Arvinas: Inaprubahan ng FDA ang VEPPANU (vepdegestrant) para sa ESR1-mutated na kanser sa suso

Nagbigay ang FDA ng buong pag-apruba para sa VEPPANU (vepdegestrant) sa ER+/HER2-, ESR1-mutated na advanced o metastatic na kanser sa suso pagkatapos ng ≥1 linya ng endocrine therapy. Natanggap ang pag-apruba bago ang June 5, 2026 PDUFA date at ito ang unang FDA-approved PROTAC degrader. Makakatanggap ang Arvinas ng $50 milyon na development milestone payment mula sa Pfizer, na binabawasan ng mga halagang utang sa Yale.

Mahahalagang fact

Na-file: May 1, 2026, 04:58 PM
Kaganapan: Pag-apruba ng FDA
Direksyon: Positibo
Kumpanya: ARVNArvinas
Asset: vepdegestrant
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · Hun 5, 2026 · Inaprubahan
Bayad sa yugto: $50.0 milyon

Sipi mula sa source

arvn-20260501 0001655759 FALSE 0001655759 2026-05-01 2026-05-01 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 __________________ FORM 8-K __________________ CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 1, 2026 __________________ Arvinas, Inc. (Exact name of registrant as specified in its charter) __________________ Delaware 001-38672 47-2566120 (State or other jurisdiction of incorporation) (Commission File Number) (IRS Employer Identification No.) 5 Science Park 395 Winchester Ave. New Haven , Connecticut 06511 (Address of principal executive offices) (Zip Code) Registrant’s telephone number, including area code: ( 203 ) 535-1456 Not applicable (Former Name or Forme

SEC 8-K