Novo Nordisk announced on Thursday, September 17, 2026 that the EMA's CHMP recommended marketing authorization for FREHEMGO (denecimig) to treat hemophilia A, with or without inhibitors, in adults and children. Denecimig is a factor VIIIa-mimetic bispecific antibody that bridges factor IXa and factor X to mimic the cofactor function of activated factor VIII. Novo says it is the first FVIIIa mimetic to offer once-monthly, once-every-two-weeks, and once-weekly prophylaxis in a single-use pre-filled pen. The application was based on the FRONTIER2, FRONTIER3, and FRONTIER4 trials, and FRONTIER5 showed no new safety signals in patients switching from emicizumab. Pending a European Commission decision, Novo expects launches in the first European countries in Q4 2026 and across the EU starting early 2027.
Jazz Pharmaceuticals (NASDAQ: JAZZ) and Zymeworks (NASDAQ: ZYME) received FDA approval Tuesday August 25, 2026 for Ziihera (zanidatamab-hrii, an anti-HER2 bispecific monoclonal antibody) in combination regimens for first-line treatment of adult patients with HER2-positive (IHC 3+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma (GEA). Approved regimens: Ziihera with chemotherapy (fluoropyrimidine and platinum), and Ziihera with tislelizumab (BeiGene's anti-PD-1 monoclonal antibody) plus chemotherapy. Trial basis: Phase 3 HERIZON-GEA-01 documented median overall survival of more than two years. Ziihera mechanism: zanidatamab-hrii is a bispecific antibody that binds two distinct epitopes on HER2 simultaneously, producing higher-affinity target engagement, receptor clustering, and immune-mediated tumor cell killing versus conventional monospecific anti-HER2 antibodies. The approval triggers a $250 million milestone payment from Jazz to Zymeworks, with Zymeworks remaining eligible for up to $1.3 billion in additional milestones plus tiered royalties of up to 20% on net sales. Jazz expects to launch Ziihera commercially in the US in this indication. The approval extends the Ziihera commercial franchise beyond its earlier accelerated approval in biliary tract cancer to a substantially larger commercial indication in HER2-positive GEA. GEA is a globally common cancer with roughly 22,000 US cases per year and substantially higher incidence in Asia; roughly 15-25% of GEA cases express HER2, defining the addressable population. The result is a positive readout for the bispecific antibody modality more broadly.
Boulevard Bio emerged from stealth on Wednesday August 12, 2026 with $65 million in founding financing from Deerfield Management, naming Georg Schett (one of the pioneers of immune reset in autoimmune disease) as co-founder. The company disclosed a precision-immunology pipeline of three drug candidates anchored by BLVD101, an internally discovered dual BAFF/APRIL-targeting bispecific antibody. Mechanism: BLVD101 is designed to inhibit BAFF (B-cell activating factor) and APRIL (a proliferation-inducing ligand), two cytokines that promote the proliferation, survival, and maturation of B cells that drive autoimmune disorders. By blocking both cytokines simultaneously, BLVD101 aims to limit the abnormal B cell activity that attacks healthy tissue in autoimmune diseases. Early Phase 1 healthy volunteer data supports a 12-week (quarterly) subcutaneous dosing interval for BLVD101 in IgA nephropathy (IgAN), a positive tolerability and pharmacokinetic profile that would compare favorably against monthly-dosing biologics in adjacent indications. The launch extends the IgAN indication activity that Trutakna and Fabhalta opened up earlier in 2026 with their FDA approvals ten days apart in the same indication category, though those two drugs target the complement pathway (factor B, C5) rather than the B-cell BAFF/APRIL axis that BLVD101 addresses.
Longhorn Vaccines and Diagnostics presents preclinical data on DRG5-BD11, a bispecific IgM monoclonal antibody targeting bacterial peptidoglycan and HSP16.3 across gram-positive, gram-negative, and mycobacterial pathogens. In vitro assays demonstrated 82% opsonophagocytic killing against E. coli and 74% against Mycobacterium smegmatis, supporting its potential as a broad-spectrum anti-infective for AMR-driven sepsis.