Biologic Drugs in Development

Dazodalibep hit its phase 3 primary endpoint at week 48, building on phase 2 data showing a 6.3-point ESSDAI reduction versus placebo.

Novo Nordisk reports that CagriSema outperformed tirzepatide with 12.4% weight loss versus 9.1% in a phase 3 trial in adults with type 2 diabetes.

Laru-zova helped 31% of high-dose patients gain 15+ letters of vision, representing the first pivotal trial to succeed in treating XLRP.

Telix will acquire ITM for $1.65 billion, gaining a phase 3-validated therapy that cut GEP-NET progression risk versus everolimus.

mAbxience and Sandoz are targeting a $5.7 billion market with a proposed emicizumab biosimilar for hemophilia A.

Fayuvi scored 23.5 points higher than untreated peers on cognitive testing, backing the first-ever approval for a Sanfilippo syndrome A gene therapy.

Dualitas will screen over 300,000 bispecific combinations for Roche, backing a deal worth up to $1 billion in immunology research.

Inebilizumab (Uplizna) cut MG-ADL scores by 1.9 points versus placebo, supporting its approval in Japan for myasthenia gravis.

Regulatory approvals, trial data, and major licensing deals in 2026 are accelerating subcutaneous biologics, cutting patient burden and reshaping biopharma strategy.

Insilico's Longevity Vaccines use circular mRNA to arm T cells against aging's earliest culprit cells, starting with immune rejuvenation.

GSK's new trispecific TCE targets 2 tumor antigens plus T cells, aiming to improve on the tolerability of current myeloma therapies.

Phio's PH-762 posted a 70% response rate in skin cancer, supporting its FDA briefing package for a planned phase 2b trial.

Cellectis is pivoting to in vivo gene editing to advancing its .HEAL-101 and .HEAL-201 candidates for lipid disorders while exiting its CAR T programs.

With 15 patients now dosed in its pivotal EMERALD trial, Resolution will build on the 70% 4-year transplant-free survival seen with RTX001 in earlier data.

Lundbeck's asedebart, which blocks ACTH signaling at its source, has won FDA orphan status for endogenous Cushingsyndrome.

Biora's BioJet capsule aims to deliver adalimumab without a needle, entering human testing after hitting 51.3% preclinical bioavailability.

Satralizumab cut MOGAD relapse risk 68% in a phase 3 trial, positioning it as the first potential treatment for this rare disease.

Ersodetug missed its phase 3 primary endpoint in congenital HI, but FDA is reviewing CGM data showing 50%+ hypoglycemia reductions.

Del-desiran missed its primary endpoint in a phase 3 DM1 trial, though secondary measures showed signs of clinical activity.

BrainChild Bio's BCB-276 extended survival to 19.8 months from diagnosis in phase 1, backing its $116 million-funded pivotal DIPG trial.

Moonwalk's $70 million new funding advances MW101, an adipose-targeted siRNA aiming to cut fat while preserving muscle in obesity patients.

Bristol Myers Squibb reported positive topline phase 2 results for arlocabtagene autoleucel, a potential first-in-class GPRC5D-directed CAR T cell therapy, in patients with quadruple-class exposed relapsed and refractory multiple myeloma who had already received a prior BCMA-targeted therapy.

9MW1911 cut severe COPD exacerbations by up to 100% at the highest dose, supporting Mabwell's push toward phase 3 development.

Acepodia's ACE723 delivers 2 cytotoxic payloads to GPC3-positive tumors, clearing FDA review to begin trials in liver cancer.

GSK's up to $1.3 billion deal centers on HUTCHMED's HMPL-A830, which pairs a KRAS inhibitor with an EGFR antibody.