Disc Medicine: Bitopertin NDA diterima 28 Nov di bawah pilot CNPV

FDA menerima NDA bitopertin pada 28 November. Aplikasi ini dipilih untuk pilot program Commissioner’s National Priority Voucher, yang mempersingkat periode review yang diharapkan menjadi 1-2 bulan dan menjaga tanggal tindakan yang diantisipasi pada akhir Januari 2026.

Fakta utama

Diajukan: 8 Des 2025, 13.40
Peristiwa: Permohonan diterima
Arah: Positif
Perusahaan: IRONDisc Medicine
Aset: bitopertin
Sumber: SEC 8-K
Keyakinan: Bersumber

Kutipan sumber

EX-99.1 2 iron-ex99_1.htm EX-99.1 2025 ASH Management Call December 7, 2025 Confidential Exhibit 99.1 Disclaimer and FLS This presentation contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, express or implied statements regarding Disc’s expectations with respect to: (i) the registrational pathway for bitopertin, including the potential for accelerated approval, benefits of the Commissioner’s National Priority Voucher (CNPV) pilot program, and the anticipated review period and action date; (ii) the potential commercial launch of bitopertin, including commercial readiness activities and the timeline for availability of drug supply; (iii) the timing, progress and results of preclinical studies and

SEC 8-K