drug_development

Cambridge, Mass. – September 13, 2026 -- Marengo Therapeutics has completed enrollment in the monotherapy cohorts of its Phase 1/2 STARt-001 trial evaluating invikafusp alfa across eight distinct PD-1-resistant tumor types, with updated results selected for an oral presentation at the ESMO 2026 Congress in Madrid, October 23-27.

Trial enrollment closes across eight PD-1-resistant tumor types

The monotherapy cohorts covered patients with MSS colorectal cancer, PD-L1-negative non-small cell lung cancer and triple-negative breast cancer, among others resistant to checkpoint blockade. Enrollment continues in standard-of-care combination cohorts, while the company plans to name lead indications for focused development alongside the ESMO data release.

Wellesley Hills, Mass. – – September 13, 2026 -- Cure Alzheimer's Fund (CureAlz) has appointed Drs. Michelle Arkin, Ronald B. DeMattos, Donna M. Huryn, and Kalpana Merchant to its Scientific Advisory Board (SAB), adding decades of pharmaceutical drug-discovery experience to the nonprofit's research-funding strategy.

Board addition brings direct experience from an FDA-cleared Alzheimer's drug

Ronald B. DeMattos spent more than 20 years in neuroscience discovery at Eli Lilly, most recently as Senior Vice President and Chief Scientific Officer for Neurobiologics, where he led development of candidates that advanced to clinical studies including donanemab, the FDA-cleared amyloid-lowering antibody marketed as Kisunla for early Alzheimer's disease.

Taipei – September 12, 2026 -- HanchorBio Inc. (TWSE: 7827) said the U.S. Food and Drug Administration has cleared its HCB101 Single-Patient Expanded Access Protocol (HCB101-EA-001) as "safe to proceed," allowing a Phase 1 patient who showed clinical benefit to continue receiving the investigational drug beyond the parent trial.

FDA authorizes continued treatment for a single Phase 1 patient

The clearance permits the patient to keep receiving HCB101 outside the standard clinical trial structure under the FDA's Expanded Access, or compassionate use, framework. The agency's review weighed the patient's clinical circumstances, including whether the potential benefit justified the risks given the severity of the disease. HanchorBio noted the determination applies only to this individual-patient protocol and does not constitute approval of HCB101 or an FDA finding on its broader safety or efficacy.

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.

Las Vegas – – September 11, 2026 -- The sarcoidosis treatment market across the seven major markets is projected to expand steadily through 2036, driven by a pipeline of seven late- and mid-stage drug candidates targeting a disease that affects an estimated 150,000 to 200,000 patients annually in the United States alone, according to a new market report from DelveInsight.

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.

Cambridge, Massachusetts – September 11, 2026 -- Harbour BioMed (HKEX: 02142) and partner Windward Bio reported positive Phase 2 interim results for HBM9378/WIN378, a twice-yearly TSLP-blocking antibody, from the 147-patient POLARIS-1 asthma trial, clearing the path for two Phase 3 studies.

Interim data show up to 174 mL lung-function gain after single dose

The Phase 2 interim analysis, conducted on the first 98 of 147 enrolled patients with uncontrolled moderate-to-severe asthma, found FEV1 increases of up to 174 mL, with a placebo-adjusted mean increase of 256 mL (p=0.033) at Week 24 after a single dose.

Biomarkers for airway inflammation drop sharply

FeNO fell by up to 24 ppb, a 43% reduction (p=0.006), while blood eosinophil counts dropped by up to 200 cells/μL, a 51% decline (p0.0001). Near-maximal effects appeared as early as Week 2 and were sustained through Week 24.

Shanghai – September 11, 2026 -- Alebund Pharmaceuticals (Jiangsu) Limited (HKEX: 09637) has received U.S. FDA clearance of its Investigational New Drug application for AP308, a first-in-class engineered recombinant IgA protease targeting IgA Nephropathy (IgAN), moving the candidate from preclinical research into clinical development.

AP308 targets a disease affecting 9.5 million people worldwide

IgAN is the most common primary glomerulonephritis globally, with an estimated 9.5 million patients in 2025, including 5.1 million in China, more than half of the global total, according to China Insights Consultancy. Under current treatment strategies, median kidney survival is approximately 11 to 12 years, and roughly 60% of patients in a Chinese cohort progressed to end-stage renal disease within 15 years of diagnosis, per long-term studies in China and the UK.

San Francisco – September 08, 2026 -- Thryv Therapeutics Inc. has signed an exclusive, worldwide, royalty-bearing license for a new SGK1 inhibitor chemical series, opening a path toward Parkinson's and Alzheimer's disease treatments alongside its existing cardiac drug programs. The agreement with Spain's Consejo Superior de Investigaciones Científicas (CSIC), the Autonomous University of Madrid (UAM) and Fundación de la Universidad Autónoma de Madrid (FUAM) became effective July 1, 2026, granting Thryv rights across all fields of use and territories, with sublicensing rights included.

Los Angeles – September 08, 2026 -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) said a peer-reviewed paper in the Journal of Molecular Biology has mapped near-atomic resolution structures of eleven proteins in its Ar-KM bacteriophage, a Pseudomonas aeruginosa-targeting phage tied to the company's late-stage AP-PA02 program.

Researchers built atomic models of eleven structural proteins using cryo-electron microscopy

The study, titled "Insights into Genome Ejection by a Therapeutic phiKMV-like Bacteriophage," combined cryo-electron microscopy, proteomics and bioinformatics to capture three distinct states of the Ar-KM phage particle from a single purified preparation. The paper is published as J Mol Biol. 2026 Nov 1; 438(21):169993. AP-PA02, an inhaled bacteriophage candidate, has completed Phase 2 studies in cystic fibrosis and non-CF bronchiectasis patients with chronic pulmonary P. aeruginosa infection.