As U.S. regulatory uncertainty swirls around the vaccine space and health care in general, Vaxcyte Inc. stands poised for a readout of phase II infant data by the end of this quarter with VAX-24, the 24-valent pneumococcal conjugate vaccine (PCV). The San Carlos, Calif.-based firm will offer top-line safety, tolerability, and immunogenicity data, to be followed by top-line data with the booster dose by the end of this year.
For executives of Lexicon Pharmaceuticals Inc., the missed primary endpoint in the phase IIb Progress study testing pilavapadin, its non-opioid candidate, in adults with moderate to severe diabetic peripheral neuropathic pain seemed merely a footnote for what CEO Mike Exton called an “exciting and long-awaited day for the Lexicon team, collaborators and patients.”
In January 2025, BioWorld tracked 171 phase I-III clinical trial updates, down from 212 in December. The month delivered 12 successful phase III outcomes, six of those in cancer, while two trials ended in failure.
After Study 1’s independent data monitoring committee said the experiment will likely fall short of its primary endpoint with ulixacaltamide in essential tremor, Praxis Precision Medicines Inc. plans to wait for full data from Study 1 as well as Study 2 in the Essential 3 phase III program before deciding on regulatory moves.
Astrazeneca plc’s good news with its oral selective estrogen receptor degrader (SERD) and estrogen receptor antagonist, camizestrant, when used as part of a combo in breast cancer raised optimism for the approach, which has caught on in various biopharma quarters.
The prospects of an oral obesity candidate used as a monotherapy or combination therapy is in question after Kallyope Inc. posted disappointing phase II data on a government website, indicating that its lead candidate, K-757, failed to meet all endpoints.
Biocity Biopharmaceutics Co. Ltd.’s selective endothelin receptor type A antagonist, SC-0062, met the primary endpoint of reducing proteinuria in a phase II diabetic kidney disease cohort. Conducted at 40 sites across China, the 2-Succeed phase II trial is designed to evaluate the efficacy and safety of SC-0062 in patients with chronic kidney disease with proteinuria.
Scientists at the University of Aberdeen developed a new scanner that distinguishes breast tumor material from healthy tissue more accurately than current magnetic resonance imaging (MRI) methods.
Several Asia biotechs this week – including Innocare Pharma Ltd., Akeso Pharmaceuticals Inc., Sanbio Co. Ltd. and Ascletis Pharma Inc. – unveiled the start of new late-stage clinical trials or interim findings from early stage studies.
Radiance Biopharma Inc. bought its way into the ROR1 antibody-drug conjugate (ADC) space through a potential $1 billion-plus licensing deal, including a $15 million up-front payment, with CSPC Megalith Biopharmaceutical Co. Ltd. for rights to RB-164 (SYS-6005) in the U.S. and select countries.
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