Industry News

New data presented at EHA 2026 showed promising efficacy and manageable safety for Imviva Biotech's investigational allogeneic CAR-T therapy CTD402 in pediatric and adult patients with relapsed or refractory T-cell acute lymphoblastic leukemia and lymphoblastic lymphoma.

Immunome has dosed the first patient in a Phase 1 clinical trial evaluating IM-1617, a potential first-in-class antibody-drug conjugate incorporating the company's proprietary HC74 topoisomerase I inhibitor payload. The study will assess safety and preliminary anti-tumor activity in patients with advanced solid tumors.

Kyowa Kirin will present new clinical and real-world evidence on mogamulizumab at the World Congress of Cutaneous Lymphomas, including patient-reported outcomes, comparative effectiveness analyses, biomarker findings, and treatment utilization data in relapsed or refractory mycosis fungoides and Sézary syndrome.

Sanofi has discontinued the Phase 3 MOBILIZE trial of riliprubart in treatment-refractory chronic inflammatory demyelinating polyneuropathy after an interim analysis found the study was unlikely to demonstrate sufficient efficacy. No new safety concerns were identified, and the company is evaluating the future of other ongoing riliprubart studies.

Eli Lilly reported Phase 3 data showing its oral GLP-1 receptor agonist Foundayo (orforglipron) achieved greater reductions in A1C and body weight than oral semaglutide in the first head-to-head trial of two oral GLP-1 therapies for type 2 diabetes.

City Therapeutics has secured $99.5 million in Series B financing to advance its next-generation RNA interference platform and pipeline, including its Phase 1 Factor XI-targeting candidate for thromboembolic diseases and a planned clinical-stage program for Stargardt disease.

Johnson & Johnson has agreed to acquire Firefly Bio in a $1 billion cash deal, gaining access to the company's Firelink degrader antibody conjugate platform for KRAS-driven cancers. The acquisition strengthens J&J's oncology pipeline and reflects continued industry interest in targeted protein degradation approaches for difficult-to-treat solid tumors.

The FDA has expanded the indication for Pfizer's Hympavzi to include pediatric patients ages 6 to 11 years and people with hemophilia A or B who have inhibitors. The approval makes Hympavzi the first subcutaneous non-factor therapy available for children ages 6 to 11 years with hemophilia B.

A Journal of Pancreatology review underscores renewed interest in TIGIT, but clinical evidence remains mixed across solid tumors.

Teva launches Ahzantive, an EMA-approved aflibercept biosimilar, in select European markets for wet AMD and other retinal diseases.

The FDA has granted Breakthrough Therapy Designation to Biogen's investigational antisense oligonucleotide salanersen for spinal muscular atrophy, supported by Phase 1b data showing motor function improvements and reduced neurodegeneration in children previously treated with gene therapy.

IDefine and UT Southwestern will assess a preclinical EHMT1 gene replacement strategy for Kleefstra syndrome.

Lilly adds Ascidian’s RNA exon-editing platform for rare inherited kidney disease targets in a deal with no disclosed clinical data.

Interim phase 1b/2 data from Tenaya Therapeutics’ MyPEAK-1 study showed TN-201 gene therapy was generally well-tolerated and associated with improvements in cardiac remodeling, symptom burden, and functional measures in patients with MYBPC3-associated hypertrophic cardiomyopathy.¹

Eli Lilly has entered a licensing agreement with Hanmi Pharmaceutical for sonefpeglutide, a long-acting GLP-2 receptor agonist in Phase 2 development for short bowel syndrome. The deal includes $75 million upfront and up to $1.2 billion in milestone payments, plus royalties.

FDA draft guidance outlines how prior scientific knowledge may support gene therapy development for rare and life-threatening diseases.

New research presented by Florida Cancer Specialists & Research Institute found similar safety and quality outcomes for CAR-T cell therapy delivered at accredited and non-accredited centers, suggesting treatment location may play an important role in improving patient access to care.

APAC clinical trials require tailored strategies to manage regulatory, operational, and cultural differences for efficient, high-quality study execution.

Biogen has completed its acquisition of Apellis Pharmaceuticals, adding complement-targeting therapies Empaveli and Syfovre to its portfolio and strengthening the company’s position in nephrology and rare disease therapeutics.

New analyses from Novo Nordisk’s Phase 3 OASIS 4 trial showed that adults taking oral Wegovy achieved substantial weight loss and improved physical mobility, reinforcing the potential of oral semaglutide in obesity management.

Kanvas Biosciences and LTZ Therapeutics raised a combined $86 million to advance novel cancer immunotherapy platforms targeting the microbiome and innate immune system, respectively.

Madrigal licensed Arrowhead's ARO-PNPLA3 to target PNPLA3 I148M-associated metabolic dysfunction–associated steatohepatitis, expanding options beyond approved resmetirom.

New long-term data reported by Eli Lilly and Company show Omvoh achieved sustained disease clearance through four years in ulcerative colitis, highlighting the potential durability of interleukin-23–targeted therapies.

Phase 3 FUZION data showed guselkumab improved fistula remission vs placebo in adults with perianal fistulizing Crohn disease.

The FDA has approved vepdegestrant, the first PROteolysis TArgeting Chimera protein degrader therapy, for estrogen receptor gene-mutated ER+/HER2- advanced breast cancer, offering a new option for patients with endocrine-resistant disease.

UCB’s planned $2.2 billion acquisition of Candid Therapeutics strengthens its immunology pipeline with bispecific T-cell engagers, led by cizutamig, a BCMA/CD3-targeting antibody in early-stage trials for autoimmune diseases.

As the biopharmaceutical industry moves increasingly toward applied AI in GMP manufacturing, emphasizing real-world use, PDA Week 2026 is expected to evolve as it further dives into risk management and data-driven quality decisions.

Survodutide delivers significant Phase III weight loss results, FDA grants RMAT status to Orca-Q, and Ligand expands its portfolio with a $739 million acquisition of XOMA.