FDA clears denifanstat Phase 3 trial as Sagimet targets once-daily oral acne treatment
FDA clears Sagimet’s 800-patient denifanstat Phase 3 acne trial after positive China data. Read why the U.S. study could reshape its outlook.
Pharma & Biotech
Pharma & Biotech
Once-monthly Cariprazine Depot clears first clinical safety test as Mapi targets 2029 NDA
Cariprazine Depot clears its first clinical safety hurdle as Mapi targets a U.S. IND in 2026 and potential 2029 NDA. See what comes next.
Pharma & Biotech
NEO100 reaches 48.9% six-month progression-free survival in difficult brain cancer
NEO100 hits its Phase 2a glioma endpoint with 48.9% six-month PFS. See why FDA talks, trial design and funding now become critical.
Pharma & Biotech
Three antibiotics, three different AMR battles: why Innoviva’s Prix Galien triple could matter beyond the awards
Innoviva’s XACDURO, ZEVTERA and NUZOLVENCE reach the 2026 Prix Galien finals, spotlighting a growing anti-infective portfolio.
Pharma & Biotech
VCN-01 moves toward Phase 2/3 retinoblastoma trial after Theriva completes study design
Theriva designs a Phase 2/3 VCN-01 retinoblastoma trial after early eye-preservation signals. See what the planned FDA meeting could change.
Pharma & Biotech
LB-102 pivotal trial accelerates as LB Pharmaceuticals expands psychiatric pipeline
LB-102 Phase 3 schizophrenia data are now due in H1 2027 as faster enrollment and $150m financing accelerate LB Pharmaceuticals’ pipeline.
Pharma & Biotech
FDA endorsement moves once-weekly sutacimig into decisive Glanzmann thrombasthenia study
Sutacimig gets an FDA-backed Phase 3 path after sustained bleed reductions in Glanzmann thrombasthenia. Read what the pivotal trial must prove.
Pharma & Biotech
SEP-479 clears first pharmacokinetic hurdle in pursuit of oral hypoparathyroidism therapy
SEP-479 shows a 3-to-4-day half-life in Phase 1, supporting once-daily oral dosing. See what Septerna must prove next in hypoparathyroidism.
Pharma & Biotech
Tenax heart failure drug fails Phase 3 test despite 49% drop in cardiac stress biomarker
TNX-103 misses its Phase 3 LEVEL endpoints as Tenax shares collapse. See why a 26.3-meter subgroup benefit could keep the program alive.
Pharma & Biotech
Beam Therapeutics is trying to rewrite a disease-causing mutation inside the liver. Its pivotal test has now begun
Beam Therapeutics has begun dosing in the global pivotal cohort of its BEAM-302 trial, advancing a one-time in vivo base-editing therapy that could address both lung and liver disease in people with severe alpha-1 antitrypsin deficiency.