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From a single lupus patient in Erlangen to pediatric trials in Rome, allogeneic programs at Allogene, and dual-targeted CD19/CD70 designs — CAR-T cell therapy is rewriting autoimmune medicine. We map the landscape: which diseases, which constructs, and who's winning the race to scale.
In a novel approach, the FDA approves re-dosing a CAR-T cell therapy in ovarian cancer after initial tumor inflammation showed signs of immune engagement. A potential paradigm shift for solid tumor cell therapy.
Lilly bets on next-generation dual-payload ADCs with the acquisition of CrossBridge Bio, whose CBB-120 platform delivers two cytotoxic agents per antibody for potentially superior tumor killing.
MIT's open-weight model matches AlphaFold3 on protein-ligand complexes while running on a single GPU. For computational chemistry teams, the implications for hit-to-lead timelines are significant — and immediate.
The antibody-drug conjugate market has grown from $16B in 2025 to over $20B in 2026, fueled by Gilead's $5B Tubulis acquisition and Lilly's CrossBridge Bio deal. A deep dive into next-gen linker-payload chemistry, dual-payload designs, and which tumor types remain white space.
With ophthalmologist Dr. Houman Hemmati emerging as frontrunner to lead the Center for Biologics Evaluation and Research, the FDA faces a credibility test. Prasad's departure leaves unfinished business: vaccine policy rewrites, accelerated approval reforms, and a demoralized biologics review staff.
The AI-designed PI3Kα inhibitor shows durable responses in HR+/HER2- breast cancer with mutant-selective specificity. A landmark for computationally designed oncology drugs.
The American College of Cardiology publishes its 2026 scientific statement on gene editing therapy for cardiovascular disease, covering CRISPR-based approaches to PCSK9, TTR amyloidosis, and hypertrophic cardiomyopathy. A formal signal that cardiology's regulatory framework is catching up to the science.
Intellia places its CRISPR gene editing therapy nex-z on partial clinical hold following a serious liver adverse event, raising questions about in vivo LNP-delivered editing safety at scale. Over 450 patients had been dosed across MAGNITUDE trials.
Clinical-stage Kailera aims to raise up to $533M on Nasdaq (ticker: KLRA), backed by four GLP-1-based candidates including a once-weekly injectable in Phase 3. The first obesity biotech IPO since Pfizer acquired Metsera for $10B signals renewed investor appetite for the $150B weight-loss market.
Guardant Health's liquid biopsy test wins CDx approval for encorafenib in BRAF V600E-mutant metastatic colorectal cancer, expanding the utility of blood-based genomic profiling across cancer types.
The largest Series B in AI pharma history signals growing conviction that foundation models can compress timelines from target to IND.
A systematic review finds six published trials of GLP-1 therapies in Parkinson's disease, with lixisenatide's LIXIPARK trial showing superiority over placebo on motor endpoints. The data fuels a growing hypothesis that incretin-based drugs may slow neurodegeneration — not just metabolic disease.
A 50/50 partnership worth up to $4.3B pairs Regeneron's antibody discovery platform with Telix's radiopharmaceutical manufacturing and global supply chain. The deal signals that biologics giants see targeted radiotherapy as the next frontier in oncology.
Clarivate highlights orforglipron (oral GLP-1) and retatrutide (GLP-1/GIP/glucagon triple agonist) as defining candidates in an obesity market projected to reach $150B by 2035. The peptide revolution accelerates.
In a landmark deal structure for AI drug discovery, Lilly commits a mid-eight-figure annual license fee to Chai Discovery for access to its biologics design foundation model. Separately, GSK pays $50M upfront to NOETIK for its oncology model. The era of AI-as-infrastructure-for-pharma is here.
Targeted protein degradation meets deep learning. Where the biology is ready, where the data is not, and what it means for drug programs targeting tau and alpha-synuclein.
The updated diffusion model achieves 58% top-1 success rate on PoseBusters, narrowing the gap with physics-based methods while maintaining speed advantages.
An industry-wide analysis finds AI-first drug candidates are achieving Phase I success rates roughly double the historical 50% average. With fewer than 15 AI-first candidates completing Phase II and none yet FDA-approved, 2026 becomes the year the hype meets definitive clinical validation.
