Record mula sa primary source
MateryalNaisumite ang aplikasyon
Patuloy na pakikipag-usap sa regulasyon ang Prime Medicine patungo sa paghahain ng BLA para sa PM359 sa CGD
Iniulat ng kumpanya ang patuloy na pakikipag-usap sa regulasyon sa FDA kasunod ng positibong Phase 1/2 proof-of-concept data para sa PM359 sa CGD. Ito ay sumusulong patungo sa potensyal na paghahain ng BLA para sa PM359, na magiging unang regulatory submission para sa isang Prime Editing therapeutic.
Mahahalagang fact
- Na-file
- May 7, 2026, 12:10 PM
- Kaganapan
- Naisumite ang aplikasyon
- Direksyon
- Neutral
- Kumpanya
PRMEPrime Medicine- Asset
- PM359
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
Sipi mula sa source
EX-99.1 2 q120268-kex991xpressrelease.htm EX-99.1 Document Exhibit 99.1 Prime Medicine Reports First Quarter 2026 Financial Results and Provides Business Updates -- On track to file IND and/or CTA for PM577 in Wilson Disease in H1 2026 and for PM647 in AATD mid-2026; initial clinical data from both programs expected in 2027 -- -- Continued regulatory dialogue with the FDA toward BLA filing for PM359 in CGD -- -- Strengthened leadership team with appointment of Svetlana Makhni as Chief Financial Officer -- -- Cash, cash equivalents, investments, and restricted cash of $149.2 million as of March 31, 2026, providing cash runway into 2027 -- Cambridge, Mass., May 7, 2026 – Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-t
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Ago 6, 2026
12:02 PM
PRMEPrime MedicinePrime Medicine: Binigyan ng FDA ng RMAT ang PM359 para sa CGD; BLA planado sa H1 2027