fda-and-biotech News
Protagonist surges on FDA approval of J&J psoriasis pill
ICOTYDE approval triggers $50M milestone payment as oral drug challenges AbbVie's dominance
Larimar Therapeutics holds steady after earnings miss amid Breakthrough Therapy optimism
Clinical-stage biotech posts $62.5M Q4 loss but investors focus on regulatory pathway for Friedreich's ataxia treatment
Vaxcyte shares surge as Lancet publishes pivotal vaccine data
Phase 3 advancement for 31-valent pneumococcal candidate positions biotech against Pfizer, Merck
Telix resubmits FDA application for brain cancer imaging agent
Pixclara aims to be first targeted amino acid PET agent for differentiating recurrent glioma from treatment changes
Opus Genetics surges on gene therapy breakthrough, $70M cash runway
Clinical-stage biotech reports positive data for retinal disease treatments, advances Phase 3 programs
Q32 Bio surges on massive EPS beat from Amgen, Akebia deals
Biotech extends cash runway into 2027, focuses pipeline on alopecia areata treatment
Dianthus shares surge on positive CIDP trial data despite earnings miss
Early GO decision in CAPTIVATE study achieved ahead of schedule, cash runway extends into 2028
Aquestive shares climb 6% as RTW provides $5M financing lifeline
Biotech beats revenue estimates despite EPS miss, extends Anaphylm marketing deadline amid FDA resubmission timeline