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AbbVie adds IL-13 antibody bet via $10.9B Apogee acquisition
AbbVie agreed to acquire Apogee Therapeutics for $10.9 billion in cash, betting on zumilokibart (APG777), a long-acting monoclonal antibody targeting IL-13. The deal values Apogee at $135.11 per...
Pfizer’s Seagen-era lung cancer ADC misses Phase 3 OS endpoint
Pfizer’s first ADC flowing from its 2023 Seagen acquisition, sigvotatug vedotin (SV), failed to reach statistical significance on overall survival in a Phase 3 non-small-cell lung cancer (NSCLC)...
FDA speeds early trials under Operation Trailblazer
The U.S. Department of Health and Human Services launched Operation Trailblazer, a department-wide strategy aimed at making early-stage prescription drug development faster. The blueprint focuses...
Regenxbio gene therapy cleared for FDA reconsideration after reversal
The FDA said it would reconsider Regenxbio’s Hunter syndrome gene therapy (RGX-121) after rejecting the application earlier this year. Regenxbio said the agency acknowledged existing clinical data...
Successes and setbacks in solid-tumor CAR-T and related approvals
As CAR-T moves into solid tumors, regulators are also shaping how developers validate targets and efficacy. The Carsgen satri-cel approval places Claudin18.2 CAR T into a new category of...
Biotech governance pressure grows with 340B dispute
Eli Lilly moved to withhold 340B discounts from hospitals that did not comply with new paperwork requirements, triggering backlash from hospital groups and appeals for federal oversight. Multiple...
Osanni Bio launches $190M Series B to build ophthalmology and cardiology pipeline
Osanni Bio raised $190 million in a Series B to build a portfolio focused on ophthalmology and cardiology. The San Francisco biotech is pursuing a structure that creates “affiliate companies” to...
Ladder Health raises $7M for virtual-first pediatric therapy model
Ladder Health raised $7 million in seed funding to expand a virtual-first pediatric therapy model. The round was led by Nina Capital with participation from multiple venture and health-focused...
Dealmaking momentum: K2 Therapeutics licenses Antengene bispecific TCEs for $2B
K2 Therapeutics acquired ex-China rights to two preclinical Antengene bispecific T-cell engager (TCE) assets through a license and option agreement. The package is valued at $980.5 million each,...
US pushes faster early-stage clinical development
The U.S. Department of Health and Human Services unveiled a blueprint to speed and streamline early clinical development, targeting first-in-human timelines of 6–12 months shorter. The package...
FDA approval cadence stays hot in May 2026
The U.S. FDA approved 24 drugs in May 2026, making it the busiest month of the year so far and lifting year-to-date approvals to 84. Of the 24 clearances, 20 were new molecular entities, according...
AbbVie’s $10.9B move for Apogee expands long-acting immunology franchise
AbbVie agreed to acquire Apogee Therapeutics for about $10.9B, targeting the atopic dermatitis drug candidate zumilokibart (APG777) as a potential long-acting immunology product with broader...
Pfizer ADC fails Phase 3 in NSCLC after Seagen acquisition
Pfizer’s first new antibody-drug conjugate (ADC) to report pivotal Phase 3 results after the Seagen acquisition missed its primary endpoint in non-small-cell lung cancer. The ADC, sigvotatug...
China approves first CAR T for solid tumors, satri-cel
China’s NMPA approved Carsgen Therapeutics’ satricabtagene autoleucel (satri-cel, CT-041), marking the first global approval of a CAR T therapy for solid tumors. The Claudin18.2-targeted,...
Regulators allow Regenxbio to reconsider Hunter syndrome gene therapy
Regenxbio said the FDA will reconsider its Hunter syndrome gene therapy after the agency reversed course following rejection. The company plans to resubmit its application for RGX-121, with...
Denali sells priority review voucher for neurodegeneration pipeline funding
Denali Therapeutics sold a priority review voucher for $195 million to support its neurodegenerative and lysosomal pipeline. The voucher was issued after FDA approval of Avlayah for Hunter...
Osanni Bio raises $190M to build ophthalmology and cardiology affiliate pipeline
Osanni Bio raised $190 million in a Series B to build ophthalmology- and cardiology-focused “affiliate companies,” designed to expand clinical and translational efforts across multiple programs....
VectorBuilder and MaxCyte partner on next-gen nonviral gene delivery for ex vivo cell therapy
VectorBuilder and MaxCyte formed a strategic partnership to co-develop a clinical-grade, next-generation nonviral gene delivery system for ex vivo cell engineering. The collaboration combines...
RNA gene-editing startup Serapha Bio launches with $230M and Chinese licensing
Serapha Bio launched after completing a reverse merger and raising $230 million in funding commitments, anchored by RA Capital and RTW Investments. The new company is building an in vivo base...
Regulatory and compliance actions
HHS unveiled a blueprint to speed up early-stage drug development, targeting first-in-human timelines by reducing documentation burden for Investigational New Drug (IND) applications and creating...