Cell therapy data, cancer trial safety-induced hold, potential mergers, and more..
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CLINICAL TRIAL NEWS
Provided feedback from FDA on their drug AD04 for Alcohol Use Disorder. Two phase 3 studies may be required, and long-term safety data.
Reported long-term follow-up data from the dose escalation portion of the ongoing ANTLER Phase 1 trial of CB-010 (CAR-T) for r/r B-NHL. More data expected in H1 2024.
Voluntary pause of Phase 2 LOTIS-9 trial evaluating ZYNLONTA+ rituximab DLBCL. The pause was due to respiratory-related treatment-emergent adverse events including seven Grade 5 fatal events and five Grade 3 or Grade 4 respiratory-related TEAEs.
NDA for tenapanor accepted for review by China’s NMPA for the control of serum phosphorus in adult patients with chronic kidney disease on hemodialysis. This triggers a $2M milestone payment from Fosun Pharma.
M&A / COLLABORATION NEWS
Entered into merger agreement with Korro Bio. combined company will focus on the advancement of Korro Bio’s portfolio of RNA editing programs and will operate as Korro Bio.
Is exploring strategic alternatives including acquisition, merger, business combination, or other transaction.
Stockholders have approved merger with MEI Pharma. The transaction remains subject to approval by MEI stockholders.
To acquire Versanis, a private clinical-stage biopharmaceutical company focused on the development of new medicines for the treatment of cardiometabolic diseases. Versanis' lead asset is bimagrumab, a monoclonal antibody that binds activin type II A and B receptors to block activin and myostatin signaling.
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