|
https://www.investors.com/news/technology/alexion-blood-dise… "ALLISON GATLIN8/20/2018 Alexion Pharmaceuticals (ALXN) could add a fourth approved drug to its portfolio as soon as February 2019 after the Food and Drug Administration accepted its priority review application for a blood-disease drug on Monday. Shares of Alexion lifted as much as 2.1% in early trading on the stock market today. Alexion stock ended the regular session up 0.2%, at 116.17. Shares have been consolidating since last September with a buy point at 149.44. The priority review voucher came as a surprise, RBC analyst Kennen MacKay said in a report to clients. Drugs approved under priority review undergo an expedited eight-month process. The standard review period is 12 months. This could allow the drug ALXN1210 to launch earlier than expected. ALXN1210 was studied as a treatment for paroxysmal nocturnal hemoglobinuria, or PNH. PNH is a chronic, progressive and potentially life-threatening blood disease. "We model $34 million in U.S. 2019 ALXN1210 sales vs. global Street estimates of $35 million in PNH," he said. "While 2019 consensus estimates are not split by quarter, our U.S. estimate is based on a midyear launch, and we see an early launch likely leading to upside revisions." Immune System Problems Alexion already sells a treatment for PNH known as Soliris. ALXN1210 is meant to be a follow-up to Soliris, which also treats another blood disease and a neuromuscular condition. Both drugs work to prevent abnormal activity within the complement system, a part of the immune system. If approved, ALXN1210 would be the first and only long-activity complement inhibitor for patients with PNH, Alexion said in a news release. In patients with PNH, the complement system becomes activated in an uncontrolled way. That could lead to the destruction of red blood cells. The studies for ALXN1210 built on Alexion's work with Soliris, Alexion spokesman John Orloff said in a written statement. The FDA set a Feb. 18, 2019, review date for ALXN1210. "Building on comprehensive results from the largest-ever Phase 3 development program in PNH, 11 years of proven (effectiveness) and safety with Soliris and 25 years of leadership in complement biology, we are on track with our efforts to establish ALXN1210 as the standard of care for patients with PNH," he said." Die zu erwartende Zulassung von alxn1210 Anfang 2019 löst milestones-Zahlungen bei Xencor aus. Die royalty-Zahlungen werden 2019 jedoch noch sehr überschaubar bleiben. Dennoch untermauert das die Aussage auf dem letzten conference call, daß die Liquidität bis in 2023 reicht. Viele Grüsse StefanR |
|
| aus der Diskussion: | Antikörper-Optimierung durch Xencor |
| Autor (Datum des Eintrages): | StefanR (22.08.18 17:53:44) |
| Beitrag: | 214 von 268 (ID:58509906) |
| Alle Angaben ohne Gewähr © wallstreetONLINE | |