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AbbVie’s $10.9B immunology expansion via Apogee
AbbVie agreed to acquire Apogee Therapeutics for about $10.9 billion, adding late-stage IL-13 candidate zumilokibart (APG777) to its immunology pipeline. The deal values Apogee at $135.11 per...
Eye disease funding surge—Ollin’s $330M for Phase 3 Vabysmo challenger
Ollin Biosciences raised $330 million in a Series B as it prepares for Phase 3 trials of its Vabysmo challenger licensed from a China-based developer. The funding is designed to support pivotal...
Gene therapy regulatory reversal—Regenxbio resubmits for Hunter syndrome
Regenxbio said the FDA has reversed course on parts of its rejection of the company’s Hunter syndrome gene therapy Navsunli (RGX-121). After earlier concerns over eligibility criteria and the need...
Diagnostic approvals and clinical adoption—Natera MRD guidance in Japan and NCCN
Natera won Japan approval for its Signatera colorectal cancer MRD test in the neoadjuvant setting, backed by position statements from the Japan Society of Clinical Oncology and Japan Society of...
Genomic editing shake-up—Sangamo files for Chapter 11 and sells key platforms
Sangamo Therapeutics filed for Chapter 11 bankruptcy and moved to sell major parts of its technology portfolio. In asset-sale agreements, Eli Lilly is set to acquire Sangamo’s capsid delivery...
Waters and IMU team up on AI-driven immune profiling workflows
Waters and IMU Biosciences announced a strategic partnership to develop IMU’s AI-powered immune profiling platform using Waters’ flow cytometry and single-cell analysis technologies. The...
Big platform and lab automation deals—AI infrastructure meets execution
Medra launched AI Experimentalist, a reasoning layer for its physical AI drug discovery robotics platform, in a collaboration with DARPA. The system translates natural-language research goals into...
Insilico and SK Biopharmaceuticals expand AI CNS drug discovery deal
SK Biopharmaceuticals signed an AI-driven collaboration with Insilico Medicine valued at more than $2.5 billion to accelerate neuroimmune disorder drug discovery in the CNS. The milestone-heavy...
Clinical trial failure—Cynata’s Cymerus misses endpoints
Cynata Therapeutics said neither of its pivotal Cymerus stem cell platform trials met primary endpoints in osteoarthritis and graft-versus-host disease (GVHD). CEO Kilian Kelly told investors the...
Large pharma dealmaking: Lilly expands discovery pact with Abbisko
Eli Lilly has signed a new drug discovery collaboration with Abbisko Therapeutics, building on an earlier pact from 2022, with potential payments to Abbisko of up to $1.9 billion. The companies’...
Crossing key delivery barriers: BioArctic and Lilly join BrainTransporter with a new program
BioArctic announced it has signed an $800 million research and collaboration agreement with Eli Lilly aimed at improving brain delivery. The deal combines BioArctic’s BrainTransporter technology...
Big pharma acquisition: AbbVie buys Apogee Therapeutics in a $10.9B immunology move
AbbVie agreed to acquire Apogee Therapeutics for about $10.9 billion, adding long-acting immunology assets to bolster its inflammatory disease portfolio. Apogee’s lead program, zumilokibart...
China regulatory milestone: first CAR T approval for solid tumors
China’s National Medical Products Administration approved Carsgen Therapeutics’ satricabtagene autoleucel (satri-cel, CT-041), marking the first global approval of a CAR T therapy for solid...
US clinical development speed: HHS/ FDA move to streamline early trials
The U.S. Department of Health and Human Services unveiled a plan to speed up early-stage drug development, including a push to reduce the timeline to first-in-human testing by 6 to 12 months. The...
Regulatory/clinical reversals: FDA agrees to accept Regenxbio resubmission path for Hunter gene therapy
Regenxbio said the FDA has reversed course on key requirements for its Hunter syndrome gene therapy (RGX-121, Navsunli) after a prior rejection. The company plans to resubmit in the third quarter...
Pivotal oncology failure: Pfizer ADC misses overall survival in Phase 3 NSCLC
Pfizer’s first pivotal readout for sigvotatug vedotin (SV, an antibody-drug conjugate acquired via Seagen) missed the overall survival primary endpoint in its Phase 3 SigVie-002 trial in advanced,...
Clinical trial disappointment for stem-cell platform: Cynata’s Cymerus fails pivotal endpoints
Cynata Therapeutics reported that neither of its pivotal Cymerus stem-cell platform trials met primary endpoints, with no statistically significant differences versus control on key efficacy...
Gene editing industry reset: Sangamo files for Chapter 11 and lines up asset sales to Lilly and Astellas
Sangamo Therapeutics filed for Chapter 11 bankruptcy protection and agreed to sell major parts of its gene editing platforms and select programs through two stalking-horse asset sale agreements....
Clinical diagnostics + guidelines: Natera Signatera MRD endorsed in NCCN bladder cancer
The National Comprehensive Cancer Network released updated bladder cancer guidelines that include Natera’s Signatera minimal residual disease (MRD) test for muscle-invasive disease after...
CAR T expands into solid tumors in China
China’s National Medical Products Administration (NMPA) has approved Carsgen Therapeutics’ satricabtagene autoleucel (satri-cel, CT-041), the first CAR T cleared globally for solid tumors. The...