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FDA manufacturing setback delays Grace Therapeutics’ aneurysmal SAH NDA
Grace Therapeutics said the FDA issued a complete response letter for its GTx-104 NDA, delaying a potential update to care for aneurysmal subarachnoid hemorrhage. The agency’s concerns were...
UCB expands neuro pipeline with Neurona acquisition
UCB has agreed to acquire Neurona Therapeutics for up to $1.15 billion, positioning the epilepsy specialist’s lead asset NRTX-1001 as a core addition to UCB’s neurology growth strategy. The deal...
Inventiva reshapes leadership ahead of MASH Phase III readout
Inventiva has added three executives to its C-suite as it prepares for a Phase III readout in 4Q26 for lanifibranor in metabolic dysfunction-associated steatohepatitis. The leadership changes...
Epigenetics and gene regulation in diabetes enter a cell-specific era
Researchers reported in Nature Metabolism that cell-specific DNA methylation programs help drive gene expression differences between pancreatic alpha and beta cells across the lifespan and in type...
Neutrophil engineering for glioma cell therapy
Researchers reported advances in in vivo CAR-neutrophil engineering aimed at glioma treatment, tackling a longstanding hurdle in cell-based therapies: direct genetic programming of neutrophils....
CAR-T platform market shakeup and public equity volatility around cash moves
Public markets tracked continued valuation adjustments and pipeline re-rating as investors assessed new data and deal timing. In the same coverage cycle, Lilly’s activity and broader pharma moves...
Neonatal transport quality improvement targets time-to-specialty care
A quality improvement initiative in neonatal critical care was reported to optimize safe, rapid transport of critically ill newborns to specialty centers. In the analysis published in Pediatric...
Smart monitoring for aortic stenosis in REACH trial
A new smart finger-cuff algorithm showed high accuracy for detecting moderate-to-severe aortic stenosis among African American patients in the REACH trial. Results were presented at the SCAI 2026...
Multiple sclerosis regulatory path in Europe after FDA CRL
Sanofi’s tolebrutinib (branded Cenrifki) cleared another regulatory hurdle as the European Medicines Agency’s CHMP issued a positive opinion for approval in a defined non-relapsing secondary...
Aneurysmal subarachnoid hemorrhage NDA setback
Grace Therapeutics’ bid to update the standard of care in aneurysmal subarachnoid hemorrhage hit a regulatory roadblock after the FDA issued a complete response letter for GTx-104. The agency...
Neuro M&A: UCB buys Neurona Therapeutics
UCB moved deeper into epilepsy with its latest acquisition, paying up to $1.15 billion for Neurona Therapeutics. The deal includes a $650 million upfront payment and additional milestone tranches,...
Cardiovascular AI screening tool for aortic stenosis
A new smart-finger cuff algorithm reported high accuracy for detecting moderate-to-severe aortic stenosis in an at-risk subgroup of African American patients. The REACH trial results were...
Retinal gene therapy financing for late-stage progression
Ray Therapeutics raised a $125 million Series B to advance its retinal gene therapy program RTx-015 for retinitis pigmentosa. The financing is intended to fund late-stage clinical development and...
Biotech venture funding: seed round for inflammation-associated anemia
Ferrosa Therapeutics secured $3.5 million in seed funding for FRS-101, a first-in-class bispecific antibody program intended for anemia of inflammation. The company is targeting multiple areas...
Synthetic control arms reframe clinical trial design
A new innovation spotlight highlighted synthetic control arms as an alternative to traditional placebo-heavy trial designs, using external datasets to estimate counterfactual outcomes. The...
C-suite expansion ahead of lanifibranor Phase III readout
Inventiva reshuffled its leadership team as it prepares for a Phase III readout for lanifibranor in metabolic dysfunction-associated steatohepatitis (MASH) targeted for 4Q26. The company named a...
Tempus and USC expand precision medicine alliance
Tempus AI signed an agreement with the University of Southern California to deploy molecular diagnostics and comprehensive genomic profiling for clinical precision medicine use across USC’s Keck...
Seed science: glioma CAR-neutrophils developed
Researchers reported progress toward in vivo CAR-neutrophil engineering as a potential new modality for glioma treatment. The approach centers on direct genetic programming of neutrophils—an area...
EU greenlights Sanofi tolebrutinib for secondary progressive MS after FDA rejection
The European Medicines Agency’s CHMP has recommended approval of Sanofi’s BTK inhibitor Cenrifki (tolebrutinib) for a targeted subgroup of patients with non-relapsing secondary progressive...
FDA priority vouchers accelerate psychedelic drug review for depression and PTSD
The FDA has issued priority review vouchers tied to three psychedelic programs, as part of the Trump administration’s push to expand access to mental health treatments. The agency’s announcement...