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UPDATE: Nuvation Bio Discontinues Development Of NUV-1511; NUV-1511 Well Tolerated; Co Has Made This Decision Due To Lack Of Sufficiently Consistent Efficacy Across Cohorts; Continues Investment In IBTROZI Launch; Resources Budgeted For NUV-1511 T...
NUVATION BIO INC NUVB | 9.44 | +5.01% |
On November 26, 2025, the Company announced its decision to discontinue development of NUV-1511, the first compound in its first-of-its-kind drug-drug conjugate (DDC) program. While NUV-1511 was well tolerated and did demonstrate promising signals in some patients, the Company has made this decision due to lack of sufficiently consistent efficacy across cohorts. The Company thanks the patients and trial investigators who have participated in clinical studies of NUV-1511. Importantly, the Company is not terminating the DDC platform. Instead, the Company will be using information learned from the NUV-1511 program to evaluate new DDC candidates that may have more consistently robust activity. Resources budgeted for NUV-1511, which included a projected $100-150 million in R&D and CMC-related costs through 2029, will be transferred to other pipeline molecules and to the development of next-generation DDC candidates, incorporating key learnings from NUV-1511.
Notably, the Company recently announced first patient in part 2 of G203, a global randomized study of safusidenib, a novel, selective, potent, oral mIDH1 inhibitor, in high-risk grade 3 or grade 4 IDH1-mutant glioma. The Company will also continue to invest in the commercial launch of IBTROZI (taletrectinib) and development of the program, including enrollment of the TRUST-IV study evaluating the medicine in the adjuvant setting of early-stage ROS1+ NSCLC.


