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Obesity franchise – Novo’s pill revenue picture
Novo Nordisk’s Q1 results added momentum to its Wegovy pill strategy after the company adjusted its outlook around adjusted sales declines and adjusted operating profit. The update followed an...
Early detection business growth despite endpoint questions
Grail reported Q1 revenue growth of 28% year over year to $40.8 million, driven by continued expansion of its Galleri multi-cancer screening test. Galleri revenue rose 37% to $39.8 million, while...
Clinical trial readout in skin disease
Avalo Therapeutics’ phase 2 trial of abdakibart in hidradenitis suppurativa met the study’s primary endpoint, propelling the company toward registrational work. In a randomized trial of 253 adults...
CAR-T supply and regulatory expansion in South Korea
South Korea’s MFDS approved Curocell’s Rimqarto (anbal-cel), positioning it as the first homegrown CAR T therapy in the country for advanced diffuse large B-cell lymphoma. The approval covers...
Precision oncology testing guidance uptick
Veracyte raised full-year revenue guidance after a strong Q1, citing continued volume growth for key assays. Q1 revenue rose 21% to $139.1 million, with testing revenue increasing 26% to $135.1...
Biotech financing – tool-enabling tech for proteomics and protein sequencing
Pumpkinseed, a Stanford spinout developing silicon chip-based protein sequencing technology, raised $20 million in a Series A round to advance from peptide sequencing toward full-length protein...
Clinical-stage company funding surge – myeloma lead toward registration
CellCentric raised $220 million in a Series D financing to advance its multiple myeloma program through registration and toward potential commercialization. The transatlantic biotech said the cash...
FDA and trial operations – real-time signal sharing pilots
The FDA launched and validated pilots for real-time clinical trials (RTCTs), aiming to shorten the time required for early-phase signal review by enabling endpoint and safety data reporting as...
Big pharma dealmaking in immunology
UCB agreed to acquire Candid Therapeutics for up to $2.2 billion, a deal designed to expand UCB’s portfolio of T-cell engager (TCE) antibodies in autoimmune and inflammatory disease. The...
FDA real-time clinical trial pilots
The FDA is moving to speed up early drug development by piloting real-time clinical trials (RTCTs), where sponsors report endpoint and signal data to the agency as it is generated. The agency says...
Late-breaking clinical efficacy in cardiomyopathy
Cytokinetics said its Phase 3 ACACIA trial hit twin efficacy goals in symptomatic, non-obstructive hypertrophic cardiomyopathy, with Myqorzo (aficamten) improving both patient-reported symptom...
Phase 3 regulatory track for chronic thyroid eye disease
Viridian Therapeutics posted positive Phase 3 top-line results for elegrobart (VRDN-003) in chronic thyroid eye disease, clearing the way for planned regulatory filings. The company said the trial...
Skin inflammation trial results with placebo hurdle
Avalo Therapeutics’ Phase 2 trial in hidradenitis suppurativa (HS) hit its primary endpoint, but the placebo-adjusted result missed the company’s internal bar, a dynamic that still moved the...
Drug discovery platform: AI-enabled diagnostic growth and partnerships
Tempus reported a 36% year-over-year increase in Q1 revenue to $348.1 million and raised full-year guidance, citing acceleration in oncology testing and continued demand for its AI-enabled...
Liquid biopsy and clinical trial collaboration
Labcorp and Fox Chase Cancer Center are collaborating on a clinical trial using the Plasma Detect test for molecular monitoring in non-small cell lung cancer (NSCLC). The study will test patients...
Clinical-stage business development in MASH
Madrigal Pharmaceuticals extended its MASH deal strategy by securing a global licensing arrangement for an Arrowhead Pharmaceuticals asset that targets a genetic driver of metabolic...
AAV gene therapy startup funding and first-in-human trajectory
Latus Bio closed a $97 million Series A to advance an AAV-capsid variant platform for gene therapies, with initial clinical data expected from two lead programs: LTS-201 for Huntington’s disease...
State-of-the-art gene-cell therapies: South Korea CAR-T milestone
South Korea’s MFDS approved Curocell’s Rimqarto (anbal-cel; anbalcabtagene-autoleucel) as the first homegrown CAR T-cell therapy for advanced diffuse large B-cell lymphoma. The authorization marks...
Big pharma M&A for autoimmune T-cell engagers
UCB agreed to acquire Candid Therapeutics for up to $2.2 billion, expanding its presence in T-cell engager (TCE) antibodies for immunology indications. The deal adds Candid’s bispecific and...
Gene therapy market pull-forward amid FDA attention
A conference report from Rome highlighted how FDA decisions are shaping sentiment for the gene therapy and cell therapy sector, even as industry leaders look for opportunities in Europe. The...