for a China-originated cancer drug.
Agios Submits Oral Mitapivat for FDA Accelerated Approval in Sickle Cell as RISE UP Phase 3 Data Heads to EHA 2026 Plenary
Agios filed for accelerated approval of mitapivat, an oral pyruvate kinase activator, on the strength of a Phase 3 trial that met its hemoglobin endpoint but missed on pain crises.