Los Angeles – September 17, 2026 -- The U.S. Food and Drug Administration has granted Breakthrough Therapy designation to Armata Pharmaceuticals' AP-SA02, an intravenous multi-phage candidate for complicated Staphylococcus aureus bacteremia, stacking the designation atop existing Fast Track and Qualified Infectious Disease Product status.
Chengdu – September 16, 2026 -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK) said phase III results for its HER2-targeted antibody-drug conjugate trastuzumab botidotin have been published in the Journal of Clinical Oncology, a journal with an impact factor of 44.7, after the drug outperformed Roche's trastuzumab emtansine (T-DM1) in a head-to-head trial and secured approval from China's National Medical Products Administration.
Seoul – September 16, 2026 -- Risvutatug rezetecan (Ris-Rez), a B7-H3-directed antibody-drug conjugate, reduced the risk of death by 54% compared with topotecan in patients with relapsed small-cell lung cancer, according to Phase III ARTEMIS-008 trial results presented at the IASLC 2026 World Conference on Lung Cancer.
The multicenter, open-label trial (NCT06498479) randomized 461 patients in China 1:1 to receive Ris-Rez at 8.0 mg/kg every three weeks or topotecan at 1.2 mg/m2 on days 1 through 5 every three weeks. More than 80% of enrolled patients had previously received PD-(L)1 inhibitors. At the June 6, 2026 data cutoff, after a median follow-up of 12.2 months, the hazard ratio for death favored Ris-Rez at 0.46 (95% CI, 0.35–0.62; P0.0001), with the survival benefit consistent across relevant subgroups.
Seoul – September 12, 2026 -- SystImmune, Inc. announced that new global Phase 1 data support 2.5 mg/kg D1D8 Q3W as the recommended Phase 3 dose for iza-bren (izalontamab brengitecan), a bispecific EGFRxHER3 antibody drug conjugate, in previously treated EGFR-mutated metastatic non-small cell lung cancer (NSCLC).
The abstract, presented in an oral session at the IASLC 2026 World Conference on Lung Cancer (WCLC) in Seoul, South Korea, evaluated iza-bren across three dose levels in a randomized dose-expansion cohort. Patients enrolled had EGFR-mutated metastatic NSCLC and had previously received a third-generation EGFR inhibitor. Results showed promising antitumor activity with a manageable safety profile, with the highest efficacy observed at the 2.5 mg/kg dose.
Indianapolis – September 16, 2026 -- Eli Lilly and Company (NYSE: LLY) has completed its acquisition of AtaiBeckley Inc., a clinical-stage biopharmaceutical company developing rapid-acting neuroplastogens for mental health conditions.
The acquisition brings Lilly control of AtaiBeckley's lead investigational program, BPL-003, targeting patients with treatment-resistant depression who have not responded to multiple prior therapies. AtaiBeckley shareholders approved the transaction at a special meeting held ahead of closing.
Durham – September 16, 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.
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.
Cambridge, Mass. – September 15, 2026 -- Vincere Biosciences has been awarded a $2.7 million Small Business Innovation Research (SBIR) Phase II grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health, to fund IND-enabling development of its USP30 inhibitor for acute kidney injury (AKI).
Acute kidney injury impacts more than 13 million people worldwide each year following ischemia, major surgery, or exposure to nephrotoxic drugs, yet treatment remains largely supportive. The two-year grant will fund genotoxicity and toxicology studies, 28-day GLP toxicology studies, and cardiovascular, respiratory, and CNS safety pharmacology required before Vincere can file an Investigational New Drug (IND) application.
Tel Aviv and Oslo – September 15, 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.
Barcelona, Spain – September 15, 2026 -- Altesa BioSciences reported that its investigational oral antiviral vapendavir significantly reduced two key inflammatory biomarkers, IP-10/CXCL10 and GM-CSF, in COPD patients experimentally infected with rhinovirus, according to data presented at the European Respiratory Society (ERS) International Congress 2026.
Nasal lavage samples from COPD patients treated with vapendavir showed significantly lower levels of IP-10/CXCL10 and GM-CSF compared to placebo over the course of rhinovirus infection. Two additional biomarkers, IFN-α2a and IFN-λ1/IL-29, trended lower with treatment but did not reach statistical significance.
South San Francisco, Calif. – September 15, 2026 -- Apeximmune Therapeutics said a peer-reviewed study published in Nature independently validates PLA2G2D as a novel immune checkpoint capable of overcoming resistance to anti-PD-1 cancer therapies, with the company's lead antibody AI-306 targeting an IND filing in the second quarter of 2027.
Apeximmune's computational screen of more than 9,000 primary tumor samples from The Cancer Genome Atlas ranked PLA2G2D as its top novel checkpoint candidate, ahead of PD-1 and CTLA-4 in the same analysis. Working separately and without knowledge of Apeximmune's program, researchers at Erasmus University Medical Center in Rotterdam used spatial proteogenomic analysis of melanoma patient samples with divergent outcomes and arrived at PLA2G2D as a top hit in dendritic cell and macrophage populations linked to poorer prognosis.