Clinical Trial Results

Indianapolis – September 30, 2026 -- Eli Lilly and Company (NYSE: LLY) said its EBGLYSS (lebrikizumab-lbkz) monotherapy met the primary and secondary endpoints of the Phase 3b ADtouch study at Week 16, with more than half of treated patients achieving clear or almost clear skin on hands and feet (HF-IGA 0/1), the company disclosed ahead of the European Academy of Dermatology and Venereology Congress in Vienna, running Sept. 30-Oct. 3.

Trial enrolled 221 patients with moderate-to-severe hand and foot atopic dermatitis

The randomized, double-blind, placebo-controlled ADtouch trial (NCT06921759) assigned 221 adults and adolescents 1:1 to EBGLYSS 250 mg or placebo every two weeks over 16 weeks, following an initial loading dose. Participants had an inadequate response to topical therapies and applied moisturizer throughout the study.

Washington – September 30, 2026 -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) reported positive topline results from a pivotal Phase III study of HETLIOZ® (tasimelteon) 20 mg in adults with Delayed Sleep-Wake Phase Disorder (DSWPD), setting up a supplemental New Drug Application (sNDA) filing with the U.S. Food and Drug Administration (FDA).

Trial meets primary endpoint with statistically significant sleep-timing shift

The study, VP-VEC-162-3502 (NCT04652882), shifted sleep onset 42.5 minutes earlier in the HETLIOZ® arm (n=20) versus 5.4 minutes on placebo (n=20), a 37.1-minute difference (p=0.022). In an exploratory responder analysis, 60% of tasimelteon-treated participants (12/20) advanced sleep onset by at least 30 minutes, compared with 15% on placebo (3/20) (p=0.008).

Shanghai – September 26, 2026 -- IASO Biotechnology reported a 90% objective response rate and 90% minimal residual disease (MRD) negativity rate for its BCMA-targeted in vivo CAR-T therapy IASO206, generated via a single intravenous infusion without lymphodepleting chemotherapy, in first-in-human Phase 1 data presented as a late-breaking oral session (LBA-11) at the 2026 International Myeloma Society Annual Meeting.

North Chicago, Ill. – – September 28, 2026 -- AbbVie (NYSE: ABBV) has secured U.S. FDA approval for JUVMO (tavapadon), the first and only selective D1/D5 receptor agonist for adults with Parkinson's disease, with commercial availability set for October 2026.

JUVMO targets dopamine pathways differently than existing D2/D3 agonists

Roopal Thakkar, AbbVie's chief scientific officer, called the approval the first dopaminergic breakthrough for Parkinson's disease in decades. The once-daily oral tablet can be taken with or without levodopa, positioning it across the full disease continuum rather than a single treatment stage.

Atlanta and Carlsbad, Calif. – September 20, 2026 -- Field Medical, Inc. reported 12-month outcomes from its first-in-human Field PULSE trial showing 94.2% per-vein durability for pulmonary vein isolation using an optimized waveform, with results published in JACC: Clinical Electrophysiology and presented as a Late-Breaking Clinical Trial at HRX Live 2026.

Subsecond ablation cuts median procedure time to 13 minutes

The trial recorded a 13-minute median elapsed pulmonary vein isolation (PVI) ablation time, with a fastest case completed in 7.7 minutes. Field Medical's high-voltage focal pulsed field ablation (PFA) architecture, delivered through its FieldForce PFA System, applies energy in under 200 milliseconds per point, reducing the need for prolonged catheter stability during atrial procedures.

Indianapolis – September 20, 2026 -- The U.S. Food and Drug Administration has granted full approval to Eli Lilly and Company's (NYSE: LLY) Inluriyo (imlunestrant) in combination with Verzenio (abemaciclib) for adults with estrogen receptor-positive (ER+), HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy.

EMBER-3 trial shows combination doubles progression-free survival

The approval rests on Phase 3 EMBER-3 data in 159 patients with ESR1-mutated metastatic breast cancer who had previously received an aromatase inhibitor, with or without a CDK4/6 inhibitor. Patients randomized to Inluriyo plus Verzenio (n=67) achieved a median progression-free survival of 11.1 months, versus 5.5 months for Inluriyo alone (n=92), a hazard ratio of 0.53 (95% CI, 0.35–0.80).

Seoul – September 16, 2026 -- Johnson & Johnson reported that its RYBREVANT (amivantamab-vmjw) plus chemotherapy combination extended median overall survival to 34.3 months in patients with EGFR exon 20 insertion-mutated advanced non-small cell lung cancer, compared with 27.9 months for chemotherapy alone, according to final data from the Phase 3 PAPILLON study.

Combination therapy nearly doubles historical survival benchmarks

The result marks the longest reported median overall survival for this patient population, which has historically faced a five-year survival rate of just 8 percent and a median overall survival ranging from 16 to 24 months. EGFR exon 20 insertion mutations account for approximately 12 percent of all EGFR mutations and have proven difficult to treat with existing targeted therapies.

Hong Kong – September 16, 2026 -- Akeso, Inc. (9926.HK) reported that its bispecific antibody ivonescimab reduced the risk of death by 27% compared with Merck's pembrolizumab in a Phase III trial of PD-L1-positive non-small cell lung cancer (NSCLC), with results presented as a Late-Breaking Abstract at the 2026 World Conference on Lung Cancer (WCLC).

Ivonescimab extends median survival to 30.8 months in head-to-head trial

In the intention-to-treat population of the HARMONi-2 study (AK112-303), patients treated with ivonescimab monotherapy achieved a median overall survival (OS) of 30.8 months versus 22.6 months for pembrolizumab (HR=0.73; 95% CI: 0.57–0.95; P=0.009). The data cutoff was August 20, 2026, with a median follow-up of 36 months and 234 OS events recorded. Professor Caicun Zhou, principal investigator and IASLC President, is scheduled to deliver the full oral presentation on September 15.