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UCB launches $2.2B TCE push with Candid buyout
UCB agreed to acquire Candid Therapeutics for up to $2.2 billion to expand its footprint in T-cell engager (TCE) antibodies for immunology, adding Candid’s bispecific and trispecific...
Tempus AI revenue and partnerships accelerate precision oncology diagnostics
Tempus AI reported a 36% year-over-year increase in Q1 revenue to $348.1 million and raised its full-year revenue guidance, citing accelerating demand for its AI-driven diagnostic...
Veracyte raises guidance as Decipher and Afirma volume growth outpaces expectations
Veracyte reported Q1 revenue of $139.1 million, up 21% year over year, and raised full-year revenue guidance after Decipher prostate and Afirma thyroid product volumes grew faster than...
Cytokinetics’ aficamten hits twin Phase 3 endpoints in non-obstructive HCM
Cytokinetics said its aficamten (Myqorzo) met both Phase 3 co-primary endpoints in symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM) in the pivotal ACACIA program. According to the...
Viridian’s elegrobart delivers another Phase 3 win and sets up 2027 filing
Viridian Therapeutics reported that its Phase 3 trial Reveal-2 met both primary endpoints for elegrobart in chronic thyroid eye disease (TED), lifting the stock as the company moves toward...
Windward Bio lands $165M for Phase 3 asthma push of long-acting anti-TSLP
Windward Bio secured a $165 million financing to advance a long-acting anti-TSLP antibody into Phase 3 development for asthma. The Swiss biotech said the capital supports late-stage progress for a...
U.S. FDA pilots real-time clinical trials to speed early signal review
The FDA said it is piloting real-time clinical trials (RTCTs), a model in which sponsors report endpoint data as it is generated to speed assessment of safety signals and early efficacy. In...
MFDS approves Rimqarto as first South Korea homegrown CAR T for DLBCL
South Korea’s Ministry of Food and Drug Safety (MFDS) approved Curocell Inc.’s Rimqarto (anbalcabtagene-autoleucel; anbal-cel) for advanced diffuse large B-cell lymphoma, marking the first...
Sonire starts U.S. trial for ultrasound-guided HIFU system targeting pancreatic tumors
Sonire Therapeutics started a U.S.-based Sunrise II study of Suizenji, its ultrasound-guided high-intensity focused ultrasound (HIFU) system designed to ablate pancreatic tumors. The company...
Passage Bio launches strategic review after FDA trial design feedback and layoffs
Passage Bio said it is launching a strategic review and reducing headcount by about 75% after the FDA did not support a single-arm registrational trial design for its lead program in...
Regulatory real-time clinical trials pilot
The FDA moved to speed early drug development by piloting real-time clinical trials (RTCTs), where sponsors report safety and endpoint signals to the agency as data are generated. The agency...
Company licensing: Madrigal adds Arrowhead siRNA to MASH combo plan
Madrigal Pharmaceuticals expanded its metabolic dysfunction-associated steatohepatitis (MASH) combination strategy by licensing an Arrowhead Pharmaceuticals small-interfering RNA therapy tied to a...
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...