Development

Etentamig cut the risk of progression or death by 60% vs standard therapies in the phase 3 CERVINO trial of triple-class exposed myeloma.

At AAPS PharmSci 360, Thermo Fisher Scientific scientists described how predictive modeling guides technology selection for poorly soluble drugs, and outlined plans to bring solvent-free KinetiSol technology to commercial scale in 2027.

Phase 1b data at ESMO 2026 show the TCR-based T-cell engager produced durable responses in PRAME-high melanoma, with 91% of patients alive at one year in the recommended dose range.

In two small phase 1b trials, the half-life-extended bispecific antibody improved skin disease and reduced airway inflammation. Aclaris will move next into a Phase 2b trial in eosinophilic esophagitis.

Risvutatug rezetecan extended median progression-free survival to 5.5 months vs 1.4 months with chemotherapy in pretreated osteosarcoma.

Izalontamab brengitecan extended median progression-free survival to 11.1 months vs 5.7 months with chemotherapy after EGFR TKI failure.

This year's PharmSci 360 will close with a plenary on fixing drug development economics given by Averin's Dr Berry.

Full Phase 3 TroFuse-005 data presented at ESMO 2026 show the TROP2-directed ADC sacituzumab tirumotecan cut the risk of death by 32% vs chemotherapy, and an FDA decision is expected by June 2027.

A patient with relapsing MS died of septic pneumonia 44 days after zola-cel CAR T infusion, as all 60 dose level 2 patients stayed off DMTs.

BioNTech and DualityBio's HER2-directed ADC modestly improved progression-free survival over chemotherapy in DYNASTY-Breast02, but higher interstitial lung disease rates and an established competitor limit its potential in this setting.

FNIH CEO Dr Julie Gerberding will open the October 25-28 meeting with a talk on using AI, adaptive trials, and alternative methods in drug development.

Phase 1 HCXT-2001, an oral macrocyclic IL-23R peptide, could be paired with emvistegrast as a daily oral IBD treatment, according to Gilead.

Roche gains exclusive global rights to ZW209, a DLL3×CD3×CD28 trispecific T-cell engager designed for CD28 co-stimulation. A phase 1 study in small cell lung cancer and other neuroendocrine tumors is underway.

Zylidac will test whether optogenetic cell lines that hit 21 g/L in small-scale CHO runs can deliver higher-yield complex biologics at GMP scale.

Revakinagene taroretcel (Encelto), the only FDA-approved MacTel therapy, slowed photoreceptor loss by up to 54.8% vs sham in phase 3 trials.

BioNTech and Bristol Myers Squibb will replace chemotherapy with Gilead’s TROP2-directed ADC sacituzumab govitecan in the Phase 3 ROSETTA Breast-01 trial of PD-L1×VEGF-A bispecific pumitamig in PD-L1-low or -negative TNBC.

Alexion’s ravulizumab won accelerated approval to reduce proteinuria in adults with IgA nephropathy after the Phase 3 I CAN trial showed a 43.4% placebo-adjusted reduction at Week 34.

Phase 1 data presented at IDWeek 2026 show TaiMed Biologics’ host-directed antibody TMB-365 lowered HIV-1 RNA without resistance, as the company advances an antibody-only maintenance regimen with TMB-380.

Dr Julie Gerberding and Dr David Berry will headline the October 25-28 New Orleans meeting, which adds a USP standards workshop and AI, organoid tracks.

Geneos Therapeutics has initiated a 90-patient randomized phase 2 trial comparing its personalized neoantigen DNA vaccine GNOS-PV02 with active surveillance in patients with high-risk hepatocellular carcinoma after surgery.

Backed by €400 million (US$449 million) in EU-cleared German aid, the new Frankfurt facility is designed to secure insulin supply for people with diabetes from 2032.

EA2251, the 7th registrational trial of ivonescimab, will test it plus chemotherapy vs pembrolizumab or durvalumab regimens in first-line BTC.

Webinar Date/Time: Thursday, October 22, 2026 11:00 AM EDT

METiS TechBio will apply its AI-driven AiLNP ionizable lipid platform to discover LNPs designed to deliver therapeutics beyond the liver, under a collaboration with Eli Lilly worth up to $1.1 billion in milestones.

Interim phase 1 data presented at UEG Week 2026 showed Bionyra Pharma’s Fc-engineered anti-TL1A antibody BYN-002 suppressed soluble TL1A with a half-life supporting potential every-3-to-6-month maintenance dosing in IBD.