The collaboration aims to run millisecond-scale MD simulations for thousands of compounds simultaneously, a potential inflection point for free energy perturbation workflows.
A new training framework for multimodal AI shows that domain-specific foundation models outperform general-purpose models by an order of magnitude on key drug discovery tasks. General LLMs fell short on approximately half the tested benchmarks, reinforcing that biology needs purpose-built models.
The GENESIS-IPF trial delivers the first clinical proof-of-concept for a fully AI-discovered drug: rentosertib, a TNIK inhibitor designed by Insilico Medicine's Chemistry42 platform, demonstrates dose-dependent FVC improvement in idiopathic pulmonary fibrosis patients. Phase IIb is underway.
The first lupus patient treated with CD19 CAR-T cells in 2021 at University Hospital Erlangen remains in complete remission. Across expanding trials, most of dozens of patients have sustained drug-free responses, validating a paradigm shift from chronic immunosuppression to one-time cellular reset.
A mid-stage biotech credits the open-source ADMET prediction tool with flagging a metabolic liability that traditional assays missed until later stages.
Two years after the legislation allowing non-animal testing methods, microphysiology systems are seeing real adoption in IND-enabling studies. Three pharma companies report replacing animal tox studies with organ chips.
A March 2026 surge saw seven billion-dollar-plus acquisitions in under two weeks, from Gilead-Tubulis to Biogen-Apellis. Analysts project total 2026 deal volume could reach $172B, surpassing the $111B spent across 32 deals in 2025.
Gilead enters a definitive agreement to acquire German biotech Tubulis for $3.15B upfront plus $1.85B in milestones. The deal adds best-in-class ADC linker-payload technology and creates a dedicated Munich R&D hub as the ADC sector surpasses $20B.
Protein folding benchmarks shift again, two more AI-native biotechs enter the clinic, and why retrosynthesis models still struggle with stereochemistry.
The synthetic biology platform expands its pharmaceutical footprint, applying its cell programming platform to optimize CHO cell lines for biologics manufacturing and engineer microbial strains for complex natural product synthesis.
TerraPower Isotopes' $450M Ac-225 production facility targets the critical bottleneck constraining alpha-emitting radiopharmaceutical development. We map the isotope supply chain, the physics of alpha vs beta emitters, and which clinical programs are supply-gated.
The RNA interference pioneer reports positive topline data for its Lp(a)-targeting siRNA in cardiovascular disease, validating oligonucleotide approaches beyond rare disease and into large patient populations.
Ultragenyx submits its BLA for DTX401, an AAV8-delivered gene therapy expressing the human G6PC gene for glycogen storage disease type Ia. The submission marks another rare disease gene therapy approaching the FDA finish line in a crowded 2026 regulatory calendar.
The first CRISPR-based therapy, Casgevy for sickle cell disease and beta-thalassemia, is now approved in the US, EU, UK, Canada, and six additional countries. Real-world data confirms durable transfusion independence.
The FDA issues draft guidance acknowledging AI-generated synthetic control arms as acceptable in certain clinical trial contexts, potentially reducing trial sizes by 20-30% and accelerating rare disease drug development.
Biogen's tender offer for Apellis Pharmaceuticals adds Empaveli and Syfovre (combined ~$689M 2025 revenue) and a nephrology pipeline, diversifying beyond its slowing MS franchise. The deal signals complement-pathway biology is now worth blockbuster acquisition prices.
The longest-surviving pig-to-human kidney transplant patient crosses the 12-month milestone with stable graft function, powered by 69 genetic edits that removed pig antigens and added human immune genes.
An innovative CAR-T therapy targeting T-cell cancers — historically difficult because CAR-T cells attack each other — receives Breakthrough Therapy designation, opening a new frontier in cell therapy.
The personalized mRNA cancer vaccine mRNA-4157 combined with Keytruda continues to show improved recurrence-free survival in high-risk melanoma. mRNA oncology is no longer theoretical.
Phase 1 data for ARV-102 shows meaningful target engagement in cerebrospinal fluid after 28 days, marking the first clinical proof-of-concept for protein degradation in neurodegenerative disease.
The Gates-backed nuclear isotope venture plans a dedicated Ac-225 facility, addressing the critical supply bottleneck that has constrained next-generation alpha-emitting radiopharmaceutical development.