Phase III
The RSV race has lost one high-profile contender as Janssen announced it is discontinuing the Phase III EVERGREEN trial studying its RSV vaccine candidate.
Intra-Cellular Therapies’ Caplyta met its primary endpoint in the Phase III Study 403 trial, easing the burden of depressive episodes in patients with major depressive disorder or bipolar depression.
Monopar Therapeutics is dropping its lead candidate, Validive, after it failed to meet efficacy markers in Phase IIb/III trials for severe oral mucositis.
Merck’s Keytruda appeared to outperform GSK’s Jemperli in a key endometrial cancer patient subgroup, based on late-stage data revealed Monday during the Society of Gynecologic Oncology 2023 Annual Meeting.
Despite a tough financing market, ArriVent Biopharma closed a $155 million Series B to fund a pivotal Phase III trial of its non-small cell lung cancer asset.
Topline data from the Phase III NATALEE study showed Novartis’ Kisqali met its primary endpoint, reducing the risk of recurrence in early breast cancer.
The FDA approved Pharming’s leniolisib, now to be marketed as Joenja, for the treatment of the ultra-rare disease-activated phosphoinositide 3-kinase delta syndrome, the company announced Friday.
The FDA has granted an advisory committee meeting for BrainStorm Cell Therapeutics’ investigational ALS therapy, NurOwn, the company announced Monday.
Relmada Therapeutics announced it would make key changes to its clinical evaluation of REL-1017 as a possible add-on treatment for major depressive disorder.
Analysts point to a missed secondary endpoint and cardiovascular risks that may delay FDA approval as possible reasons for the unexpected drop in Karuna’s stock following the data reveal.
PRESS RELEASES