Disc Medicine: Bitopertin NDA tinanggap noong Nob 28 sa ilalim ng CNPV pilot

Tinanggap ng FDA ang bitopertin NDA noong Nobyembre 28. Napili ang aplikasyon para sa Commissioner’s National Priority Voucher pilot, na nagpapaikli sa inaasahang panahon ng pagsusuri sa 1-2 buwan at pinapanatili ang inaasahang petsa ng aksyon sa pagtatapos ng Enero 2026.

Mahahalagang fact

Na-file: Dis 8, 2025, 01:40 PM
Kaganapan: Tinanggap ang aplikasyon
Direksyon: Positibo
Kumpanya: IRONDisc Medicine
Asset: bitopertin
Pinagmulan: SEC 8-K
Kumpiyansa: May source

Sipi mula sa source

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