Clinical Trial Update

Sydney – October 13, 2026 -- The Safety Review Committee (SRC) for Racura Oncology's HARNESS-1 trial has cleared lead drug RC220 to escalate to 100 mg/m2, after finding no dose-limiting toxicities in either Cohort 1 patient. The Phase 1a/b study combines RC220 with osimertinib in patients with EGFR-mutant non-small cell lung cancer (NSCLC).

Both Cohort 1 patients received RC220 at 50 mg/m2 by intravenous infusion alongside osimertinib at 80 mg daily. The second patient has received three RC220 doses, given 21 days apart, with no dose-limiting toxicities or treatment-related safety concerns.

Orange County, Calif. – October 08, 2026 -- The Institute for Molecular Medicine (IMM) and Nuravax have dosed the first four participants in TAURUS-1980, a Phase 1 trial testing AV-1980R, described as the world's first active immunotherapy targeting pathological tau protein linked to Alzheimer's disease.

Trial targets at-risk adults before cognitive symptoms appear

TAURUS-1980 will enroll up to 48 cognitively unimpaired adults aged 65 to 80 who have biomarker-confirmed brain amyloid pathology, a known precursor to Alzheimer's. Participants are randomized 3:1 to receive AV-1980R or placebo across three ascending-dose cohorts of 20, 60, and 180 micrograms.

LONDON – – October 07, 2026 -- OncoBayes has completed preclinical work on OB-001, an oral drug candidate designed to overcome antibody-drug conjugate (ADC) resistance and boost brain penetration of tyrosine kinase inhibitors (TKIs), the privately held clinical-stage pharmaceutical company announced.

OB-001 raises osimertinib brain exposure by nearly 400% in mouse studies

In perfused-brain mouse models, pretreatment with OB-001 increased brain exposure of osimertinib by almost 400%, while plasma exposure remained broadly unchanged. The data, presented at AACR 2026, covered four gold-standard kinase inhibitors and showed systemic drug levels were largely unaffected by the efflux-pump inhibition.

Dallas – October 06, 2026 -- Nanoscope Therapeutics will present four-year durability data from its RESTORE Phase 2b/3 trial of optogenetic therapy MCO-010 in retinitis pigmentosa at the American Academy of Ophthalmology (AAO) 2026 Annual Meeting, running October 8–13 in New Orleans.

Four-year REMAIN data to show durability of vision gains in retinitis pigmentosa

Dr. Kenneth C. Fan will present the REMAIN study results on Sunday, October 11, highlighting sustained vision improvement among patients treated with MCO-010 in the RESTORE trial. A separate scientific poster from Dr. David S. Boyer will detail vision improvement with sonpiretigene isteparvovec in dry age-related macular degeneration, drawn from what the company describes as the first direct-to-Phase 2 randomized controlled trial in that indication.

San Diego – October 06, 2026 -- Viking Therapeutics (NASDAQ: VKTX) has initiated Part 2 of a maintenance dosing study for VK2735, its dual GLP-1/GIP receptor agonist, testing oral tablet regimens alongside subcutaneous options to sustain weight loss after initial treatment.

Trial enrolls 195 obese adults to test five maintenance pathways

The randomized, double-blind, placebo-controlled study will enroll approximately 195 adults with obesity (BMI ≥30 kg/m2). All participants first receive 21 weeks of weekly subcutaneous VK2735 or placebo before transitioning to one of five maintenance arms: daily oral doses, weekly oral doses, monthly subcutaneous doses, every-other-week subcutaneous doses, or placebo. The study runs through Week 33, tracking safety, tolerability, pharmacokinetics, and body weight change from baseline and from Week 21.

SEATTLE – October 06, 2026 -- Mozart Therapeutics presented three new data sets on its lead candidate MTX-101 at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD), held September 28–October 06, 2026, in Milan, Italy, advancing the bispecific antibody toward a planned Phase 2a trial in Stage 3 type 1 diabetes with enrollment targeted for the first half of 2027.

Phase 1a/b data show MTX-101 is well tolerated and may affect C-peptide levels

The first presentation detailed safety, pharmacokinetic and pharmacodynamic results from a Phase 1a/b study in healthy adults and type 1 diabetes patients. Clinical data collected to date indicate MTX-101 has been relatively safe and well tolerated, with early signals suggesting a positive effect on C-peptide levels in patients with Stage 3 disease.

Taipei – October 05, 2026 -- AnnJi Pharmaceutical Co., Ltd. (TPEx: 7754) is proceeding with the U.S. portion of its pivotal Phase 3 ROMA-KD trial for AJ201, an oral small molecule targeting spinal and bulbar muscular atrophy (SBMA), also known as Kennedy's disease, a rare inherited neuromuscular disorder with no FDA-approved treatment.

AJ201 becomes the only investigational SBMA therapy in Phase 3 development worldwide

AnnJi submitted the Phase 3 protocol to the U.S. FDA under its active Investigational New Drug application and will now move to activate U.S. trial sites. The global, multicenter, randomized, double-blind, placebo-controlled ROMA-KD study is designed to evaluate efficacy and safety in ambulatory patients with symptomatic SBMA, with approximately 200 patients expected to enroll worldwide and the United States serving as a key region.

Staten Island, N.Y. – September 29, 2026 -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) has enrolled the first patient in its PATHFINDER clinical trial evaluating ibezapolstat in patients with multiply-recurrent Clostridioides difficile infection (rCDI), a condition affecting up to 40% of patients treated with vancomycin after multiple prior episodes.

Fully funded pilot trial targets approximately 20 patients with severe recurrence history

The Phase 2 PATHFINDER study is a multicenter, open-label, single-arm trial enrolling patients who have experienced at least three CDI episodes within the past 12 months. Participants receive ibezapolstat for 14 days, with assessments for Clinical Cure at Day 16, Sustained Clinical Cure at Day 42, and recurrence rates tracked through Week 24.

San Francisco – September 29, 2026 -- Innovent Biologics reported an 84.6% overall response rate for its trispecific antibody IBI3003 at the recommended Phase 2 dose in heavily pretreated multiple myeloma patients, data presented in an oral session at the 23rd International Myeloma Society Annual Meeting 2026.

Trial identifies 360 μg/kg as the optimal dose after testing three dose levels

Among 26 patients treated at 360 μg/kg with a median follow-up of 7.57 months, median progression-free survival has not yet been reached. The cohort produced 11 stringent complete responses, 4 very good partial responses, and 7 partial responses. Response rates climbed to 94.7% among 19 patients who had received only 2 to 4 prior lines of therapy, and 92.3% among 13 patients without extramedullary disease.

Toronto – September 24, 2026 -- Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) has hit its 110-patient enrollment target for the pivotal Phase III MAVERIC trial ahead of its end-of-September guidance, and will now expand recruitment to as many as 150 patients.

Blinded review shows fewer recurrences than expected in pericarditis trial

A blinded review of patients randomized 1:1 to CardiolRxTM or placebo found a lower-than-anticipated rate of pericarditis recurrence, according to Cardiol. The MAVERIC Steering Committee recommended the enrollment increase to capture enough clinical events for a statistically robust efficacy read.

President and CEO David Elsley said the company is not aware of any change in routine clinical practice that would explain the reduced recurrence rate, calling the finding encouraging.