Viridian: Inaprubahan ng FDA ang Lumvoa (veligrotug) para sa TED noong Hunyo 26, 2026

Inaprubahan ng FDA ang Lumvoa (veligrotug) para sa thyroid eye disease noong Hunyo 26, 2026, bago pa ang target na PDUFA date, at agad na inilunsad ang produkto sa U.S. Lumipat na ang Viridian sa isang commercial-stage company na may maagang pakikipag-ugnayan sa mga manggagamot sa 95% ng mga pangunahing nagreseta at unang dosis ng pasyente na ibinigay noong Hulyo 2026.

Mahahalagang fact

Na-file: Ago 6, 2026, 11:05 AM
Kaganapan: Pag-apruba ng FDA
Direksyon: Positibo
Kumpanya: VRDNViridian Therapeutics
Asset: veligrotug
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · Hun 30, 2026 · Inaprubahan

Sipi mula sa source

EX-99.1 2 d174744dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Viridian Therapeutics Highlights Recent Business Progress and Reports Second Quarter 2026 Financial Results - Lumvoa ™ (veligrotug-vvze) approved by the FDA for thyroid eye disease (TED) on June 26, 2026, ahead of target PDUFA date and immediately launched in the U.S. - - Elegrobart, potentially the first subcutaneous autoinjector for the treatment of TED, on track for BLA submission Q1 2027 - - Pipeline progress continues, with FcRn and TSHR program development milestones on track in 2026 - - Completed convertible debt and equity financing in May 2026 with gross proceeds of $394 million; cash, cash equivalents, and marketable securities of $982 million as of June 30, 2026 - WALTHAM, Mass. – August 6, 2026 – Viridian Therapeut

SEC 8-K