Record mula sa primary source
MateryalNaisumite ang aplikasyon
enGene nagpaplano ng pagsisimula ng BLA para sa detalimogene sa 4Q 2026
enGene nagpahayag ng mga plano na simulan ang paghahain ng BLA para sa detalimogene sa 4Q 2026. Isang pre-BLA meeting kasama ang FDA ay naka-iskedyul para sa parehong quarter, at ang na-update na pivotal-cohort data tungkol sa CR sa anumang oras at durability ay ilalabas nang sabay. Nilinis din ng kompanya ang surfactant safety run-in at magho-host ng KOL webinar sa Oktubre 15, 2026.
Mahahalagang fact
- Na-file
- Set 8, 2026, 11:33 AM
- Kaganapan
- Naisumite ang aplikasyon
- Direksyon
- Neutral
- Kumpanya
ENGNenGene- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
Sipi mula sa source
EX-99.1 2 engn-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 enGene Reports Third Quarter 2026 Financial Results and Provides Business Update Data update on key regulatory endpoints, complete response (CR) at any time and maturing durability, as well as landmark CR rates from LEGEND's pivotal cohort planned for 4Q 2026 Pre-Biologics License Application (BLA) meeting with the FDA on track for 4Q 2026 Initiation of BLA submission for detalimogene planned for 4Q 2026 Detalimogene plus surfactant cohort safety run-in successfully cleared; Webinar on surfactant plus detalimogene preclinical data and cohort enrollment guidance planned for October 15, 2026 Well-capitalized with $266 million in cash, cash equivalents, and marketable securities, supporting continued capital discipline and execution to
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