Clinical Trial Results

Indianapolis – October 03, 2026 -- The U.S. Food and Drug Administration has approved an expanded indication for Eli Lilly and Company's Jaypirca (pirtobrutinib), clearing the non-covalent BTK inhibitor as a first-line treatment for adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) without 17p deletion.

Phase 3 trial data show an 80% reduction in disease progression risk

The approval rests on the BRUIN CLL-313 trial, which randomized 282 treatment-naïve patients 1:1 to pirtobrutinib or bendamustine plus rituximab (BR) chemoimmunotherapy. At a median follow-up of 28 months, pirtobrutinib cut the risk of disease progression by 80% versus BR (HR=0.20; 95% CI, 0.11–0.37; p0.0001). Median progression-free survival was not yet reached in the pirtobrutinib arm, compared with 33.5 months for BR.

Westminster, Colo. – October 02, 2026 -- The Centers for Medicare & Medicaid Services has granted New Technology Add-On Payment status to Cerapedics Inc.'s PearlMatrix P-15 Peptide Enhanced Bone Graft, enabling hospitals to recoup up to 65% of the additional cost tied to the device starting October 02, 2026.

CMS approves alternative NTAP pathway tied to FDA Breakthrough Device status

PearlMatrix, a Class III drug-device combination product for skeletally mature patients with degenerative disc disease in the lumbar spine, received NTAP designation under CMS' alternative pathway, which recognizes products holding U.S. FDA Breakthrough Device designation. The reimbursement applies to eligible Medicare beneficiaries treated as inpatients at hospitals paid under the Medicare Inpatient Prospective Payment System.

Tel Aviv, Israel – October 01, 2026 -- Lutris Pharma reported that its topical B-Raf inhibitor LUT014 achieved Treatment Success in 71.8% of patients with EGFR inhibitor-induced acneiform rash, compared with 38.5% on placebo (p=0.003), in updated Phase 2 data presented at the 35th EADV Congress in Vienna.

LUT014 0.1% gel cuts clinician-assessed rash severity and patient symptom burden

Among the composite endpoint's components, 56.4% of patients on LUT014 0.1% achieved at least a one-grade improvement on the CTCAE v5.0 acneiform rash scale versus 15.4% on placebo (p=0.0002). Using the FACT-EGFRI-18 patient-reported symptom score, 53.8% of treated patients reported at least a five-point improvement versus 28.2% on placebo (p=0.021).

Valby, Denmark – October 01, 2026 -- H. Lundbeck A/S reported that 60% of participants in its Phase IV THRIVE trial achieved 'much improved' or 'very much improved' status on a standardized patient scale after switching to eptinezumab, marketed as VYEPTI, following an inadequate response to a prior CGRP-targeting preventive migraine therapy.

Trial enrolled 164 adults who had failed one prior CGRP preventive treatment

The 24-week, open-label, multicenter trial (NCT06701526) was conducted in the United States and enrolled 164 adults with at least eight monthly migraine days who had previously used either a subcutaneous anti-CGRP monoclonal antibody or a preventive gepant, but had not received eptinezumab. Participants started on 100 mg of eptinezumab, escalating to 300 mg at week 12, with 147 receiving both infusions; 84% (138/164) completed the trial.

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 29, 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 21, 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 21, 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).