Deramiocel gets three more months at FDA as Capricor shifts Duchenne approval case to arm function
FDA extends deramiocel review to November 22 as Capricor submits new HOPE-3 data supporting an upper limb function indication in Duchenne.
Pharma & Biotech
Pharma & Biotech
ACTG repurposes osteoporosis drug alendronate in 30-person trial targeting the hidden HIV reservoir
STAIR-HIV will randomize 30 virally suppressed adults to weekly alendronate or placebo, testing whether a familiar osteoporosis medicine can perturb persistent HIV reservoirs despite continued ART.
Pharma & Biotech
Ipsen closes up to $1.75bn Kartos deal as navtemadlin enters its decisive Phase 3 myelofibrosis test
Ipsen has completed its Kartos Therapeutics acquisition, paying $450 million upfront with up to $1.3 billion in milestones while the 600-patient POIESIS trial tests navtemadlin plus ruxolitinib.
Pharma & Biotech
Harbour BioMed takes HBICE platform into global clinical testing with B7H4×CD3 bispecific HBM7004
HBM7004 can now enter clinical development in both China and the United States after NMPA and FDA IND clearances, putting Harbour BioMed’s B7H4-dependent T-cell engager into its first human test.
Pharma & Biotech
Can XIAFLEX straighten hammer toe without surgery? Keenova begins pivotal US trial
Keenova has dosed the first patient in a randomized Phase 3 study evaluating whether collagenase injections can reduce fixed toe contracture and provide a nonsurgical treatment for hammer toe.
Pharma & Biotech
Lupin’s VISUfarma gets exclusive European YUVEZZI rights as presbyopia eye drops become a competitive category
Lupin’s VISUfarma will handle YUVEZZI regulation and commercialization across the EU, UK and selected European markets, while Tenpoint receives an investment, milestones and tiered royalties.
Pharma & Biotech
Can CG-0416 reduce fat without sacrificing muscle? CureGene begins first human test
CureGene has dosed the first participant in a randomized Phase 1 study of CG-0416, an oral liver-targeted THR-β prodrug whose weight-loss and muscle-preservation claims remain based on preclinical evidence.
Pharma & Biotech
BRII-179 shows its strongest signal before treatment, not during it, as Brii Bio reshapes its hepatitis B cure strategy
ENRICH recorded HBsAg loss rates of 42.9% and 40% after BRII-179 priming, while a concurrent triple regimen underperformed expectations and a recalled assay kit now requires retesting of another cohort.
Pharma & Biotech
Can an inhaled peptide do more than slow lung fibrosis? Rein Therapeutics moves LTI-03 deeper into Phase 2
FDA Fast Track gives Rein Therapeutics closer regulatory access as its 120-patient RENEW trial tests whether inhaled LTI-03 can translate promising biomarker effects into measurable preservation of lung function.
Pharma & Biotech
Can patients slow AFib-RVR at home? Milestone enrolls first patient in pivotal ReVeRA-301
ReVeRA-301 will test self-administered etripamil in about 150 patients, using ventricular-rate reduction within 30 minutes as the primary endpoint and the same regimen already approved for PSVT.