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Annexon: tanruprubart MAA filing para sa GBS nakaplano Enero 2026

Nakasaad sa dokumento na ang kasalukuyang tanruprubart GBS dossier ay nasa tamang landas para sa MAA filing sa Enero 2026. Nabanggit din ang patuloy na talakayan sa FDA tungkol sa generalizability package upang suportahan ang hinaharap na BLA submission. Walang approval, CRL, o topline data na naiulat.

Mahahalagang fact

Na-file
Nob 10, 2025, 09:08 PM
Kaganapan
Naisumite ang aplikasyon
Direksyon
Neutral
Kumpanya
ANNXAnnexon
Asset
tanruprubart
Pinagmulan
SEC 8-K
Kumpiyansa
May source

Sipi mula sa source

EX-99.1 2 annx-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Annexon Reports Third Quarter 2025 Financial Results, Portfolio Progress and Key Anticipated Milestones Late-Stage Neuroinflammation Platform Advancing Global Registrational Programs in Guillain-Barré Syndrome (GBS) and Geographic Atrophy (GA) Current Tanruprubart GBS Dossier On Track for MAA Filing in January 2026; Potential to Be the First Approved Targeted and Fast-Acting Therapy for the Treatment of GBS; Continued FDA Discussions Regarding Generalizability Package in Support of BLA Filing Topline ARCHER II Pivotal Data for Vonaprument in Dry AMD with GA on Track for Second Half of 2026; Potential to Be the First Approved Vision Sparing Therapy for the Treatment of Eight Million GA Patients Worldwide ANX1502 Cold Agglutinin D

SEC 8-K

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