PDS Biotech Amends Phase 3 Trial for Accelerated Approval
PDS Biotechnology has amended its Phase 3 VERSATILE-003 trial to add progression-free survival as an interim primary endpoint to...
eClinical Tech News
FDA Approves Phase 2 Trial for Daré’s Promising HPV Drug
FDA has cleared Daré Bioscience’s IND for DARE-HPV, a fixed-dose lopinavir/ritonavir vaginal insert, enabling a Phase 2 study in...
Cyclerion Advances CYC-126 Phase 2 Study With FDA Feedback
Cyclerion received positive written FDA feedback on its planned Phase 2 proof‑of‑concept study of CYC‑126 in treatment‑resistant depression, with...
Annovis Alzheimer’s Drug Advances to Pivotal Phase 3 Trial
An independent DSMB found no safety concerns at six months in Annovis Bio’s pivotal Phase 3 Alzheimer’s trial of...
ImmunoSensor Doses First AGS Patient in New Phase 1b Study
Phase 1a data in healthy volunteers showed IMSB301 was well tolerated across a broad dose range, produced dose-dependent and...
Vaxcyte Doses First Adults in VAX-31 Phase 3 Vaccine Trial
In prior adult Phase 1/2 data, VAX-31 produced robust opsonophagocytic activity across all 31 serotypes, met superiority criteria on...
Upstream Bio Sees Positive Results in Phase 2 Asthma Trial
Upstream Bio’s Phase 2 VALIANT study in severe asthma cut annualized asthma exacerbation rate by 56% with verekitug 100...
Remarkable Results: Microbiotica’s MB310 Colitis Trial
Clinical remission was achieved in 63.2% (12/19) of patients treated with MB310 versus 30.0% (3/10) on placebo in an...
PathAI Expands AISight Platform for IBD Clinical Trials
PathAI has expanded its AISight Clinical Trials platform for inflammatory bowel disease with the launch of IBDExplore, joining its...
Septerna Presents Phase 1 Trial Data for Mast Cell Diseases
Septerna will present first-in-human, proof‑of‑mechanism data for SEP‑631, an oral MRGPRX2 negative allosteric modulator, at the AAAAI Annual Meeting...