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argenx agrees to acquire macrocyclic peptide developer Unnatural Products for up to about $1.15 billion, Johnson & Johnson’s pasritamig and JNJ-9401 bispecific regimen achieves a 73% PSA response in phase 1 in metastatic castration-resistant prostate cancer, and Janux Therapeutics’ TRBV6-targeted T-cell engager JANX011 shows deep B-cell depletion in healthy volunteers.

More monoclonal antibodies are moving from IV infusion to subcutaneous injection, but dose, volume, and viscosity still limit the switch. This FAQ covers the formulation science, the enabling technologies, what regulators require, and what remains unresolved.

argenx's acquisition of Unnatural Products adds macrocyclic peptides that could yield oral or long-acting treatments for immune-mediated diseases.

A single subcutaneous dose of Janux’s CD19-targeted T-cell engager JANX011 depleted more than 90% of B cells in three of five healthy volunteers at the top dose, with only Grade 1 cytokine release syndrome. Patient studies in immune thrombocytopenia and rheumatoid arthritis are planned for 2027.

Bimekizumab-bkzx (Bimzelx) produced ACR50 joint responses in 54.9% of psoriatic arthritis patients at week 24 vs 43.8% with risankizumab.

In a phase 1 study, Johnson & Johnson’s combination of pasritamig and JNJ-9401, two bispecific antibodies targeting KLK2 and PSMA, cut PSA by at least 50% in 73% of patients with metastatic castration-resistant prostate cancer. The regimen is now in phase 3.

A real-world study found evolocumab cut fatal or nonfatal heart attack risk 20% vs ezetimibe in adults with ASCVD and prior statin use.

FDA grants accelerated approval to Johnson & Johnson’s subcutaneous EGFR/MET bispecific Rybrevant Faspro for previously treated head and neck squamous cell carcinoma, T-Therapeutics raises a $133 million Series B to take TCR-CD3 bispecifics into clinical trials, and Alethio Therapeutics raises a $90 million Series A to advance its first-in-class G6B antibody for essential thrombocythemia.

Johnson & Johnson's amivantamab (Rybrevant Faspro) won accelerated FDA approval for pretreated recurrent head and neck cancer.

T-Therapeutics closed an oversubscribed $133 million Series B backed by Eli Lilly, JJDC, and others. The funding will take its first T-cell receptor bispecifics in cancer and autoimmune disease into clinical trials.

China’s NMPA grants priority review to Akeso’s PD-1/VEGF bispecific ivonescimab with chemotherapy for first-line biliary tract cancer, VeonGen Therapeutics aligns with FDA on a phase 3 design for its dual-AAV Stargardt gene therapy VG801, and Caldera Therapeutics’ IL-23p19×TL1A bispecific CLD-423 shows a half-life of more than 40 days in a phase 1a trial.

FDA’s draft framework would let sponsors add patient-specific genome editing variants to an approved BLA using in vitro data. Here is what the guidance proposes, what evidence it asks for, and what remains unresolved.

Healthy-volunteer data show sustained TL1A suppression and a profile supporting infrequent subcutaneous dosing. Caldera also licensed a second bispecific, targeting IL-17 and TL1A, from Qyuns Therapeutics.