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ALS precision medicine milestone
Otsuka Pharmaceutical and Ionis Pharmaceuticals reported positive Phase III results for ulefnersen in the Fusion study for FUS-associated amyotrophic lateral sclerosis, a rare ALS subtype with no...
Obesity pipeline intensifies with China-sourced innovation
Novo Nordisk struck a discovery-to-milestone deal with Hengrui Pharma for HRS-1596, a dual GLP-1/GIP receptor agonist intended for once-weekly, oral dosing. Under the terms, Novo will pay $300...
Merck expands KRAS G12D bets via SciBrunch
Merck & Co. closed an exclusive global licensing deal with Scibrunch Therapeutics for SPR-2015, a preclinical oral KRAS G12D(on) inhibitor, with total deal value up to $2.13 billion. The...
AstraZeneca takes equity stake and adds clinical collaboration with Summit
AstraZeneca committed $2 billion into Summit Therapeutics via a convertible preferred stock purchase, gaining exposure to Summit’s PD-1/VEGF bispecific ivonescimab. The investment corresponds to a...
Gene therapy durability under scrutiny in Huntington’s
UniQure’s Huntington’s disease gene therapy AMT-130 continued to show disease-slowing effects at the four-year follow-up, but the company disclosed that the magnitude of benefit has waned versus...
Regulatory setbacks hit B7-H3 ADC in small-cell lung cancer
Daiichi Sankyo and Merck voluntarily withdrew their BLA for ifinatamab deruxtecan (i-dxd) in extensive-stage small-cell lung cancer after progressing on or after platinum chemotherapy. The...
Ophthalmology Phase III breakthrough for Kodiak’s wet AMD franchise
Kodiak Sciences announced that its Phase III programs for Zenkuda (tarcocimab tedromer) met primary endpoints in wet age-related macular degeneration versus Regeneron’s Eylea, using individualized...
FDA adds a new Parkinson’s pill option
The U.S. FDA approved AbbVie’s oral Parkinson’s disease therapy Juvmo (tavapadon), a selective D1/D5 receptor agonist with partial agonist activity at D1/D4. AbbVie positioned the drug as a...
Clinical evidence focus: EMA weighs in on “one pivotal study” debate
In an editorial, the European Medicines Agency argued that regulators and sponsors should prioritize generating robust evidence rather than adhering to a fixed trial count standard. EMA executive...
New capital for immune reprogramming in Tregs
Regcell raised $66 million in new financing along with Japanese government support to move its Nobel-linked regulatory T-cell platform toward the clinic. The company’s approach centers on...
AstraZeneca expands Summit’s PD-1/VEGF platform with $2B equity investment
AstraZeneca agreed to invest $2 billion in Summit Therapeutics, taking equity and scaling Summit’s PD-1xVEGF bispecific program around ivonescimab. The companies will begin by testing ivonescimab...
Novo licenses weekly oral GLP-1/GIP weight-loss drug candidate from Hengrui
Novo Nordisk will pay $300 million upfront to license a preclinical weekly oral GLP-1/GIP receptor agonist from China’s Hengrui Pharma. The licensed asset is designed for once-weekly dosing and is...
Kodiak’s Phase 3 dual readouts propel wet AMD drugs toward potential FDA submission
Kodiak Sciences reported Phase 3 success in wet age-related macular degeneration, with tarcocimab tedromer (Zenkuda) demonstrating statistical equivalence to Regeneron’s Eylea and tabirafusp alfa...
FDA backs AnaCardio’s heart failure drug runway after $70.9M Series B
AnaCardio raised €62.5 million (about $70.9 million) in a Series B to advance its chronic advanced heart failure program toward registrational development. The Stockholm-based biotech said the...
Mirum delivers Phase 3 HDV and secures additional regulatory progress via Atebrioz and brelovitug
Mirum Pharmaceuticals announced U.S. FDA approval of its once-daily oral ALK2 inhibitor Atebrioz (zilurgisertib) for fibrodysplasia ossificans progressiva and followed with positive Phase 3...
AbbVie’s Juvmo wins FDA approval as a new oral Parkinson’s option
The FDA approved AbbVie’s Juvmo (tavapadon), an oral selective D1/D5 receptor agonist, as a new Parkinson’s disease treatment option. Juvmo is described as first-in-class for its receptor...
Merck expands KRAS G12D business with $2.13B SciBrunch license
Merck closed an exclusive global license deal with SciBrunch Therapeutics for an undisclosed preclinical oral KRAS G12D inhibitor candidate. The agreement includes $400 million upfront and total...
Egetis gets FDA approval for tiratricol in rare X-linked genetic disease
Egetis Therapeutics received FDA approval for Emcitate (tiratricol) for patients with a rare X-linked genetic disease associated with reduced life expectancy to around age 35. The approval...
Veeva launches Claude-powered AI agent to accelerate clinical trial study configuration
Veeva Systems unveiled a new AI agent, Study Builder, aimed at speeding up clinical trial study configuration for sponsors using Veeva EDC and Data Quality System. The tool ingests trial protocols...
Adicet shows remission signals in off-the-shelf CAR-T for lupus
Adicet Bio reported early human data for its off-the-shelf CAR-T program prula-cel in lupus, showing that the therapy drove complete kidney responses in evaluable lupus nephritis patients and that...