Nuvation Bio: IBTROZI (taletrectinib) aprubado noong Hunyo 2025 para sa advanced ROS1+ NSCLC

Kinukumpirma ng 8-K ang pag-apruba ng U.S. FDA sa IBTROZI noong Hunyo 11, 2025 para sa advanced ROS1+ NSCLC (line-agnostic). Iniulat ng kumpanya ang 204 bagong pasyenteng nagsimula sa Q3 2025 at 80% payor coverage, na nagpapakita ng komersyal na pag-unlad. Ipinapakita ng na-update na data noong Agosto 2025 ang median DOR na 50 buwan sa mga pasyenteng TKI-naïve, na sumusuporta sa planadong supplemental NDA filing sa pagtatapos ng 2025.

Mahahalagang fact

Na-file: Nob 26, 2025, 01:34 PM
Kaganapan: Pag-apruba ng FDA
Direksyon: Positibo
Kumpanya: NUVBNuvation Bio
Asset: taletrectinib
Pinagmulan: SEC 8-K
Kumpiyansa: May source
cORR sa TKI-naive: 89%
saklaw ng payor: 80%
Gitnang DOR sa TKI-naive: 50 buwan
mga pasyenteng nagsimula q3 2025: 204

Sipi mula sa source

EX-99.1 2 d82457dex991.htm EX-99.1 EX-99.1 DRIVEN BY SCIENCE FOCUSED ON LIFE Nobyembre 2025 Exhibit 99.1 Forward-looking statements Certain statements included in this presentation (this “Presentation”) that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are no

SEC 8-K