Biologic Drugs in Development

Teprotumumab N01 (Sycume) reduced eye bulging in 60.4% of patients with chronic, inactive thyroid eye disease in a phase 3 trial.

Genglycos, the gene therapy that earned the voucher, will fund new Ultragenyx therapies for other rare and ultra-rare diseases.

Caribou is halting vispa-cel and CB-011, allogeneic CAR-T therapies that showed up to 92% response rates, citing a difficult financing environment.

AbbVie's c-Met ADC Temab-A showed a 15.6% response rate in late-line colorectal cancer ahead of its 2 new FDA breakthrough designations.

CSL and Alentis will co-develop lixudebart, an antibody targeting claudin-1, across 3 rare kidney and liver disease indications.

AL050 aims to treat GBA1-driven Parkinson disease by delivering a GCase enzyme across the blood-brain barrier.

Manufacturing remediation, not efficacy or safety data, is delaying US approval of Novo's h+emophilia A therapy denecimig.

Doubled drug substance capacity at Alvotech's Reykjavik, Iceland, site aims to secure steady US supply of the Humira biosimilar Simlandi.

LumaLex Law's Dustin Robinson explains why retatrutide compounding remains illegal regardless of the Seventh Circuit's pending classification ruling.

Artiva Biotherapeutics will present data on AlloNK, an allogeneic, non-genetically modified NK cell therapy given with rituximab, in refractory rheumatoid arthritis, Sjögren disease and systemic sclerosis at ACR Convergence 2026, ahead of a planned phase 3 trial in rheumatoid arthritis.

Novartis has secured an exclusive worldwide license to ABO2203, Abogen's investigational mRNA-encoded CD19xCD3 T-cell engager designed to produce the bispecific inside the body to reset B cells in autoimmune disease. The agreement also includes options on other programs built on Abogen's RNA platform.

The 15-month project could let living cell therapies ship and store at room temperature, cutting cold-chain costs that limit patient access.

A planned phase 3 trial will test the TROP2 ADC and PD-1/VEGF bispecific together in 1st-line triple-negative breast cancer.

Next-gen bioprocessing, cloud-driven AI, and personalized immunizations are accelerating global therapy delivery while reinforcing cleanroom and trial compliance.

Following an FDA meeting, Wave Life Sciences plans a single 2-year registrational trial of WVE-006, its GalNAc-conjugated RNA editing oligonucleotide for alpha-1 antitrypsin deficiency, with a 1-year interim analysis that could support accelerated approval based on biomarkers.

Keith Knutson, PhD, of Mayo Clinic explains why vaccine manufacturing speed and cost will determine real-world scalability.

Patients suffered pyrogenic reactions before Fresenius Kabi recalled 3 contaminated batches at its 430,000-sq-ft Melrose Park, Ill., biologics plant.

Sanofi is paying Regeneron up to $8 billion to co-develop REGN20423 and 3 other long-acting antibodies beyond dupilumab (Dupixent).

Denosumab-adet now covers all 3 Xgeva indications, widening lower-cost treatment access for cancer patients with bone complications.

More than half of patients achieved clear or almost clear hands and feet with lebrikizumab by week 16, and 77% reported satisfaction with clearance.

Novo gains global rights, excluding Greater China, to HRS-1596, a phase 1-ready GLP-1/GIP dual receptor agonist that Hengrui says has potential for once-weekly oral dosing in obesity and type 2 diabetes.

NouvSight001 isn't limited to the RPE65-mutation subset current gene therapy treats, potentially reaching more of the 1.5 million with RP worldwide.

Updated 36-month data in 15 high-dose patients showed 80% slowing on cUHDRS, while the 48-month cUHDRS result did not reach statistical significance. uniQure attributes the gap to attrition in the external control, and the FDA is reviewing a BLA based on the 36-month data.

Ivonescimab, in phase 3 trials across 8 tumor types, will be paired with sonesitatug vedotin in new gastrointestinal cancer trials.

Daiichi Sankyo and Merck pulled ifinatamab deruxtecan's FDA filing in small cell lung cancer after a 187-patient trial fell short.