Clinical Trial Update

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.

Boulder, Colorado – September 22, 2026 -- Edgewise Therapeutics (Nasdaq: EWTX) disclosed preclinical data showing its lead cardiac drug candidate EDG-7500 improves heart relaxation while preserving systolic function, a mechanism the company says addresses a core driver of hypertrophic cardiomyopathy (HCM) that current therapies do not fully target.

Edgewise screened over 7,000 candidates to isolate a first-in-class RLC modulator

The company's Chief Scientific Officer, Alan Russell, said Edgewise screened more than 7,000 pharmacologically diverse compounds targeting the Regulatory Light Chain (RLC) before selecting molecules exhibiting positive lusitropic properties without compromising systolic performance. "EDG-7500's diastolic-biased profile has the potential to address a central pathologic driver of both symptomatic obstructive and nonobstructive HCM," Russell said.

Morristown, N.J. – September 17, 2026 -- Whitehawk Therapeutics (Nasdaq: WHWK) presented real-world data at the IASLC 2026 World Conference on Lung Cancer in Seoul showing that PTK7 expression remains stable in pretreated, EGFR wild-type non-small cell lung cancer (NSCLC), reinforcing the target biology behind its Phase 1 antibody-drug conjugate (ADC) HWK-007.

Tel Aviv and Oslo – September 16, 2026 -- BioLineRx Ltd. (NASDAQ/TASE: BLRX) and Hemispherian AS will present two abstracts on their oncology candidate GLIX1 at the 21st Meeting of the European Association of Neuro-Oncology (EANO 2026) in Rome, Italy, September 24-27, with one abstract selected for oral presentation.