PRAXIS: FDA nagpalawig ng relutrigine NDA PDUFA ng 3 buwan hanggang Disyembre 27, 2026

Inuri ng FDA ang pagsusumite ng NDA ng karagdagang sensitivity analyses bilang isang major amendment, na nagpalawig ng PDUFA target action date mula Setyembre 27, 2026 hanggang Disyembre 27, 2026. Walang bagong klinikal na pag-aaral ang hiniling at walang nabanggit na alalahanin sa kaligtasan o pagmamanupaktura. Ang pagsusuri ay nananatiling aktibo at nagpapatuloy.

Mahahalagang fact

Na-file: Hun 29, 2026, 08:40 PM
Kaganapan: Pinalawig ang petsa ng PDUFA
Direksyon: Neutral
Kumpanya: PRAXPraxis
Asset: relutrigine
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · Dis 27, 2026 · Positibo

Sipi mula sa source

prax-20260629 FALSE 0001689548 0001689548 2026-06-29 2026-06-29 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): June 29, 2026 PRAXIS PRECISION MEDICINES, INC. (Exact name of registrant as specified in its charter) Delaware 001-39620 47-5195942 (State or other jurisdiction of incorporation) (Commission File Number) (I.R.S. Employer Identification No.) Praxis Precision Medicines, Inc. 99 High Street , 30th Floor Boston , Massachusetts 02110 (Address of principal executive offices, including zip code) ( 617 ) 300-8460 (Registrant’s telephone number, including area code) Not Applicable (Former Name or Former Address, if

SEC 8-K