Record mula sa primary source

Decision-gradeUpdate sa FDA label

Nuvation Bio: Na-update ang median DOR ng IBTROZI (taletrectinib) sa 50 buwan

Ang data cutoff noong Agosto 2025 ay nagpapakita na ang median duration of response ay tumaas sa 50 buwan sa mga pasyenteng TKI-naïve, na sumusuporta sa planong supplemental NDA filing sa pagtatapos ng 2025. Pinatitibay nito ang clinical profile para sa IBTROZI na naaprubahan na para sa advanced ROS1+ NSCLC.

Mahahalagang fact

Na-file
Nob 17, 2025, 10:31 PM
Kaganapan
Update sa FDA label
Direksyon
Positibo
Pinagmulan
SEC 8-K
Kumpiyansa
May source
cORR
89% (pinagsama)
mPFS
46 buwan
Gitnang DOR
50 buwan

Sipi mula sa source

EX-99.1 2 d845081dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 DRIVEN BY SCIENCE FOCUSED ON LIFE November 2025 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

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Nuvation Bio: umabot sa 50 buwan ang median DOR ng IBTROZI; 204 bagong pasyente ang nagsimula

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