clinical_trials

Cambridge, Mass. – September 13, 2026 -- Solstice Oncology has launched with a $225 million Series A financing led by RA Capital Management, with participation from Canaan Partners, Forbion and other investors, to advance a second-generation CTLA-4 antibody into earlier-stage cancer treatment.

Solstice secures $225 million to fund neoadjuvant immuno-oncology program

The clinical-stage company is focused on treating cancer in the neoadjuvant setting, before tumors have hardened resistance to therapy. Its lead candidate, porustobart, is a differentiated, Fc-enhanced CTLA-4 antibody being developed across two clinical indications, including microsatellite-stable (MSS) colon cancer and a second, undisclosed indication.

Toronto – September 13, 2026 -- Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) will hold a fireside chat at the H.C. Wainwright 28th Annual Global Investment Conference in New York on September 14, 2026, at 10:30 a.m. EDT.

Cardiol schedules investor session at Lotte New York Palace Hotel

The session takes place in the Louis Room on the fourth floor of the venue. A live webcast will be available under the Events & Presentations section of the company's investor website.

Company advances Phase III trial for recurrent pericarditis treatment

Cardiol's lead candidate, CardiolRx, is being evaluated in the pivotal Phase III MAVERIC trial (NCT06708299) for recurrent pericarditis, following the completed Phase II MAvERIC-Pilot study (NCT05494788). The U.S. FDA has granted Orphan Drug Designation to CardiolRx for pericarditis, including the recurrent form of the disease.

Sydney – September 13, 2026 -- Kazia Therapeutics Limited (NASDAQ: KZIA) has dosed the first patient in Arm A of PNOC035, a Phase 2 platform study testing paxalisib combined with gemcitabine for recurrent or progressive atypical teratoid/rhabdoid tumor (AT/RT), an aggressive pediatric brain cancer with no approved therapies.

Preclinical data showed the combination nearly quadrupled median survival in an AT/RT model

In an orthotopic AT/RT preclinical model, the paxalisib-gemcitabine combination extended median survival from 22 to 82.5 days (p0.0001) and showed complementary anti-tumor activity across multiple AT/RT cell lines. These findings, previously presented at ISPNO, AACR and Neuro-Oncology meetings, formed the scientific basis for advancing into the multicenter PNOC035 trial.

Dallas – September 13, 2026 -- The U.S. Food and Drug Administration has accepted and filed the Biologics License Application for MOGENRY, an optogenetic gene therapy from Nanoscope Therapeutics designed to restore vision in retinitis pigmentosa patients with severe vision loss. If approved, MOGENRY would become the first gene-agnostic treatment available for this patient population, which currently has no approved therapy.

RESTORE trial data anchors the regulatory filing

The BLA is supported by the Phase 2b/3 RESTORE trial (NCT04945772), a multicenter, randomized, double-masked, sham-controlled study that met its primary and key secondary endpoints, showing improvements in visual acuity at weeks 52 and 76. No treatment-related serious adverse events were reported. Additional efficacy and safety data come from the earlier Phase 1/2a trial (NCT04919473).

South San Francisco, Calif. – September 12, 2026 -- IDEAYA Biosciences and Servier have dosed the first patient in OptimUM-11, a global Phase 3 trial testing darovasertib combined with crizotinib as adjuvant therapy for primary uveal melanoma, targeting a disease segment with no approved systemic treatment options.

Trial design pairs oral PKC and cMET inhibitors for high-risk patients post-local therapy

OptimUM-11 will enroll approximately 450 patients who have completed local therapy for primary uveal melanoma and face elevated risk of metastatic recurrence. Patients will be randomized 1:1 to receive darovasertib plus crizotinib for 12 months or to observation, regardless of HLA status. The primary endpoint is relapse-free survival.

Shanghai – September 12, 2026 -- CorrectSequence Therapeutics (Correctseq) reported that its transformer Base Editor (tBE) platform achieved sustained transfusion independence or elimination of vaso-occlusive crises (VOCs) in four new patients from Nigeria, Laos, Malaysia and Pakistan, extending clinical validation beyond the Chinese cohort where five patients previously achieved full transfusion independence.

Study published in Cell Stem Cell confirms cross-genetic efficacy of CS-101/CS-206

The peer-reviewed paper, published online September 7, 2026, details results from one sickle cell disease (SCD) patient and three transfusion-dependent β-thalassemia (TDT) patients treated with CS-101/CS-206. All four achieved rapid hematopoietic reconstitution, sustained high-level pancellular fetal hemoglobin (HbF) expression, and no detectable off-target edits or product-related adverse events.

Hong Kong – September 11, 2026 -- Ascletis Pharma Inc. (HKEX: 1672) has initiated a U.S. Phase I trial of ASC36, an oral amylin receptor peptide agonist for obesity, after securing Investigational New Drug clearance from the FDA.

Trial enrolls 86 participants to test safety and dosing

The study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of ASC36 across single and multiple ascending oral doses in 86 participants with obesity (BMI ≥ 30.0 kg/m2) or overweight status (BMI ≥ 27.0 kg/m2). This marks the fourth Phase I peptide study Ascletis has launched in 2026.

San Diego – September 11, 2026 -- Inhibrx Biosciences reported that its OX40 agonist INBRX-106, combined with pembrolizumab, produced a 48.3% confirmed objective response rate in first-line head and neck squamous cell carcinoma patients, nearly double the 26.5% seen with pembrolizumab alone.

Phase 2 data show the combination therapy nearly doubles response rates versus standard treatment

The randomized Phase 2 portion of the HexAgon study enrolled 68 patients across more than 80 sites in the United States, Europe and Asia, with 63 evaluable for the primary endpoint. Four patients (13.8%) on the combination arm achieved complete responses, compared with zero in the pembrolizumab-only control arm. Six-month progression-free survival reached 72.4% for the combination versus 42.8% for monotherapy, with median PFS of 9.6 months versus 4.9 months as of the August 19, 2026 data cutoff.

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.

Shanghai – September 09, 2026 -- Clover Biopharmaceuticals (HKEX: 02197) reported positive preliminary Phase 2 data in Australia for two combination respiratory vaccine candidates, SCB-1022 (RSV+hMPV) and SCB-1033 (RSV+hMPV+PIV3), targeting older adults aged 60-85.

Trial enrolled 420 older adults across multiple Australian sites

The randomized, observer-blinded study randomized 420 participants to receive SCB-1022, SCB-1033 or placebo. Antibody titers at 28 days post-vaccination were in line with or trended higher than prior Phase 1 results.