Phanes Therapeutics advances CLDN18.2 and CD47 bispecific spevatamig in biliary tract cancer
FDA Fast Track gives spevatamig a faster regulatory path in biliary tract cancer as Phanes advances its Phase 2 and pembrolizumab strategy.
Pharma & Biotech
Pharma & Biotech
Aurisco passed an FDA inspection for inclisiran sodium, but the bigger story is what comes next for generic oligonucleotides
Aurisco’s FDA inspection for inclisiran sodium puts generic oligonucleotide manufacturing closer to a crucial regulatory and commercial test.
Pharma & Biotech
Fate Therapeutics starts potentially registrational FT819 trial in lupus nephritis
Fate Therapeutics has treated the first participant in RECLAIM-LN, a Phase 2 study evaluating its off-the-shelf CD19-directed CAR T-cell candidate FT819 in people with refractory moderate-to-severe lupus nephritis. The company disclosed the trial initiation on August 14, 2026, saying the first participant received FT819 in an outpatient setting and was discharged on the same day.
Pharma & Biotech
Rezatapopt Phase 2 enrollment completes as PMV targets 2027 ovarian cancer NDA
Rezatapopt completes key Phase 2 enrollment as PMV targets a Q1 2027 accelerated approval filing in TP53 Y220C ovarian cancer.
Pharma & Biotech
NervGen takes small but encouraging NVG-291 dataset into a pivotal chronic tetraplegia trial
NVG-291 Phase 3 screening starts in September as NervGen targets hand-function recovery in chronic tetraplegia. See what RESTORE must prove.
Pharma & Biotech
Off-the-shelf FT819 moves into Phase 2 lupus nephritis trial with outpatient dosing
FT819 enters a potentially registrational lupus nephritis trial with outpatient same-day dosing. See why Fate’s off-the-shelf CAR T model matters.
Pharma & Biotech
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
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
What FDA expanded enrollment means for Signature Biologics’ Duchenne cell therapy program
FDA allows up to 30 more patients in Signature Biologics’ DMD UC-MSC program, expanding access while efficacy remains unproven.