Record mula sa primary source

MateryalNaitakda ang petsa ng PDUFA

Anaptys: Vanda imsidolimab PDUFA itinakda sa Dis 12 2026 sa GPP

Ang press release ay nagsasaad na ang FDA ay nagtalaga ng target action date na December 12, 2026 para sa imsidolimab BLA sa generalized pustular psoriasis. Ito lang ang hinaharap na regulatory milestone na malinaw na may petsa sa dokumento.

Mahahalagang fact

Na-file
May 12, 2026, 08:17 PM
Kaganapan
Naitakda ang petsa ng PDUFA
Direksyon
Neutral
Pinagmulan
SEC 8-K
Kumpiyansa
May source
Kalendaryo
Desisyon ng FDA (PDUFA) · Dis 12, 2026

Sipi mula sa source

EX-99.1 2 anab-ex99_1.htm EX-99.1 EX-99.1 Anaptys Announces First Quarter 2026 Financial Results and Provides Business Update • Completed spin-off of First Tracks Biotherapeutics, Inc., its former biopharma operations business • Now exclusively manages the financial collaborations for Jemperli with GSK and imsidolimab with Vanda • Announced appointment of Chris Murphy as CFO • Announced appointments of Susannah Gray, former CFO of Royalty Pharma, and Owen Hughes, current CEO of XOMA Royalty, to its Board of Directors SAN DIEGO, CA — May 12, 2026 — AnaptysBio, Inc. (Nasdaq: ANAB), a company focused on managing the financial collaborations for Jemperli with GSK and imsidolimab with Vanda, today reported financial results for the first quarter ended March 31, 2026, and provided a busin

SEC 8-K

Higit pa tungkol sa asset na ito

Okt 2, 2026
09:06 PM
VNDAVanda Pharmaceuticals

Ipapakita ni Vanda ang data ng imsidolimab GPP sa 2026 EADV Annual Meeting

Presentasyon sa kumperensyaPress release ng kumpanya
Set 24, 2026
03:21 PM
ANABAnaptysBio

imsidolimab · NCT06830044 update sa rehistro

Pagbabago sa trial registryClinicalTrials.gov
Hul 16, 2026
08:30 PM
VNDAVanda Pharmaceuticals

Vanda: Positibong opinyon ng EMA para sa orphan designation ng imsidolimab sa GPP

Designation ng FDAPress release ng kumpanya
Anaptys: Vanda imsidolimab PDUFA itinakda sa Dis 12 2026 sa GPP | SimianX AI