Metrics & Benchmarks

LUCENT-3 trial open-label extension data show 63.5% of adults with ulcerative colitis administered mirikizumab (Omvoh) who achieved disease clearance at one year maintained composite disease clearance through four years of treatment.

Guselkumab (Tremfya) showed higher 24-week fistula remission than placebo in adults with perianal fistulizing Crohn disease.

Elranatamab-bcmm (Elrexfio) improved progression-free survival in a Phase 3 trial of relapsed or refractory multiple myeloma after at least 1 prior therapy.

Oral semaglutide lowered HbA1c vs placebo in a phase 3 trial in adolescents with type 2 diabetes, pending full data and review.

A systematic review pooling data from 17 clinical trials—including 15 involving failed or withdrawn therapies—concludes that amyloid-targeting antibodies offer little clinically meaningful benefit, prompting widespread pushback from Alzheimer's researchers.

New findings from a Phase II study indicate that antenatal treatment with the FcRn blocker nipocalimab resulted in low fetal drug exposure and transient reductions in infant IgG levels at birth, without evidence of impaired immune recovery or vaccine response through nearly two years of follow-up.

Phase IIb JASMINE data show nipocalimab met its primary endpoint in adults with systemic lupus erythematosus, marking the first positive readout for an FcRn blocker in this disease.

The FDA has cleared subcutaneous mosunetuzumab for adults with relapsed or refractory follicular lymphoma after two or more prior therapies, supported by Phase I/II data showing durable responses and a manageable safety profile with markedly reduced administration time.

The FDA has approved Exdensur depemokimab-ulaa as an add-on maintenance therapy for severe asthma in patients aged 12 and older, supported by Phase III SWIFT trial data showing significant reductions in annual exacerbations with twice-yearly dosing.

The FDA has granted accelerated approval to Otsuka’s Voyxact for adults with primary IgAN at risk of disease progression, based on Phase III VISIONARY trial results showing a 51% reduction in proteinuria at nine months and a generally well-tolerated safety profile, offering the first targeted APRIL-blocking therapy for this patient population.

The approval of AstraZeneca’s Imfinzi in combination with perioperative FLOT chemotherapy marks the first immunotherapy regimen for resectable gastric and gastroesophageal junction cancers, delivering a 22% overall survival benefit and establishing a new standard of care.

FDA approval of Itvisma, the first gene replacement therapy for adolescents, teens, and adults with SMA, is backed by Phase III data showing meaningful gains in motor function and a consistent safety profile across previously untreated and previously treated patients.

New 48-week results from the Phase IIIb APEX trial show Tremfya delivers sustained radiographic protection and deeper clinical responses in active psoriatic arthritis, reinforcing its potential as an early, structural-sparing therapy.

Phase III HERIZON-GEA-01 trial results show Ziihera combinations, with or without tislelizumab, significantly improve progression-free and overall survival in patients with HER2-positive advanced gastroesophageal adenocarcinoma, positioning these regimens as potential new first-line standards of care.

New 48-week results from Johnson & Johnson’s Phase IIIb APEX trial show Tremfya delivers durable symptom improvement, slows radiographic progression, and maintains a consistent safety profile in biologic-naïve psoriatic arthritis patients—supporting J&J’s sBLA to expand the therapy’s label.

FDA has approved Komzifti (ziftomenib) as the first once-daily, oral menin inhibitor for adults with relapsed or refractory NPM1-mutated AML, supported by Phase II KOMET-001 data showing meaningful remission rates, durable responses, and a manageable safety profile in a population with limited treatment options.

The ARTISTRY-1 Phase III trial demonstrated that a single-tablet regimen of bictegravir 75 mg/lenacapavir 50 mg maintains viral suppression and simplifies therapy for people living with HIV, supporting safer, more convenient treatment options.

In Vibrance-2, oral alixorexton significantly improved wakefulness and reduced excessive daytime sleepiness with a favorable safety profile, positioning the OX2R agonist for rapid advancement into Phase III trials.

Cogent Biosciences’ combination therapy cut the risk of disease progression or death by 50% compared to sunitinib alone, with a favorable safety profile and plans for FDA submission in early 2026.

Caplyta (lumateperone) demonstrated significant symptom improvement and favorable tolerability as an add-on treatment for adults with major depressive disorder, supported by two pivotal Phase III trials and long-term extension data.

New post hoc and pooled analyses from the OASIS 4 trial presented at ObesityWeek 2025 show that oral semaglutide 25 mg improves glycemic control, cardiovascular risk factors, and weight outcomes across diverse patient populations.

New data from the Phase II study of eloralintide, a once-weekly selective amylin receptor agonist, reveal strong dose-dependent weight loss and a favorable tolerability profile, supporting advancement to Phase III trials.

Kygevvi (doxecitine and doxribtimine) earned FDA approval as the first treatment for thymidine kinase 2 deficiency, supported by data from a Phase II trial and multiple retrospective studies showing marked survival improvement and motor milestone recovery.