Cocrystal Pharma advanced CDI-988 in a Phase 1b norovirus study and received FDA Fast Track designation. Nuvation Bio reported $18.5 million in IBTROZI net product revenues and presented updated TRUST trial data. Nautilus Biotechnology progressed its proteomics platform toward commercialization, maintaining a cash runway through 2027.
The FDA has accepted for review a supplemental application for taletrectinib in advanced ROS1-positive NSCLC, with a PDUFA date of January 4, 2027. Updated TRUST-I and TRUST-2 data showed high response rates, durable responses and no new safety signals.
The FDA approved 46 novel drugs in 2025, down from 50 in 2024. Small molecules accounted for 31 approvals (67%), with oncology leading at nine approvals. Large molecules contributed 15 approvals (33%), spanning ADCs, bispecifics, and subcutaneous delivery innovations.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07742384 |
Study on the Effect of Famotidine on Pharmacokinetics of Taletrectinib |
NOT_YET_RECRUITING | PHASE1 |
| NCT06214793 |
Taletrectinib in Previously Treated Metastatic CDH1-mutated Invasive Lobular Cancer (ILC) |
SUSPENDED | PHASE2 |
