Catatan sumber primer
MaterialTanggal PDUFA ditetapkan
Lantheus: FDA Tetapkan Tanggal PDUFA untuk Tiga Agen Pencitraan PET
FDA telah menetapkan tiga tanggal tindakan target PDUFA baru: 6 Maret 2026 untuk formulasi baru piflufolastat F 18 PSMA PET, 29 Maret 2026 untuk LNTH-2501 (kit Ga 68 edotreotide untuk NET SSTR+), dan 13 Agustus 2026 untuk MK-6240 (agen PET tau F 18). Tanggal-tanggal ini menetapkan tonggak regulasi berikutnya untuk pipeline radiofarmasi Lantheus.
Fakta utama
- Diajukan
- 6 Nov 2025, 12.39
- Peristiwa
- Tanggal PDUFA ditetapkan
- Arah
- Netral
- Perusahaan
LNTHLantheus- Sumber
- SEC 8-K
- Keyakinan
- Bersumber
- Kalender
- Keputusan FDA (PDUFA) · 6 Mar 2026 · Disetujui
Kutipan sumber
EX-99.1 2 lnth-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Lantheus Reports Third Quarter 2025 Financial Results and Provides Business Update • Recorded third quarter 2025 worldwide revenue of $384.0 million, GAAP fully diluted earnings per share of $0.41, adjusted fully diluted earnings per share of $1.27 and free cash flow of $94.7 million • Separately announced upcoming retirement of CEO, departure of President and appointment of prior CEO to Executive Chairperson; Board conducting CEO search • Announced PDUFA dates for its new formulation of piflufolastat F 18 PSMA PET imaging agent; for MK-6240, its F 18 tau-targeted positron emission tomography (PET) imaging agent; and for LNTH-2501, its Ga 68 PET diagnostic imaging kit targeting somatostatin receptor-positive (SSTR+) neuroendocrine