APELLIS PHARMACT.DL-,0001 WKN: A2JAAW ISIN: US03753U1060 Kürzel: APLS Forum: Aktien Thema: Hauptdiskussion

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Apellis Receives Permanent J-Code (J2781) for SYFOVRE® (pegcetacoplan injection), Effective October 1, 2023 https://conferencecalltranscripts.com/summary/?id=525312&pr=true

Ps. Wünscht uns bitte ganz viel Glück bei T2 Biosystems. Gerade die FDA-Clearance für deren Testpanel (u.a. für Sepsis) erhalten. Meine Gewinne von Apellis stecken alle darin & ich glaube mit ein wenig Glück wird es ein 5-10xBagger. Wer mitmachen will, bitte vorher ein wenig einlesen & gute Nerven mitbringen.

Apellis Pharmaceuticals (NASDAQ:APLS) added ~9% pre-market Tuesday after its rival in the eye care market, Astellas Pharma (OTCPK:ALPMF) (OTCPK:ALPMY), announced long-term data for its FDA-approved therapy, Izervay. Astellas (OTCPK:ALPMF) added Izervay as part of its recent acquisition of U.S. biotech Iveric Bio. In August, the FDA greenlighted the complement C5 inhibitor for geographic atrophy (GA) secondary to age-related macular degeneration (AMD), a common type of age-related vision loss. Months earlier, Apellis (APLS) won U.S. clearance for Syfovre, a C3-targeting complement therapy for the same indication. Citing topline data from the Phase 3 GATHER2 clinical trial, Astellas (OTCPK:ALPMF) said that Izervay met the primary endpoint, "significantly" slowing GA growth against a comparator at 24 months with monthly dosing. There was a similar clinical effect with an every-other-month dosing regimen, the Japanese drugmaker noted, adding that the safety results of GATHER2 were also in line with 12-month data for Izervay, and there were no new safety signals. In July, Apellis (APLS) announced long-term data for Syfovre, noting that the treatment with monthly and every-other-month dosing cut the GA lesion growth against a comparator. The effects representing 24–30 months of data were statistically significant.