FDAEgetis Therapeutics has submitted a rolling NDA for Tiratricol to treat rare MCT8 transporter deficiency. The application for priority review is based on positive ReTRIACt study results.
Tag Archive for: Phase III
PubChemRoche has unveiled detailed data for its oral selective estrogen receptor degrader (SERD), giredestrant, at the 2025 San Antonio Breast Cancer Symposium.
Adobe stock photos - nadiaCSL has signed an option and collaboration agreement with VarmX valued at up to US$2.2bn. The company will pay US$117m upfront and will fund a global Phase III trial of VMX-C001.
By Coolcaesar - wikipedia.orgCalifornia-based Cytokinetics Inc (CYTK) recorded a big jump in Nasdaq prices, at 40.45%, after presenting the results of its Phase III MAPLE-HCM study at the European Society of Cardiology Congress 2025.
By Benff - Own work, CC BY-SA 4.0, https://commons.wikimedia.org/w/index.php?curid=128081038In both, liver fibrosis and resolution of MASH, Novo Nordisk’s GLP1 modulator semaglutide has shown convincing results in the Phase III ESSENCE study suggesting a label extension of the obesity blockbuster.
AstraZenecaA Phase III trial evaluating AstraZeneca and Daiichi Sankyo’s potential “blockbuster” lung cancer drug Dato-DXd showed no significant improvement over standard chemotherapy. Investors reacted quickly: AstraZeneca’s share price dropped 5% following the announcement.
Pfizer and Valneva announced the completion of enrolment in Phase 3 VALOR trial for Lyme borreliosis vaccine candidate VLA15. More then 9,000 participants were enrolled.
Swiss Spexis AG has announced a US$2.5m capital commitment to fund a two-part pivotal Phase III study to get market approval for its inhaled cystic fibrosis antibiotic colistimethate sodium.
Eli Lilly’s Alzheimer’s drug donanemab has speedy removed amyloid plaques in a pivotal Phase III trail halting disease progression for one year in half of patients.
French Abivax SA has raised €130m capital led by TCGX to accelerate Phase III testing of its ulcerative colitis candidate obefazimod extend its cashflow.