Deals, Development and Manufacturing

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

Accelerated approval for dostarlimab-gxly (Jemperli) pairs a single-arm phase 2 dataset with an FDA-authorized biomarker test and confirmatory requirements.

AVT29, a proposed aflibercept biosimilar to Eylea 8 mg, could extend retinal disease treatment intervals to 16 weeks, versus 8 weeks today.

Gilead will develop up to three PRO-XTEN T-cell engagers discovered by Vir Biotechnology for solid tumors in a deal worth up to $1.74 billion.

Rona's ALK7 RNAi candidate, licensed to Roche for up to $1.06 billion in milestones, aims to cut visceral fat while sparing lean mass.

Phase 3 interim data for RYZ101, the lead asset from Bristol Myers Squibb’s $4.1 billion RayzeBio deal, meet the primary endpoint.

Efzimfotase alfa missed significance on the six-minute walk test in adolescents and adults, while the FDA review of the therapy proceeds toward 2027.

Once-weekly amylin analog petrelintide produced up to 9.2% weight loss at 28 weeks in adults with obesity and type 2 diabetes, Zealand Pharma reports.

Tecentriq plus chemotherapy gains FDA approval for stage III dMMR colon cancer after a phase 3 trial showed improved disease-free survival.

Series A led by Oxford Science Enterprises and up to $20 million in public funding will move cell-based mRNA production toward clinical-grade scale.

Rocket’s modified protocol keeps the first three patients in a 12-patient efficacy population, with topline Danon disease data expected in mid-2028.

Celltrion USA's Omlyclo, the first interchangeable biosimilar to Xolair, reaches the U.S. market across four allergic and inflammatory indications.

Alvotech turns to a CDMO's 40,000-liter Syracuse facility for biosimilar drug substance as it expands its manufacturing network.

Topline phase 3 data show epcoritamab plus R-CHOP reduced the risk of progression or death by 51% in newly diagnosed diffuse large B-cell lymphoma.

Part 2 of the VK2735 maintenance study tests whether daily or weekly oral tablets can hold weight loss first achieved with weekly subcutaneous injections.

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.

Litifilimab extended skin responses through 52 weeks in phase 2 AMETHYST data in cutaneous lupus erythematosus, with phase 3 results expected in 2027.

The glucagon/GLP-1 dual agonist hit both weight loss endpoints in phase 3, though gastrointestinal discontinuations and competitor data temper the readout.

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

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

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

Genentech is paying Earendil Labs $55 million upfront in a deal worth over $1.5 billion to develop bispecific antibodies for hard-to-treat cancers.

InnoCare will discover compounds against up to 5 targets for Lilly, backing a deal worth up to $3.35 billion in milestones.

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