Clinical Trials

Pittsburgh – September 19, 2026 -- PhaseWell Research has acquired Community Clinical Research (CCR), an Austin, Texas-based inpatient-capable CNS clinical trial site, in a deal advised exclusively by The Braff Group. The transaction gives PhaseWell, a Shore Capital Partners portfolio company headquartered in Nashville, its first inpatient neuropsychiatric research capability.

CCR brings a 20-bed psychiatric research unit staffed around the clock

The site operates a purpose-built, 24/7-staffed, 20-bed psychiatric research unit designed for complex central nervous system (CNS) studies requiring intensive patient monitoring. CCR's clinical team is led by Dr. Brown, with Dr. Samuel Collier serving as Principal Investigator, alongside Sub-Investigator Reid Luedecke, PMHNP-BC, and Mark Embry.

Edina, Minn. – September 18, 2026 -- ReEmerge, Inc. has closed an oversubscribed $37 million Series A financing and exited stealth mode to advance a novel therapy targeting chronic cognitive impairment caused by traumatic brain injury (TBI).

Investor syndicate backs first-of-its-kind neural stimulation approach

U.S. Venture Partners (USVP) and Santé co-led the round, joined by Oxford Science Enterprises, 415 Capital, IAG Capital Partners, The Vertical Group, and Dendrion Ventures. The capital will fund an upcoming clinical study, technology development, and expansion of clinical and regulatory operations.

Dallas – September 18, 2026 -- Nanoscope Therapeutics will unveil four-year follow-up data showing sustained visual acuity gains from its gene therapy MOGENRY® in retinitis pigmentosa patients, with the FDA already having accepted and filed the company's Biologics License Application.

Christine Kay to present long-term durability data at Retina Society meeting

Dr. Christine Kay, Director of Clinical Research and Retinal Genetics at Vitreoretinal Associates in Gainesville, will present the data on September 23, 2026, at the 59th Annual Scientific Meeting of the Retina Society in Los Angeles. The presentation, titled "Lasting Vision Improvement With MCO-010 Optogenetic Therapy," draws on the REMAIN 4-year extension of the RESTORE Phase 2b/3 trial (NCT04945772) and is scheduled for 3:15 PM PT at the Fairmont Century Plaza Hotel.

Boston – September 18, 2026 -- Xylo Bio has dosed the first participants in a Phase 1 clinical trial of XYL-1001, a selective 5-HT2A receptor agonist targeting major depressive disorder (MDD), marking the company's transition to a clinical-stage biotechnology organization.

Phase 1 trial spans single and multiple ascending dose cohorts in Australia

The randomized, double-blind, placebo-controlled study is evaluating safety, tolerability, pharmacokinetics, and pharmacodynamic activity of XYL-1001 in healthy volunteers. The trial design incorporates translational biomarkers intended to characterize pharmacodynamic engagement and inform future clinical development decisions.

Staten Island, N.Y. – September 17, 2026 -- Acurx Pharmaceuticals (NASDAQ: ACXP) presented new in vitro data showing its lead antibiotic ibezapolstat achieved a 5.51-log reduction against Clostridioides difficile in co-culture with vancomycin-resistant Enterococcus (VRE), significantly outperforming vancomycin (p=0.0112), the current standard of care.

The poster, presented by Dr. Eugenie Bassères of the University of Houston College of Pharmacy, was unveiled at the 9th International C. difficile Symposium in Bled, Slovenia, held September 8-10, 2026.

VRE strains showed high-level resistance to vancomycin but not to ibezapolstat

All tested VRE strains exhibited vancomycin resistance with minimum inhibitory concentrations (MIC) above 128 μg/mL. Ibezapolstat and fidaxomicin maintained equivalent, lower susceptibility thresholds of 2-16 μg/mL.

Arlington, Mass. – – September 17, 2026 -- Eloxx Pharmaceuticals, Inc. (Nasdaq: ELOX) has dosed the first two patients in the EXACT Study, a Phase 2b trial evaluating its investigational drug exaluren in patients with nonsense mutation Alport syndrome (NMAS), a rare kidney disease with no FDA-approved therapy targeting its genetic cause.

Trial targets 24 patients with a 16-week placebo-controlled start

The global, randomized, delayed-start Phase 2b trial will enroll 24 patients carrying nonsense mutations in the COL4A3, COL4A4, or COL4A5 genes. The initial 16-week placebo-controlled portion measures the drug's effect on structural podocyte changes via foot process effacement, assessed through kidney biopsies in non-U.S. pediatric patients and all adult participants.

Durham – September 17, 2026 -- Seismic Pharmaceuticals has enrolled the first patient in its global Phase 3 trial testing istaroxime for heart-failure-related cardiogenic shock, a condition with no FDA-approved pharmacologic therapy. The study, RESCUE HF-CS, targets approximately 600 patients recruited at clinical sites across the United States, Europe, China and South America.

No approved drug currently exists for cardiogenic shock, a high-mortality condition

Cardiogenic shock occurs when the heart cannot pump enough blood to meet the body's needs, cutting off oxygen delivery to vital organs. Despite advances in critical care, the condition continues to carry high complication and mortality rates, and no medication has been specifically approved to treat it.

Las Vegas – – September 16, 2026 -- The obesity therapeutics market across the seven major markets was valued at approximately USD 16 billion in 2025 and is projected to grow at a 27% CAGR through 2036, according to DelveInsight, as a wave of next-generation candidates threatens to disrupt the Eli Lilly-Novo Nordisk duopoly.

Oral GLP-1 Therapies Accelerate Patient Uptake

Novo Nordisk's oral WEGOVY surpassed 5 million cumulative U.S. prescriptions within 30 weeks of launch, while Eli Lilly's oral FOUNDAYO (orforglipron) gained significant traction among patients initiating obesity treatment by mid-2026. Aparna Thakur, Project Manager of Forecasting & Analytics at DelveInsight, said FOUNDAYO's once-daily oral formulation positions it for rapid uptake as a more convenient alternative to injectable therapies.

Grand Rapids – September 16, 2026 -- Headlands Research has established a new clinical trial site in Grand Rapids, Michigan, led by board-certified rheumatologist Eric Slavin, MD, FACP, FACR, expanding the network's capacity for rheumatology, autoimmune disease, and cardiometabolic trials in the Midwest.

New de novo site targets high-demand therapeutic areas

Headlands Research - Grand Rapids is currently under development and expected to open later in 2026. The site will focus on rheumatology, bone and joint conditions, and autoimmune and inflammatory diseases, while also conducting studies in general medicine, chronic kidney disease, obesity, hypertension, hyperlipidemia, and vaccines.

Kyle Burtnett, CEO of Headlands Research, said sponsor demand for rheumatology and autoimmune disease trials continues to climb, positioning the new site to address that gap in the Midwest market.

Durham – September 16, 2026 -- Seismic Pharmaceuticals has enrolled the first patient in RESCUE HF-CS, a global Phase 3 trial testing istaroxime as a potential first-ever approved drug for heart-failure-related cardiogenic shock, a condition with no FDA-approved treatment.

Trial to enroll 600 patients across four continents

The study will recruit approximately 600 patients at clinical sites in the United States, Europe, China and South America. It builds on four completed Phase 2 trials that enrolled more than 350 patients.

Cardiogenic shock carries high mortality despite critical care advances

The condition occurs when the heart cannot pump enough blood to meet the body's needs, cutting oxygen delivery to vital organs. It often complicates acute heart failure or other serious cardiac events, and no pharmacologic therapy has been developed specifically to treat it.