What's Going On With Regeneron Pharmaceuticals Stock On Friday?
What's Going On With Regeneron Pharmaceuticals Stock On Friday?
On Friday, Regeneron Pharmaceuticals Inc (NASDAQ:REGN) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending conditional approval of odronextamab for relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy.
再生元製藥公司（NASDAQ:REGN）週五宣佈，歐洲藥品管理局人用藥品委員會已經採納積極意見，建議有條件批准odronextamab用於復發/難治性濾泡性淋巴瘤（FL）或復發/難治性瀰漫性B細胞淋巴瘤（DLBCL），該藥物在經過兩條或兩條以上的全身療法之後。
Relapsed/refractory (R/R) follicular lymphoma (FL) refers to cases where FL comes back after initial treatment (relapsed) or doesn't respond to treatment (refractory). Similarly, R/R diffuse large B-cell lymphoma (DLBCL) occurs when DLBCL relapses or doesn't respond to therapy.
復發/難治性濾泡性淋巴瘤（FL）指FL在初步治療後復發或不應對治療。同樣，復發/難治性瀰漫性B細胞淋巴瘤（DLBCL）是指DLBCL復發或不應對療法的情況。
The European Commission is expected to announce a final decision in the coming months.
歐盟委員會預計將在未來幾個月宣佈最終決定。
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FL and DLBCL are the two most common subtypes of B-cell non-Hodgkin lymphoma (B-NHL).
FL和DLBCL是B細胞非何傑金淋巴瘤（B-NHL）的最常見亞型。
It is estimated that approximately 120,000 FL cases and 163,000 DLBCL cases are diagnosed annually worldwide. In Europe, it is estimated that approximately 15,000 FL cases and 31,000 DLBCL cases are diagnosed each year.
全球每年約有約120,000例FL和163,000例DLBCL病例被診斷出。在歐洲，每年約有約15,000例FL和31,000例DLBCL病例被診斷出。
The positive CHMP opinion is supported by results from the Phase 1 ELM-1 and Phase 2 ELM-2 trials, which demonstrated robust, durable response rates and an acceptable safety profile of odronextamab.
積極的CHMP意見得到了Phase 1 ELM-1和Phase 2 ELM-2試驗的結果的支持，這些試驗證明odronextamab具有持久的響應率和可接受的安全性。
Regeneron continues to evaluate the use of odronextamab as a monotherapy and in combination across earlier lines of therapy in challenging-to-treat lymphomas.
再生元製藥公司繼續評估odronextamab在治療難以治療的淋巴瘤早期線和組合療法中的使用。
This includes the registrational ELM-1 and ELM-2 studies, the Phase 3 OLYMPIA development program, which is one of the largest clinical programs in lymphoma evaluating odronextamab in earlier lines of therapy and additional B-NHLs, and early-stage trials with chemotherapy-free combinations.
其中包括記錄ELM-1和ELM-2研究、第三階段OLYMPIA發展項目，該項目是評估odronextamab在早期治療線和其他B-NHL中的最大臨床項目之一，以及與無化療的組合療法的早期試驗。
In addition to the Phase 3 OLYMPIA development program, Regeneron is investigating odronextamab in combination with a costimulatory bispecific antibody, REGN5837 (CD22xCD28), and Regeneron's cemiplimab for R/R aggressive B-NHL through the ATHENA-1 and CLIO-1 studies, respectively.
除了第三階段OLYMPIA發展項目之外，再生元製藥公司還通過ATHENA-1和CLIO-1研究調查odronextamab與一種共刺激雙特異性抗體REGN5837（CD22xCD28）和再生元製藥公司的CEMIPLIMAB聯合用於R/R侵襲性B-NHL。
Price Action: REGN shares closed at $1,050.86 on Thursday.
REGN股票週四收盤價爲1050.86美元。
譯文內容由第三人軟體翻譯。