clinical_trial_results

PeproMene's BAFF-R CAR-T Hits 80% Complete Remission in Lancet Study

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PeproMene's BAFF-R CAR-T Hits 80% Complete Remission in Lancet Study

Irvine, California – September 10, 2026 -- PeproMene Bio, Inc. reported that seven of nine patients (80%) treated with its BAFF-R-targeted CAR-T therapy PMB-CT01 achieved complete remission in a Phase 1 trial, with results now published in The Lancet.

All complete responses remained relapse-free at data cutoff, with the longest sustained remission reaching 35 months

Four of six patients who had previously progressed after conventional CD19-directed CAR-T therapy also achieved complete response under the new BAFF-R approach, described in the study as "CAR after CAR" treatment. No relapses were observed among any of the seven complete responders as of the data cutoff.

Epicyt Pharma's BAFA Cuts Urinary Calcium Loss in Bypass Patients

Gothenburg – – September 10, 2026 -- Epicyt Pharma AB reported positive topline results from a Phase 1/2a first-in-human study of its oral drug candidate BAFA, showing a statistically significant reduction in urinary calcium excretion in patients who underwent Roux-en-Y gastric bypass (RYGB) surgery. The Gothenburg-based clinical-stage biopharmaceutical company said the trial, completed in March 2026, also recorded improvements in key biomarkers of calcium homeostasis, consistent with enhanced intestinal calcium uptake.

BAFA targets a market of 3.5 million patients across the EU and US

Epicyt estimates that approximately 3.5 million people in the EU and US currently live with impaired calcium homeostasis following bariatric surgery, with roughly 250,000 new patients added annually. RYGB is widely used to treat severe obesity but frequently impairs calcium uptake, raising the risk of secondary hyperparathyroidism, reduced bone density and fractures.

Six Proteomic Clocks Confirm Insilico's AI Drug Reverses Biological Age

Cambridge, Massachusetts – September 09, 2026 -- Insilico Medicine has published data in Nature Biotechnology showing that its AI-designed idiopathic pulmonary fibrosis (IPF) candidate rentosertib reversed predicted biological age by up to six years in some patients, based on six independently developed proteomic aging clocks.

Sky Labs' CART Ring Shows 80% Data Accuracy in AFib, Heart Failure Trials

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Sky Labs' CART Ring Shows 80% Data Accuracy in AFib, Heart Failure Trials

Munich – September 09, 2026 -- Sky Labs presented new clinical trial data for its ring-based blood pressure monitor, CART, at the ESC Congress 2026 in Munich on September 7, showing an 80% data evaluability rate in continuous monitoring of atrial fibrillation (AFib) patients and high correlation with standard ambulatory blood pressure monitoring (ABPM) in severe heart failure cases.

CART achieves 80% evaluability rate in 24-hour monitoring of atrial fibrillation patients

Professor Ki-Hong Lee of Chonnam National University Hospital reported that CART's ring-based 24-hour monitoring achieved approximately 80% data evaluability in AFib patients, enabling continuous tracking of nocturnal blood pressure dipping patterns that irregular pulse rates typically disrupt for cuff-based devices.

Akeso's Ivonescimab Beats Pembrolizumab on Survival in Phase III NSCLC Trial

Hong Kong – September 07, 2026 -- Akeso, Inc. (9926.HK) said its bispecific antibody ivonescimab produced a statistically significant and clinically meaningful overall survival benefit versus Merck's pembrolizumab in a pre-specified interim analysis of the Phase III HARMONi-2 trial, as assessed by an Independent Data Monitoring Committee.

Ivonescimab clears key secondary survival endpoint against Keytruda

The HARMONi-2 (AK112-303) study is a randomized, double-blind, multicenter registrational trial testing ivonescimab against pembrolizumab as first-line therapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 at a TPS of 1% or higher. Detailed interim overall survival data will be presented at an upcoming international medical conference and published in a peer-reviewed journal.

RZL-012 Hits All Phase 3 Endpoints, Clears Path to China NDA Filing

Hod Hasharon, Israel & Shanghai – September 07, 2026 -- Raziel Therapeutics and Fosun Pharma reported that RZL-012, an injectable lipolytic drug for submental fat reduction, met every primary and secondary endpoint in a 480-patient Phase 3 trial in China, with the primary responder rate outperforming placebo by 30 percentage points after a single treatment cycle.

Pivotal China trial clears statistical bar with wide margin over placebo

The registration study, conducted with Fosun Pharma affiliate JuveStar, enrolled 360 patients on active treatment and 120 on placebo, evaluating efficacy 84 days after one treatment cycle. Results showed a decisive statistical advantage across all measured endpoints, according to the companies.