Phase III

ADCs from BioNTech, Daiichi Sankyo and Merck are the subject of high-profile abstracts featured at the oncology meeting, along with Merck’s late-breaking Phase III non-small cell lung cancer data.
Akebia announced it will submit a new NDA targeting CKD patients on dialysis, which will not involve additional trials.
Marstacimab decreased bleeding rates by 92% in patients with severe hemophilia A and moderately severe to severe hemophilia B without inhibitors.
DUO-E trial data show AstraZeneca’s Imfinzi, either alone or in combination with Lynparza, boosts progression-free survival in endometrial cancer.
Eli Lilly’s recently registered Phase IIIb SURMOUNT-5 trial will compare its Mounjaro with Novo Nordisk’s Wegovy in obese or overweight patients with weight-related health conditions.
Bristol Myers Squibb’s Reblozyl induced nearly twice the red blood cell transfusion independence compared with the current standard treatment epoetin alfa for lower-risk myelodysplastic syndrome.
The company will present data at the oncology meeting showing the drug’s significant survival benefit in patients with advanced renal cancer and recurrent, persistent and metastatic cervical cancer.
Although still in early-stage testing, Ensysce Biosciences’ formulation has demonstrated the potential to address addiction problems associated with oral oxycodone.
The investigational kinase inhibitor failed to improve overall survival in the SAPPHIRE study of patients with non-squamous non-small cell lung cancer, causing Mirati to discontinue its development.
Despite a disappointing showing in the Phase III MOVE-FA trial, PTC Therapeutics says it will move forward with regulatory talks for the Friedreich’s ataxia treatment. Meanwhile, the company is discontinuing several early-stage gene therapies and reducing its headcount.
PRESS RELEASES