Record mula sa primary source
MateryalTinanggap ang aplikasyon
Biohaven: Tinanggap ng FDA ang muling pagsusumite ng NDA para sa troriluzole para sa SCA na may Q1 2027 PDUFA at plano para sa AdComm
Tinanggap ng FDA ang muling pagsusumite ng NDA ng Biohaven para sa troriluzole (Vyglxia) sa spinocerebellar ataxia bilang kumpletong tugon sa nakaraang CRL. Itinakda ang isang user fee goal date para sa Q1 2027 at plano ang isang advisory committee meeting.
Mahahalagang fact
- Na-file
- Okt 22, 2026, 11:00 AM
- Kaganapan
- Tinanggap ang aplikasyon
- Direksyon
- Positibo
- Kumpanya
BHVNBiohaven- Asset
- troriluzole
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
- Kalendaryo
- Desisyon ng FDA (PDUFA) · Ene 1, 2027
Sipi mula sa source
bhvn-20261022 0001935979 false 0001935979 2026-10-22 2026-10-22 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 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): October 22, 2026 Biohaven Ltd. (Exact name of registrant as specified in its charter) British Virgin Islands 001-41477 Not applicable (State or other jurisdiction of incorporation) (Commission File Number) (IRS Employer Identification No.) c/o Biohaven Pharmaceuticals, Inc. 215 Church Street New Haven , Connecticut 06510 (Address of principal executive offices, including zip code) ( 203 ) 404-0410 (Registrant’s telephone number, including area code) Not applicable (Former name or former address, if changed since