What will Eloxx Pharmaceuticals’ EXACT trial reveal about exaluren in Alport syndrome?
Eloxx starts Phase 2b testing of exaluren in nonsense mutation Alport syndrome, with a 16-week biomarker readout expected in mid-2027.
Pharma & Biotech
Pharma & Biotech
FDA accepts Nanoscope Therapeutics’ MOGENRY BLA for severe retinitis pigmentosa
FDA accepts Nanoscope’s MOGENRY BLA for severe retinitis pigmentosa, moving a mutation-independent optogenetic therapy into formal review.
Pharma & Biotech
UCB gets FDA Breakthrough Therapy designation for certolizumab pegol in high-risk APS pregnancy
FDA grants UCB Breakthrough Therapy status for certolizumab pegol in high-risk APS pregnancy, based on promising but non-randomized Phase 2 evidence.
Pharma & Biotech
Can Insilico Medicine’s rentosertib slow FVC decline in Phase 3 IPF study?
Insilico Medicine starts Phase 3 testing of rentosertib in IPF, putting its AI-discovered TNIK inhibitor through a decisive 52-week trial.
Pharma & Biotech
What does Samsung Biologics’ new $262m Songdo manufacturing deal signal?
Samsung Biologics adds a $262 million manufacturing deal through 2033 as its capacity, acquisitions and global CDMO ambitions expand.
Pharma & Biotech
Seismic Pharmaceuticals starts Phase 3 istaroxime trial in cardiogenic shock
Seismic Pharmaceuticals begins Phase 3 testing of istaroxime in cardiogenic shock, putting a 600-patient global trial at center stage.
Pharma & Biotech
Orphalan starts Phase 3 once-daily trientine trial against D-penicillamine in Wilson disease
Orphalan has launched the global Phase 3 TRADITiONAL study comparing an investigational once-daily trientine tetrahydrochloride formulation with D-penicillamine over 48 weeks.
Pharma & Biotech
Efti gets a new development path as Immutep investigates manufacturing link to Phase III setback
Immutep finds manufacturing differences after TACTI-004 and refocuses efti on head and neck cancer and sarcoma. See what comes next.
Pharma & Biotech
FDA clears Alebund AP308 IND for first-in-human IgA nephropathy study
The FDA has cleared Alebund Pharmaceuticals’ AP308 IND, allowing a first-in-human study of an engineered IgA protease designed to remove pathogenic IgA and immune complexes in IgA nephropathy.
Pharma & Biotech
Only about 40% of extensive-stage SCLC patients reach second-line therapy. Amgen and AstraZeneca are moving Imdelltra earlier
Amgen’s Phase 3 DeLLphi-305 trial met its primary overall survival endpoint with Imdelltra plus Imfinzi as first-line maintenance in extensive-stage small cell lung cancer.