LX2020 gains FDA RMAT status after early PKP2 heart gene therapy data
LX2020 gains FDA RMAT status after early PKP2 heart data. Read what the designation changes and why the evidence remains preliminary.
Pharma & Biotech
Pharma & Biotech
Acrivon moves ACR-2316 into dose expansion across six solid tumor groups
ACR-2316 enters randomized expansion after early lung cancer responses. Read how Acrivon will compare two weekly doses across six tumor groups.
Pharma & Biotech
Bria-PROS+ moves into Phase 1/2a testing with FDA clearance in prostate cancer
FDA clearance allows Bria-PROS+ to enter Phase 1/2a prostate cancer testing. Read how the off-the-shelf cellular immunotherapy works.
Pharma & Biotech
BP-205 Phase 1 data support once-daily dosing as orexin drug race intensifies
BP-205 Phase 1 data show a 25-hour half-life and support once-daily dosing as Harmony advances its orexin agonist into further clinical testing.
Pharma & Biotech
First patient dosed in BEAM-302 pivotal cohort for alpha-1 antitrypsin deficiency
BEAM-302 enters pivotal AATD testing after early base-editing data. Read how the study could support an accelerated approval pathway.
Pharma & Biotech
Rhythm Pharmaceuticals advances RM-718 after encouraging Phase 2 obesity results
Rhythm Pharmaceuticals reports an 11.6% BMI reduction with weekly RM-718 in a small hypothalamic obesity study. See what the data reveal.
Pharma & Biotech
Aravax FDA fast-track win moves PVX108 closer to its defining peanut allergy test
Aravax wins FDA Fast Track status for PVX108 as Phase 2 peanut allergy data approach. Read what the designation changes for development.
Pharma & Biotech
What the Obsidian Therapeutics and Galera Therapeutics merger means for OBX-115
Obsidian Therapeutics closes its Galera merger and $350 million financing, putting OBX-115 melanoma data and execution under investor scrutiny.
Pharma & Biotech
What FDA’s latest ibezapolstat guidance means for Acurx and the IBZ-ASPIRE trial
FDA feedback may let Acurx use one Phase 3 ibezapolstat trial for C. difficile treatment and recurrence, but evidence and funding remain decisive.
Pharma & Biotech
Lilly’s rare pancreatic cancer target just gained FDA momentum, but olomorasib still faces its hardest test
Eli Lilly and Company has secured an expedited United States regulatory pathway for olomorasib in a rare, previously treated pancreatic cancer population. The designation increases FDA engagement around the programme, but the investigational therapy still needs a pancreatic cancer-specific evidence package capable of supporting approval.