Annexon: inaasahang pagsusumite ng tanruprubart BLA sa Q4 2026

Nakasaad sa dokumento na plano ng Annexon na magsumite ng BLA para sa tanruprubart sa GBS sa Q4 2026, na sinusuportahan ng Phase 3, FORWARD open-label, at real-world evidence data. Isasama sa filing ang data mula sa U.S. at Europe at itinuturing ito bilang susunod na regulatory milestone matapos na nasa ilalim na ng review ang EU MAA.

Mahahalagang fact

Na-file: Ago 12, 2026, 10:30 AM
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 d119960dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Annexon Reports Second Quarter 2026 Financial Results, Business Updates and Key Anticipated Milestones Rapid, Positive Clinical Outcomes in GBS FORWARD Study Reinforce Consistency and Reproducibility of Tanruprubart Treatment Effect Demonstrated in Phase 3 and Real-World Evidence Studies; BLA Submission Expected in Q4 2026 Vonaprument Phase 3 GA Program Expanded with Month 15 / 24 Dual Primary Endpoint Strategy and Launch of Open-Label Extension Study; Month 15 Primary Endpoint on Track for Q4 2026 POC Data for ANX1502, a First-in-Kind Oral C1 Inhibitor for Autoimmune Disease, Expected in Fall 2026 $200 Million Credit Facility Strengthens Balance Sheet and Capabilities; Anticipated Runway Extended into 2028 Company to Host Busin

SEC 8-K