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Phase 2 failure: Intercept’s next-gen FXR agonist stumbles
Intercept Pharmaceuticals reported that its next-generation FXR agonist, INT-787, failed to show clear potential in a Phase 2 study, marking another setback for the Italian-owned...
Big pharma M&A: UCB to acquire Candid for up to $2.2B
UCB agreed to buy bispecific T-cell engager maker Candid Therapeutics in a deal valued at $2.2 billion, betting on autoimmune “immune reset” therapies and China-sourced assets. Under the terms...
Cell therapy: MFDS approves first homegrown CAR T in South Korea
South Korea’s MFDS approved Curocell’s Rimqarto (anbal-cel) as the first homegrown CAR T-cell therapy for patients with advanced diffuse large B-cell lymphoma. The approval, announced April 29,...
Biotech layoffs: BioNTech to shrink manufacturing footprint
BioNTech said it will scale down manufacturing and that up to 1,860 manufacturing staff could be affected by its planned downsizing, according to its first-quarter earnings release. The move...
Phase 3 update: Viridian’s elegrobart beats in chronic thyroid eye disease
Viridian Therapeutics reported positive top-line results from its Phase 3 Reveal-2 study of elegrobart in chronic thyroid eye disease, driving a sharp stock move and setting up a planned BLA...
Trial design/regulatory friction: Passage cuts 75% after FDA requires randomized design
Passage Bio disclosed it will cut about 75% of its workforce after the FDA rejected its planned registrational trial design for its lead gene therapy candidate PBFT02 in frontotemporal dementia...
Diagnostic/Med-tech regulation: Applied BioCode gets expanded FDA clearance with Thermo automation
Applied BioCode secured expanded FDA 510(k) clearance for its BioCode Respiratory Pathogen Panel, adding automated extraction using Thermo Fisher Scientific’s KingFisher Flex platform. The cleared...
Diagnostics demand and guidance: Biodesix lifts full-year outlook after Q1 growth
Biodesix reported a 42% year-over-year jump in Q1 2026 revenue and raised its full-year revenue guidance, citing increased diagnostic testing volume and improving economics. In the quarter ended...
Regulatory modernization at FDA
The FDA has begun piloting real-time clinical trials (RTCTs) designed to speed early-phase decision-making by allowing sponsors to report safety and endpoint signals as data are generated. The...
Big pharma deal spree in autoimmune T cell engagers
UCB agreed to buy Candid Therapeutics for $2 billion up front, adding two clinical-stage bispecific T-cell engager programs to its autoimmune pipeline, including the lead BCMA/CD3 asset cizutamig...
Phase 3 momentum for thyroid eye disease rivals
Viridian Therapeutics’ elegrobart scored another Phase 3 win in chronic thyroid eye disease, rebuilding investor confidence after earlier results disappointed. Analysts framed the new data as more...
Clinical efficacy setback reshapes Pfizer’s Trillium CD47/TCE strategy
Pfizer ended the remaining clinical development tied to its $2.3 billion Trillium Therapeutics acquisition, scrapping the second and final clinical-stage candidate linked to the CD47 blocker and...
Oncology dealmaking option for trispecific HH-160
Beone Medicines secured an exclusive worldwide option to develop Huahui Health’s trispecific antibody HH-160 in a deal potentially worth more than $2 billion. The arrangement gives Beone global...
New CAR T milestone in South Korea
South Korea’s MFDS approved Curocell’s Rimqarto (anbal-cel), positioning it as the first homegrown CAR T-cell therapy for advanced diffuse large B-cell lymphoma. The approval marks a manufacturing...
Diagnostics: Applied BioCode wins expanded 510(k) clearance for automated respiratory testing
Applied BioCode received expanded FDA 510(k) clearance for its BioCode Respiratory Pathogen Panel, adding automated extraction using Thermo Fisher Scientific’s KingFisher Flex platform. The...
Fundraising for next-generation T-cell engager startup
Cytospire Therapeutics raised £61 million (about $83 million) in a Series A to advance its pan gamma-delta T-cell engager platform toward clinical proof-of-concept. The company’s lead program, CYT...
Company restructuring after FDA trial design feedback
Passage Bio disclosed a strategic review alongside layoffs after FDA feedback shifted the design requirements for its lead gene therapy in frontotemporal dementia with granulin mutations....
Take-private style gene therapy pipeline funding in rare disease
Latus Bio closed a $97 million Series A to fund its AAV capsid-variant platform, with initial clinical work expected to start across Huntington’s disease (LTS-201) and late-infantile neuronal...
Biotech dealmaking in autoimmune immunology
UCB is accelerating its immunology expansion by agreeing to buy Candid Therapeutics in a deal valued at $2 billion up front, with up to $200 million in additional milestone payments. The...
FDA modernization for faster clinical reads
The FDA launched pilot efforts for real-time clinical trials (RTCTs) designed to compress early-phase timelines by sharing endpoint and safety signals as they are generated. The agency said it...